§ [Relevant document: The First Report from the Culture, Media and Sport Committee, Session 2003–04, Cultural objects: developments since 2000, HC 59, is relevant.]
§ Order for Second Reading read.1.43 pm
§ The Minister of State, Department of Health (Ms Rosie Winterton)
I beg to move, That the Bill be now read a Second time.
The origins of the legislation lie in the distress, grief and anger felt by families in Bristol and Liverpool when they discovered that the organs of their deceased loved ones had been retained without consent. The Bristol, Alder Hey and Isaacs inquiries demonstrated that that had taken place on a large scale. It was a tragedy for the families affected and it was unacceptable. The aim of the legislation is to ensure that it will not happen again.
The Bill has five key functions. First, it will ensure that no human bodies, body parts, organs or tissue will be taken for research or other specified purposes without the consent of relatives or patients. Secondly, it will prevent a recurrence of the distress caused by the retention of tissue and organs without proper consent by providing safeguards and penalties. Thirdly, it will improve public confidence so that people will be more willing to agree to valuable uses of tissue and organs for research and transplantation.
The Bill will also improve professional confidence so that properly authorised supplies of tissue for research, education and transplantation can be maintained and improved. Finally, the Bill will allow national museums to repatriate human remains in response to claims from the descendants of indigenous people whose remains are held in museums.
§ Dr. Brian Iddon (Bolton, South-East) (Lab)
There is a lot of difficulty over the phrase "appropriate consent" in the Bill. As my hon. Friend has already referred to consent, without using that phrase, will she expand on and explain to the House exactly what the Government mean by "appropriate consent"?
§ Ms Winterton
If my hon. Friend will bear with me, I will come to that point later.
In 1999, at the public inquiry on children's heart surgery in Bristol, it emerged that it was commonplace for children's hearts and other organs to be retained post mortem without the parents' knowledge or consent. The subsequent Alder Hey inquiry, the Isaacs inquiry and the chief medical officer's 2001 census left us in absolutely no doubt as to the scale on which tissue and organs were being retained without consent.
Those reports showed that that practice was not limited to particular hospitals or to children's post-mortems. More than 100,000 hearts, brains, lungs and other organs of children and adults were being kept. In Northern Ireland, the human organs inquiry confirmed that similar practices had occurred there. Part of the tragedy was that, ironically, in many cases the families 985 concerned would readily have accepted the use of their loved ones' tissues or organs for medical research if only they had been asked.
§ Mr. Martyn Jones (Clwyd, South) (Lab)
My hon. Friend will be aware of the Valentines, a family in my constituency whose daughter Kayleigh was subject to the problems at Alder Hey. They had three lots of organs returned to them, which has made them distraught over 11 years. Through me, can she assure them that the Bill will insist on prior informed parental consent in such circumstances so that this never happens again?
§ Ms Winterton
Yes, I can assure my hon. Friend that that will be the case, particularly because we are very aware of exactly the type of case that he has highlighted. It is difficult for us in the House to imagine the distress that families such as the one in his constituency have been through. That is why we are introducing the legislation. He is right in that post-mortem practice that is unacceptable in today's society had developed over many years. While practice was directed at supporting medical knowledge and research, it failed to respect the interests of families in the way that he described. It had become routine for tissue taken post mortem to be kept for archives, research and education, but without proper discussion with those close to the deceased.
§ Rev. Martin Smyth (Belfast, South) (UUP)
The Minister referred to Northern Ireland and she is right that people would have been prepared to give permission. In a particular case in my constituency, people gave permission on certain organs, but no more. However, that was not accepted and, later on, they were horrified to discover not only that things had been done against their wishes, but that the residue was sent back to them separately, leading to three separate interments.
§ Ms Winterton
That is exactly the sort of situation that has led to continuing distress for many families, which is why we want the legislation to be specific. The guidance that will be issued will make it clear that relatives should be given the maximum information on exactly what tissues or organs are to be used.
§ Mr. Andrew Lansley (South Cambridgeshire) (Con)
As the Minister is helpfully explaining circumstances that gave rise to this Bill, it might help if she were to include circumstances in which consent has not simply not been sought or given, but in which organs were retained when it was the deceased's express wish that they be buried intact for religious reasons. That occurred in relation to Mr. Isaacs, the subject of the Isaacs report, and in relation to the husband of one of my constituents, who was also referred to in the anatomy inspector's report. We must deal with that problem.
§ Ms Winterton
As I shall say later in my speech, Mrs. Elaine Isaacs, worked extremely hard to highlight that case. The Isaacs report showed that that was one of many occasions on which that had occurred, and that is another reason why it is important that we introduce this legislation, after having considered all the different circumstances that could apply.
986 Following the various reports that I have highlighted, we asked the chief medical officer, Sir Liam Donaldson, to make recommendations on the retention and use of human tissue and organs. Sir Liam reported in January 2001 and made 17 recommendations, all of which we accepted. Those recommendations were also formally accepted by the chief medical officer for Wales, and the National Assembly has worked closely with the Department of Health and other stakeholders in pursuing that agenda.
§ Liz Blackman (Erewash) (Lab)
I listened carefully to an interview that my hon. Friend gave on Radio 4 this morning with a member of the scientific fraternity. Can she assure me that during the passage of the Bill she will resist any attempt to soften the guidance and protocols in relation to the removal of tissue as well as organs, and that consent will also remain the watchword in that regard?
§ Ms Winterton
I can give my hon. Friend that reassurance. As I shall say later, we have consulted extensively with the medical research community and the scientific community in putting together the proposals in the Bill. As I am sure she knows, the Bill encapsulates best practice that is already taking place. We do not expect to move away from the principle of consent that is enshrined. What most affects the medical and scientific community in research is the current situation, in which the law is not clear. The Bill clarifies the law and enables further research to go ahead. It gives the public and the research community confidence to be able to proceed as they wish to do.
§ Dr. Andrew Murrison (Westbury) (Con)
Notwithstanding the Minister's remarks and those of the hon. Member for Erewash (Liz Blackman), does she accept that, in the minds of the general public, a clear distinction exists between blocks and slides and whole organs, and that that needs to be reflected in the Bill?
§ Ms Winterton
Yes, a certain amount of discussion has taken place, as the hon. Gentleman knows, about the definition of tissue and organs. It was felt that defining that too closely could cause confusion. We believe that our approach, and the guidance that will be issued by the Human Tissue Authority, will make that clear.
In implementing Sir Liam's recommendations and in making other changes, we have worked closely with professional and family support groups. I want to mention particularly the members of the national committee on organ retention, PITY 2—Parents who have Interred their Young twice; other support groups, including the Relatives Reference Group in Northern Ireland; and, as I said earlier, the tireless work of Mrs. Elaine Isaacs. I also thank the members and president of the Royal College of Pathologists, who recognised the need for change and have taken clear and positive steps forward. With their help and that of others, we have already achieved a lot.
In April 2001, we established the Retained Organs Commission, which has provided advocacy, overseen the return of organs and tissue to families and given guidance to trusts. It has carried out admirably the most difficult of tasks in the most difficult of circumstances, 987 and I pay tribute to the chair and members of the commission for their dedication and commitment. We have published guidance and consent forms for post-mortems. We have given advice that clarifies the law as it currently stands. We have set in train a programme of work that includes providing information and support to bereaved families. We are supporting further training and development for health professionals so that the practices and principles that underlie the Bill can be taken up fully in future practice. Parallel work is being undertaken in Northern Ireland, and in Wales we have focused on the establishment of a network of trust co-ordinators to facilitate all aspects of change in anticipation of the Bill.
The underlying principle of the changes is informed consent. Much has already been done, but the chief medical officer recommended that there should be a comprehensive review of the law relating to the whole area of the use of human tissue, from the living as well as the deceased, and its use for transplantation, research and other purposes, such as donation for teaching and education.
§ Mr. Tam Dalyell (Linlithgow) (Lab)
What is the time scale of this review? When are we likely to have any guidance on the question of presumed consent?
§ Ms Winterton
The review to which I refer is the review that the chief medical officer asked us to conduct. That has now been completed, and its form is within the Human Tissue Bill that we are considering today. With regard to the issue of presumed consent, clearly, that has been given serious consideration. The principle of this Bill, however, is informed consent.
We have looked closely at the experience of other countries with presumed consent, and while there may be a legal framework of presumed consent, the practice in all countries—Spain is highlighted as a country in which presumed consent is considered to have led to increased rates of organ donation—is that relatives are asked for their permission for organ donation to go ahead. If they object, that permission is not given. It is also necessary to approach relatives for health screening purposes, in case anything in the recent history of an individual could lead to infection if an organ were given to another person.
The evidence that has emerged is that the structures that are set in place are what enable organ donation to happen: for example, having nurses or others who can approach relatives at critical points to secure organ donation. We have used the example of places such as Spain in our transplant framework, we have set in train those structures in this country, and we are already seeing improvements in organ donation rates. All the evidence is that that is the way to improve organ donation, and not through a system of presumed consent.
§ Mr. Desmond Swayne (New Forest, West) (Con)
The Minister rightly stresses the importance of informed consent. What measures is she taking to ensure that more people give that consent? We could do much more to increase the number of people on the donor register. And what can be done to give effect to consent? Many 988 organs are wasted because action is not taken quickly enough following deaths. Current common law does not allow some forms of elective ventilation; perhaps, in certain circumstances, they could be granted legislative approval.
§ Ms Winterton
We aim to have 16 million people on the register by 2010. Moreover, the Bill contains measures allowing organs to be preserved so that relatives can be approached within a specific period, and others providing that the wishes of those who have indicated that they want their organs to be donated must be respected. We must deal with the practicalities, however, and relatives will always be asked for information about a person's recent social history. We cannot claim that the Bill will solve everything, but it does contain provisions relating to the issues raised by the hon. Gentleman.
§ Mr. Kenneth Clarke (Rushcliffe) (Con)
Surely the Spanish experience shows that a system of presumed consent can be operated in an entirely sensitive way, and that families can be consulted and their wishes considered, but on a different basis from that which obtains here. The Spanish system assumes at the outset that there are no strong objections, which has resulted in a rate of cadaver donations more than twice as high as ours. The change was not drastic, but it has proved to be very significant. Meanwhile, we are left with one of the worst records in western Europe: we have a serious shortage of organ donors and donations.
§ Ms Winterton
The right hon. and learned Gentleman assumes that the legal framework in Spain has brought about the current position there. The former director of the National Organ Commission in Spain has clearly stated that the increase in the number of donations has been achieved not by anything to do with presumed consent, but by the structures that we are replicating here.
The right hon. and learned Gentleman should also bear in mind that following outrage among some families about practices that had taken place, France returned to a system of informed consent. Some people felt that consent might have been presumed but not verified, which caused enormous distress. We strongly favour the principles of informed consent underlying the Bill, combined with the other measures that I have described.
§ Dr. Evan Harris (Oxford, West and Abingdon) (LD)
I hope the Minister will accept that there is some debate about her recitation of history in the context of France, and also that there is a genuine argument to be had about presumed consent and opting in versus opting out. Many professionals believe the evidence suggests that it is a significant factor.
The system proposed by, among others, the British Medical Association, is used in Belgium, where there is strong evidence that it has made a difference. It does involve relatives being asked for the social history, so it is a straw dog otherwise, and strong objections are taken into account under that system of presumed consent.
§ Ms Winterton
As I have said, relatives' objections are always taken into account and are rarely overridden.
989 We are talking about the rights of individuals, not just those of the state. The state does not own a human body; nor do doctors or scientists. It is up to individuals to choose whether to make this important gift, for it is a gift. We must respect their wishes. We must give them as much information as possible about the benefits of organ donation, but ultimately it is a matter of individual choice. We must empower people to make that choice, but we do not feel that it is for the state to dictate, or to presume that it has a right to someone's body if that person does not want to proceed.
As I have said, there was considerable uncertainty about the law, and we conducted a great deal of consultation. In July 2002, jointly with the National Assembly for Wales, we published the consultation document "Human Bodies, Human Choices". We published the results of our consultation with a wide range of interested groups and individuals in April 2003, and presented broad legislative proposals in September. We then held a further round of stakeholder meetings with families, clinicians, researchers, heads of royal colleges and anatomic and other organisations including the BMA, the Retained Organs Commission, the Wellcome Trust, UK Transplant, the Human Genetics Commission and the National Assembly's organ retention advisory group.
§ Mr. Lansley
The Minister will know that in April 2003 her predecessor, responding to a debate in the House, undertook that a draft Bill would be published before the summer recess. Notwithstanding the Minister's belief that the Bill clarifies the law, it has not been clarified as much as many people—including members of the organisations she just mentioned—hoped it would be. Pre-legislative scrutiny is designed expressly for that purpose. Why was a draft Bill not published for pre-legislative scrutiny, as was intended?
§ Ms Winterton
I know it was hoped that time would be found for the publication of a draft Bill, but unfortunately that was not possible. That is why we published our broad legislative proposals in September, and held a further round of meetings. The organisations referred to by the hon. Gentleman, such as family support groups, want us to get on with establishing a legislative framework. The House will have an opportunity to debate the proposals, and they will be scrutinised in Committee. Given the broad consensus that emerged during extensive consultations, we decided that this was the best way of making our proposals law as quickly as possible. As a result of that work, we are proposing the Bill today.
Part 1 deals with consent. We propose a comprehensive framework in which principles of consent will apply to all medical uses of human bodies, organs and tissue and to public display. We can therefore move forward in the knowledge that proper legal and ethical standards will apply to all circumstances in which tissue can be kept and used for the public benefit. The same principles will apply to the removal, keeping and use of tissue following post-mortem, and to the keeping and use of tissue from living patients. Except to the extent necessary to maintain the integrity of the coroner's investigation or the criminal justice system, the decision will lie first and foremost with the individual.
990 The role of the family or person closest to the deceased, where the individual's wishes were not given before his or her death, will be made clear and explicit, and there will be offences for keeping or using tissue or organs without consent.
Clause 1 provides that consent will be needed for carrying out a hospital post-mortem, and that it will be needed for the subsequent keeping or use of tissue or organs for transplantation, research, education and training. For certain particularly sensitive purposes—the donation of the whole body to a medical school teaching anatomy for anatomical examination or for public display, as in Professor von Hagens' "Bodyworlds" exhibition—the prior personal consent of the individual will always be required. The Bill will not interfere with the coroner's authority to order a post-mortem for his purposes, related to establishing the cause of death, or with his power to ask for tissues or organs to be retained, should they be needed, for his purposes. That is made clear in clause 9.
§ Harry Cohen (Leyton and Wanstead) (Lab)
I saw the exhibition to which the Minister refers, as did many thousands of other people. It was informative, interesting and could be viewed in some respects as an exhibition of art—however gruesome some people might consider it. Do the Minister's comments mean that the exhibition would have been banned in this country?
§ Ms Winterton
Such an exhibition would be allowed to go ahead if it had been properly licensed and if the prior consent of each deceased person had been properly obtained.
Where tissue is taken from living patients, some purposes are so bound up with general diagnostic and clinical care that the consent that the patient gives to the procedure itself can be regarded as consent to those other purposes. These are set out in part 2 of schedule 1 and include clinical audit, quality control and on-the-job training in the laboratory. Separate consent will not be needed in those cases or for public health monitoring where tissue taken from living patients is used—unlinked and anonymised—for epidemiological studies. Those issues were discussed extensively with representatives of the medical and research communities as the proposals for the Bill developed.
Although consent will not be needed for those particular uses, it will be good practice nevertheless to ensure that patients are aware that such uses might be made of their tissue or samples. That could include, for example, notices in waiting rooms or leaflets from outpatients, as set out in Department of Health guidance. However, consent from patients will be needed for further uses of tissue, by which we mean all material that contains cells—except hair and nail, which are regarded as disposable—such as for research, education and transplantation.
My hon. Friend the Member for Leyton and Wanstead (Harry Cohen) asked about consent. Appropriate consent identifies whose consent is relevant in the circumstances, not what is needed by way of consent. It can come from an individual, nominated representative or next of kin, as I shall explain more fully later.
991 Failing to obtain consent—whether from patients themselves or, in the case of the deceased, from other appropriate people—may be a criminal offence and subject to penalty. I say "may" because there will be safeguards to ensure that people cannot commit an offence inadvertently. For example, it is not intended that individual researchers be subject to the licensing requirements and they will not, in fact, themselves retrieve the tissue from patients. They will probably receive it from others, perhaps a tissue bank. In those circumstances, the researcher could quite reasonably rely on the regulated system to deliver tissue that has the appropriate consent for the purpose.
§ Mr. Lansley
I am grateful to the Minister for being so generous in giving way. I wish to be clear about the question posed by the hon. Member for Bolton, South-East (Dr. Iddon). The Bill defines appropriate consent and therefore qualifies what consent means, but the definition of consent is effectively left to the code set out by the Human Tissue Authority. If the House wants to qualify the consent process to make it acceptable, it will need to do more with the Bill to make that happen.
§ Ms Winterton
As the hon. Gentleman says, the Human Tissue Authority will issue further guidance on that matter. It is true that the Bill does not set out precisely what form consent should take in any particular situation. The Bill gives statutory effect to the current requirement for consent. It would be unrealistic to imagine that we could set all that out in primary legislation. Consent to treatment, for example, is a current common law requirement, which is subject to quite extensive guidance from the Department of Health, the General Medical Council, the British Medical Association and the Medical Research Council, which also deal with the need for consent before taking tissue for research purposes. The regulatory body established by the Bill will issue a code of practice on obtaining consent. Clearly, that will have to be pragmatic.
In some cases—for example, where tissue might be kept for some time—the fact that consent has been given needs to be recorded for future reference; and in many cases, as when blood samples are given, consent may be verbal or even a gesture such as holding out an arm. For surgical procedures, however, consent is likely to be recorded on a signed form. In all cases, consent will need to meet the general requirement that it is properly informed and freely given.
The process of seeking and obtaining consent will reflect current good practice and need not be onerous, even where consent for research use is being considered. We know that people overwhelmingly support the use of surplus tissue for research. We are, in effect, setting out in the Bill what is already current good practice—for example, in the GMC guidelines. Moreover, as at present, research ethics committees will continue to have a role in considering whether legal and ethical standards have been met in the context of the specific projects that they consider.
§ Dr. Evan Harris
On the question of authorised consent for transplantation, it is clear from clause 3 that 992 pre-morbid consent by the individual constitutes the consent and that—quite rightly, in my view—it is inappropriate for relatives to be allowed to veto it. Is it the Minister's understanding that the current donor card represents written and "appropriate consent", and that the current practice of relatives being allowed to veto that donor card request should therefore be discontinued as a matter of course, even in a minority of cases?
§ Ms Winterton
I am not familiar with the wording on my donor card, but I shall certainly look into the issue to see whether any changes need to be made.
§ Nick Harvey (North Devon) (LD)
Perhaps I can help the Minister. I have my donor card with me, which states,Please let your relatives know your wishes, and keep this card with you at all times.
§ Ms Winterton
That is the point. In such circumstances we can make absolutely clear what we expect to happen, but if relatives have to be consulted for screening purposes—in this day and age, that is increasingly important—and they choose to withhold that information, problems can arise. We must accept that there will always be some circumstances in which we cannot move forward as we would like.
§ Dr. Iddon
My hon. Friend is being very patient in giving way. Researchers are extremely worried about future research that they may need to conduct. Will she assure them that they will have access to such tissue through the "appropriate consent" form, which was signed by the individual in question, or their relatives, way back in history? Researchers are concerned that they may be about to commit a criminal act by examining tissue for research, when consent was not gained for such a research application.
§ 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 993 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:Where the child concerned has died and the activity involves storage for use, or use, for the purpose of anatomical examination…'appropriate consent' means his consent in writing.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 994 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.
§ 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.
995 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 996 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 997 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 he 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 998 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 999 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.
1000 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 1001 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.
§ Mr. Dalyell
Is the hon. Gentleman likely to oppose the Bill that will be presented by my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) on 3 February? Does he recollect that the Conservative party used to have very different views? I presented a ten-minute Bill on 18 May 1971. As usual, hon. Members filed out of the Chamber, but one colleague who remained to hear what I said was the then Prime Minister, Ted Heath. Two days later he told me that he was sympathetic to my cause but that I would never persuade Keith Joseph. What is the Conservative party's position, a third of a century later, on presumed consent?
§ Mr. Lansley
I understand that the hon. Member for Mitcham and Morden (Siobhain McDonagh) will present a ten-minute Bill and I try, whenever possible, not to oppose leave to bring in a Bill. If it makes progress, we would then consider it substantively. The implication of my views is, however, that I would also oppose her Bill on principle at Second Reading, if we ever reached that stage. I would also oppose the introduction of presumed consent to the Bill before us. That is a personal view, although I think that it is shared by my hon. Friend the Member for Westbury (Dr. Murrison), who is in his place on the Front Bench. It is an ethical point of view: we believe that presumed consent is inconsistent with the principle that we should allow people to decide themselves whether and for what purpose their bodies and organs are used. The Minister made the same point.
I do not pretend that my view is the uniform view of the Conservative party. We may discover later that my right hon. and hon. Friends have different views—
§ Mr. Lansley
I look forward to hearing that argument, because I know that it will be presented as effectively as an argument can be.
I hope that in the next three weeks we can provide an assurance to those who have suffered in the past that it will not happen again—as the Minister said. I hope that we can allay the many concerns of those who believe that excessive burdens might be imposed on medical research, education and training as a result. I hope that we can legislate for a regulatory structure and that we can be reasonably certain that normal practice in health care will not develop over time so that the bureaucratic compliance requirements of the legislation are met, but the substance of what was intended is avoided. We would do better if some of the changes that I have mentioned were included in the Bill, so that we focus on 1002 the substance of giving informed consent and understand the emotional implications of doing so, especially for the loved ones of those who have recently died. I hope that we can also ensure that if there are those who treat human tissue negligently or maliciously, the regulatory structure will ensure that they cannot continue to do so for years, as happened in the past. On that basis, I hope that the House will give the Bill a Second Reading, with the intention of being appropriately critical during subsequent consideration.
§ Mr. Deputy Speaker (Sir Alan Haselhurst)
The opening speeches have taken a little longer than anticipated. No time limit was imposed on Back Benchers' speeches, but we may now have a difficulty with time. It would be appreciated if hon. Members tried to be as concise as possible.
§ 3.5 pm
§ Mr. Frank Dobson (Holborn and St. Pancras) (Lab)
I welcome the Bill, for which I must take some responsibility. I met the Bristol parents and listened to their arguments, and I decided to establish the inquiry into what had happened to their children. That set in train the process that revealed the extent and nature of the massive holdings of human tissue across the NHS. It struck me in those meetings that while the Bristol parents were concerned to find out what had happened to their children, they also wanted to ensure that arrangements were put in place to prevent it from ever happening again. That needs to be the theme of today's debate.
The Bill seeks to update, codify and clarify the law on the retention of human tissue by health professionals for the purposes of research and training. It is based on the concept that those professionals should be required to obtain the informed consent of the individual whose body parts may be used, or their parent, parents or representatives, in place of the practice in the past, when health professionals sought simply to demonstrate the lack of objection. We must not pretend that the process of securing consent is simple or easy for anyone involved. A patient who faces a dangerous operation may be reluctant to hear questions about what should be done with their body if the operation fails. The professionals involved may also, for obvious reasons, be reluctant to put such questions. If someone has been seriously injured in an accident and then dies, the doctors and nurses may be exhausted, upset and disappointed that they failed to save a life. They will not be in a good state to approach distraught and heartbroken parents or other relatives. We can discuss the Bill in the cool, calm and collected atmosphere of the Chamber—at least, it is this afternoon—but that is not always the situation in hospital for patients, relatives or professionals.
We owe it to all concerned to get the law right and, above all, to make it clear and easy to understand for those who will have to operate it. We should not forget that we propose to introduce criminal sanctions if they fail to comply with the law. We should do our level best to keep lawyers out of hospitals, except when they are there as patients. We need to make the law clear, so that 1003 it can be understood by those who have to implement it in difficult circumstances, day after day. We also need to try to keep down the bureaucratic burden.
At the same time, we do not want to inhibit the use of human tissue for training and research. Health professionals need to be trained to understand the workings of the human body, and some of that understanding can be obtained only by studying parts of the human body—an organ or piece of tissue—from the inside. That is less necessary these days, because of technological change, but observation of diseased specimens, for example, is still crucial to the proper training of health professionals.
I have real concerns about several threats to medical research. The Bill could be a threat to medical research if we were to get it wrong, but I do not think that we will do that. The animal rights lobby is clearly a threat to some research on animals that is intended to benefit human beings. The combined impact of rather frightened ethical committees and the data protection law already seems to be inhibiting several epidemiological studies.
We cannot over-emphasise the importance of medical research on human tissues for the rest of us. For a start, such research helps us to identify specific illnesses and conditions. After such conditions are identified, the research enables professionals to understand their causes, and it is only after the causes are understood that professionals may come forward with a basis for the prevention or treatment of conditions. Medical research saves lives and relieves pain and suffering, and we must remember that it has gone on since time immemorial—from the Greeks studying anatomy to William Harvey discovering the circulation of the blood.
I have a more recent example of the benefits that can flow from research. We are faced with variant Creutzfeldt-Jakob disease, but the variant form of the disease was discovered only because of the post-mortem examination of the brains of people who had suffered from it. The later discovery that the disease was probably linked to bovine spongiform encephalopathy in cattle—although that is not certain even now—was possible only because of the post-mortem examination of brains. That evidence led to the enhanced slaughtering of cattle, which we hope has reduced the impact of CJD on the rest of the population.
Such research is still going on, and requires the examination of not only the brains of those who have died from vCJD, but the brains of people who have died from classic CJD and other degenerative conditions of the brain, because comparing the two is one way of identifying specific characteristics that might eventually prove useful. If we are to deal with the condition, it is vital that we continue that research. Given those circumstances, it is necessary for relatives to be willing to allow the brains of their loved ones to be used for research in an effort to ensure that we prevent the condition affecting other people.
We intend to make the law clearer on tissue taken from the dead and to make it clear that informed consent is required. However, as the hon. Member for South Cambridgeshire (Mr. Lansley) said, we must ensure that such consent is wide and long-lasting so that 1004 after it has been given, further research that was not mentioned when it was given may be carried out. I do not imagine that many people would object to that.
The Bill also deals with the subject of tissue taken from the living. I understand that consent has not been required for the study of such tissue up to now. The examination, study and analysis of cancerous growths taken from people during the treatment of their cancer have transformed our understanding of genetic and other aspects of the process and progress of cancer, which has meant that professionals have become more able to treat cancerous conditions. That progress would not have been made without the study of human tissue. The Bill will require consent to be given for such activities in future, so we must ensure that it is broad and long lasting.
Few people know that samples of tonsils and appendices that were removed during routine operations have been held in slides throughout the country for decades. When I was Health Secretary, I was asked to authorise the study of the slides as an attempt to find out the prevalence of vCJD in the general population. If the material had not been held—it would otherwise have been discarded—such surveillance would not have been possible. We hope that the information that it provides will throw light on the progress of the disease because it has so far defied anyone's attempts to understand it. Will the Bill inhibit the retention of such material? I hope that it will not. I cannot possibly expect the Under-Secretary of State for Health, my hon. Friend the Member for South Thanet (Dr. Ladyman) to respond today to all the technical matters that I am raising, but we must consider them carefully.
I was struck at the time that the examination of that material was subject to decisions by local ethical committees—there are more than 200 in the country. The process was time-consuming and unpredictable, so we should contemplate establishing a national ethical committee—perhaps, although not necessarily, through the Bill—that could decide on the ethical provenance, if that is the right word, of such national schemes so that progress could be made quickly if it seemed it were necessary.
I have a further worry about the interpretation of rules on data protection by ethical committees. At present, programmes of the anonymous and totally unlinked sampling of blood and tissue exist as an attempt to establish the spread of HIV/AIDS. Some local ethical committees are concerned that such sampling could be contrary to data protection laws, so if that is the case we need the Bill to ensure that the data protection lot keep their noses out of it because the sampling is intended to benefit humanity generally. We must be clear about whether such a programme will be lawful if the sampling is anonymous. If the research is unlawful, society as a whole will be worse off.
I raise a further detailed issue with the Under-Secretary. If I were to go into hospital and a blood sample were taken as part of my treatment, I understand that I would not need to give consent for any research that its pathology laboratory might carry out during my treatment. However, pathology laboratories, in the pursuit of quality standards, rightly organise sample testing to determine the standard of their analyses. If a test is run on a person's blood sugar level, the laboratory 1005 will examine a sample of blood sugar tests to check whether they are accurate. As such an activity would be research rather than treatment for a person's benefit, the Bill would require people to give research consent before the sampling could take place—I do not know whether that is the case but it is my interpretation of the Bill. We clearly do not intend for that to happen, so the Bill should make it clear that it will not.
Professionals in my area are studying aneurisms that have burst and caused sudden death. There is little use in trying to study the aneurism of a person who has been the subject of an attempted surgical effort to keep them alive because it would undoubtedly be destroyed in the process. The professionals want to examine aneurisms that have been cut out of people's bodies during coroners' post mortems. As I understand it, the law currently says that a coroner can keep parts associated with the cause of death. If an aneurism was the cause of death, by keeping the tissue in which it occurred the coroner is doing something that is a straightforward part of their role. However, is relatives' consent needed to conduct research on aneurisms? How is that research to be carried out and how can we facilitate it?
There are a number of detailed points that we need to consider, and no doubt others will make them. However, my main theme is that the Government and the professions need to bang the drum about the merits of crucial research on human tissues if we are to continue make progress in treating people. We must not let the monstrous activities of Gunther von Hagens at Alder Hey ruin medical progress. We must not get too carried away. We need to get that message across because, like the Bristol parents, most decent people would he happy for parts of their own or loved ones' bodies to be used for research if they were asked for permission and were confident that it would be of benefit to everyone.
Willing consent is therefore a big step forward, but we must be clear about the aim of the legislation. We are introducing criminal sanctions in a difficult area, and there is a danger that we will inhibit research by placing too many bureaucratic restraints on people so that, as a result, they do not seek consent for taking tissue because it is simply too much bother. We need to avoid that consequence. As the Minister of State said at the outset, if we can create public confidence in the consent procedure and convince people that the research is worth while everyone will benefit. There are no party political differences about the Bill, and I hope that all the time available can be devoted to getting it right. However, more consultation will be needed with the Royal College of Pathologists, the Royal College of Physicians and others to try to make sure that we get the details right and achieve what we all want to achieve—a clear law that can be implemented by the people who are doing their job day in, day out, in difficult circumstances.
§ Mr. Paul Burstow (Sutton and Cheam) (LD)
I echo the remarks of the right hon. Member for Holborn and St. Pancras (Mr. Dobson)—a clear law that restores clarity to the issue will restore public confidence, thus enabling us to ensure that medical research and education continue to thrive and prosper. We do not want them to be damaged by the way in which the Bill 1006 may, or may not, work—something about which hon. Members on both sides of the House have voiced concern. Providing that clarity in the Bill will be the task of the Standing Committee.
We ought to acknowledge the fact that in some ways the Bill is born of failure: first, the failure of drafting and scrutiny by those who framed the Human Tissue Act 1961; secondly, the failure of pathologists and physicians who allowed the retention of organs after post-mortem without the family's knowledge to become commonplace; and, thirdly, the failure of institutions and managers either to provide adequate oversight of staff or to act on complaints. The Alder Hey and Bristol inquiries paint an extremely disturbing picture. Parents buried their children without knowing that many of them had not had their organs returned. In some cases, they did not even know that organs had been removed. It is impossible to step into the shoes of the parents who were affected and fully understand their anger, pain and sense of betrayal.
The chief medical officer's report on the census of organs and tissues retained by pathology services revealed that, while the malpractice of one particular pathologist was not the norm, poor practice and paternalistic attitudes were widespread. Over almost 30 years, 54,300 organs, body parts, stillbirths or foetuses were retained by pathology services. The census found that the vast majority of NHS trusts complied with the letter of the law and had signed forms of agreement from relatives. However, the Alder Hey inquiry and, indeed, the census found poor cataloguing and recording of retained tissues and organs in hospitals and university research collections. The distress caused to some families by second, third and fourth funerals must never be repeated.
As the summit held by the chief medical officer in January 2001 revealed, many parents had no idea what had happened. Some were given inaccurate and misleading information, some were lied to and told that they were burying children with all their organs returned. I cannot pass up the opportunity to cite part of the transcript of the summit, as it sums up the feelings of many parents who spoke that day:It almost was—I mean, if I could just use an analogy, it was almost like scrap cars being taken to a scrapyard. The cars were dismantled, the alternators were taken out, the batteries were taken out, put on a shelf, then when somebody comes along and wants one of those parts they pay for it. In the case of our children, they were disassembled completely. The organs were stored, never used.That is how one of the parents expressed their feelings and anger. The words, "never used" certainly stay in my memory. Their children's organs were poorly stored and, in some cases, left on a shelf. Even when they were used, the lack of accurate records meant that there was no feedback to the families on any research that was undertaken. There was therefore no opportunity to provide a modicum of comfort that the research had led to some good.
The inquiries, census and summit led to the publication of 17 recommendations in a report by the chief medical officer entitled, "The Removal, Retention and Use of Human Organs and Tissue from Postmortem Examination" in 2001. The first recommendation, which has already been referred to, 1007 was to act immediately to amend the Human Tissue Act to remove any confusion between lack of objection and informed consent. That Act provides for a person to express their preferences in respect of the use of their body after death. In the absence of such an express wish, the onus is on the clinician to make such reasonable inquiries as are practicable to ascertain whether the surviving spouse or any other surviving relative objects to the removal of organs or tissue.
The test was therefore lack of objection. However, there was a defect in the Act, as it was vague about clinicians' tasks and how hard they should try to obtain the views of patients and relatives. Parliament's intention was not so vague. In introducing Second Reading in December 1960, the then Parliamentary Secretary to the Ministry of Health said:It is proposed to recommend hospital authorities to adopt the same procedure of obtaining consent of relatives where they are available in relation to the removal of any part of the body as authorised by this Bill.In other words, a requirement for consent formed part of Parliament's intentions when the Human Tissue Bill was debated in 1960. However, that requirement seems to have been lost. Indeed, the Parliamentary Secretary went on to say:The hospital authorities will also be recommended to ask the available relatives whether they know of others who might object. Any relative will be able to object to the removal, and this will override the consent of any other relative … This is felt to be a wise precaution to avoid the risk of causing offence to the feelings of any known relatives."—[Official Report, 20 December 1960; Vol. 632, c. 1232–33.]That issue may be contentious today, but it was not debated further on Second Reading of the Human Tissue Bill. The Parliamentary Secretary made the position clear at the outset of the debate, so perhaps the drafting of the Bill and the lack of debate on consent are a reflection of the prevailing paternalism at the time. Although a recommendation to seek consent was made, a provision was not included in the Bill. It is academic now whether or not the Department of Health did, in fact, implement the Minister's words. The evidence of the inquiries and the census all points to a departure from the intended spirit of the law and, at best, an adherence to its letter. The Bill will put right the mistake of over 40 years ago by making it clear that consent must be obtained.
One issue that struck me in preparing for the debate was the importance of sensitive support for families at the time of bereavement. That picks up the point of the right hon. Member for Holborn and St. Pancras about the pressures on staff and on relatives and the emotions that emerge at that time. The report of the inquiry into children's heart surgery at Bristol royal infirmary identified the need to improve bereavement services in the NHS. That was covered in recommendation 12 of the CMO's report, which states:All NHS Trusts should provide support and advice to families at the time of bereavement.It continues:This support should include the services of a bereavement adviser, who can help families in the difficult period following death or where the situation allows to offer support through the dying process.1008 However, the practice to date has been to ask relatives to authorise post-mortems shortly after death—in some cases, just after the news of death was broken.
Treating family members with dignity and respect and discussing complex emotional issues, such as postmortems and the retention of tissues and organs, is difficult at the best of times, and I am told that it is poorly taught in medical training. Perhaps such training needs to be reviewed to ensure that it is the very best. Families need time to come to terms with their grief. When a post-mortem is suggested, unbiased information written in plain English and other languages should be supplied and support offered.
NHS trusts have been required to designate a named individual to act as bereavement adviser since 2000, so what is the current position in respect of bereavement services? The answer is that it is patchy: some are good, some are average, some are bad and some are developing. That is my reading of the results of the bereavement services report produced by the Department of Health following its survey back in 2001. That report's conclusion says:It is clear that every Trust does provide support to the bereaved in some form, but the extent of this support seems to vary. It is mentioned frequently that greater consistency could be achieved by training more (if not all) hospital staff in basic bereavement awareness and communication skills.The report's findings include the fact that fewer than half of NHS trusts had a dedicated member of staff to look after bereavement. Only 15 per cent. had a bereavement officer, and 20 per cent. said that they were doing well on issues relating to post-mortems and organ donation, while 7 per cent. said that they were not doing well. The report is silent about the other 73 per cent. of trusts. That should be a cause for concern.
Almost a third of trusts said that their provision of follow-up support and visiting needs much improvement. It is no wonder therefore that the CMO in his progress report on his web pages says:More work needs to be done to ensure that the provision of bereavement services is given the priority and attention that it needs.To be fair, the Bill's explanatory notes state that £2.7 million per annum has been included in the NHS baseline to develop bereavement services in 2003–04. Of course that is welcome, but it remains to be seen how it will work on the ground.
The explanatory notes say that the funding is sufficient to develop services that will be compliant with the Bill. However, will that extend to developing the follow-up support and visiting services that are so important? Can the Minister say whether strategic health authorities will include the development of bereavement services in their performance management work? I understand that the Department is supposed to be undertaking a follow-up survey to find out how improvements are progressing. It would be useful to know the time scale for that work.
One of the reasons why I raise bereavement support is that it goes to the heart of how we ensure that appropriate consent is achieved. Bereavement services that provide support in a helpful, informed and unbiased way can help people to reach decisions more easily. I raise that issue in particular because of a case that demonstrates that bereavement services have a long 1009 way to go. It occurred over the Christmas period at the St. Helier hospital, which is part of the Epsom and St. Helier NHS trust.
The case was drawn to my attention by my constituents, Mr. and Mrs. Cornwell, who were visiting a relative of theirs, Mrs. Howe. They were rung by the hospital at 4 pm on 3 January and told that her condition was deteriorating and that they should come soon to see her. They visited and stayed until 7 pm, and they said their goodbyes. When asked, the doctor said that what was meant by the word "deteriorating" was that their relative was dying. They went home, which was very nearby, but they had no call from the hospital after that.
On Sunday 4 January, Mr. and Mrs. Cornwell decided to visit the hospital again, thinking that their relative was perhaps still alive—they wanted to see her again. They rang the hospital before setting out, and they were told by a junior staff nurse, after some discussions among the nursing and other teams at the hospital, that their relative had died at 9 pm the previous evening—two hours after they had left—and that they should contact the bereavement officer after 10 am on Monday. No information or counselling was provided and no suggestion was given as to what else they should do. They rang the bereavement office on Monday and told the person there that they had not been informed about the death, but had learned about it through their own positive action.
The office took the details and phoned back that afternoon to say that there was concern about the cause of death and that there would need to be a post-mortem. It did not inform medical staff that the relatives had not been informed and it told the Cornwells that they should go to the ward to collect their relative's personal effects. I cite what happened, because it is an example of how things can go wrong. Even when the relatives were told about the need for a post-mortem, no reference was made to the fact that forms had to be signed or to the issues that the Bill is all about. That is why the system must be improved.
To be fair to the trust, it has acknowledged that it made mistakes. In particular, it acknowledged three mistakes at a meeting that took place in my constituency this morning. The first was that, when the night duty nurse went to the ward on the Saturday, there was a misunderstanding from the duty nurse about whether the relatives had been informed of the death. A box was ticked, but there was no follow-up—not even when the relatives did not arrive and the body was moved to the mortuary. The bereavement office should have been informed by medical staff, but it was not. Therefore, it should not have told the Cornwells to pick up the personal effects. Finally, the trust did not provide all the information that it should have done to the Cornwells. It certainly failed to provide them with support.
The trust has acknowledged the mistakes and is putting in place procedures, but they should have such procedures now. If the interim procedure is already in place, it should inform how such matters are dealt with today. The fact that it does not is a great cause of concern for me and for others.
Transplantation is the second issue that I want to raise, and it has already been touched on in the debate. According to UK Transplant, the number of people 1010 waiting for organ transplants has increased by almost a third in the last 10 years. Today, 7,172 people need a lifesaving or life-changing transplant. Every year, nearly 400 people die waiting for a suitable organ to become available. They are the ones lucky enough to get on the transplant list in the first place.
I understand from a press notice issued by UK Transplant that 10.9 million people have already pledged their organs for transplant by joining the NHS organ donation register. I can testify, having tried it out quite recently—perhaps having been stimulated by preparing for the debate—that it can take a matter of a few minutes, if that, to register one's intent to donate one's organs on death. I urge anyone to visit the website and to take the steps to doing just that.
One question that must be asked about the Bill is whether it will help to tackle the serious shortfall between the number of people awaiting donor organs and the number of people taking the positive step of registering their willingness to be donors. Planning for one's own death is still something of a taboo subject in this country. We do not like to talk about that or our mortality. That deters people from taking the positive step of recording their wishes to donate.
Polls have found that 70 per cent. of the population say that they are willing to donate their organs for transplantation after their death, yet just 15 per cent. formally register. One way—and I stress that it is one way—to bridge the gap between what people say they want to do and what they actually do would be to adopt a system of presumed consent. I stress that such a system of opting out would not mean that the views of relatives would be ignored, but it would change the nature of the discussion between the clinicians and members of the family that takes place at such a crucial point. The BMA briefing for the debate says:most families do not discuss their wishes about donation and, when asked at the time of bereavement, many opt for the default position, which is not to donate. Studies show that many people later regret this decision.The worrying thing is that the refusal rate is increasing, so what is the current state of public opinion on the question of presumed consent? A survey commissioned by the Department of Health in 1999 found that 50 per cent. supported the current opt-in system and that 28 per cent. supported presumed consent, with 21 per cent. having no preference. Since then, two further surveys found that concern about the availability of organs for transplants has led to a shift in opinion. The National Kidney Research Fund discovered that 57 per cent of the persons sampled supported a system of presumed consent. The BMA system would allow organs to be removed for donation after a person's death unless the individual had registered an objection during his or her lifetime; or if it were clear from information provided by the spouse or partner—or where there is no spouse or partner, by a parent or child—that the individual had expressed an objection to donation that had not been officially registered; or if it were clear that the donation would cause major distress to the individual's partner or, where there is no partner, a parent or child. The BMA makes it plain that that arrangement would not apply to persons under the age of 16. I do not pretend that presumed consent alone would solve the shortage of donor organs but it should form part of a wider strategy to increase donation rates.
1011 I recognise that the issue is one of conscience for many right hon. and hon. Members. If during the passage of the Bill there is the opportunity to debate and vote on a suitable amendment, I hope that it will be the subject of a free vote. I certainly welcome the indication by the hon. Member for South Cambridgeshire (Mr. Lansley) that such an approach will be taken by the Conservatives. My hon. Friend the Member for Oxford, West and Abingdon (Dr. Harris) hopes to catch your eye, Mr. Speaker, and to develop the arguments for presumed consent.
The hon. Member for South Cambridgeshire mentioned the problem of defining human tissue and organs—an issue that he raised in an Adjournment debate last April. The chief medical officer's report stated that "tissue" had not been explained in the past. In particular, it was not made clear that it could include whole organs, especially in small babies. Most parents thought that the term meant small amounts of tissue for microscopic examination. Informed consent would require clear communication and shared understanding. The Bill ducks that issue. Definitions of tissue and organs should not be left to guidance or codes of practice alone. I hope that the Committee will debate and arrive at a consensus to move that aspect forward.
The Royal College of Pathologists makes the point that while the Human Tissue Act 1961 is vague and misleading, the Bill is so tortuously worded that it will be incomprehensible to those who, under its regulations, will risk being exposed to penalties. The college suggests that schedule 1 should distinguish more clearly between activities for which consent would be mandatory and those not always requiring consent, as determined by the proposed Human Tissue Authority. I hope that the Minister will give some reassurances on that point when he winds up.
Those who remove tissue from living patients will be expected to seek consent for all subsequent uses of it. Persons working in medical education or research, for example, will need to ascertain the material's consent status. Does the NHS have the capacity to take on that additional work and cost? The Royal College of Pathologists states that to record the explicit wishes of all patients in a manner that allows laboratory staff rapidly to retrieve relevant information on large numbers of patients will require investment in information technology that cannot reasonably be funded from existing NHS laboratory or hospital budgets. It is estimated that 3 million solid tissue samples are taken from living patients each year. Is the Minister confident that existing resources are sufficient to put in place the necessary systems to implement the spirit and letter of the law?
If a doctor publishes a research paper in support of a hypothesis that includes pathological diagnoses culled from pathology reports, is a criminal offence committed if it transpires that in one of the cases, the consent for research box on the surgical consent form was not ticked? If an offence is committed, who commits it—the pathologist, the physician or the doctor who writes the paper?
The Bill deals with many public concerns about the way in which organs and tissues are removed, retained and used. It is a vast improvement on the 1961 Act and 1012 it should receive a Second Reading. It took almost 40 years before the weaknesses in the 1961 Act were exposed. The Bill is not the subject of party political dispute and I hope that that will liberate the Standing Committee that examines it and allow it to do a genuine job of revision and improvement.
Members of Parliament can never hope to make up for the pain and suffering of the Alder Hey families but we can ensure that their legacy is a sound system that safeguards individuals' rights to give their consent and respects the rights of the family.
§ Dr. Ian Gibson (Norwich, North) (Lab)
The erudition shown by all hon. Members makes it easy not to be repetitive and ask the same questions, which will be tackled in many places.
I have seen many human tissues from cancer patients and worked with them at all levels. I have especially examined DNA and cancer genes, which have recently been shown to be important in defining whether someone may get cancer and whether it runs in the family. It was important that we did not have to go back for permission once it had been secured. I hope that we will preserve that because this country has been at the forefront of such work and won Nobel prizes for it. It has also been important to share the information internationally.
During the Alder Hey business, several constituents who had, sadly, lost their children approached me. They were worried about the location of tissues and I took them to various hospitals throughout the country. I especially remember Great Ormond Street hospital because the parents wanted the microscope slides and tissues—not organs but tissues. After negotiations, and because of the furore, they were able to bury the microscope slides. Whatever our personal feelings, we must understand how those parents felt. For them, something had been taken away and they wanted it restored.
We need to restore public confidence in science and medicine. The march of knowledge depends on that; we cannot move forward without the public behind us. The Bill recognises that—it is one of its major features. I believe that the measure will be a landmark Bill, of which we shall all be proud.
Any regulations that we make require the serious thought and involvement of many different parties. We get it wrong at our peril. If we do not get it right, there will be media controversy, communication breakdown and a lingering cynicism about organisations whose intent is honourable. We must get the conditions right. Public trust is hard to win but exceptionally easy to lose. We all have experience of that. Trust is often the key to the political success or failure of regulation.
Scientific and medical authority will no longer legitimise new regulation. I said "authority" but some people would use the word "arrogance" for the assumption that one can act without asking permission. When we took tissues, we had long discussions with people about the purposes for which they might be used. After a while, they would come back and ask, "What did you find out?" It is in the nature of things that one does not always have much to say, but such questions emphasise that people have given tissues and expect something to happen.
1013 Open government requires public engagement, which is difficult to achieve. Attempts to get the public to come forward and get involved are plagued with many difficulties. We are finding that with genetically modified crops and measles, mumps and rubella. We must take on the problem and try to ensure that the process is inclusive and that nobody is denied the right to say something. In that context, the fastest growing profession is that of people called ethicists. They are crawling out of the woodwork and making millions. The subject used to be called moral philosophy. Is there a difference? I can never understand it, but people will go on for hours about the difference between an ethicist and a moral philosopher.
Earlier, it was said that one can never tell what one will find from tissues that are kept and maintained. One never knows what will be found as knowledge moves forward. Let me give two examples of that, because it is important to get this message across to the public during the debate on these issues. The causal agent of peptic ulcers was discovered by a pathologist—an histologist, indeed—who looked at tissue and saw some wiggly things that turned out to be bacteria in the ulcer material. He asked permission to examine certain archive material and, blow me, he found the bacterium helicobacter in every piece of ulcer material. That caused a revolution in the way in which we treat peptic ulcers. Instead of using all the treatments that had been available previously, we suddenly had the drug that had been developed against that bacterium. That discovery revolutionised the treatment.
The other example involves rectal tumours. People suddenly discovered, by examining tissue, that they had to cut out more than just the rectal cancer. They discovered that they had to extend the surgery a little further because the cancer returned in those patients who did not receive such treatment. When examining the cases of patients who had survived for long periods of time, it was found that extra tissue had been taken from around the rectal cancer. That discovery was made while examining archive material. There are many similar examples, and I am sure that the professional organisations could get involved in telling us all about those developments.
The examples of those two practices could be used to build public confidence as the Bill proceeds. We shall all be very proud that, following the tragedies that have occurred, we have found a way of restoring public confidence, not only in the practice of taking tissues but in science and medicine generally. That confidence is badly in need of repair, and we are now part of a huge process of revolutionising medicine and science in this country.
§ Mr. Kenneth Clarke (Rushcliffe) (Con)
I welcome the Bill, so far as it goes, and I certainly agree that this area of the law is in need of modernisation and clarification. The law as it will be after the Bill has been enacted will be a considerable improvement on what we have now. I hope that we get it right, and that the Government continue to pay attention to the concerns of those in the medical research and other establishments, and to ensure that we do not over-react to the understandable public horror at the excesses that were revealed a few years ago in such a way as to damage worthwhile 1014 medical research. I share the views of those who are not sure that the wording of the Bill is quite right, and who think that there is a need to consult, particularly as it was not possible to produce a draft Bill. We shall not have an opportunity to return to this issue often.
I hesitate to upstage the Father of the House, but I recall that, when I was a student, I went into the Strangers Gallery after a dinner in the House and found myself listening to the Second Reading of the Human Tissue Bill. At the time, I did not think that I had picked the best possible evening to witness the heights of political rhetoric, but subsequent experience in the Department of Health and of the reactions to recent events has shown what a sensitive subject this is. I think that the hon. Member for Sutton and Cheam (Mr. Burstow) was a little harsh to criticise the authors of the 1961 Act; it has lasted for more than 40 years. We do, however, need to re-establish such principles as informed consent and to re-establish the reputation of those who need human tissue if they are to make valuable progress in medical research.
The subject on which I propose to concentrate today is the impact of the Bill on the problem of the shortage of donor organs for transplant in the national health service. I have always believed that that is a serious clinical problem, and it is getting steadily worse, year on year. In 2001, when I drew a place in the ballot for private Members' Bills, I produced a Bill called the Transplant of Human Organs Bill to enable us to have a debate on the problem of that shortage and to seek to tackle some of the essentially legal problems that are causing the difficulties involved. I was drawn seventh in the ballot, so the contents of my Bill were extremely modest—it had to be non-controversial in order to get through. It did, however, give us the opportunity to canvass opinion on other things.
My Bill did not receive the support of the Government or the then Minister, whose response was that the Government were waiting for the comprehensive survey of all the legislation on which they would then embark. I was somewhat irked by that response, but I congratulate the Government and the present Minister on having addressed at least one of the fears that I expressed at that time. I feared that it would take years to get parliamentary time for a comprehensive Bill on the subject, so I congratulate her on having got a measure into this year's programme and giving us a chance to address the problem.
Whatever the Bill's impact in the other important and sensitive areas involving human tissue, including its retention, control and use, I fear that it may be regarded as a missed opportunity to do something positive about the continuing shortage of donor organs. I understand why the Government are cautious in this area—the issue is terribly sensitive, so they are right to be cautious—but opportunities rarely arise to rectify the legal problems that give rise to the needless death of many patients awaiting donor organs.
In 2001, there was a fear that the strong and understandable public reaction to the tragedies and scandals that had been unveiled at Alder Hey and at Bristol would damage the organ donor programme. 1015 Fortunately, that did not happen directly because everybody struggled to ensure that it did not happen, but the Government's approach to the Bill has been coloured by the recollections of the ferocious public reaction to the subject as a whole. That has made them more cautious than they need otherwise have been on organ transplantation and the availability of donor organs.
The bulk of the public recognise the value of having donor organs for those who suffer failure of one kind or another, of their kidneys or hearts in particular, and there are different public attitudes on that subject, which are easier to address than some problems that arise in the examples of anatomy, training, research and so on.
The organ donor problem is important. Although successive Governments, for as long as I can remember, have tried to tackle it, we ought to face up to the fact that our efforts have not been very effective. It is one of the biggest problems in the NHS that large numbers of people are dying needlessly because of the shortage of organs for transplant. It has already been stated that several hundred die each year who are on the waiting list, waiting for an organ to become available.
The problem goes beyond that in my opinion, because, quite apart from the death of those who are still waiting, the difficulties in the lives of people who spend some years waiting for an organ transplant while contending with dialysis or with exhaustion, which can affect a patient who needs a heart transplant, are considerable and do enormous damage to the quality of life of many of our constituents.
The difficulty is that the problem is increasing. The situation is getting slightly worse year by year, not getting better. I am obliged to the Library for enabling me to tell the House that the lengthening waiting lists had reached 5,793 at the end of November 2003. Those are all people who could benefit if more donor organs became available.
In practice, although the number of patients who are getting on to waiting lists because medical science will enable them to benefit is increasing, the number of donors—in particular, cadaver donors—is slightly decreasing each year. The problem is therefore getting worse. I believe, and I think we all accept in principle, that that situation could be improved by changes in procedures, but also by changes in the law. Legislation would not in itself solve the problem, but where it could contribute we must ensure that we take this opportunity to get it right.
I welcome some changes that are being made to the procedures designed to speed up the process of identifying available donor organs and making them available to those who are going to treat patients, as well as the Government's attempts to streamline the functions of UK Transplant. The Bill also tidies up some important details of the law, which I addressed in my private Member's Bill, but it does not go to the heart of the matter. The biggest and most important question about the availability of donor organs from people who are deceased is that of consent. I am afraid that the Government have taken too cautious a view.
Let me make it clear: I realise that assent is at the core of every aspect of this Bill. The principle of 1016 informed consent is absolutely essential, and I trust that no civilised person would seek to deny that as long as we do not take it too far in the case of blood samples and minor slide samples, as others have mentioned. Of course, it is essential that no organ is used for donation to a sick patient if we have any reason to believe that the deceased person would have objected to that, or, if the deceased person had expressed no view, if some close family member would be deeply distressed if it took place or believed that the deceased person would have objected. All that must be coped with. The present position, however, puts many obstacles in the way of making use of available cadaver organs, which goes far beyond that.
The biggest single issue that troubles me, however, is not presumed consent, about which I will speak briefly in a moment. The first issue that I hope we can address is the present confused situation in which people carry donor cards or have their names on the NHS organ donor register. We all accept that not enough people carry cards, and not enough people put their names on the register. We should ask ourselves, however, what assumption are people making if, as I hope everybody in the Chamber does, they carry a card or their name is on the register? I think that we all assume that if that desperate misfortune happens, and we are run over crossing the street and die, when someone finds the card in our wallet, or looks up our name on the register, the whole process will instantly move into gear, with the transplant co-ordinator trying to find out whether anyone can make use of such organs that remain in a usable condition. As I understand it, however, that is not what occurs.
In many cases, the card that we carry is used by the staff of the hospital to assist them in getting the consent of the relatives for the use of the organs. It is used as a basis to try to persuade no doubt desperately bereaved relatives that the person who has just died would have wished that to happen. That is no doubt helpful, but it does not cut out the process of deciding which relatives to consult, getting hold of them and handling people at a time when they are most vulnerable, and sometimes least rational, and trying to get them, in the middle of their grief, to address the problem of whether the kidneys or heart can be removed for the benefit of another patient.
It is astonishing that the Minister—in no way am I criticising her—was not able to answer when the hon. Member for Oxford, West and Abingdon (Dr. Harris) asked her what I think is the most important question: what is the effect of the Bill on the status of donor cards, and, I would add, on those on the register? I realise the difficulties of holding all the details of such a complex Bill, but if the Minister cannot answer it, what will happen to the practitioners in the field who want to know their legal position? That may require some alteration to the wording of the donor cards, but my belief is that it should normally be assumed that if the deceased person was found to be carrying a donor card, that is the deceased person's consent to going straight into the process of using the organs. My belief about that is even stronger in the case of the NHS register.
In the course of consideration of the Bill, I hope that that issue can be addressed. The Transplant Partnership and the British Medical Association have long 1017 advocated that the law should refer specifically to the NHS register—I would add donor cards to their recommendation—to put the question beyond doubt. When we try to persuade our fellow citizens to indicate a willingness to make their organs available if they should tragically or suddenly die, in conditions in which they have available organs for use, that should be taken as full consent authorising fully what happens.
Staff will in any case try to contact relatives and discuss the tragedy with them—there will be no question of their not knowing what is going on—but I see no reason why the long list of relatives specified in the Bill should have the final say. It is, after all, conceivable that some half-brother who had had no contact with the deceased person for some time might turn out to hold religious beliefs that the deceased person did not have, and refuse consent; or the divorced parents of a deceased child might have arguments that staff could not resolve. The point of the cards and the register is to avoid such problems.
It will be suggested that staff find it convenient to have the cards in order to obtain the consent of relatives. I am sure that that is true, as most relatives do consent when they know that the person carried a card. The problem, however, is not that when people get around to it they cannot use the cards to obtain the consent of relatives, but that the process involved puts people off. In a hard-pressed intensive care unit people simply may not bother to work through all the relatives and find a suitable one, while ensuring that no relative in a priority category has been missed out. No bother will be necessary if the discovery of a card means it is possible to proceed, and then inform relatives as quickly and as sensitively as possible.
The Minister was not able to answer off the cuff when asked this question earlier, but can we be told whether the carrying of a donor card or the registering of a name will in itself constitute sufficient consent for organs to be donated? If the answer is not clear, will the Minister undertake to ensure that it is made clear during the Bill's progress, so that in due course an Act will make it crystal clear that carrying a card gives the go-ahead for the use of organs?
I shall not say a great deal about presumed consent, because the issues are clear and no doubt the subject will be discussed when an amendment is tabled. Obviously there will be a free vote for all parties, given that the issue is devoid of party politics. I support what the Transplant Partnership and the BMA have called the soft presumed-consent procedure, whereby the seeking of relatives' consent starts from a presumption that if there is no evidence that the deceased person took any steps to object, that constitutes his consent—but if relatives who are found express strong views priority must immediately be given to their feelings.
That would not constitute a dramatic change in itself. No one is suggesting that relatives should not be consulted or informed of what is going on. I believe, however, that presumed consent would give rise to a more positive view of transplantation generally in the NHS, and indeed would help relatives. If the presumption is that organs will be used unless relatives have strong moral or religious objections, or believe that the deceased person would have objected, relatives will in fact be relieved of some of the burden of having to 1018 give positive agreement to the cutting up of a body to remove organs that are not diseased. In their desperate state, they may not feel able to make such a decision.
That is what the Spanish do. I accept that it is not the only thing that is done right in Spain, and not the only thing that produces a better record than ours throughout western Europe when it comes to the availability of donor organs. I believe, however, that it must contribute to that. As I said earlier, the cadaver donor rate per million of population in Spain is more than double our own rate. I believe that we have the worst record in western Europe. We must do something about that weakness in the law.
§ Mr. Dalyell
The right hon. and learned Gentleman did vote for it. When I did a long survey over 42 days, it was almost pathetic to note that many people who had not given permission for some part of their loved ones to be used later regretted it. It was a matter of considerable sadness to them that they had not been able to help other people.
§ Mr. Clarke
I quite agree, which is why it is so much better for people to indicate their wishes during their lifetime or to make a presumption that they would have consented unless a relative is quite sure that they would not have. In fact, we waste many available organs: after making inquiries into many deaths, in only a small proportion of cases is it found that people persisted in objecting to the removal of a kidney or heart for a transplantation operation. I hope that the issue will he re-assessed during the Bill's passage through both Houses.
We all agree that it is not a partisan issue and we have all joined in congratulating the Government on presenting a Bill that provides us with an opportunity to deal with all transplantation and other human tissue issues in one piece of legislation, tidying up and clarifying the law. However, if we make no advance on our present law and practice in respect of the shortage of donor organs, we will regret having missed that opportunity. I hope that the House will encourage the Government to be more ambitious in their intentions and to press more ambitious amendments as the Bill proceeds. Otherwise, we will have a growing scandal of a steadily deteriorating position in which people are dying needlessly or having their lives destroyed by waiting for organs that never become available.
§ Mr. Robert N. Wareing (Liverpool, West Derby) (Lab)
I, too, welcome the Bill, as it signifies the Government's clear intention to clarify the law. I have some reservations about it on the grounds that it does not completely clarify the law and is less comprehensive than I would have liked.
Practice over the use of a patient's organs has varied from place to place, and the Bill attempts to put into statute what is already best practice. I certainly welcome that. However, because it is not comprehensive enough, 1019 it needs to be examined carefully in Committee. I only hope that the Committee has enough time. The hon. Member for South Cambridgeshire (Mr. Lansley) is right that we must have enough time to examine the Bill carefully.
The Bill has been introduced without following through what the chief medical officer said should happen in January 2001, which relates to my reservations. At the chief medical officer's summit on 11 January 2001, Professor Donaldson said that, after the publication of Royal Liverpool's children inquiry, the move forward on any necessary changes, including legislative changes, should be "all in one go". He also said that the Department had large research programmes and that there was "no way" that it would wishto divert or suppress any research".Professor Donaldson was, I believe, looking for a more comprehensive measure than the Bill before us this evening. I hope that we will reflect carefully on what he had to say.
The chief medical officer's report of January 2001 was entitled, "The Removal, Retention and Use of Human Organs and Tissue from Post-Mortem Examination". What Professor Donaldson recommended was accepted:As soon as possible, there should be a more fundamental and broader revision of the law, encompassing the taking, storage and use of human tissue from the living and the dead and introducing an independent system of regulatory control. To be comprehensive this should encompass aspects of Coroners' practice. It should shift the emphasis from 'retention' to 'donation' to signal a new relationship with the public and bereaved families.For me, the issue is why these matters have not been followed through. We need to take a proper look at the question of consent for coroners, which, of course, is automatic at the time of the inquest. Permission is required after the inquest has been conducted; however, many people are misled by the existing legislation.
I want to express my admiration for the excellent work of the staff of the Royal children's hospital, Liverpool—or Alder Hey, as it is better known—which is just across my constituency border. It has treated patients from all over the United Kingdom, and even from abroad, and its reputation will undoubtedly outlive its recent problems and shortcomings. It has for a long time had a unit devoted to assisting bereaved parents with the utmost compassion. In my view, it remains a world leader in the treatment of children.
Following inquiries into the events at Alder Hey, however, it became apparent, as my right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) said, that the storage of human organs and tissue without consent was widespread. Both the hospital and university authorities—they have not been mentioned specifically in the debate so far—were culpable. There was no criminal sanction, but the existing law proved ambiguous. Parents were told at the time of their bereavement that all the organs had been returned to the bodies. That was untrue. The situation was horrendous, and, as has been said, in some cases the bereaved parents had to endure multiple 1020 funerals. Even where consent was given, the parents had no idea that it meant the extraction of all organs, and that what they were burying were the mere shells of their loved ones. I hope that the proposed Human Tissue Authority will address that issue properly when drawing up a code of practice.
I am a little worried about codes of practice. Will the code, which should certainly be very clear, be enforced in the manner of the highway code, for example? If it is not to be regarded by the health service in the way the highway code is regarded so far as transport matters are concerned, there should be clear legislative enactment of it. People ought to know that a criminal sanction will apply, should the code be offended against.
Some say that there should be a presumption of consent, but I am a little unhappy about that. In my view, the needs of research and medical training should never take precedence over the rights of bereaved relatives.
§ Dr. Evan Harris
I can reassure the hon. Gentleman that those Members who support the option of presumed consent—including a "soft" version, whereby relatives are consulted—propose that it apply not to organ use for teaching and research, or to children's organs, but only to life-saving transplantations.
§ Mr. Wareing
I welcome the hon. Gentleman's comments, which are in accord with my views on what should happen.
The right balance should be struck between the needs of society and the interests of parents. The right hon. and learned Member for Rushcliffe (Mr. Clarke) was present when we discussed this issue, but he was unable to interject and offer his wise comments. The Human Tissue Act 1961 certainly fails in respect of creating the right balance. Currently, medical education comes first, and the retention of organs is based on lack of objection, rather than on consent. That issue needs to be looked at very carefully when the Bill is gone through in detail in Committee.
Clause 24 deals with qualifying relationships in respect of who may give or refuse consent—I think the right hon. and learned Member for Rushcliffe wrongly referred to clause 35 in that regard. However, it is unclear what would happen if there was disagreement between two persons of equal ranking under the provisions. There could be religious objections of the type referred to by the right hon. and learned Gentleman, or the person might not have seen the deceased for many years, or even decades, and their views might stand in the way of what the deceased person might have wanted. It is possible that a majority of people will continue not to carry donor cards, and although I hope that situation will change it seems unlikely to do so significantly.
The Bill provides that a living child may give its consent if competent, but what exactly is meant by "competent"? How is one to discover whether a child is competent?
The Bill does not include provision for a decision to be made on behalf of mentally incapacitated living donors. Will that matter be addressed in Committee, or will the Government's mental health Bill include a suitable clause to cover such contingencies?
1021 When news of the retention of organs broke, Alder Hey made an attempt to provide families with counselling, which was a good thing. However, the counsellors either were, or were assumed to be, connected with Alder Hey and thus not independent, so families were sometimes reluctant to take up the service. Should not counselling support be independent of the organisation at fault? Will the Minister consider tabling a new clause on that issue? Many bereaved parents—certainly in the Liverpool area—did not go to the hospital for counselling because they thought that the counsellors were in league with the people at fault over their loved ones.
We tend to ignore the international dimension of these matters. There are many differences of practice between states. Is not there a need for harmonisation, at least between the countries of the European Union? United Kingdom citizens should be covered when abroad. Spain has been mentioned, but I believe that in Austria all organs are stripped from a dead person. That has happened to British tourists, no doubt against the wishes of their bereaved relatives.
What is our current policy on the European convention on human rights and biomedicine? About two years ago, in their reply to my question on that subject, the Government seemed to be of the view that they were considering the convention, but I do not think that anything has happened since then. What is the current situation?
I hope that the Minister can answer my questions. The Bill deserves a Second Reading and I am sure that the whole House will support it, but it needs detailed consideration, and although I shall support the programme motion it is very restrictive.
§ Mr. David Wilshire (Spelthorne) (Con)
Although the Bill is about more than organ donation, it is on that subject that I rise to speak. I do not speak as a party politician; this has to be free-vote territory. I speak simply as an individual whose awful experience may help others to clarify their approach to at least one of the difficult issues raised by the Bill.
At the outset, I want to make it clear that I have no objections at all, in principle, to the removal of parts of a dead body. In fact, I have carried a donor card for many years. However, I do have some concerns about consent, and they arise from the death of my daughter.
Twenty-two years ago, my 12-year-old daughter choked to death at school. Very shortly after that catastrophic event, I met some of her teachers and some of the staff at the hospital to which she had been taken. I was too distraught to turn my mind to organ donation, and I suspect that they were too kind to risk causing me further distress by raising the subject. As a result, no part of the body that was no longer of any use to Sarah could be used to help others. As the Father of the House predicted a few minutes ago, that is something that I deeply regret to this day.
When they hear me recount that story, people might believe that it is an argument in favour of presumed consent. However—and perhaps curiously to some people's minds—that experience has led me to become an opponent of presumed consent, and I want to try to explain to the House why that is so.
1022 All hon. Members have probably received representations recently urging us to use the Bill to introduce some form of presumed consent for the removal of organs from a dead body unless someone has registered opposition to that course of action. I readily accept that there are powerful arguments in favour of that approach. Principal among them are the shortage of donor organs noted by my right hon. and learned Friend the Member for Rushcliffe (Mr. Clarke), and the many and growing opportunities to help people in need of organ transplants.
I accept that helping those people is an entirely worthy objective, and I hope that the entire House supports it. I certainly do, but I believe that we can achieve that objective by means other than through presumed consent. There are serious anxieties about presumed consent, and I have my doubts about whether it would solve all the problems that its supporters claim that it would solve. The potential abuse of presumed consent is a very real fear. Appropriate amendments to the Bill might resolve that problem, but we must also consider the impact of presumed consent on bereaved relatives.
If presumed consent had been in operation on that June evening so many years ago—and I take the point about its not applying to children made by the hon. Member for Oxford, West and Abingdon (Dr. Harris)—a doctor would have got on with what he judged needed to be done, or he would have had to check that I had no objections. If I had discovered later that, although I was in the hospital, no one had taken the trouble to consult me, I would have been outraged. Had I been invited to object rather than to agree, it is probable that I would have been made to feel guilty for the rest of my life if I had found the need to refuse.
Please believe me: the last thing that a person who is struggling to cope with the death of a daughter wants is additional and avoidable grief. That is why I oppose presumed consent. To my mind, something that has the capacity to add outrage and guilt to the hell that one goes through in those circumstances simply has to be wrong.
That said, I can readily understand why I might sound selfish to other people. I know that doctors are busy people, so why put obstacles in their way? It is not easy to ask permission from a bereaved family, so why make clinicians do something difficult and unpleasant?
Let me give my answers to those two questions. If there were ever a situation where the needs and wishes of patients and their families must come first, this is it. On such occasions, clinical convenience must always be a secondary issue. Presumed consent would not spare doctors the difficult task of raising the subject of organ donation with bereaved families—all it would do, as the hon. Member for Sutton and Cheam (Mr. Burstow) said, is alter the nature of that discussion. In my opinion, asking, "Do you wish to object?" is no easier than asking, "Please may we?", but to my mind, "Please may we?" is much kinder and much gentler.
Those who speak on any subject have a duty, if they oppose a certain way of achieving something desirable, to say what the alternative ways of achieving it are. In this case, I suggest "required request". Let me give the House a few examples of what I have in mind. We could 1023 train, then require, GPs to raise the issue with their patients, especially when registering new patients, and they could record all those agreements on a central database. We could help, then require, hospital managers to add a question to their admission forms: I am sure that that would help. We could train, then require, hospital doctors, especially those who specialise in accident and emergency, to raise the subject gently with the bereaved. I would have been eternally grateful had they done that with me those 22 years ago.
Before I conclude, I add a footnote about the events at Alder Hey hospital that triggered the drafting of the Bill. I, too, had constituents who were affected and a local hospital that was involved, and I therefore witnessed for myself the distress, grief and anger to which the Minister referred. Because of the death of my daughter and the post-mortem that followed, I, too, could have been personally involved. Had I been, the last thing I would have wanted—whatever the facts that may have been discovered—would be someone knocking on my door 20 years later and reopening a still very sore wound. I may sound like a coward, but some things that people demand that they know, I would rather not know. My hon. Friend the Member for South Cambridgeshire (Mr. Lansley) put it well when he said that there is a right not to know, as well as a right to know.
The Bill raises many more issues than those that I have mentioned. I readily accept that they are all important, that they are all difficult, and that none of them is party political. Using human tissue and organs can save the lives of others and is essential for medical research—that is why I support it—but we must not allow our enthusiasm to help others run away with us in the decisions that we take. Potential donors and their families must have equal consideration.
I realise that it is probably inevitable that I am on the side of the bereaved, and I feel no need to apologise for that. Even if others disagree with me, I hope that sharing Sarah's experience and my conclusions with the House may, in some small way, help this House to reach compassionate conclusions on all the intensely personal issues that are raised by the Bill.
§ Mr. Tom Watson (West Bromwich, East) (Lab)
This is a good Bill. As many hon. Members said, it is the result of a desire on both sides of the House to provide justice for the families of Alder Hey and Bristol. What better tribute could there be to the daughter of the hon. Member for Spelthorne (Mr. Wilshire) than that we can have an open debate about how we can advance compassion in medical science?
The hon. Member for Spelthorne made a powerful case for an opt-in system and advanced some creative ideas as to how we can improve the organ donor register. I should like to put it on record that I believe that the initiatives that the Government have taken in the past two years are excellent—not least, sending out licence reminders to 6 million people and encouraging electoral returning officers to add an opt-in system to people's voter registration forms. That obviously means that we can advance towards the target that the Minister discussed earlier, and 11 million people on the organ donor register must be welcome.
1024 I would like to take this opportunity to advance the cause of presumed consent. Many Members have said that they believe in a system of weak consent. When I first approached the matter, I believed that if a deceased person's body could be used to save a life, then a hard form of presumed consent should be included in legislation. I must say that I have changed my view because of conversations with my constituents, which is true of my approach to many debates in the House.
One such constituent is David Nix, who is a great man. He runs the organ Donor Family Network and, having received a small grant from the Department of Health, he operates the organ donor bus. Week in, week out, he tours the country and has signed up tens of thousands of people to the organ donor register. David convinced me that families must be involved in the decision to donate organs. When I attended a ceremony in my constituency to honour the memory of Sarah Lewis, I met Sarah's parents, David and Katherine. At the time of their maximum grief, only a few months after her death, they took solace from knowing that Sarah's organs had saved many lives. That helped them in their grief and convinced me that, if we are to introduce a form of presumed consent, parents must be consulted and have the right to veto, and that all the issues must be dealt with sensitively.
Transplants are the wonder of modern medicine. I hope that the Bill results in robust legislation that stands the test of time like the Human Tissue Act 1961—I agree with the right hon. and learned Member for Rushcliffe (Mr. Clarke) that that was a good Act. When the legislation was debated in 1961, medical science had not developed ways to transplant spleens, kidneys, hearts and lungs and to conduct multiple transplant operations. The 1961 Act has stood the test of time, but it is right for us to take the time to consider the advances of the next 40 years. I hope that the Bill will allow for future advances such as xenotransplantation and stem cell research, and that will be an issue in Committee.
As the Minister in the debate in 1961 said, the test of the Bill will be whether we can build public confidence and convince people that organ donation is morally right. The 1961 Act succeeded. As has been said, most market research shows that at least three quarters of the British public believe in organ donation, and some surveys show that 90 per cent. of the population believe in organ donation. If nine out of 10 people in Britain support organ donation, it is obviously a problem that only 15 per cent. of people are on the organ donor register. As the Father of the House said, one way of addressing that gap is presumed consent.
I have read the Father of the House's contribution to the 1971 debate, and I have read the five further contributions that he made throughout the 1970s. Although it was not unexpected, I was sad to hear the announcement of his retirement at the end of this Parliament. As a new entrant in 2001, I had the benefit of his support and advice when I moved a ten-minute Bill on organ donation last year. He is renowned for yielding to no one in pursuing what he thinks is right, be it organ donation, the sinking of the General Belgrano 1025 or, dare I say it, the decision of this House to enter Iraq. He will be sadly missed and I hope that he can still make a contribution after he leaves the House.
The House does not have a great reputation for introducing legislation that meets the advances of medical science. The Corneal Grafting Bill was introduced by the then hon. Member for Tonbridge in 1952, but we had the technology to do corneal grafts in 1900. It took the House 52 years to pass an Act with a framework with which clinicians could engage. I would like to think that we will ensure that we do not make that mistake again.
During the course of my research for the debate, I came across a Select Committee report from 1828 and a debate on the Bill that became the Anatomy Act 1832, which dealt with body snatchers. The debates arose because colleges could not teach medicine without cadavers, so a black market for them existed. If the Government do not reduce the gap between the number of people who require organs and the number of organs available for transplant, we will create a black market again. I do not want us to lack the courage to act today and thus create an eBay body-snatcher culture of the kind that we have read about in the press in the past two weeks. I hope that we can be bold, and that those on both Front Benches may be convinced not to close the door entirely on presumed consent, while trying to be as sensitive as possible to the views of parents and loved ones.
§ Dr. Richard Taylor (Wyre Forest) (Ind)
It is with some diffidence that I start by declaring an interest, because it is relatively unimportant compared with the major aspects of the Bill: I must own up to still possessing the skeleton that I bought as a student along with Gray's "Anatomy" and dissecting instruments—it cost the princely sum of £16. The language of the Bill is fairly incomprehensible, as I shall go on to illustrate in relation to more important matters, so I am not sure whether I have possession of the specimen only for the purpose for which I was so authorised to have possession of it. I am not sure whether I am legally allowed to lend it to my children for display in their schools during lessons in human biology. I am not sure whether I am allowed to sell it at what would be its value today of something like 240 quid. That is just one example of how difficult it is to understand provisions in the Bill.
At yesterday's briefing by Cancer Research UK, we heard that it thinks that the Bill's drafting is incomprehensible. It said:Complexity is not an excuse for opacity.I cannot resist reading to you, Mr. Deputy Speaker, a sentence from the Bill that Stephen McGinness of the Library staff drew to my attention. Clause 30(4) is a classic of incomprehensibility that says:Regulations under subsection (3) shall include provision for decisions of the Authority in relation to matters which fall to be decided by it under the regulations to be subject, in such circumstances as the regulations may provide, to reconsideration in accordance with such procedure as the regulations may provide".That is rather abstruse. I do not share the Minister's belief that schedule 1 is clear because several items in part 2 of the schedule—purposes not normally requiring consent—require the use of human tissue, so the situation needs clarifying.
1026 As many hon. Members have said, by far the most important aspect of the Bill is consent. Consent is crucial to patients, families, clinicians and, especially, pathologists. The word "appropriate" has already been discussed. Why are we in a position in which we require legislation on the use of human tissue, which is a basic necessity? It is because requests for operations and post-mortems in many hospitals have been delegated to the most junior member of the team for generations. The houseman who has only just arrived on the scene has no knowledge of what the pathologist is going to do. I myself have been guilty of obscuring the difference between the removal of tissue and the removal of a whole organ. I am probably one of the few hon. Members with experience of asking for post-mortems and transplantation. A basic and practical point is when is the best time to make such a request? Should doctors do it at the same time that they tell the family about the death, or should they bring them back the next day, ostensibly to collect their relative's belongings, so that they can ask them at an easier time? Is it an easier time for the doctors, or is it easier for the family? There are therefore practical issues that need to be addressed.
From the doctor's point of view, a post-mortem to confirm diagnosis and the effects of treatment is vital. Attendance at the post-mortem provides an educational opportunity for the clinical team, which is often split by shift working, to come together. An article in the British Medical Journal in October by the vice-president of the New Zealand Medical Association examined the effect of the declining number of autopsies on medical student training. It said of post-mortems:Attendance also heightens awareness of the large number of patients with multiple conditions and the level of uncertainty in medicine.That experience is not easily gained elsewhere, so post-mortems are still of great importance. Consent is crucial, and equally crucial is the method of obtaining it. I have a copy of the agreement form for post-mortems that is used in my own trust and which, I am sure, is representative of forms used throughout the country. It is daunting for a hard pressed doctor to find the time to supervise the answering of 14 questions with ticks and filling in two boxes. The Minister of State kindly said that she was determined that it would not be onerous to request consent. However, it will be onerous if we do not get it right, and I hope that the Standing Committee will address that in detail. My trust's consent form ends with a killer request:Please read the booklet 'Information for Relatives' before you sign this form.Much work therefore needs to be done on the way in which consent is requested. For example, should the pathologist be involved in obtaining consent?
I shall deal briefly with the Human Tissue Authority, because I am sure that it will be addressed at greater length in Committee. Codes of practice and licensing requirements are an essential part of its role. Provisions on its membership are loose in the Bill, but the Royal College of Pathologists would like representation, as 1027 would the General Medical Council. I shall not spend more than a moment talking about consent for the transplantation of organs, because it has been fully covered by the hon. Member for Spelthorne (Mr. Wilshire), who spoke from very personal experience. The right hon. and learned Member for Rushcliffe (Mr. Clarke) mentioned a serious drawback for practising clinicians. In the intensive care unit of the hospital where I used to work, we almost groaned when someone was able to donate organs for transplantation because of the time that that took to organise. People do not realise that not only kidneys, hearts and livers, but skin may be used, which is incredibly disfiguring and one of the things to which relatives can really object.
Research has been fully covered by the right hon. Member for Holborn and St. Pancras (Mr. Dobson) and the hon. Member for Norwich, North (Dr. Gibson). The crucial importance of human tissue to research has already been mentioned.
I will conclude with some warnings from practical pathologists that illustrate some of the points made by the hon. Member for South Cambridgeshire (Mr. Lansley). First, a practising pathologist in Manchester said:While the intention of the bill regarding tissues from the deceased is entirely laudable, it also legislates for tissues from the living. As a consequence, any use of human tissues for teaching not 'incidental to medical diagnosis or treatment' and all use for research will require explicit consent from the patientor the relatives. That is a huge burden. Another pathologist also emphasises the tortuousness, the lack of clarity and how hard the language is to follow. He even goes to say that he believes that there is a risk of defensive practices by pathologists, who may withdraw from activities that might put them at risk of criminal prosecution.
It is crucial to separate the retention and use of tissues from the deceased, which is emotive, from the use of surplus tissue excised for the good of the patients, which is obviously far easier to understand. So I welcome the intentions of the Bill, but I feel that there is a tremendous lot of work to do in Committee, and I am rather doubtful whether enough time will be allowed for that.
§ Mr. Deputy Speaker
Order. May I try to help the House? Four hon. Members are seeking to catch my eye. We must wind up the debate at 5.30 pm, or thereabouts. If the time can be shared, everyone should be satisfied, I hope.
§ Harry Cohen (Leyton and Wanstead) (Lab)
The hon. Member for Wyre Forest (Dr. Taylor) made a valid point about improving the clarity of the language used in the Bill, and I hope that the Government will take that on board and that that will come about in the later stages, as the Bill passes through Parliament. However, I welcome the Bill as a whole.
The Bristol royal infirmary and the Royal Liverpool Children's NHS trust, Alder Hey, cases were scandals, and it is right that the Government have come up with 1028 the Bill to address such issues. Body parts were kept without the consent or knowledge of parents and relatives, and the doctors failed to communicate with the families. Those families were denied their right to bury their loved ones wholly, and suffered subsequent anxieties. We have heard about some of those anxieties today, such as having to carry out multiple burials and dealing with the fact that some of the parts could have been experimented on without the family's consent.
The Bill rightly makes consent the principle for the retention and use of human tissues and organs. The post-mortem laws will remain unchanged. The removal and storage of human material at the direction of the coroner to determine the cause of death remains. Also, the police can still use human tissue for DNA testing to investigate suspected crimes—again, without consent. I want to return to those issues a little later in my remarks.
I welcome the principle of consent and the setting up of the Human Tissue Authority. It will have regulatory powers and responsibilities, including licensing for the specific purposes where it will be legitimate to store and use body parts. It will also have a general role in informing the public about the issues involved. When considering the creation of such quangos, what went through my mind was the Food Standards Agency, which is a good organisation—I am not critical of it—but it has a bit of a balance to address, and I sometimes think that it leans more towards the industry than consumers. I would not want that to be the case with the Human Tissue Authority. It is important that it recognises the public interest as opposed to those of the industry or, in this case, the pressure groups concerned with anatomy issues.
The authority will have the power to determine legally binding standards without oversight from Parliament. Again, I am not very happy about that. That means that the authority will not be as properly accountable as I would like it to be. The authority should report to Parliament annually to make it more accountable. Overall, however, I welcome the fact that it is to be set up.
The Bill rightly creates a new offence of trafficking in human bodies or body parts. That problem is very much linked to poverty and desperation, so it is absolutely right that such trafficking should be made illegal and subject to penalties. Harsher penalties should be imposed on those trading in organs than on the desperate people who sell them. However, the provisions on that should not stop proper organ transplants that would save lives.
We shall have to consider the modern ethical issues relating to reproductive and genetic tissue. Cell lines from stem cells can be used in the production of commercial products. There can be variations in the way in which the human material is used irrespective of how the original consent was obtained. That and the issues of whether the body part can be tracked back to the donor or whether the donor's or his family's privacy has been affected also create ethical questions.
Perhaps banks of tissues could be set up in the private sector—it is likely that they would be in the private sector—for subsequent profitable production. Therefore, the Human Tissue Authority should have the power to intervene if the use and storage of parts and 1029 tissues is deemed to be contrary to the public interest. The profits of a corporation do not provide sufficient reason for there to be a loophole that could lead to the retention and use of many body parts. I re-emphasise my point that the authority should not be in the pocket of industry when it considers such important ethical issues.
The Minister referred to the "Bodyworlds" exhibition. I think that it was an excellent exhibition. It was extremely educative. It had an art element as well as changing and informing perspectives on the human body and how it works, and on death itself. It would have been wrong to ban the exhibition, although it was banned in Germany, for example. It was seen by more than 100,000 people and they probably learned a lot. The Human Tissue Authority should have to consider all the issues involved with such an event and it should do so openly.
My main reason for wanting to take part in the debate is that I asked a parliamentary question about the rules for the removals of brains, and was told in reply that organs and tissues may be removed if a personwho has died has authorised that prior to their death".The removal can also be authorised by their relatives or by a coroner who can remove or retain organs on his own authority. However, if they are used for a subsequent purpose, he must obtain a separate authorisation. The organs may also be removedfor anatomical examination when a person has bequeathed his or her body for this purpose."—[Official Report, 4 June 2003; Vol. 406, c. 485W.]That was updated by the 1984 coroners rules, which state that the brain can be removed if that material, in the coroner's opinion, bears upon the cause of death and that it can be kept for such period as the coroner thinks fit. The coroner's opinion may not be openly stated and be in the public domain and the period might not be specified, so the organ could be kept for much longer—and those are only coroners rules, not reality.
I suspect that there may be loopholes, particularly in respect of major criminals—who sometimes hold a fascination that is out of proportion. I was amazed to read a report that Ronnie Kray was buried without his brain. Clearly, prior consent from Ronnie Kray or his relatives was neither sought nor obtained—which I found offensive. Although I asked a number of parliamentary questions, I could not get to the bottom of how that procedure was allowed and how widespread it is in relation to criminals. I have tabled another question asking whether Harold Shipman's body will be disposed of intact, and look forward to receiving the answer. Treating criminals in that way is a form of mediaeval punishment, showing contempt and disrespect post-death. It seems uncalled for and verges on barbarity.
Such practices also give rise to the possibility of Frankenstein-type experimentation. Together with the possible future reproduction of stem cells, the retention of the brains of criminals such as Ronnie Kray could make possible the recreation of criminals by a mad Dr. Frankenstein-type scientist or even by an officer of a state institution, perhaps accidentally. I am still not confident that such risks are ruled out by the Bill. There could be a loophole via the police, a coroner or the Human Tissue Authority that allowed such procedures, even if they were not explicitly or directly authorised. 1030 Such a loophole would be an abuse of the role of the state. Are criminals treated differently from other members of society? They are not mentioned specifically in the Bill, yet in the past they have been treated differently. Does Crown immunity come into this? I do not think that it should apply.
My hon. Friend the Member for Liverpool, West Derby (Mr. Wareing) made the point that mentally ill persons may be alone and unable to make reasoned, proper judgments. The Bill should be reviewed in Committee to give such persons greater protection and to clarify their position.
I very much welcome the Bill. The Government have been brave to tackle this issue and have done a good job in bringing the measure before us—but I hope that the aspects that I have mentioned will be reviewed before the Bill completes its passage through the House.
§ 5.4 pm
§ Dr. Evan Harris (Oxford, West and Abingdon) (LD)
I congratulate the Government on introducing the Bill, which has many good aspects. I also congratulate the Minister on her stamina in sitting in the Chamber throughout our debate. That is most welcome.
I declare a personal interest in the organ retention aspects of the measure because my father was professor of child health at Alder Hey hospital before Professor van Velzen carried out his unacceptable practices. My father was mentioned in the Redfern report—because he was involved in van Velzen's appointment—but he was completely exonerated by the General Medical Council.
§ Mr. Dobson
I thank the hon. Gentleman for correcting me. I said the wrong name in my speech. Van Velzen was indeed the villain of the piece.
§ Dr. Harris
I am glad that the right hon. Gentleman could make that point.
Events at Alder Hey are an example of what happened throughout the country, and of an old-fashioned paternalistic attitude. Something that was unacceptable on deeper reflection became routine practice. There is no doubt that, at Alder Hey and perhaps elsewhere, there was deviousness if not malice in the continuation of such practices, not simply with thoughtlessness or recklessness about consent, but with disregard to whether consent had been given.
As far as the Bill's provisions on retaining organs for research go, they are an appropriate response, as was the Government's action when the Alder Hey affair came to light. However, it should be stressed that pathology is an honourable profession. Pathologists are an essential part of a modern and effective health service. It can only be regretted that some of the side effects of the controversy mean that they have felt personally oppressed by some press coverage. That also applies to some extent to paediatricians. We can only be pleased that the reputation of Alder Hey hospital's clinical work, which, as others have said, is second to none, has been maintained after the controversy.
I want to consider presumed consent. I acknowledge with due humility the long-standing contributions of the hon. Member for Linlithgow (Mr. Dalyell) and the right hon. and learned Member for Rushcliffe (Mr. Clarke). 1031 The hon. Members for Broxtowe (Dr. Palmer) and for West Bromwich, East (Mr. Watson) introduced ten-minute Bills on the subject, and I understand that the hon. Member for Mitcham and Morden (Siobhain McDonagh) intends to introduce one. A broad cross-section of hon. Members have therefore made contributions on the issue. In 1998, I introduced a ten-minute Bill on it.
My interest arose from the time that I spent working on a renal ward as a senior house officer. I saw the other side of the equation—the people who were literally dying while waiting for transplants. However, in my three years in acute hospital practice, I also saw the donor side and how often that was handled badly, if at all. I am a member of the British Medical Association medical ethics committee and of the Transplant Partnership. I spent four years on a research ethics committee that considered research protocols, some of which used tissues. I currently chair the all-party kidney group.
Opinion is clearly split and we must acknowledge that both sides have strongly held views that have been powerfully expressed. However, the issue is so important that it places an extra onus on us beyond the usual practice of the House, which sometimes does not extend further than party political point scoring—I am as guilty as anyone else of that. There is an onus on the Government to allow a proper debate in the House and a public debate. As far as it is within their power, they should provide for a free vote, which should also apply to the payroll vote, given that the matter is an issue of conscience. Those of us who support presumed consent have a duty to try to deal with the concerns of the other side.
Those on each side of the debate have a duty not to fiddle the figures and to ensure that, when statements are verifiable and quantifiable, the evidence is presented at the same time. Simply making assertions and claiming that they are facts does not do justice to the issue.
We on our side of the argument must recognise the opposition of conscience of people who feel strongly about bereaved relatives' rights to consultation and veto. They may feel that those rights should be above the presumed wishes of the patients, above the interests of those dying while waiting and above the interests of the other set of relatives, who will soon be bereaved unless something is done. I hope that we make that recognition clear in our debates. However, we must start by recognising, as many have done, the need to increase the number of organs for donation, although I shall not repeat the figures that have been given. That is why we have a duty to be careful. I, for one, would drop my support for presumed consent if any of the following three things were demonstrated: that it was not effective; that there was public opposition; or that there was an ethical consensus against it. I hope, by the same token, that the Government and others, apart from those who have a fundamental objection of conscience, would drop their opposition to my proposal if they were shown evidence that it was effective, that there was public support and that there was not an ethical consensus against it. I hope that we will see that development in the coming debates.
1032 It is important to deal with some of the arguments against presumed consent. First, we should say what presumed consent is. It would give adults—it is important to note that it would not apply to children—the right and opportunity to opt out in multiple ways, such as using post offices, driver's licences or electoral registration forms. Such a scheme would promote discussion among relatives who would be asked at the appropriate time, the opt-out register having been checked, whether they knew of any objection that had not been registered. Of course, relatives would also be asked the usual questions about social history required for screening purposes. There is no difference between the two schemes in that regard, so it is not appropriate for the Government to argue that that need means that presumed consent could not work.
The difference between the two schemes is that under presumed consent, relatives would have to volunteer their opposition. Organs would not be taken despite there being no opt-out or evidence of one if that opposition were significant and taking organs would cause the relatives major distress. But the presumption would be that donation would take place. That has been shown to reduce the stress on relatives who would otherwise have to second-guess, and to increase the number of organs made available.
Presumed consent is also more likely to give autonomy to the person whose organs are involved. We know that between 70 and 85 per cent. of people want their organs to be used, but that when relatives are asked, 50 per cent. say no. That cannot be right. We are talking not about going against a person's wishes, but ensuring that we are more likely to satisfy those wishes.
The hon. Member for Spelthorne (Mr. Wilshire), in his moving and eloquent contribution, was very helpful in pointing out the stresses on relatives during the current process, even if that process is not practised, as in his tragic case, when he was not approached. I have to say, however, that the point of presumed consent is that patients would come first because their wishes would not be vetoed by the family. The interests of the relatives would also be taken into account because they would be less likely to be feeling guilty for saying no at the height of their grief, despite the patient having had no known opposition, and some good would then have come from the death of their loved one. Relatives would not be asked, as the hon. Gentleman suggested, "Do you wish to object?" They would be asked, "Do you know whether your loved one had an opposition to organ donation that we have not found on the register?" If the relatives answered no to that, they would then be given an opportunity to volunteer their own fundamental objections, but that would not be fished for as at present. That system has been acceptable to the public and to relatives where it has been used.
That is the soft system of presumed consent. No one is suggesting that organs would be taken against the fiercely held views of relatives. Indeed, the Government recognise in the Bill that there is a clash. From my reading of clause 4, it suggests that if there is a donor card that satisfactorily fulfils the requirements for appropriate consent—as the right hon. and learned Member for Rushcliffe said—relatives will not be able to veto that consent, in that opt-in approach. The question 1033 of relatives' views being against the presumed or actual views of the patient is not new in respect of presumed consent.
I want to deal with the question of evidence. In a press release yesterday, the Government said:There is no evidence that a policy of presumed consent increases the number of organs for transplantation.I find that surprising, especially when that statement is not accompanied by any dossier that I can find in the Library to verify it. In fact, the published evidence is that that policy has a positive effect. A review was published that stated:In three western countries there is evidence that changing to a contracting out system resulted in an increase in organs".That review is very clear, and first among its authors is Professor Sir Ian Kennedy, who is also the author of the Bristol review. The source for that information is The Lancet of 30 May 1998, volume 351, so there is some evidence there.
In October 1999, Transplant Newsletter reported the findings of an expert committee of the Council of Europe. At section 4.6.1, that report said:Presumed consent laws, when fully accepted, seem to benefit donation".That is another clear example of evidence from a review group. I can also cite, although I will not go into it, the paper by Paul Michielsen entitled "Presumed Consent to Organ Donation: 10 Years' Experience in Belgium", which appeared in the December 1996 edition of the Journal of the Royal Society of Medicine, volume 89, and a paper by Roels and Vanrenterghem in Annals of Transplantation, volume 1, No. 4, entitled "Legislative Aspects of Organ and Tissue Donation in Belgium".
If the Government are going to keep saying that there is no evidence that such a policy would be effective, they have to provide the data to hon. Members, because the data that I can find suggest that the expert view is that it does produce an effect.
Presumed consent is not the only game in town and those of us who support it are not of the view that introducing it is the only thing that needs to be done. We recognise the other steps that the Government are taking.
In respect of public support, according to this morning's edition of The Guardian, the Government have claimed that doctors do not support presumed consent, but the British Medical Association overwhelmingly supported a move to presumed consent. At the moment, there is not sufficient opinion poll evidence to tell either way what the situation is. I certainly would not back as good opinion poll evidence a listeners' poll on the "Today" programme, but it was interesting and I pay respect to the powerful advocacy of Richard Spurgin, who made a case for a change in the law.
Although I acknowledge the Government's attempts to increase the supply of organs, the paper recently produced by UK Transplant shows that there is a significant problem: when relatives are asked about transplantation, 50 per cent. say no. Only a small number are never asked and there is only a small number of cases in which organ donation is not considered. That deals with the question of the "required request" that was raised by the hon. Member for Spelthorne. My proposal could have a powerful effect and I ask the Government to give it a fair wind. They should allow and join in a public debate on this important issue.
§ Dr. Doug Naysmith (Bristol, North-West) (Lab/Co-op)
Although time is precious, I must refer to the very personal speech made by the hon. Member for Spelthorne (Mr. Wilshire). At one stage, he said, I think, that some might consider him a coward. I can assure him that nothing he said sounded in any way like cowardly behaviour to me.
I welcome the opportunity to take part in this debate on Second Reading for two main reasons. As a Member representing a Bristol constituency, I am well aware of the suffering experienced by parents during the events associated with paediatric surgery at Bristol royal infirmary and during the subsequent Kennedy report on those events. The Minister talked of distress, grief and anger. I certainly agree with her about that. Taken with the somewhat similar occurrences at Alder Hey, those events created the impetus to produce the Bill that we are considering today, which ought to ensure that the stress and pain associated with relatives discovering that organs had been retained from their dead loved ones' bodies—without their consent—does not happen again. I very much welcome that, as does almost everyone in Bristol.
My second particular interest is almost professional, in that before being elected to the House I worked as a research immunologist for more than 30 years. My work was mostly in pathology departments and frequently made use of human lymphocytes, lymph node tissue and occasionally other small pieces of human tissue. I know that the uses to which those pieces of tissue were put were at least sometimes of benefit either to the individuals concerned or to other people in the wider sense, and occasionally for both purposes. It is unlikely that specific consent was given for such procedures in every case—hon. Members should remember that I am going back more than 30 years—although I suspect that in almost all cases it would have been freely given if it had been properly sought, albeit that it would not always have been possible.
My right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) outlined clearly in his excellent speech the importance of being able to use small quantities of living tissue for experimental and investigative purposes. That conclusion was reinforced by the examples outlined succinctly and clearly by my hon. Friend the Member for Norwich, North (Dr. Gibson).
Although it is clear that the public need to be confident that strict guidelines and procedures are in place to control the use of organs and tissues both from cadaveric and living donors—whether to be used for transplantation, teaching or research purposes—it is crucial that regulations and guidelines are not drawn so restrictively that they inhibit necessary and worthwhile clinical medicine and research.
I have received two letters that illustrate that dilemma. One is from a distinguished emeritus professor of pathology at Cambridge, who believes that the Bill is too long, too complex and badly drafted. He believes thatwe have lost sight of the proper balance of the rights of the individual and the rights of society".1035 Others will have seen copies of the second letter from a consultant histopathologist in Manchester, to which the hon. Member for Wyre Forest (Dr. Taylor) has already referred. He is concerned that while agreeing that the provisions of the Bill regarding tissues from the deceased are entirely laudable, there will be problems in dealing with some aspects of the use of tissues taken from living donors. He says:The distinctions between diagnosis, teaching, quality assurance, audit and research are simply not as clear-cut as one might at first think and there are dangers of both defensive practice by pathologists withdrawing from activities which might put them at risk, and also of criminal prosecution for entirely harmless and socially beneficial activities. I would like to see a clear separation between the retention and uses of tissues from the deceased, which is highly emotive for some, and the use of surplus material by NHS laboratories for the common good, which should be allowed to continue without the threat of criminal sanctions.Although I do not necessarily agree with everything in that and some other quotations that we have heard this afternoon, it seems to me that some improvements can be made to this Bill, and I hope that my hon. Friend the Minister intends to be flexible in Committee.
I know that the Minister has made it clear that she does not see this Bill as a suitable vehicle for the introduction of presumption of consent permission, particularly for organ donation purposes. That is a pity—I have supported such a change for a very long time. I understand why she says that, however. Perhaps it would complicate the Bill too much, and even make it too controversial. It is really good to have all-party support for such an important measure, and I understand why she does not want to prejudice it. I hope, however, that she does not intend to include any provisions in the Bill or subsequent regulations and guidelines that will make its eventual introduction more difficult or even impossible.
§ Nick Harvey (North Devon) (LD)
I, too, welcome the introduction of the Bill. I have taken an interest in these matters since I was involved in the mid-1990s in helping to uncover the events at the Bristol royal infirmary. It is worth remembering that the parents involved at Bristol went through three subsequent sessions of anguish: first, losing a baby, which is a tragedy in itself; then, some years later, discovering that it was not simply an accident, as they had thought, but part of a wider picture; and, some years after that, coming to terms with the extraordinary news that they had buried babies who were not complete and, without their knowledge, had had parts removed. I want to pay tribute particularly to my constituent, Mrs. Michaela Willis, who, having gone through all that, still found the energy to campaign for an inquiry into the events at Bristol.
I congratulate the right hon. Member for Holborn and St. Pancras (Mr. Dobson) on setting up that inquiry, thus honouring a commitment made by his Conservative predecessor, who had pledged that such an inquiry would be held after the GMC proceedings. I also pay tribute to Professor Kennedy, who diverted slightly from his remit to consider this important matter and report on it separately.
1036 When what had been happening arrived in the public domain, people were astonished. When it became clear that it had been relatively common practice for years and had been going on more or less anywhere, they became more and more astonished and indignant. Immediately after that, the chief medical officer conducted a survey to establish just how widespread the practice had been and how far it had gone. We had meetings here with groups from all over the country who were worried about what had been going on in their local hospitals.
As a result of all those events, the relationship between the medical professions and patients has changed significantly. I do not think that things will ever be quite the same after the events of Bristol. Of course this is not the only factor in the change in the relationship between patients and doctors; the growth of medical information on the internet, for example, has made patients much better informed. The idea that the doctor is always right is part of a paternalistic tradition that, I am glad to say, seems now to be fading.
Many Members have spoken of the importance of striking a balance. They are right: no one wants to thwart medical progress. Recent developments in medical science have already necessitated the use of tissue that has been retained for many years. Who can say what may happen in the next few years? Who can say what new diseases or threats we may uncover, and what scientific breakthroughs may be made? In such circumstances, going back and looking at tissue could be valuable. We must not establish a regime that would prevent that, would traumatise professionals, or would simply make the process of obtaining consent for their important work too cumbersome.
What is most important is the position of patients and relatives, and the principle of informed consent that the Bill rightly attempts to introduce. There is copious evidence that many grieving relatives are only too willing to give consent—that, indeed, they derive comfort from the thought that some good will come from the use of organs or tissue from their loved ones for the benefit of others who may not have to suffer in the same way. It is, however, essential for us to ensure that the arrangements for consent are comprehensive, that consent is informed, that it is obtained sensitively and—as the hon. Member for Wyre Forest (Dr. Taylor) said—that the arrangements are not so heavy-handed that they are impossible to administer.
Presumed consent has been raised several times today. Let me say to those in favour of it that there is a real danger of our undoing the basic good that the Bill tries to do. We are trying to bring about a new climate, a new atmosphere of informed consent and a new relationship between patients and doctors. There is a real risk that presumed consent could undermine that. The hon. Member for Norwich, North (Dr. Gibson) said how easy it was to throw away trust, and how difficult it was to gain it. I merely sound a warning bell to my hon. Friend the Member for Oxford, West and Abingdon (Dr. Harris) and others about the risk of undoing some of the good that the Bill aims to achieve.
Let me also say that the public are nowhere near ready for a system under which they would be expected to opt out. There is not nearly enough public understanding. There would have to be a huge campaign of information and education for people to make sense of the system 1037 and participate in it. Such a campaign would always bring us full circle. As the Minister suggested, that, rather than the legal aspects, might bring about a transformation in organ availability. She pointed out that what was happening in Spain might be more to do with the boost in availability there than with the law itself.
I have an old school friend, also a constituent, who has been waiting a long time for a kidney transplant. As far as I can see, he is going to have to wait much longer. He shared one of his concerns with me. He was told—I am not sure that it is still the case—that if people are killed in a road traffic accident in the more remote parts of the west country, even though they have a donor card, have signed up and are on the register, the practical arrangements are simply not in place—in such a sparsely populated area with so many miles of road—to get the organs into the medical system to benefit someone who can make use of them. Much work remains to be done—I entirely accept that the Government have already embarked on some of the necessary good work—on improving the practical arrangements of organ donation.
There is a danger of thinking that the presumed consent issue will be some sort of magical solution; in truth, I am not convinced that it will. I shall keep an open mind when it comes to any votes, but I believe that a warning needs to be sounded that it will not be a magical panacea.
Having said that, the Bill stands every opportunity of providing a valuable legacy for those whose organs were improperly retained and for grieving relatives who went through so much pain, but fought on to see this Bill introduced. It is incumbent on the House to get the detail right. Some hon. Members will deliberate on the Bill in Committee, and I wish them well in that task.
§ Dr. Andrew Murrison (Westbury) (Con)
The Opposition welcome the Bill. It is a good Bill, and we have had a good debate. Twelve Back Benchers have spoken and, more importantly, we have heard speeches of real quality. That is just as well, because the pre-legislative input that we called for did not happen. As a consequence, the Bill has been robbed of the expert and informed contribution of people in the know in a complex and sensitive field. However, we are where we are, and we have to move on; and today's debate has been characterised by good humour and general consent. Indeed, the Bill is all about consent, drawing as it does on the Kennedy and Redfern inquiries into the unsatisfactory state of affairs at the Bristol royal infirmary and at Alder Hey in Liverpool.
In our general enthusiasm for the Bill, however, we should also be aware of the possible hurdles that it could put in the way of medical research, education and all the things that we hope will deliver us a better tomorrow. The hon. Member for Norwich, North (Dr. Gibson), with his long experience in these matters, reminded us firmly of that.
Between 1979 and 1985, I was in the foothills of my medical career at Bristol. Looking back, I can well recognise the patrician mind-set that led to the distressing circumstances revealed by Kennedy. To be fair to health professionals, they have gone a long way 1038 to put their own house in order, and I am pleased that they have largely welcomed this attempt to put good practice on a statutory footing.
I should like to deal with presumed consent. Although it is not expressly in the Bill, it has been raised by several right hon. and hon. Members. My right hon. and learned Friend the Member for Rushcliffe (Mr. Clarke)—I see that he is not in his place—supported it so well, and the hon. Members for Sutton and Cheam (Mr. Burstow), for Oxford, West and Abingdon (Dr. Harris) and for Bristol, North-West (Dr. Naysmith) also supported it. In two notable Back-Bench contributions, the hon. Member for North Devon (Nick Harvey) and my hon. Friend the Member for Spelthorne (Mr. Wilshire) took a contrary line. All hon. Members who were present would acknowledge that my hon. Friend's speech will remain with them for some time. All hon. Members bring valuable experiences to the House, and my hon. Friend demonstrated the value of them in his contribution. The Bill, as I understand it, is about making consent explicit and fully informed—or it is nothing. Presumed consent, I submit, is no consent at all.
We certainly need more organs to be donated, as the hon. Member for West Bromwich, East (Mr. Watson) said in his contribution. Although the majority of people are in favour of organ donation, many of us would be uncomfortable with the appropriation of body parts by the state in the manner that appears to be favoured by the British Medical Association. I hope that the Bill will help to restore confidence in the gifting of body parts, not make the public more suspicious of what for many, particularly in the light of recent events, is a shady, even slightly sinister, domain. For those people, the doctrine of presumed consent would not help.
For our part, we suggest a stronger role for the Human Tissue Authority in the popularisation of voluntary organ donation, and we are disappointed that that is poorly reflected in the Bill's wording. My right hon. and learned Friend the Member for Rushcliffe mentioned the organ donor card and its status in, his contribution—an issue that, I must confess, had not occurred to me. I am sure that we will examine that issue very closely in Committee, and table amendments that will improve the card's status, thereby increasing, we hope, the number of organs available for donation.
In response to the Adjournment debate led by my hon. Friend the Member for South Cambridgeshire (Mr. Lansley) on 29 April last year, the hon. Member for Salford (Ms Blears) said that the Human Tissue Act 1961 was "unclear" and "ambiguous". I was given a copy of it earlier today. It extends to two and a half sides of A4—how different from the measure before us today! Nevertheless, it was apparently unclear and ambiguous. In contrast, the hon. Lady promised us that, before the summer break, draft proposals would be available for parliamentary scrutiny that were "unambiguous and transparent". I regret that in both timing and intention, the Government have fallen well short of their laudable intentions.
The Bill is remarkably difficult to navigate, given that it is meant to lend clarity to the obscurities relating to the removal, storage and use of body parts. A number of organisations have voiced concerns, several of which we 1039 have heard today. There is a real risk that the vagueness of the Bill's wording and its lack of clarity in places will act as a disincentive to engaging in legitimate research and teaching based on human material. We will urge improvements on Ministers, to ensure that those working for our benefit—researchers and clinical teachers—do not feel that the heavy hand of the law will for ever be resting on their shoulder. The right hon. Member for Holborn and St. Pancras (Mr. Dobson) said in his excellent contribution that lawyers should be kept out of hospitals unless they are patients. He might have added that we should do what we can to keep doctors out of the law courts.
Cancer Research UK is worried that those making career choices in research are already inclining towards basic science, in preference to the clinical research that would embroil them in regulation and bureaucracy and the possibility of legal dispute. It has noted the implications for cancer registries of the Data Protection Act 1998 and the forthcoming implementation of the EU clinical trials directive, and fears that this latest initiative will add to the wheelbarrow of material that is preventing it from doing what it wants to do—improve the lot of people with cancer. That is the very last thing that those involved with Alder Hey would want.
It is important to point out that much of the distress caused by Alder Hey had less to do with the removal of organs than with the fact that they were stored and not turned to any great purpose. The hon. Member for Liverpool, West Derby (Mr. Wareing) will relate to that point, given his obvious constituency interest. Indeed, we are told that many parents would have been far less troubled had organs been used, and at least some good had come from their removal.
In examining the Bill, we must constantly remind ourselves that the general public apply different significance and weight to various types of human material, and to the various ways in which it may be handled and used. For most people, blocks and slides of tumour removed during surgery are a world apart from a cadaver in an anatomy suite, or a child's heart in a pot in a medical school. For most people, surgically removed tissue is uncontested waste. Few owners will agonise, for example, over the fate of a necrotising section of malignant colon, but the removal of an organ—diseased or otherwise—from a loved one after death has a completely different psychological and emotional context. It is important that the Bill in its final form reflects that reality.
The Bill does not take the opportunity to deal in any depth with the human anatomical displays that can pass as art in UK galleries. The hon. Member for Leyton and Wanstead (Harry Cohen)—he is not in his place—enthused about the activities of Professor Gunther von Hagens and his "Bodyworlds". But it is probably true to say that what one might describe as the Damien Hirst school of anatomy sails fairly close to the wind legally, and it is certainly regarded by many as not being in particularly good taste. With that in mind, I am not sure that so-called "qualifying" museums should be accorded the special status and freedom from licensing given by the Bill, as to do so would deny easy access by the Human Tissue Authority and its inspectors. We must bear it in mind that Professor Gunther von Hagens 1040 may hold exhibitions in the future and that an obvious place for them to be held would be in a qualifying museum.
We should remember that post-mortem suites, medical school dissecting rooms, research laboratories and their staff are already multiply regulated, scrutinised and licensed for all manner of things. Why then, when constructing the Bill, was so little attention paid to areas that are, arguably, far more opaque?
I am concerned about the lack of scrutiny of imported material and am worried that that could lead to exploitation. I recall with affection the skeleton that accompanied me throughout my medical school career. The hon. Member for Wyre Forest (Dr. Taylor) has a similar recollection, but unlike him I have no idea where my skeleton is now. At the time, however, I was informed that, like hundreds of others, it came from the Indian subcontinent to circumvent the difficulties that arise in this country from the process of skelatinisation. The Minister will probably say that that loophole—if loophole it is—is a matter for a code of practice, but I fear that the Bill leaves so many aspects to be covered by codes of practice in future that the House can have but little idea of what the actual landscape that will eventually result will look like.
The failure to make words crystal clear in the Bill risks repeating the mistakes of the Human Tissue Act 1961. I shall set out a few examples, starting with the notion of appropriate consent. Organisations that we have consulted are concerned that future research needs, of a sort that we may not be able to anticipate at present, may be precluded because of the difficulties inherent in the notion of appropriate consent. There is, for example, confusion in the Bill about the use of existing specimens for DNA work. It is necessary to be more explicit about the nature of consent so that researchers, institutions and charities have the confidence to proceed with their work, which will, in any case, be subject to the rigours of local ethics committees.
The Bill does not really get to grips with licensing. We can all understand both the need for proper premises and that they should be licensed and inspected, but does the Minister have in mind an institution, a building or just a suite of rooms? Under extant legislation, there are licensed teachers, who are hands-on—I remember them well from my time at medical school; they were doctors who carried out dissections and taught students and were very much in control of the situation. The Bill does not indicate who our future licensees will be: will they be chief executives of hospital trusts or pathologists on the shop floor? We do not know. What responsibility will the licensees have for end users—for research workers from Cancer Research UK, for example? Representatives from that organisation and from the Wellcome Trust kindly met several of us last night.
The Bill refers to "relevant material", but we are left with no great understanding of its authors' intentions. Human cells seem to be a common thread, but does that include acellular serum and plasma, which, for their owners, are just as much blood as whole blood is? Why should cell lines be excluded? They may be created outside the human body but they are still very much related to the donor of the index tissue. Too much in the Bill defaults to codes of practice, and too much latitude is given to Secretaries of State to amend it by order at some future date.
1041 In conclusion, I commend the Minister of State for introducing the Bill, with which my party is in general agreement. There are certainly some rough edges that might have been smoothed out during the pre-legislative scrutiny that we did not get, but we look forward to contributing in Committee so that the next time the measure comes before the House it will hold the confidence of the public, the research community and health professionals.
§ The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman)
If the House will forgive me, I shall begin by quoting something that the hon. Member for Westbury (Dr. Murrison) has just said:The Opposition welcome the Bill. It is a good Bill".I repeated that because I never expected to hear those words in the Chamber and I never expect to hear them again.
The hon. Gentleman's words sum up the tone of the debate. Members on both sides of the House have contributed their knowledge, experience and wisdom. The mood of the debate was constructive and it is clear that it will be followed by an interesting Committee stage, to which I greatly look forward.
Before I get into my speech proper, I want to pick up on one thing that the hon. Member for Westbury said. He said that Cancer Research UK claimed that there was evidence already that people who were deciding about their careers were choosing to steer away from clinical science in favour of basic science. The reason for that was that they feared getting involved in the difficulties that this Bill might impose.
I am a scientist. I know scientists—I have worked with them all my life, until I became a Member of Parliament in 1997—and I do not buy that for a second. I do not believe that such considerations feature on people's radar screens when they are making their choice of career.
If we are to have a constructive debate, in Committee and with scientists outside the House, we must all avoid hyperbole. It is important that we try to ensure that everyone understands what the Bill is about, and what its impact will be.
§ Dr. Murrison
The Minister needs to speak to Cancer Research UK, as I am sure he has in the past. I spoke to the organisation as recently as this morning. I understand that its survey of the vast number of students whom it is sponsoring for PhDs and other higher degrees has shown that about 70 per cent. are seriously considering doing basic science rather than clinical science, for the reasons that I outlined. I can do no better than quote Cancer Research UK.
§ Dr. Ladyman
I have no doubt that the organisation reported those figures. I simply do not believe them, or the survey. My extensive experience of talking to people making career choices in science makes it hard for me to believe that such considerations make it on to their radar screens. However, we must not get bogged down in that.
The background to this Bill is scandal. The organs of children and adults were routinely kept after postmortem examinations, without the knowledge of 1042 families. That was unacceptable, and the distress that it caused was immense. A practice that resulted in such tragedy for so many families may once have had its place, but it certainly has no place in today's health service.
The hon. Member for Westbury referred to the patrician mindset that dictated how many people involved in clinical practice at the time made their judgments. That mindset is not acceptable now.
The expectations of individuals and families are, quite rightly, that they should know what is happening. They should be consulted, and they should consent. Practice had to change, and it has changed, but the damage has been done. Families have discovered—sometimes many years later—that they did not bury their loved ones in the way that they had believed and expected.
Many hon. Members have spoken about their constituency experiences, and the hon. Member for North Devon (Nick Harvey) recounted the distressing experiences of some of his constituents. The Bristol and Alder Hey inquiries, and the Isaacs report, exposed not a bungle or a mix-up, but a scandal. We would be failing in our duty if we did not take steps to address it.
Of course, as the hon. Member for Oxford, West and Abingdon (Dr. Harris) said, pathology is an honourable profession. I would go further, and say that it is a vital profession. However, we do it no justice by ignoring the mistakes that have been made. I am delighted that the mood of the House is that we should not ignore those mistakes and that we should move forward with this Bill.
In January 2001, the chief medical officer published his recommendations, and the Government accepted them in their entirety. That has led to a range of linked initiatives, including the establishment, in April 2001, of the Retained Organs Commission to oversee the return of organs, to give guidance to trusts, and to give support and advocacy to families.
The Government published new post-mortem consent forms, and a code of practice on communication with families. We have allocated £2.7 million per year in the current spending round for trusts to use in the development of bereavement services. We are also supporting an ongoing programme of professional education and training and public education.
There have been changes and improvements in practice, and more are taking place right now, but the Bill is needed to secure them firmly for the future. That is why we looked at the whole picture and prepared a Bill that is comprehensive and forward looking. But we have not done it alone. Through extensive consultation, we have found much consensus among family groups, professionals and other bodies, and we are pleased to have had a strong contribution from family support groups throughout the country. We also received good support from many groups, including those from Liverpool, Birmingham, Cambridge, Plymouth and Oxford, all of which helped in putting together a well prepared and welcome Bill.
I was happy to hear the hon. Member for South Cambridgeshire (Mr. Lansley) commit the Opposition to working co-operatively to get the Bill right. Certainly, 1043 the Government intend to do that. My hon. Friend the Member for Bristol, North-West (Dr. Naysmith) asked whether we were open minded. As he knows, my hon. Friend the Minister of State and I have well deserved reputations for always being prepared to compromise, to see the other guy's point of view, and to go the extra mile to achieve consensus; and I doubt that our approach to the remaining stages of this Bill will be any different.
The hon. Member for South Cambridgeshire said that people often act in a way that they believe to be benign. He is absolutely right—the road to hell can be paved with good intentions. That is why we have to balance the rights of individuals against the needs of researchers.
The hon. Gentleman also asked, rightly, why we did not have pre-legislative scrutiny. We had hoped to do so, and to publish a Bill earlier, but it was simply impossible because drafting resources were unavailable. We therefore had to make a judgment call—do we balance the need for scrutiny against the needs of the families who are demanding that we make progress? We decided that making progress was more important than publishing the Bill in draft. However, given that we undertook two rounds of thorough consultation to reach this stage, we are not lacking the necessary level of scrutiny; and the Committee will provide a further opportunity to consider the Bill and to get it absolutely right.
Several hon. Members, including the hon. Members for South Cambridgeshire and for Wyre Forest (Dr. Taylor) and my hon. Friend the Member for Bristol, North-West, accused us of making the Bill too complicated or convoluted. It replaces several pieces of legislation, including the Anatomy Act 1984, the Human Tissue Act 1961 and the Human Organ Transplants Act 1989, and provides a single legislative framework in an area where there is confusion and uncertainty. If that was not the case—if the current legislation had the degree of clarity that we are trying to achieve—would we face this problem or have had these scandals? Of course not.
Although the Bill has its complexities, as does all legislation, it is important that we make the effort to try to get it right. I believe that it is simple and understandable, and that we will be able to explain it to the scientific community and to give them the reassurances that they seek. We have tried to make it as flexible as possible in order that it should, I hope, last as long as the Acts that it replaces, and several right hon. and hon. Members alluded to that. Instead of trying to include all the possibilities and to predict everything that science may throw at us in the coming decades, we have created codes of practice that can be changed as good practice changes. That is the right way forward.
The hon. Member for South Cambridgeshire pointed out that the status of grandparents in the consent hierarchy is missing. I give him a commitment that we will consider that in Committee.
My right hon. Friend the Member for Holborn and St. Pancras (Mr. Dobson) discussed whether consent would be wide and long lasting. He talked about the future uses of material and pointed out, as did the hon. 1044 Member for Sutton and Cheam (Mr. Burstow), that some discoveries relied on the fact that people were able to go back to old material. My hon. Friend the Member for Norwich, North (Dr. Gibson) gave some specific examples of that. The question was put whether medical staff must constantly return to relatives to obtain consent if new uses for material arise. The Bill sets out the fact that consent is needed for the use of tissue in research, but it does not limit the duration and breadth of the consent, so we would not expect patients to have to be revisited for further consents. I hope that that reassures them.
The hon. Member for Sutton and Cheam correctly raised the issue of bereavement services. The Government demand that NHS staff be sensitive to the needs of bereaved people when they gather consents, whether for organ donations or any other reason. He asked me a specific question about a follow-up survey, and we are supporting a survey, which I am pleased to tell him will begin in the spring.
My hon. Friend the Member for West Bromwich, East (Mr. Watson), the right hon. and learned Member for Rushcliffe (Mr. Clarke) and the hon. Member for Oxford, West and Abingdon all raised the issue of presumed consent. I suspect that we will return to that many times over the coming weeks, so I will not go into it in great detail. My hon. Friend raised the need to close the gap between demand for and availability of organs. I assure him that we are taking positive steps to increase the availability of organs. We have already made significant progress in reducing the gap between supply and demand without the need for presumed consent.
The hon. Member for Spelthorne (Mr. Wilshire) made a moving and very brave contribution to the presumed consent debate—I doubt whether I could have made that speech if I were in his position. I congratulate him on giving us the other side of the presumed consent issue. I say to those who support presumed consent that, if we own nothing else in this world, we own our bodies. There is no question but that we have the right to determine how our bodies are used in life and how they end up in death. If we move to a system that challenges that ethical principle, we will make a significant mistake.
The hon. Member for Oxford, West and Abingdon challenged the Government on whether in certain circumstances we might drop our objections to presumed consent. In return, I have a challenge for him: will he drop his campaign for presumed consent if we can show him in Committee that progress can be made without presumed consent, because it would not add significantly to the availability of organs, as he believes and hopes?
§ Mr. Kenneth Clarke
Has the Minister had time to take further advice on the Bill's effect on donor cards? Will carrying a donor card be sufficient evidence of consent so that other objections can be overruled if relatives disagree or cannot be found?
§ Dr. Ladyman
Carrying a donor card would take precedence, but since we would need to survey relatives 1045 for screening purposes and would never perform a transplant against the strong wishes of a relative whether or not we had presumed consent, in practice the situation would not change. As far as the Bill is concerned, the donor card is a clear statement of the individual's preference.
I shall correct one other point mentioned by the right hon. and learned Member for Rushcliffe. He said that the Transplant Partnership supports presumed consent, but I can tell him that it does not—it is the British Medical Association that supports presumed consent.
My hon. Friend the Member for Liverpool, West Derby (Mr. Wareing) asked whether the code will be enforceable in law. Not following the codes of practice will not trigger proceedings, but the authority may take not doing so into account when it comes to issuing, reviewing or withdrawing licences. I hope that I have dealt with most of the points that have been raised; we will deal with the other points in Committee. I strongly commend the Bill to the House.
§ Question put and agreed to.
§ Bill accordingly read a Second time.