My Lords, it is my pleasure to congratulate the noble Lord, Lord Hughes of Woodside, on his excellent, well informed and well argued maiden speech. The noble Lord comes to your Lordships' House with a wealth of experience in the other place as a former Minister and Front Bench spokesman for his party and with the reputation of one who has acquired in his long political career a depth of knowledge on Scottish affairs, transport and agriculture, to name but a handful of his political interests, which few can match. It is our privilege to have heard him speak this evening on yet another of his areas of expertise, that of health. I am sure all of your Lordships will have found what the noble Lord said both wise and persuasive, as well as elegantly put, and will, like me, look forward to many contributions from him in our debates in the future.
I join other noble Lords in thanking my noble friend Lord Norrie for introducing this important topic. I congratulate him on the clear way he did so. It seems to me that he highlighted the key issues which bear upon his Question. I should like to explore some of them further and elaborate somewhat on his conclusions. My noble friend, not unnaturally, focused particularly on kidney patients. As many kidney transplants are performed in the UK as of all other solid organ transplants combined, and while demand outstrips supply for all transplantable organs, and the need for more donors is self-evidently acute across the board, it is the lack of kidney donors which affects the greatest number of patients in clinical need. At the most recent count the active national transplant waiting list for kidneys—as my noble friend mentioned—stood at some 5,500 people, compared to the number of kidney transplants performed in a year of some 1,600 to 1,700. That gap between demand and supply has been growing steadily for at least 10 years due in part to the progressive decline in the number of deaths from road accidents and, it must be added, the scarce supply of intensive care beds in hospitals.
Unlike the patient awaiting a liver or a heart transplant, the kidney patient has an alternative treatment available; namely, dialysis. But dialysis, although life-saving, is, as my noble friend pointed out, 631 a second best option. It does not enable the patient to lead a normal life and it involves considerable physical discomfort. Compared to a transplant it is also much more expensive. A patient on dialysis costs the NHS approximately £20,000 to £25,000 a year. By contrast, a transplant operation costs around £20,000, followed by recurring annual costs of between £1,000 and £3,000.
Therefore, from the taxpayer's perspective, as well as that of the patient, a renal transplant is infinitely the preferred form of treatment for kidney failure. Yet, as we heard from my noble friend, the UK lags behind many of our European Union partners in the percentage of kidney patients who receive a transplant. How might it be possible to increase the number of kidneys available for donation? Raising public awareness of the issues is, I think, essential, and should be a continuous process, but it is not enough. The sad fact is that over the years such efforts have simply failed to make an impact. Public attitude surveys show that about 25 per cent. of the population is actively opposed to organ donation compared, for example, to 5 to 10 per cent. of people in Belgium. Persuading even a quarter of that 25 per cent. would make a huge difference to the available supply of organs.
In parallel with this come the options for legislative change. It does not perhaps need pointing out that any debate to modify the law is necessarily suffused and overlaid with questions of medical ethics. At the moment in the UK, doctors are required to obtain the confirmation of the next of kin that they have no objection to the removal of an organ and that they do not believe the donor would have objected. Frequently. this procedure leads to consent being withheld or, if not withheld, being obtained too late for an organ to be used in a transplant.
Are these requirements too strict? I shall not dwell too long on the arguments for introducing a system of presumed consent for organ donation or "opting out", as it is known. Such a system would cause grave ethical difficulties for the medical profession. But even setting those aside for one moment it seems to me highly doubtful, for a variety of reasons, that it would gain public approval, not least because people would feel that improper pressure was being put on them. A system of opting out has been adopted in both Belgium and Austria, and donor rates are higher in those countries than they are here. But it is far from clear whether one is the cause of the other. Of much more significance, some argue. is the clear difference to be found in those countries in public attitudes towards organ donation.
A more fruitful area for discussion, as my noble friend indicated, is elective ventilation. To permit a protocol of ventilatory support for patients who stop breathing after an untreatable stroke, solely to allow that patient, when brain dead, to become a donor is an idea which many surgeons see as ethically acceptable. For most, if not all, those surgeons, the procedure could take place only if all concerned, including the patient's relatives, had given their informed consent. But there are other practitioners who entertain the most profound doubts about the ethical acceptability of a procedure which does not respect the patient's own autonomy, which carries a risk of that patient being placed into a 632 persistent vegetative state, and which is inherently distasteful and undignified in that it manipulates the manner of a patient's death.
Elective ventilation also falls foul of legal difficulties. Here again, the issue of consent is central. Unless the patient himself has previously given specific, unambiguous consent to artificial ventilation for organ donation, that ventilation may not be permitted. No consent from any other source will do. The patient is alive; if a doctor is to administer treatment without consent, that treatment must be for the patient's direct benefit. Anything that falls outside this definition could constitute common law assault. These are the reasons which led the Department of Health to suspend the procedure some time ago.
In fact the difficulties do not stop there. I believe there are important practical issues relating to the capacity of intensive care units to devote resources to a type of treatment which is unrelated to a patient's recovery. However, I shall be interested to hear from the Minister whether she thinks that the legal difficulties are capable of satisfactory resolution. Does she think that the answer simply lies in a system of more detailed and informed consent by prospective donors? Or would she seek to go further and look for ways of permitting elective ventilation without such consent provided that certain conditions were met?
I wonder, too, whether the Minister could comment on another type of procedure where the law is at present unclear, at least to me. This relates to a technique for preserving in situ the kidneys of potential donors who are dead. As the noble Baroness will know, kidneys which have been taken from a patient who has suffered respiratory and cardiac arrest can be transplanted successfully provided they are removed within 60 minutes of the heart stopping. In those circumstances, the best way of protecting the kidneys prior to removal is to cool them by inserting a catheter. This procedure is of greatest use in cases of sudden or unexpected death where the next of kin are not on hand to give consent to the immediate removal of an organ: it buys time. The issue it raises, however, is the legality and ethical propriety of carrying out a procedure on a dead body without permission.
The technique I have described is one which has been adopted successfully in Leicester with, I understand, the approval of the local coroner and with no objections raised elsewhere. If taken up nationwide, it has the potential to increase the supply of organs for donation by a very substantial percentage. Can the Minister add her own perspective to this issue? Can she say whether health authorities might be encouraged by the Government to promote kidney cooling in non-heart-beating donors as part of a wider campaign to raise public awareness?
On a similarly practical level, I mention the role of transplant co-ordinators. This specialist discipline has grown up on a somewhat ad hoc basis over the past 15 to 20 years but is a key component in a hospital's ability to arrange organ transplants successfully. It is felt by many people that there should be a proper managerial structure for supervising and training transplant 633 co-ordinators and that this could usefully take the form of a national umbrella body to promote consistency across the country. Can the Minister say how far the Department of Health has progressed in its examination of this issue?
I wish for a moment to revert to the issue of dialysis facilities. For all this country's expertise in the care of patients with renal failure, we lag behind many of our European neighbours in the number of renal units and the number of new patients starting dialysis each year. The sobering conclusion from that is that some individuals needing treatment are not receiving it, or are not receiving it soon enough.
The need for dialysis can vary considerably by region. For example, I understand that renal failure is more common among the Asian community than in other ethnic groups, necessitating greater provision of renal facilities in Asian centres of population. More generally, many patients have to travel a long way in order to attend a renal unit. Indeed, I should like to share with the House some advice well known among patients with kidney failure in the West Country. Do not live in Wiltshire! The health authority there has turned down overtures from patients in the area to fund a renal unit in Swindon. As it is, patients are required to travel to Portsmouth, Oxford or Bristol for their dialysis. Has the Minister any news about the PH hospital project proposed for Swindon and can she provide any reassurance to kidney patients there that when the hospital is built there will be a dialysis unit in it?
On a separate but related point, will the Minister undertake to look at Wiltshire health authority's purchasing policy for renal services? Concern has been expressed to me that renal care is effectively being rationed in Wiltshire on cost grounds and that elderly patients in particular are being denied the care they need.
As my noble friend mentioned, the publication today of the Audit Commission report, Higher Purchase: Commissioning Specialised Services in the NHS is timely in this context because it identifies a number of ways in which health authorities could improve the manner in which specialised services including renal care are commissioned. I look forward to the Government's response to that report in due course.
The issues raised by my noble friend are of fundamental importance for many thousands of men and women. I hope that the Government will take on board the very real concerns that have been expressed and will confirm their determination to see more resources devoted to this key area of patient care. I look forward very much to hearing what the Minister has to say.
§ 7.15 p.m.
§ Baroness Wharton
My Lords, I am grateful to the noble Lord, Lord Norrie, for raising this issue tonight. My noble friend Lord Soulsby of Swaffham Prior would have taken part in the debate tonight were it not for the fact that he is on business of the House in Atlanta.
We have spoken many times about the ethical, moral and animal welfare issues involved in xenotransplantation. As an honorary associate of the 634 British Veterinary Association, I should like to put forward a view which covers the veterinary aspects as well as the animal welfare of the pig donors.
The first animal-to-human transplant was in 1906 when a French surgeon implanted a pig's kidney into one woman and a goat's liver into another. Needless to say, neither survived. But here we are, 91 years later and on the threshold of a break-through some few years hence. Previous speakers have already mentioned the acute shortage of donor organs and the waiting lists. Therefore I shall not go into that.
The long-term possibility of producing human organs or tissues in vitro, coupled with significant advances in mechanical devices, may eventually provide sources of replacement organs. The immediate need could be solved by the science of xenotransplantation, although some may not agree. The pig is the ideal animal for such work, having a relatively short gestation period (approximately 112 days) and producing an average of eight offspring per litter.
Progress to date in xenotransplantation has been to modify by 0.0001 per cent. the genetic make-up of the pig with human genetic material, so that when it is transplanted into humans it is not immediately rejected. In other words, the pigs are genetically engineered to carry human proteins on the surface of their cells. This will allow pig organs to be used as a temporary bridge for patients awaiting a human organ or, as has happened in the USA in the case of human liver failure, to use pig livers kept alive in a sterile container and perfuse them with the patient's blood, rather like kidney dialysis.
The ethical aspects of xenotransplantation have exercised the collective minds of several committees. The Nuffield Council on Bioethics concluded that the routine supply of pig organs was ethically acceptable and the report also identified the possible transmission of infectious disease as an important consideration. The Kennedy Advisory Committee set up by the Department of Health last year came to similar conclusions and recommended the establishment of the UK xenotransplantation interim regulatory authority to oversee developments in this field.
The British Veterinary Association's ethics committee has recently considered the issue of transplantation between species. The committee considers that it is not unethical to use, to modify genetically and to breed pigs so that their organs may be used in transplants into humans. Xenotransplantation is seen by the committee as an effective means of countering the current organ shortfall, since present and future needs for organs seem unlikely to be met by other means. However, and I stress this, the use of primate organs for transplantation into humans is considered unethical and totally unacceptable. The BVA also considers that the welfare of animals bred for transplantation should be carefully safeguarded and commercial pressures should not he allowed to jeopardise animal welfare standards.
Provided that the very real benefits in terms of the relief of human suffering can be achieved without causing unnecessary suffering to or adversely affect the 635 welfare of the pigs concerned, the committee does not object to the practice of xenotransplantation on ethical grounds.
Perhaps the most worrying aspect of xenotransplantation is the presence of viruses, particularly retroviruses, in donor pig organs which are capable of infecting human cell lines. Although it is not known whether such viruses can become established and cause disease in the recipient, the fact that recipients are immuno-suppressed adds a measure of caution. It may be possible to breed pigs free of retroviruses, though that is considered extremely difficult. An alternative would be to try to genetically engineer pigs so that they lack the ability to harbour retroviruses.
It is right that great caution is necessary in the introduction of that technology to human medicine and it is important that animal-to-human transplants are offered to patients only when there is a good chance that they will work. Obviously the patients themselves will have to be fully informed so that they can make an informed decision before accepting an organ from a non-human donor. I am sure that many committed animal welfarists might find this technology both ethically and morally unacceptable; but we must remember that pigs are already farmed for meat.
The welfare of these animals is paramount. The genetically engineered piglets will be born into a controlled environment. At that stage the unmodified sow will be lost; but it is to be hoped that in the future, when the herd has been built up, the by now genetically altered sow will be able to survive to suckle her young. They will be able to do all the things that pigs normally do and their quality of life will be carefully monitored. The RSPCA is concerned that animals might be reared in a sterile and barren environment; and the society's concerns also relate specifically to the consequences of xenotransplantation for animals.
I have talked to the noble Lord, Lord Soulsby, about this problem. He has observed the piglets and assures me that they are happy and well cared for. The RSPCA would also want to ensure that the five freedoms recommended for farm animals by the Farm Animal Welfare Council would be applied as a minimum basis for animal husbandry standards. They are freedom from fear and stress; freedom from pain and injury; freedom from hunger, thirst and disease; freedom from discomfort; and, finally, freedom to express normal behaviour.
The RSPCA's position as a charity would in any case not allow the society to oppose a use of animals that is considered by majority view to be of human benefit, but would ask that every attempt be made to find alternative solutions to the shortage of human organs before resorting further to taking the lives of our fellow creatures. Finally, we must also be sure that pigs do not suffer during organ removal.
§ 7.23 p.m.
§ Baroness Sharples
My Lords, I thank my noble friend Lord Norrie for initiating this debate. Noble Lords may recall a long time ago a determined campaign by Elizabeth Ward on kidney transplants, 636 because her young son, Timothy, had to endure years of dialysis. As a result of knowing the Wards over many years, I decided to change my will in order to donate my organs. My family are all aware of my wishes. I can understand that many people will not see things in the same way. However, I hope that this evening's debate will persuade some noble Lords seriously to consider doing as I have done. I have been told that I am too old for anyone to benefit from my decision! However, there are many young Members in this House who no doubt could, and should, follow my example.
§ 7.25 p.m.
§ Baroness Robson of Kiddington
My Lords, I, too, thank the noble Lord, Lord Norrie, for introducing the debate. I congratulate the noble Lord. Lord Hughes of Woodside, on his maiden speech. Being the final speaker before the Minister, I have listened to all the speeches. They have been very well-informed and I agree with most of the arguments advanced. I wish to concentrate purely on kidney transplants. I do not intend to talk about the transplantation of other organs.
It is a tragedy that there is such a shortage of donor kidneys. I wonder whether there is a thought in the back of people's minds that the matter is not all that urgent because, after all, people can live on dialysis. That might to some extent account for the lack of people coming forward.
There are, after all, nearly 4 million people carrying donor cards, who are listed on the NHS donor register. That is 7.6 per cent. of the population. It is quite a large number of people. But despite that large number, there have been only 15 donors per million of the population. The number has been more or less constant for the past seven to eight years. So there is something wrong in the way we approach this subject.
As the noble Lord, Lord Norrie, mentioned, the donor rate in Spain is much higher; it is 26.8 per cent. In this country approximately 1,700 kidney transplants take place per annum, of which 10 per cent. of the organs donated come from members of the family. That is a tremendous sacrifice for a family member, but something to which I believe the family member quite happily agrees. In other countries, such as Norway, 40 per cent. of donations are from the family. Noble Lords will realise that when a kidney comes from a member of the same family, the danger of rejection is very much smaller.
Every speaker has mentioned the Human Tissue Act 1961, which created the "contracting in" system. It required written consent by the person who wanted to contract in. However, when, 10 years later, we introduced the donor card, we failed to clarify and resolve whether the card constituted an authorised form of consent. I should have thought that that would be so. I should not personally carry a donor card unless I meant it to apply if anything happened to me. But that has not always been the case.
The problem has been made more difficult because the law has allowed relatives to countermand the wishes indicated by the would be donor. That is rather like allowing relatives to reverse a dead man's will in any 637 other form. We must respect the wishes of the donor. It is high time that the Government clarified the position of the donor and, I hope, make it the final arbiter in any decision as to whether an organ can be transplanted.
Those difficulties, as mentioned by the noble Lord, Lord Norrie, have given rise to some surgeons advocating the introduction of a contracting out system to improve the supply of organs. I would not be prepared to go that far. However, I should like to see a strengthening of the law so that where a person has indicated his wish to become a donor his wish may be carried out without interference.
Apart from the shortage of donors, we have the problem which was mentioned by most speakers of the care of people awaiting transplants in the National Health Service. The waiting list was quoted by some speakers. The number of people living on dialysis is highest in the age groups 30, 40 and 50. Only one in three of the people on the waiting list will receive a transplant in any one year.
According to the medical opinion which I have obtained, it is claimed that there is now no shortage of machines, but there is a great and growing shortage of staff, both nurses and technicians. Therefore, it is important that we ensure that the existing centres are fully staffed so that we can make the maximum use of the machinery we have at our disposal. The cost of dialysis was also mentioned. It is very great, much greater than the long-term cost of a transplant operation.
However, quite apart from whether it costs a lot of money, we must achieve a higher output of organ transplants because not only is there the hardship for the patient of having to attend a hospital, sometimes every day or for long periods during the week, but the illness also prevents the patient from living a full life and often from working.
Of course, not all hospitals perform transplants, but it may be that we have too many. The UK transplant audit shows that the relative performance of those hospitals varies by as much as 20 per cent. Iyy do not believe that that is acceptable. The standard should be level over the country. We need proper national standards and larger centres where the staff—both doctors and nurses—get enough experience to be able to achieve the highest standards attainable. We should not accept anything less.
What we also need above all, as was mentioned, in order to counteract the resistance to being a donor, is a nationally organised system of education for the public, emphasising that out of one tragedy there is the chance of giving a new life to someone who needs it desperately. We should be able to persuade the nation that that is what we should all consider. If you resist the thought of someone removing your organs when you are dead, you should turn your mind to the happiness it might give to someone else.
§ 7.33 p.m.
§ Baroness Jay of Paddington
My Lords, first I wish to thank the noble Lord, Lord Norrie, for giving the House the opportunity to debate these important issues 638 by asking his Question this evening. I also wish to pay tribute to the noble Lord's energetic leadership as President of the National Kidney Federation. As I am sure noble Lords are aware, the voluntary sector plays an important part in transplantation and organ donation. I am grateful to the noble Lord and others involved in the voluntary sector for the time they have taken to give me useful personal briefings since I became a Minister. I am also grateful for their important work in the field.
I also wish to congratulate my noble friend Lord Hughes of Woodside on a distinguished maiden speech, in which he revealed an authoritative and long-standing interest in the issues we are discussing tonight. Although he said that his translation from another place had not always been easy, in the context of this evening's discussion we could describe him as a very successful transplant. We look forward to hearing him a great deal in the future.
As is so often the case in your Lordships' House on issues of this kind, all the speeches have been extremely well informed and wise. But even in this brief debate we have seen revealed the variety of strongly held views on the subject which reflect the controversy not only about the ethics but the practice involved in transplant policy.
Perhaps I may begin by replying to the first part of the Question from the noble Lord, Lord Norrie, about the care of patients waiting for organ transplants. I believe that things are getting better. Significant progress has been made in improving the treatment of people waiting for organ transplants and the way that they are looked after, particularly in the area of renal dialysis. When the national review of renal services was first published last year, it was clear that there were marked differences in the provision of services which patients could and should expect. Compared with other European countries, as the noble Lord said, the number of new patients taken on in England for renal dialysis was comparatively low, but much has been done to address that in the recent past.
The NHS Executive has issued guidelines on commissioning renal replacement therapy which include a model to enable health authorities to project the number of people requiring treatment. Taken together with the health needs assessment review that is currently being updated, health authorities and clinicians will be able to work together to ensure that all patients with renal problems receive specialist assessment and, we hope, specialist treatment.
The good progress that has been made recently is evident in the preliminary information from a national survey which we will publish shortly and to which the noble Lord, Lord Norrie, referred. The survey was commissioned by the NHS Executive as a follow-up to the national renal review. I am pleased to report that it shows a significant increase in the numbers of patients receiving dialysis during the past few years since the original review was carried out and a significant reduction in the variation in new patients taken on for dialysis which was a feature of the previous survey.
There are as well increases in the numbers being prescribed important specialised drugs, in those using the modern disconnect system and those receiving 639 dialysis three times a week. As noble Lords will know, there is considerable variation in the proportion of patients using the disconnect system, but it is beneficial to many. For the benefit of anyone unfamiliar with it, as I was before I was well briefed by the noble Lord, Lord Norrie, and others working in the field, I should explain briefly that it is an enhanced system of continuous dialysis which enables the patient to be more mobile, to have more control and therefore to have a better quality of life.
The variations in the provisions of the system are not viewed with any complacency by the Government, and I hope that it will be feasible for all patients to have access to this higher quality, though it has to be said more costly, system as soon as local resources permit. However, inevitably it will take some time to achieve, given the pressure on renal services in some parts of the country, to which noble Lords have drawn attention. That is largely due to the increased numbers being taken on for treatment and the overriding need to ensure that patients are offered dialysis as soon as they need it. That has to take priority.
I am pleased to say that the new report also shows that since 1992 there has been a marked rise in the number of renal satellite units and a significant rise in the number of consultant nephrologists. Both the national renal review and the local report of the London Implementation Group a few years ago made recommendations for the future configuration of renal services which suggested that people adopt what is known colloquially as the "hub and spoke" approach, which included the use of more satellite units. That should reduce the distance which patients have to travel for treatment. As we know, that can place an unacceptable burden on the elderly and infirm and it can bring with it considerable costs.
The noble Earl, Lord Howe, raised the question in relation to Wiltshire of whether there was specific discrimination on the grounds of age in regard to kidney dialysis. I wish to make it clear that nationally we firmly adhere to the principle that NHS treatments should be open to all on the basis of clinical need. We would regard it as unacceptable for appropriate treatment to be denied on grounds of a patient's age alone. However, there are clearly issues like the general health of the patient that are taken into account when discussing with a patient and carers whether to embark on renal replacement therapy. But I can assure the House that there are many patients over the age of 70 who are currently receiving renal dialysis.
The noble Earl, Lord Howe, raised that question specifically in relation to the PFI undertaking in regard to the new hospital in Swindon. All I can say at the moment is that there are threatening matters which seem to suggest that a successful conclusion of the PFI arrangement may not be reached as quickly as we had hoped. It was one of the arrangements which was prioritised by the new Government in the summer. We hope that it will meet its deadlines and milestones by financial close, which should happen by the end of the year. If the PFI deal does reach a successful conclusion, it is expected that there will be adequate renal services included in it.
640 Perhaps I may return briefly to other national initiatives which we think will be helpful. They include the National Renal Registry, funded in part by the NHS Executive, which will provide an up-to-date clinical audit covering several aspects of treatment. The NHS Executive is also funding an update of guidance on how to conduct an epidemiological needs assessment of renal failure. We hope that that will help health authorities in assessing a likely level of need in their population.
In addition, the NHS Executive funded a health technology assessment of renal dialysis based on a comprehensive review. That will be widely disseminated. Finally, a report on standards of renal dialysis will be published shortly by the Renal Association and the Royal College of Physicians. The executive intends to help with the cost of disseminating that to the NHS.
In connection with those national initiatives on service standards and clinical effectiveness, I emphasise that it is this Government's clear intention to pursue a policy of national benchmarking for all types of complex therapies and treatments. I hope that when our White Paper on the NHS is published, which will be shortly, noble Lords will see that among its primary objectives is the establishment of monitoring methods for measuring the quality of care and the outcomes for patients. Those will be the touchstones of success by which the NHS will be judged in the future, and I expect them to produce greater consistencies of treatment across the country for all types of therapies.
I turn to the second part of the noble Lord's question in relation to the donation of organs for transplant. Each year in the UK some 1,500 kidneys, 300 hearts, 150 lungs and 600 livers are transplanted from fewer than 900 donors. Sadly, in 1996, for the first time there was a fall in all of those kinds of transplants. The main constraints for all transplants is on the pool of potential donors, and that is something to which noble Lords referred this evening. That pool has been shrinking for some years due to the reduction in the number of road accidents and the improvement in the treatment of stroke and other sudden brain injuries. What is clearly a great improvement in the well-being of one section of the population, for one set of patients, has paradoxically been a major disadvantage for another—for those waiting for transplants.
As all noble Lords who spoke in the debate emphasised, we all want to see donations increase. We shall therefore continue to encourage organ donation through national and local publicity campaigns aimed at persuading people to join the NHS donor register, to carry a donor card at all times and, very importantly, as noble Lords emphasised this evening, to tell their families of their wishes. Already, as the noble Lord, Lord Norrie, said in introducing the debate, 4.5 million people joined the organ donor register and applications are coming in at the rate of 20,000 a week. I do not believe it is a rash pledge to make: I am pretty confident that we will reach 5 million by the year 2000, as the noble Lord asked me to project.
People can register as donors at their family doctor surgery when applying for a driving licence or passport or they can obtain a form by ringing a freephone 641 number. I have no shame in your Lordships' House in giving a commercial for that freephone number. It is 0800 555 777. Perhaps if it is recorded in Hansard we shall reach 5 million tomorrow.
I have had a series of meetings over the past few months with representatives of the medical profession and organisations involved with organ donation, including, as I said at the beginning, the noble Lord, Lord Norrie. They have been helpful in producing different views on the ways in which donations could be increased. I commend the actions of those organisations; I was greatly assisted by my discussions with them. But I draw attention also, as did the noble Baroness, Lady Sharples, to the work of the British Kidney Patient Association and its president, Mrs. Elizabeth Ward. The BKPA is supporting the work of the organ donor register by carrying out an intensive recruitment drive in one area. I shall be interested to see the results of that exercise, which may prove to be a pilot for a wider programme.
In some parts of England programmes of training are being held to help clinicians deal with grieving families and to try to find the best ways of discussing donation with them—a subject raised by several contributors to tonight's debate. That has the aim of securing their agreement that organs may be taken. In other programmes some hospitals are looking into ways in which they might identify and maintain more potential donors and so increase the number of organs. Again, I am keen to learn the outcome of those different methods of approaching the problem. Several of them may produce models for national programmes.
As the noble Lord, Lord Norrie, suggested, we will continue to examine information received in relation to donation and transplantation programmes abroad. We need to learn all the lessons that we can from them. The noble Lord, Lord Norrie, specifically requested that people should visit Spain. I can say to him that consultants working for the UK Transplant Support Service Authority have already visited that country and prepared a report on their findings. We are also in touch with the Spanish transplant community through the Council of Europe. If more information is needed, we shall certainly consider another visit to Spain.
As several noble Lords emphasised, the law in this country allows organs to be taken from a person who has died and left instructions to that effect. It also allows organs to be taken if the deceased person left no such instruction, provided that the family does not object. Unfortunately—I was surprised to learn this—relatives object in around one-quarter of all cases. My noble friend Lord Hughes of Woodside drew attention to some of the reasons why there may be concern among families.
As several noble Lords suggested, it could be that the loss is overcome by introducing an opt-out system whereby organs may be taken from any person unless that person had expressed objection. However, on the other side, it has also been said that relatives would be just as likely to object if such a scheme were introduced. Some people would like to see relatives prevented from objecting to the donation, and several noble Lords 642 referred this evening to the attempts of Lord Finsberg to bring that into law. As my noble friend mentioned, a further unsuccessful attempt was made in another place.
Common sense suggests that it is difficult to imagine doctors asserting a right to remove organs against the wishes of a grieving family. In any case, refusal by the patient's family is almost unknown when the relatives know that their loved one wished to donate. That is why our publicity stresses and will continue to emphasise, "Let your family know your wishes". That point was eloquently reinforced by the noble Baroness, Lady Robson.
The problem in regard to elective ventilation is one that has—if I may mix my metaphors—been well aired this evening. The noble Lord, Lord Norrie, gave us an eloquent explanation of the case for that. I fully understand the motivation for looking at the potential means of increasing organ donation through that route. However, it is a controversial and difficult subject and we would need to take both the legal and moral issues carefully into consideration. Addressing the point raised by the noble Earl, Lord Howe, there are anxieties in relation to the legal situation which may be resolved if more clever brains than mine were put to it. But it is not easy to respond to that point in a debate such as this.
What does elective ventilation involve? The process is that patients on ordinary wards who are expected to die shortly would be, with the permission of their families of course, taken to intensive care and placed on life support systems so that once death was pronounced their organs could be maintained until they could be removed for transplantation. At the moment—this is where we enter the legal minefield—as the law stands the practice is illegal. As the noble Earl, Lord Howe, made clear, any intervention made without the patient's consent must be in the patient's best interests or it will be judged as an assault. Clearly, elective ventilation in the circumstances I have outlined cannot be described as of benefit to the patient being treated. The procedures involved are not minor and could clearly be interpreted, in the legal niceties, as assault.
Elective ventilation is illegal at the moment, so why not change the law to overcome that obstacle? Again, as I said just now, this is not simple. A change in the law would hinge around consent to treatment. As one who sat for nearly two years on the Committee on Medical Ethics of the noble Lord, Lord Walton of Detchant, I know how difficult and how long drawn-out these discussions can be. The general principle that a person may not, without consent, be given treatment which is not in his or her own interests is an important one. It would be very difficult to modify it, as we have discussed in many different contexts.
On the other hand, my noble and learned friend the Lord Chancellor is reviewing the recommendations of the Law Commission on mental incapacity and consent. There will, I am sure, be further opportunities to look at all of these issues, but I would emphasise that, even in the broadest terms as described under the Law Commission's recommendations, an advance directive, as it is called, cannot direct doctors to do what is illegal. I suspect that we would very soon enter into the 643 problematic area of definitions of what constitutes death. We all remember the controversies of a decade and a half ago when disputes about the definition of death as being brain-stem death led to a collapse in organs being offered for transplantation. It was thought that they might be taken at a time when brain-stem death had been agreed but that was not publicly or culturally accepted.
To attempt any such change in the law we would also have to be sure that elective ventilation was the best way forward in terms of practice. Can we be certain about that? The noble Earl, Lord Howe, made the point that many people both inside and outside the medical profession have grave reservations about the possibility of subjecting a patient to invasive procedures which would be of no benefit to that patient but were aimed solely at maintaining organs for eventual transplantation into others. Indeed, a report by the British Transplantation Society found that, of 97 intensive care units which had considered elective ventilation, almost 60 per cent. were opposed to the practice. That is not surprising because, as I have tried to describe in a very short time, the issues are difficult and the questions surrounding anticipated death are worrying for many people. Any move forward in this direction must have the confidence of the general public in order to be sure that we do not raise difficulties and scares which might lead to a worsening of the situation rather than the improvement which we all want to see.
The noble Earl, Lord Howe, referred to the question of cooling kidneys and the possible potential for taking that forward. He referred in particular to the practice that has been occurring in several local areas. As he will know, this is known as non-heart beating donors. We are aware that some protocols are in operation in different parts of the United Kingdom. But, again, the issue is not clear-cut. To decide on a legal change, it would be necessary to look at each protocol and see what was proposed. I would be very interested to hear what the outcomes of this practice are. But we need to emphasise again that public confidence must be maintained. This could be another area where bad publicity could arise, which, I believe, is what happened in the United States when non-heart beating donations in some areas resulted in a fall in organ donation.
We are talking here about general cultural attitudes, a point raised very eloquently by the noble Baroness, Lady Robson, at the end of her contribution. It is difficult to foresee how we make changes to the law which in a sense run ahead of changes in cultural attitudes to transplants. My belief is that we need to work more firmly and directly on the kinds of considerations that the noble Baroness raised about the need for gifts of life before we can seek to change the law in an area where many people may feel threatened.
Several noble Lords who spoke, notably the noble Lord, Lord Morrie, and the noble Baroness, Lady Wharton, raised the possibility of transplanting animal 644 organs into humans—the process known as xenotransplantation. I would say to the noble Baroness, Lady Wharton, that the questions of animal welfare are being taken very much into account in the protocols surrounding the interim authority which is looking after these issues.
Several noble Lords raised the question of the Kennedy Report about transplanting animal tissue into humans. The report concluded that the potential benefits of xenotransplantation made it an important avenue to explore, but there is insufficient evidence to justify an immediate move to clinical trials involving humans. We are all concerned not just about the possible infection risks but about the likely efficacy as well as the ethics of any such procedure. We must be as sure as we can be, for the good of both the individual patient and for our wider population, that the procedure may work, that the organ will not be rejected and that infection will not be transmitted to the patient and thence to a wider population.
Having said that, we clearly see the potential of xenotransplantation. Recently, I visited Imutran, a British firm which is at the leading edge of developing this technology. I was extremely interested to hear about its work and to see the transgenic pigs it is breeding. The United Kingdom Xenotransplantation Interim Regulatory Authority, very wisely chaired by the noble Lord, Lord Habgood, is charged with advising the Government on these important developments. I am very grateful to it. The authority has worked hard during its first six months. We are now looking at its proposals to take its work forward and considering whether or not it is appropriate for it to become a statutory commission.
I have covered much ground today. I am aware that time is running on and that, although the debate is not timed, I should now conclude. I simply want to say that further management as well as medical developments need to be considered before we take any further decisions about the reorganisation of the transplant system. The noble Earl, Lord Howe, raised the question of an umbrella body to look after transplantation policy. Certainly, a review of the Transplant Special Health Authority is being looked at. That is something I shall want to consider.
On the general question of organ transplantation, we are looking at all the different issues raised by various noble Lords today which have been expressed in ways which reveal, as I said at the beginning, both their authority and their wisdom on the subject. I say to the noble Lord, Lord Morrie, that I hope he will accept that we have an open mind, that I do not think we are afraid of being brave in this area, but that any action the Government take must be based both on widespread consultation, as my noble friend Lord Hughes suggested, and also on the basis that the public will come with us and will not be frightened by any measures we take.
§ House adjourned at three minutes before eight o'clock.