HC Deb 29 January 1997 vol 289 cc315-21 12.30 pm
Sir John Hannam (Exeter)

I am pleased to have this opportunity to raise an important issue of public health—the transplantation of kidneys and other organs, and the decline in the number of organ donors which is being experienced in the 1990s after a steady rise in the 1980s. Some 20 years ago, in the 1970s, there was a great deal of optimism about an abundance of kidneys for transplants—we just had to go out and get them. Some 20 years later, it is plain that such optimism was very wide of the mark.

During the 1980s, various factors combined to increase the number of kidney transplants from 814 in 1981 to 1,736 in 1990. Despite that, the waiting list of patients doubled from 2,000 to about 4,000, and the latest estimate is of more than 5,000. We need about 3,500 transplants a year to meet the demand. Since 1990, the number of transplants each year has fallen despite intensive efforts by the Government and health authorities to obtain kidney donors. The current refusal rate in the United Kingdom for organ donation is 25 to 30 per cent., but that is radically corrected if relatives know that a potential donor had wished to donate organs.

The excellent report by a working party of the British Transplantation Society makes several suggestions for improving the situation. However, I should like to concentrate on a method that was introduced in the Exeter transplant unit in 1988 but which had to be abandoned in 1984 after ethical objections, which resulted in a ban on legal grounds by the Department of Health.

The system is known as elective ventilation or interventional ventilation. Under it, patients who were dying, mainly from strokes, were put on ventilators in the intensive care unit until they were declared brain-stem dead, at which point their organs were retrieved for transplantation. That was done with the full permission of the patients' relatives and of clinicians, and in accordance with the Exeter protocol.

The Exeter unit achieved significant success with elective ventilation from 1988 to 1994. Whereas, throughout the country, dialysis numbers were steadily increasing, in Exeter they remained constant and under control, and the number of transplants went up year by year. In 1993, the Exeter unit performed 43 transplants and was one of the busiest in Europe, based on transplants per head of population. It had an 80 per cent. increase in donors. In 1994, when the system was banned in the second half of the year, there were only 23 transplants. In 1995, the figure dropped to 20, and was down to only 10 last year.

In 1993, with optimism running high at the unit, the Exeter and district community health council reported, a patient in Exeter could almost be guaranteed a transplant within 12 months. Sadly, that has now radically changed, and, as the transplant rate has gone down, the number of patients on dialysis has grown. There is a national shortage of donor organs, because the number of deaths among those whose organs are suitable for transplantation has decreased. For example, because of increased car safety, there are not as many road accidents.

Renal units are full of people who cannot receive transplants because of difficulty over the supply of kidneys. The consequences of that for patients' quality of life and for the effective use of resources has been devastating.

In October 1994, as a result of a medical practitioner in, I think, Bristol complaining that, under existing legislation, it was illegal and unethical for a patient to be kept on a ventilator when there was no hope of survival purely to accommodate procedures of contact with relatives to gain approval for organ donation, I took a delegation of renal experts to see the Under-Secretary of State for the Home Department, my hon. Friend the Member for Bolton, West (Mr. Sackville), to try to find a solution to the problem.

The Minister was sympathetic but was reluctant to move towards a change in the law on this ethical problem in the absence of consensus within the medical profession. He suggested that the profession should consult and seek such a consensus, following which the Government might legislate to bring us more into line with most other European Union countries in which procedures allow seriously ill, comatose patients to be routinely admitted to intensive care units while undergoing investigation, often while ventilated. In those countries, interventional or elective ventilation is not necessary: patients already receive such treatment.

We are caught in an ethical trap. Our common law principles state that patients have the right to give or withhold consent to treatment, but that such consent extends only to treatment that is intended to benefit the patient. If, as in these cases, the patient is unconscious, treatment may be given in the absence of consent, but only to the extent that is necessary to save the patient's life, and provided it is not against the patient's known wishes. If the clinician considers that there remains any possible benefit from intensive care, the treatment is lawful. The problem is that of obtaining the consent of a patient who is effectively brain-stem dead.

Throughout the country, thousands of relatives and renal consultants would like legislation to re-establish elective ventilation as a possible avenue to organ donation in cases where both the transplant and intensive care unit teams are in favour; where the next of kin agree; and where pressure on the unit's facilities permit.

The working party of the British Transplantation Society, in taking account of ethical concerns in the medical profession, proposed that certain precautions should apply. For example, it proposed that a clinical trial by a nationally agreed protocol could assess the risk of persistent vegetative state, which is one of the worries that has been expressed. In 1995, the British Medical Association asked the Government to introduce legislation, and, on the issue of ethics, both the BMA and the Royal College of Physicians have approved of elective ventilation, as have health trusts and health authorities.

The report by Exeter and District community health council, which was compiled between April and September 1996, states that the council did not meet a single individual, whether patient or professional, who supported the current ban on elective ventilation. I have a letter from Frank Howarth, the co-chairman of the National Kidney Federation, which represents more than 24,000 renal patients in the United Kingdom. The letter states: The current waiting list for kidney transplants in the UK at 31 December 1996 was 5,421; therefore, it is imperative every avenue is explored to ensure this waiting list is reduced. I was fortunate enough to receive a kidney transplant in 1991, which still functions well and will testify to the difference it makes—it really is the 'Gift of Life'—and the most cost effective method of dealing with end stage renal failure. Elective ventilation was the subject of a discussion document published by the British Transplantation Society in September 1995 This paper outlines a recommended protocol and, amongst other recommendations, recommends the Government should introduce legislation to enable elective ventilation to be re-introduced as an avenue to organ donation by making specific exemptions from the requirement to treat for the patient's own benefit. I also have a letter from Professor Fabre, of the Institute of Child Health, and should like to quote a couple of important passages from it. He writes: elective ventilation remains a potentially extremely valuable additional avenue to organ donation and, most importantly, it is a source of donors entirely distinct from and additional to the current pool of potential donors. Every single donor obtained by elective ventilation is a donor that could not possibly have been obtained by any initiative other than elective ventilation (or a massive increase in intensive care facilities). When the Minister says that there is no evidence that elective ventilation increases organ donation, it is clear that he does not understand this fundamental point. Professor Fabre continues: The Department says that it will not contemplate changes in the law for elective ventilation while the medical profession is divided. This is a transparent cover for sitting on their hands. They know that the medical profession (and indeed any other group) will always be divided on any ethical issue. Abortion is a good example where differences of opinion (strongly held) do not preclude legislation on the basis of a broadly held consensus, with doctors and patients proceeding as their individual consciences dictate. Elective ventilation has the support of the BMA, the Royal College of Surgeons, the Royal College of Physicians, the Royal College of General Practitioners and several other august bodies. This hardly represents a divided profession. However, the Department has not taken a single constructive step or made any suggestions whatsoever as to how we might proceed on this issue. My feeling is that it does not matter how many influential medical organisations support elective ventilation. Fear of the vocal minority will keep the Government from acting. Powerful bodies of medical opinion have found the procedure ethically justifiable, yet the clinical practice has been stopped by a point of law raised by some medical practitioners.

On an emotional level, I remind the House that many families with a terminally injured loved one would prefer to have the opportunity of saying their farewells while their loved one is still on the ventilator, with blood circulation maintained, rather than when he or she is completely brain-stem dead and with the ventilator switched off. Those relatives might also take solace from the thought that organ donation gives life to several other desperately ill patients, and that some good will come from their personal tragedy. It is well known that such thoughts sometimes help grieving relatives to come to terms with their loss.

I ask my hon. Friend the Minister to accept the case for giving elective ventilation a chance—to enable a substantial increase in kidney transplants and many more heart, lung and liver transplants. By doing so, the overall benefit to patient care in Britain will be considerable, and the anguish of many sufferers will be relieved.

Last weekend in Taunton, a young man was admitted to hospital suffering from a massive brain haemorrhage. He was obviously going die, but his wife—who was extremely well informed on the transplant crisis—asked that his organs be used to help others. That young wife was most aggrieved when she was told that, under current law, her husband, because he was going to die, could not be put on a ventilator. Her sense of bereavement was intensified.

I hope that my hon. Friend will take the initiative now in asking the leaders of our esteemed medical colleges to set up without delay a working party to secure a consensus on this matter, which we all desire.

12.43 pm
The Parliamentary Under-Secretary of State for Health (Mr. John Horam)

I am grateful to my hon. Friend the Member for Exeter (Sir J. Hannam) for providing this opportunity to speak about organ transplantation—which is a wonder of modern medical science and has, as he said, truly been the gift of life for so many people. I appreciate his long interest in health and disability issues. In this debate, he spoke with his customary eloquence and feeling.

It has been little more than 30 years since people diagnosed as having end stage renal, heart or liver failure were bound to die within a few months. Thanks to the marvel of organ transplantation, it is now possible for such people to live long and active lives—to work, to enjoy taking part in strenuous sports—and to do all those things that fully fit people can do. I pay tribute to the doctors who regularly perform those modern miracles, and to the nurses, transplant co-ordinators and other support staff who contribute to transplantation.

I should also like to express my deepest gratitude—I am sure that all hon. Members in the Chamber, although they are few in number, will join me—to those who have donated their organs so that others might live. In the United Kingdom each year, more than 1,500 kidneys, 300 hearts and 600 livers are transplanted, thanks to the selflessness of others. Lungs, pancreas and bowels can also be transplanted, and increasing numbers of those operations take place every year. Moreover, each year about 2,500 corneal transplants are performed, giving precious sight to others. All that is due to the generosity of those who have died, and of their families. I am sure that my hon. Friend the Member for Exeter will agree that it is a wonderful success story.

We should not forget, however, that 6,000 people are currently on the waiting list for organs, and that 5,000 of them are waiting for kidneys. My hon. Friend rightly drew attention to those figures. The number of those waiting is due not to a lack of money or of clinical expertise but to a shortage of donor organs. Usually, only organs from people who have died from sudden brain injury are suitable, but, as my hon. Friend pointed out, vastly improved road accident figures and improvements in neurology have reduced the pool of potential donors. Furthermore, the organs of some of those in the pool will be unsuitable because of damage or disease. Sadly, the chronic shortage of organs is a worldwide problem.

It is for those reasons that we continue to encourage people to become organ donors. The Department of Health currently spends over £1 million a year on publicity to achieve that goal, and the publicity's value can be judged from the fact that almost 4 million people have joined the NHS organ donor register since we launched it a short time ago, in October 1994. A tremendous amount of publicity is also provided by voluntary organisations. I am sure that the House will join me in thanking them for their splendid efforts on behalf of organ donation.

After all the publicity, the number of transplants is being maintained. Demand is rising, however, and supply is not keeping pace. It is therefore unsurprising that radical solutions to the problem have been suggested, including the procedure known as "elective ventilation".

The majority of organs for transplant are taken from people who, having suffered sudden brain injury, have been taken into intensive care and placed on life support systems—with the object of saving their lives—but who, sadly, have died there. If they or their families have agreed to organ donation, their bodies remain in intensive care and their lungs remain artificially ventilated so that blood can continue to circulate until the organs can be removed. That has to be done, or the organs would rapidly deteriorate and be unsuitable for transplantation.

Some people who might be suitable as organ donors die in hospital, although not in intensive care. A few years ago, doctors at one hospital devised a protocol under which patients on ordinary wards who were expected to die shortly were—with the permission of their families, as my hon. Friend said—taken to intensive care and placed on life support systems, so that their organs could be maintained until they could be removed for transplantation after death was pronounced. That is a description of the procedure known as "elective ventilation", which is the subject of this debate.

In 1990, details of the elective ventilation protocol and the results obtained were published in The Lancet. The article suggested that the procedure could achieve a significant increase in the number of transplants performed. However, many people, both inside and outside the medical profession, had grave reservations about the ethics and the legality of subjecting a patient to invasive procedures that were of no benefit to that patient but aimed solely at maintaining organs for eventual transplantation into others.

As far as I am aware, elective ventilation was practised very little outside the hospital where it was originally devised, probably because of the concerns about the ethical and legal position. My hon. Friend is slightly at variance on that, because he suggested that it was rather more widely practised than I understand it to have been.

In 1994, an independent research study team informed the Department of Health that they had received a legal opinion that elective ventilation was unlawful. The Department of Health therefore sought and obtained an opinion from Queen's counsel, which was that elective ventilation was indeed unlawful, because any intervention made without the patient's consent must be in the patient's best interests, or it could be judged to be an assault. Clearly, elective ventilation is of no benefit to the person receiving it.

The United Kingdom Health Departments informed the national health service of counsel's opinion, and the practice of elective ventilation ceased at that point. To have done otherwise could have left health authorities, NHS trusts and individual clinicians open to prosecution. I am sure that none of us would have wanted that to happen.

Understandably, the supporters of elective ventilation, especially the people at the hospital that pioneered it, which is in my hon. Friend's constituency, were unhappy about the effect of the legal opinion. A number of them met my predecessor, as my hon. Friend said, and put to him their arguments in favour of the procedure. In essence, those were that, under the protocol, the procedure was carried out only with the fully informed consent of the patient's relatives, and that, without elective ventilation, the number of transplants would fall. The supporters of elective ventilation also suggested that a change in the law might be sought to enable it to take place.

For the law, the issue hinges on consent to treatment. As I have said, legal advice is that any intervention, if it is not done in the interests of the patient, could be judged an assault, even though the patient's relatives have given consent. There are sound reasons for that: the patient would not, for example, otherwise have protection against unnecessary major surgery. Intubation of a patient in intensive care is not a minor procedure, and the question of anticipated death is worrying for many people.

At what stage is it possible to say that a patient will inevitably die? Placing people in intensive care under such circumstances also carries the risk, albeit probably a small one of inducing persistent vegetative state in the patient—a subject to which my hon. Friend referred. Such a scenario could do great harm to the cause of organ donation, as other bad news—and, indeed, rumour—has done in the past. It would, of course, also be a cause of great distress to the family, and would place them under additional stress.

The general principle that a person may not, without consent, be given treatment that is not in his or her own interest is clearly important. Anyone attempting to alter that principle would find themselves in a minefield. They would have to find a way of modifying the principle without leaving a breach through which others might gallop. It could be argued, for example, that a patient expected to die should, before death, be subjected to treatment that would facilitate research on his or her body after death. Justification for such treatment might be claimed on the ground that the research might result in saving other lives. Many people will find that argument unacceptable.

In 1994, when the NHS was informed of the legal opinion on elective ventilation, some people expressed fears that the number of transplants would drop. Happily, that did not happen. In 1993, there were 1,571 cadaveric kidney transplants in the United Kingdom; in 1994, there were 1,601; and in 1995, there were 1,645. Heart transplants, including heart and lung transplants, rose from 338 in 1993 to 366 in 1994; in 1995, there were 349. In 1993, there were 534 liver transplants; in 1994, there were 620; and in 1995, there were 667. The cessation of elective ventilation does not appear to have had an effect nationally, although I accept that the story may well be different in the hospital in Exeter that my hon. Friend knows so well.

Having made that point, I make it clear that we are not complacent—indeed, we are far from complacent—about the transplantation figures. The numbers of kidney and heart transplants have not increased greatly in recent years, although the figures for liver transplants have been somewhat better. The so-called plateau effect in kidneys and hearts is being experienced in other countries which, like the UK, have been performing transplants for a number of years.

We have therefore introduced a number of measures aimed at maintaining and, if possible, improving the transplant figures. Apart from the NHS organ donor register, which I have mentioned, we have introduced donor declarations on driving licences, a reimbursement scheme for hospitals whose intensive care units maintain organ donors, multi-organ retrieval teams which have resulted in more organs being retrieved per donor, and support for the education of hospital staff involved in organ donation and transplantation.

We continue to monitor and review provisions for organ procurement and publicity for organ donation Together with the medical and nursing professions, the transplant co-ordinators and the voluntary organisations, we will continue to consider carefully all suggestions put to us that might result in more transplants and the gift of life, about which my hon. Friend spoke so eloquently, for many more people. In that context, I welcome my hon. Friend's specific suggestion about discussions between the royal colleges. Such discussions could be extremely valuable, and I will look into the matter sympathetically.