HL Deb 21 December 1989 vol 514 cc379-86

1.25 p.m.

The Parliamentary Under-Secretary of State Department of Health (Baroness Hooper) rose to move, That the draft regulations laid before the House on 15th November be approved [1st Report from the Joint Committee].

The noble Baroness said: My Lords, this set of regulations has its origins in Section 2(7) of the Human Organ Transplants Act 1989, which your Lordships debated thoroughly earlier this year, and seeks to achieve two objectives. Those are: first, to establish and constitute the authority referred to in Section 2(3) of the Act which will be known as the Unrelated Live Transplant Regulatory Authority, or ULTRA for short; and, secondly, to specify the conditions required to be satisfied in cases to which the regulations apply.

The purpose of ULTRA is to enable organ donation to take place between living persons who are not genetically related according to the definition in Section 2(2) of the Act. In every instance, therefore, where an organ transplant is proposed between a living donor and a recipient who are not genetically related, such cases must be referred to ULTRA. It will be the duty of ULTRA to satisfy itself that no payment for the supply of an organ has been or is to be made in contravention of Section 1 of the Act and that other conditions set out in regulations have been met before granting exemption from the prohibition of Section 2(1) of the Act.

The total number of kidney transplants carried out each year in the United Kingdom involving live donors is approximately 200. We envisage that less than half that number will be the subject of applications to ULTRA. We do not therefore expect ULTRA to have a heavy case load but that will in no way belittle the importance of its work. Live transplants will still be the exception but will continue to be possible when the motives for donating arise from genuine altruism.

With the approval of Parliament, ULTRA will begin its legal existence on 1st January 1990.

Submission of applications for exemption from Section 2(1) of the Act must be made by a registered medical practitioner. One of the first tasks of ULTRA will be to determine the form which these submissions will take and how the decision of the authority is to be made. Advice on submission of applications, guidance on procedures and other information will be prepared by ULTRA and made available to health authorities, health boards and the independent sector before the remaining regulations come into force on 1st April 1990. Those other regulations, currently the subject of negative procedures, deal with tests for establishing genetic relationships and information to be supplied about transplants.

The constitution of the authority is set out in Regulation 2 before us. Members of the authority will be appointed by the Secretary of State and will consist of a chairman and not less than seven and not more than 11 other members. The chairman and at least three other members must be registered medical practitioners and at least four members must be appointed who are not, nor have been, registered medical practitioners.

Although not specified in the regulations, it is our intention that as well as registered medical practitioners, members of the authority will include persons experienced in tissue typing and genetics and in ethical and moral issues. We should also expect some members to have no involvement in transplantation. Members will be chosen for their individual expertise and not as representatives of any specific organisation. Membership of the authority will cover as many interests as possible and will take into account the geographical spread within the United Kingdom.

The constitution of the authority will attempt to strike a balance between the necessary medical and other professional expertise directly associated with organ transplantation and public interest and concern about organ donation. ULTRA's secretariat will be provided by the Department of Health and the authority will also have access to legal advice.

We have proposed in paragraph (1)(b) of Regulation 3 that the doctor who has clinical responsibility for the donor should be the person to refer to ULTRA a proposal to undertake a transplant between two living, unrelated persons. It is not unusual for a doctor who has clinical responsibility for the donor also to have clinical responsibility for the recipient. The regulations do not disqualify a doctor having clinical responsibility for both patients. The significance of Regulation 3, paragraph (1)(b) is that the application is made with explicit recognition that the doctor in that instance is responsible for the clinical care of the donor and must therefore have in mind the donor's best interests and well-being.

Regulation 3, paragraph (1)(c) is intended to deal with instances such as so-called domino transplants in which, for example, the heart and lungs of a dead donor are transplanted into a recipient whose lungs are diseased but whose own heart is also removed as part of the transplant technique. That heart, if found suitable, can be used for a second recipient. In such a case the first recipient is acting as a live heart donor for the second recipient. Under those circumstances, because the heart of the first recipient was not removed for the primary purpose of transplantation into another person but as an integral part of the patient's treatment, it seems sensible that the conditions specified in Regulation 3, paragraph (2) need not be applied. However, ULTRA would still be required to satisfy itself that Section 1 of the Act had not been breached.

Conditions specified in Regulation 3, paragraph (2) are largely self-explanatory and take on board the concerns expressed by this House and in another place during the various stages of the Bill; namely, that a doctor should give an explanation of the procedures involved, that the donor understands those procedures and their risks, that he has been given the opportunity to withdraw his consent, has given his consent willingly and so far as can be established has received no inducements or been subject to any threat.

ULTRA must receive reports on the conditions set out in Regulation 3, sub-paragraphs 2(a) to 2(d) from suitably qualified persons who are skilled in interviewing techniques. Such persons, for example, may be fellows or members of the Royal College of Psychiatrists or the Royal College of Physicians or fellows of the Royal College of Surgeons. Of course it will be for ULTRA to decide from whom it will accept reports. It is important that the status and qualifications of persons reporting to ULTRA should lend credibility to their report.

The regulations are straightforward and uncomplicated and, I believe, comply with the wishes of your Lordships to put into place a mechanism for an effective check on the motives behind transplants proposed between persons who are not genetically related. On that basis I recommend the regulations to your Lordships. I beg to move.

Moved, that the draft regulations laid before the House on 15th November be approved [1st Report from the Joint Committee].—(Baroness Hooper.)

1.30 p.m.

Lord Ennals

My Lords, once again the Christmas spirit abounds and I warmly welcome the Minister's presentation and the regulations before us. However, I am slightly quizzical and cannot be totally complimentary. I remember that when the Government came to office 10 years ago there was a marvellous campaign slogan saying that they would get rid of all the quangos. I suspect—I might put down a Written Question after Christmas about this—that we now have far more quangos than we did 10 years ago. We are always setting up new ones. The idea that we should call this authority ULTRA is intolerable. There should be a regulation stating that in future no one should refer to it as ULTRA. ULTRA is obviously a Tory word and I would not serve on an organisation of that name. So I plead with the Minister to think of some better way of referring to a body which has such a responsible task.

I was a little surprised that the Minister did not list the membership. I want to know who the chairman and the other 10 members are because, after all, they spring into action on 1st January. There is the Christmas break; some of them will be off with their families and the post will be a little delayed. How will they come together on 1st January? Perhaps they have not been asked or have not replied, or perhaps the Minister has not got around to it, but why does she not announce the membership of the body today? As she has not told us, I shall have to ask what voluntary appointments are included. Does the body include, for instance, a representative of the British Kidney Patient Association which has had a great deal of experience in the matter? Does it include someone whom I should have thought would be very important; namely, a transplant co-ordinator who, while not a professional, has an important role in making certain that the organ is available at the right time for the right person?

Perhaps I may ask the Minister a quite different question: to what extent will the authority—perhaps I may call it that—be able to deal with policies? I was privileged to be invited by the Parliamentary Under-Secretary of State, Mr. Roger Freeman, to attend the seminar which he organised a few weeks ago on the subject of organ transplants. It was an interesting conference and I was most grateful to him for organising it and inviting me.

One of the matters that we discussed was whether, in view of the continuing shortage of organs for transplantation at the time they are needed, we should give more consideration to the opting-out procedure rather than the opting-in procedure. Under that it is assumed that, unless we have said that we do not want our organs to be used to save the life of another, it is assumed that we are perfectly happy for them to be used. I realise that we are talking about those who have died, for example, in an accident, but that is one way of ensuring that we have more organs available at the time they are needed. Will the authority be able to deal with those issues? Will it be able, for instance, to conduct an opinion poll on this or any other question?

We have some worries. I hope that the authority will look at the problem. I note that it was said in the Fourth Standing Committee on Statutory Instruments in another place on 12th December 1989 that: the problem with voluntary donations is not that people are not asked—apparently, only 6 per cent. of relatives are not asked—but that 30 per cent. of relatives [speaking on behalf of the dead] said no … within days of the Minister's announcement that the problem is not that people are not asked but that relatives do not wish to donate organs, two television appeals for livers were made, and within a couple of weeks there was a 100 per cent. increase in donations. If the problem is that people do not support the transplant programme and do not want to make donations, that would not necessarily have happened". The new authority should be able to tackle those questions as to how we can make the programme more effective and successful so that there is a standing committee which is constantly considering the problem. I should be grateful if the Minister would comment on that point in her reply.

In conclusion, as I said at the beginning, I warmly welcome the legislation and the speed with which the Government have decided to set up such an authority. I rather regret what seems to me to be the laxity in inviting and accepting those people so that they are ready to start work on New Year's Day.

Baroness Phillips

My Lords, I wish to ask a simple question which I had thought my noble friend would ask. I was not clear whether every transplant would necessitate a submission to the authority or whether it was only a certain number where there seemed to be some doubt. I am sorry that I must dissent from the enthusiasm for opting-out of my noble friend on the Front Bench. I should certainly like to be the one who decided whether any of my organs were useful to anyone else. There are two surgeons in my family. When one of them once invited me to go to hospital to deal with a painful wrist, I said, "No thank you. I shall go in because there is something wrong with my wrist and you will remove all my organs". The surgeon was always very enthusiastic. I was somewhat reassured when he said, "Oh no, Nan, they're too old". That was at least some consolation.

On a serious note, in view of those dreadful cases of which we have heard—I note that the words "inducement" or "threat" have been used —we must ensure that there is never any inducement or threat to anyone. Since that seems to me to be the custom in certain other parts of the world from where unfortunately we always seem to borrow their worst as well as their best habits, I should like to know that it is absolutely 100 per cent. certain that before anything of this kind takes place there will be an application made to the authorities.

Baroness Seear

My Lords, I also should like to ask the noble Baroness whether there is no better way of obtaining the information that we want our bits and pieces disposed of so that they can be tracked down at once. I know that I signed something but I cannot now find it. If I should be run over, I wager that the piece of paper that I signed some time ago will not be found until my spare parts are no longer of use to anybody.

In these days of high technology can it not be ensured that once a person has given his or her name as someone who is prepared to be carved up, organs can be taken at once when that person is dead? I have looked for the piece of paper which I signed but I seem to have lost it. I do not think that it is an efficient way of obtaining my parts.

Lord Kennet

My Lords, I should like to follow up something said by the noble Lord, Lord Ennals, and to combine two points together into one. The noble Lord said that there were too many quangos and asked whether we could have fewer quangos in the world. It has occurred to me and perhaps also to the Government—if not, no doubt they could think about this matter because there is no special hurry—that it might be an advantage not to have a great many separate authorities, boards, licensing committees or whatever for different fields of the advancing technology of transferring parts of the human body into another body, but to have one umbrella authority which would cover the whole, starting with organ transplants and continuing with in vitro treatments and research, gamete donations and the use of embryo tissue. There are so many procedures that are now coming forward. They are all creating their own problems and give rise to legislation or orders.

It seems to me that in fact there is a risk that some of them may go off in opposite directions. For instance, the regulations now before us assume that consanguinity or genetic relationship is a good thing, and that one need only worry about pressure being brought in cases of people who are not genetically related. In the case of transplants that is understandable and clearly right. However, in the Warnock Report (though I do not think that this is in the embryology Bill) it was stated that genetic relationship was a bad thing in the donation of ova. There was no reason given for that opinion, but it does not seem to me to be a bad idea for a sister to donate ova to her sister, if the latter is infertile in a way that can only be put right by such a donation. If there is a contradiction it needs thinking about, and clearly it should not be thought about other than by a body of wise people who are skilled in the whole of this field.

I should define the field quite simply as transferring parts of people into other people. That is very amateurish, but some such definition seems to me right. If that were to be done it should be done after these regulations are in force and after the Bill is in force. It would be quite a simple matter administratively to set up a joint overall authority.

Every one of these types of procedure introduces ethical problems. Sometimes I think we all tend to believe that an ethical problem is a rather simple matter. One simply asks whether a thing is right or wrong and one decides in a simple yes or no manner and settles the matter. However in fact almost all the ethical problems in the world, and certainly those in this field because they are new, are extraordinarily complicated and tend to go wider and even wider.

When she comes to wind up the debate perhaps the noble Baroness will be able to tell the House something about who will be providing the skilled ethical input into the body that we may or may not be calling ULTRA and how they will be providing it.

1.45 p.m.

Lord Swinfen

My Lords, when introducing these regulations my noble friend said that the donor might well be advised by a medical practitioner who is also the medical adviser to the recipient. I can understand that the person who treats both in hospital may well be the same specialist but I should be interested to know what arrangements are being made for the donor to receive independent advice from a medical practitioner who is not the medical practitioner of the recipient.

In most cases it is unlikely that there would be a conflict of interest but on the odd occasion it may arise. I think that this is a safeguard that should be included somewhere. I do not see it in the regulations and I did not hear it in the explanations given by my noble friend.

Lord Monson

My Lords, this is the second time in the past half hour that I have risen to my feet. The noble Baroness could be forgiven for thinking that when I hear or even sense the phrase "accepted wisdom" I reach for my gun. However, the Human Organ Transplants Act 1989 had an exceptionally easy ride in your Lordships' House—I happened to be away at the time—and there is a respectable opposing case which deserves a brief hearing.

Governments should never legislate to ban things which are merely distasteful. Undoubtedly the idea of organ transplants is aesthetically distasteful, at least to non-medical people. I contend that governments should only ban things which are demonstrably harmful to either individuals or society. Obviously exploitation is harmful. Any simple individual from outside Europe who is persuaded to part with his kidney for a derisory sum is unquestionably being exploited and such exploitation should be clamped down upon very hard.

However, if the element of financial exploitation is absent, are not matters slightly different? It is perfectly possible to have only one kidney and yet to lead a perfectly normal life. I know at least one person with only one lung and two or three people who have only one kidney, one of whom happens to be a niece of mine. Not only is she extremely fit, active and a first-class skier but she has borne two strapping sons since losing her kidney. So it does not seem to have done her an enormous amount of harm.

If that is so, and if someone is going to die—not just be uncomfortable—for lack of a kidney and if (subject to a panel of doctors certifying him or her to be of good health) an individual is prepared to sell one of his or her kidneys for a sum which fully reflects the statistically minor risk which both the operation itself and the subsequent absence of one kidney entails, a sum which would almost certainly be ten or twenty times that which has recently been paid to people from Turkey, then why should that not be allowed to happen? One life would unquestionably be saved—possibly a young life—at the expense on the other side of the scale of a very slight statistical shortening of another life.

I do not for one single moment expect that the Government will change their mind but I want to suggest that there are logical and humane arguments on both sides.

Baroness Hooper

My Lords, I am grateful to the noble Lord, Lord Ennals, for having given me advance warning of his new year question to me. Beyond that, while I appreciate his difficulties over the name, I suggest that it is open to him to use the full title. He can refer to it at all times as the Unrelated Live Transplant Regulatory Authority.

With regard to membership, the members cannot be appointed until these regulations have been approved. However, we are looking very carefully at the interests which the membership should cover and will certainly bear in mind the suggestions that the noble Lord has made.

He also asked whether the authority was able to make policies. ULTRA is not a policy-making body under the Act but may make recommendations to the Minister.

Lord Ennals

My Lords, my question was not on taking decisions, but whether it could consider and make recommendations.

Baroness Hooper

My Lords, I confirm that not only can it consider recommendations but it can make them to Ministers on policies.

On improving the supply of organ donation and the need for a Standing Committee, we believe that that cannot be a function of the Unrelated Live Transplant Regulatory Authority. The functions of the authority are simply those set out in the regulations before us.

The noble Baroness, Lady Seear, asked about recording her wish to donate. We have looked carefully at the possibility of maintaining a register. Experiments are going on to try out computerised registers. When we have the results, we shall decide whether to take the idea forward more widely. In the light of developing technology, matters are becoming increasingly facilitated. However, in the meantime, perhaps I may suggest to the noble Baroness that she ensures that at least some of her close relatives are aware of her wish to be a donor so that if they should ever need to be asked there is no risk that they would say no.

On the point raised by the noble Baroness, Lady Phillips, ULTRA will consider applications for prospective organ transplants only between live unrelated donors and recipients. That is the extent of the authority's powers. All such cases must be referred to the authority.

The noble Lord, Lord Kennet, raised points rather wide of the regulations before us. He referred to matters that will arise in our discussions on the embryology Bill. The authority under that Bill will not make decisions on the way IVF treatment is given. It will not therefore decide whether gametes should be donated by a person who is related to a person who is being given treatment for infertility. The authority will have power to issue codes of practice.

On the point raised by my noble Lord Swinfen, the regulations do not make specific provision for independent advice. However, the person who provides the report for ULTRA will be expected to ensure that the donor has been given unbiased advice. I have noted the points made by the noble Lord, Lord Monson. I commend these regulations to your Lordships.

On Question, Motion agreed to.