Corneal Tissue Bill (Hansard, 19 May 1986)

HL Deb 19 May 1986 vol 475 cc70-5 70

§ 7.8 p.m.

§ Lord Cullen of Ashbourne
My Lords, I beg to move that this Bill be now read a second time.
Fortunately for people on the waiting list for eye transplants, my honourable friend Mr. John Hannam was lucky in the ballot in another place for Private Members' Bills, and his Corneal Tissue Bill had a smooth passage with the support of Her Majesty's Government and the other parties. He has asked me to sponsor his Bill in your Lordships' House, and this I gladly do.
The Bill amends the Human Tissue Act 1961 and its Long Title. That Act requires that the removal of organs from bodies for medical purposes can be carried out only by fully registered medical practitioners. This has been a perfectly proper requirement and needs to continue for organs other than eyes or parts of eyes. Nowadays, however, a comparatively simple operation for the removal of eyes can be carried out, as it is in other countries, by eye technicians suitably trained and supervised. The whole purpose of this Bill is to bring that about.
The limited number of ophthalmic surgeons are under great pressure of work and cannot be available by day and by night to interview relatives to get their permission and then remove the eye tissue. This is the reason why hundreds of people are on waiting lists for eye transplants. By adding trained and supervised technicians to ophthalmic surgeons it would be possible to set up eye banks similar to those in the United States and Europe. In this country we currently perform 1,500 to 2,000 grafts annually. In the United States, in 1984, 24,000 corneal removals were carried out, 98 per cent, by eye technicians.
I must stress that the Bill is concerned only with the removal of eye tissue from bodies. The actual graft, a highly skilled and delicate operation, would still be performed only by an ophthalmic surgeon. The cornea is the circular and transparent lens on the front of the eye and is 11 by 13 millimetres in size. When disease, degeneration or injury causes a loss of transparency of the cornea, light fails to get through to the retina and blindness occurs. The operation is to transplant a graft of donor tissue of some 7 by 8 millimetres in size into a recipient hole in the eye.
This Bill enjoys the support of ophthalmic surgeons, the National Health Service, RNIB and Her Majesty's Government. Even more important is the support of hundreds of people facing the prospect of blindness and desperately awaiting transplants. I hope and trust that the House will also support it.
If the Bill is enacted and more corneal tissue is made available, it will be possible to set up eye banks. It is to be hoped that new procedures will make it possible to store corneas for quite a long time. Thus ophthalmic surgeons may soon be able to choose from a well-stocked eye bank corneal tissue suitable for each patient. They are increasingly preferring to use tissue-matched corneas, and this obviously means that there needs to be a greater range, and therefore supply, of donor material available.
There is little that I need to say about the amendments to be moved in Committee. The first 71 four are simply drafting amendments. Amendment No. 5, by removing the word "fully" opens the way for Amendment No. 6, which ensures that the person who is instructed to remove the eyes, or parts of eyes, will be a properly trained technician, employed either in the health service or at a hospital ophthalmic unit. Amendment No. 7 explains the separate definitions for the English, Welsh and Scottish health authorities. In the case of Northern Ireland, which country wishes to implement this legislation, the amendment will need to be made by Order in Council. Amendment No. 8 is to remedy a mistake in the Long Title of the printed Bill and brings it into line with the Human Tissue Act 1961.
Finally, I should like to pay a tribute to the Iris Fund and in particular to its director, Mrs. Susanne Burr. The Iris Fund, which, with the support of the DHSS and the South-West Regional Health Authority, in 1983 established the United Kingdom Corneal Transplant Service in Bristol, is promoting this change in legislation—a change which I believe will be of incalculable benefit to very many people in the future. I therefore commend the Bill to your Lordships. I beg to move.

§ Moved, That the Bill be now read a second time.—(Lord Cullen of Ashbourne.)

§ 7.15 p.m.

§ Lord Ennals
My Lords, I first congratulate the noble Lord, Lord Cullen, upon introducing this very valuable Bill and echo his tribute to the Iris Fund. I think it shows the role that a voluntary organisation, with dedicated commitment, can play by bringing forward a Bill which we laymen would not have thought of. I should like to add, as the noble Lord, Lord Cullen did, my thanks to Mr. John Hannam, of another place, for having introduced the Bill in the first place.
As the noble Lord, Lord Cullen, said, there are over 1,500 corneal transplant operations in Britain every year. In 1985 the UK Corneal Transplant Service handled 529 corneas, with some 4,500 corneal transplants having been performed nationally since the inception of the UK Corneal Transplant Service in the autumn of 1983. Sadly, there is still a long queue of patients on the waiting list and organ culture may well provide the answer.
Over the whole country, some 4,000 eye grafts have taken place during the past two years, in hospitals as far apart as Bristol to Edinburgh. As many as 1,500 extra transplants a year could take place if this Bill is enacted. The life of eye tissue is very short—a matter of 14 hours from removal to transplantation—so the need for an efficient system is obvious. At present the Human Tissue Act 1961 requires that corneal tissues be removed for the purpose of corneal grafting only by registered medical practitioners. This makes very heavy demands on the valuable and limited time of ophthalmic surgeons. In practice it means they have considerable difficulty in removing corneal tissue from donors who happen to die elsewhere than in hospitals that have an ophthalmic surgery department. In turn, this means that in most departments of ophthalmic surgery corneal grafting is still an emergency 72 procedure undertaken only as and when the right sort of corneal tissue becomes available for a particular patient. This often results in the wasteful use of hospital beds and theatre time, heavy additional demands on surgeons and theatre nurses, and uncertainty for patients. If more corneal tissue became available, corneal grafting could become a scheduled procedure and much would be gained.
As the noble Lord, Lord Cullen said, the purpose of this Bill is to enable this task to be done not necessarily by ophthalmic surgeons but by suitably trained technicians. They would be able to operate more quickly and while it would not save lives it might save the eyesight of very many people who at present are waiting, and have been waiting for a long time. We perhaps talk much more about other transplantable organs such as kidneys, hearts and livers but there are some differences. First, in the case of corneal tissue removing, it is a much less complex procedure than for other organs. It does not require the skills of an experienced surgeon. Secondly, the cornea does not deteriorate so quickly. It can safely be removed from a body up to several hours after death.
So far as I can see there are no disadvantages, no unfortunate side effects and no dangers in the Bill now before us. I warmly welcome it and I hope that it will have a rapid and harmonious progress through your Lordships' House.

§ The Parliamentary Under-Secretary of State, Department of Health and Social Security (Baroness Trumpington)
My Lords, St. Cecilia, the patron saint of music and of the blind is said—I beg your pardon!

§ 7.20 p.m.

§ Lord Rugby
My Lords, I want to congratulate the noble Lord, Lord Cullen of Ashbourne, on introducing this Bill. Am I allowed to make a statement at this point? I thought I was entitled to do so.

§ Baroness Hooper
My Lords, I think that it is normal practice for noble Lords to inform the House and put their names on the speakers' list so that we know who intends to speak, but there is no reason why the noble Lord should not speak.

§ Lord Rugby
My Lords, all I have to say is that I feel it is important to look carefully at the wording of the Bill, especially at the word "safeguards". It may so happen that eyes are taken for commercial purposes by fringe medical people and so they could be turned to a commercial purpose. That is all I have to say at the moment. I think that we shall have to wait until the Report stage in order to make quite sure that the correct people will obtain these eyes for medical education and experimentation.

§ 7.22 p.m.

§ Baroness Trumpington
My Lords, I shall start again. St. Cecilia, the patron saint of music and of the blind, is said to have been given new eyes after she had plucked out her own. The first recorded ophthalmic surgery for the removal of cataracts took place in ancient Egypt. The first successful corneal graft was 73 performed in 1886—which was 100 years ago—and the first corneal graft in this country was in 1925.
These are surprising facts, and I am glad to say we have come a long way since then. Today it gives me great pleasure to express the Government's gratitude to my noble friend Lord Cullen of Ashbourne for introducing this important Bill. My noble friend has already explained the purpose of the Bill, and I am glad to record the Government's full support for a measure that will have the effect of facilitating what is now a well-established and accepted procedure, which is very successful in restoring sight to people who are in danger of becoming blind.
Under the provisions of the Human Tissue Act 1961 organs may be removed from a body after death for the purposes of transplantation only by a registered medical practitioner. In the case of most transplantable organs, such as kidneys, hearts, livers and pancreases, this restriction is necessary and it is our intention that it should remain in force. But the removal of corneal tissue is different from the removal of the other organs that I have mentioned in two important respects. The first is that the removal of corneas—as the noble Lord, Lord Ennals, has already mentioned—is a much simpler procedure that does not require the skills of an experienced surgeon; and the other is that corneal tissue is suitable for transplantation even when it is removed several hours after death.
At present the requirement that corneas be removed only by a qualified doctor is a serious constraint on the supply of corneal tissue which is urgently needed for corneal grafting. My noble friend Lord Cullen has referred to the heavy demands on the valuable and limited time of ophthalmic surgeons, and in practice it means that with rare exceptions corneal tissue is removed only from donors who die in hospitals that have ophthalmic surgery departments. This, in turn, means that a high proportion of corneal grafts are performed as emergency procedures as and when the right sort of tissue becomes available, making unnecessary demands on hospital resources and creating uncertainty for patients. If the constraints on the procurement of corneal tissue were to be eased, and the supply increased, much would be gained.
The number of people who die in circumstances where corneal donation is practicable is far in excess of the number of people who die in circumstances that enable them to become potential donors of other organs. Corneal tissue suitable for grafting can be taken from patients in older age groups, and the longer permissible period between death and the removal of the tissue means that tissue can be taken from donors who die in hospital wards and even at home. But under the present requirements it is not possible to profit from these advantages, since the constraining factor is the surgeon's time. The potential benefits will be realised only if more people are permitted to remove corneal tissue, and the comparative simplicity of the procedure means that suitably trained health service staff who are not doctors are capable of doing so. The effect of the Bill will be to permit this.
Yet it would be wrong to allow the removal of corneas from bodies unless the procedure were undertaken competently and sensitively; so certain 74 safeguards are needed. The safeguards need to be flexible enough to ensure that the procurement of corneal tissue is not unnecessarily constrained and yet rigid enough to ensure that due regard is given to the safety of patients and the sensitivities of relatives. The Bill provides four safeguards to achieve this balance.
The first is that non-medical staff may remove corneal tissue only if they are acting under a doctor's instructions. This means that non-medical staff may go to distant hospitals and to people's homes to remove corneal tissue, but only if they are acting on the instructions of a doctor; and the doctor would, of course, be professionally accountable for any instructions he gave.
The second safeguard is that the doctor who gives the instructions must satisfy himself that the staff he instructs are suitably qualified and trained. For obvious reasons there are at the moment no recognised qualifications or training courses in this field, and we think that the most appropriate safeguard for ensuring their competence is that responsibility should be laid upon the doctor. I am pleased to say that the medical profession is prepared to accept this. Your Lordships will be interested to know that the United Kingdom Transplant Service in Bristol is preparing a training course on the procurement of corneal tissue which will be run in the event of this Bill becoming law. We have every confidence in the UKTS, and its training course could make an important contribution in getting the new arrangements off the ground.
The third safeguard is that the people who will be permitted to remove corneal tissue must be employees of a health authority. As employees these people will be subject to whatever procedures their employing health authority considers necessary, and this provision will ensure that the procurement of corneal tissue does not become an entrepreneurial activity undertaken outside health authority control. I hope that that meets the point of the noble Lord, Lord Rugby. I should add that we do not see this restriction as presenting an unreasonable constraint on private hospitals. Private hospitals will not be prevented from undertaking corneal grafts; they will be able to obtain the necessary tissue either through making arrangements with a health authority or through their doctors procuring their own corneal tissue as now.
The fourth safeguard is that certification of death will remain very firmly a prerogative of the medical profession. It would be totally wrong for corneal tissue to be removed before death had been properly certified by a doctor, but the doctor who certifies death will not under this provision necessarily have to be the same doctor as the one who gives the instructions for the tissue to be removed.
So I commend the Corneal Tissue Bill to your Lordships' House. Corneal grafting is a procedure that can safeguard or restore people's sight, but it can be performed only if an adequate supply of tissue is available. As things stand the last confirmed number of corneal grafts performed in the UK annually was in the region of 1,200. New techniques are being developed which enable corneal tissue to be successfully stored, but the eye bank to which my noble friend Lord Cullen referred will need to be well stocked, and this will require an increase in supply. The Bill will 75 significantly ease the present constraints on supply, and do so in a way that will ensure that the needs of donors and their relatives are properly safeguarded. So patients will benefit, and the National Health Service as a whole will benefit as demands on staff time are reduced and resources allocated more efficiently.
I have been told that two of the sponsors of this Bill in another place, the honourable Members for Richmond and Barnes and Weston-Super-Mare, have had corneal grafts. Their personal experiences may well be shared by Members of your Lordships' House.
In congratulating the noble Lord, Lord Cullen of Ashbourne, I should also like to thank my honourable friend the Member for Exeter who introduced the Bill in another place, and to join with both my noble friend Lord Cullen and the noble Lord, Lord Ennals, in congratulating Miss Susanna Burr of the Iris Fund who did so much of the groundwork in preparing the way. I can assure your Lordships that the Bill has the Government's unqualified support.

§ Lord Cullen of Ashbourne
My Lords, I am extremely grateful both to the noble Lord, Lord Ennals, and to my noble friend Lady Trumpington for their strong support for the Bill. I am particularly grateful for a lot of additional information that my noble friend gave us about the subject, on which I am by no means an expert. What I hope also is that the noble Lord, Lord Rugby, will have been pleased to hear about the various safeguards that my noble friend mentioned and that as a result of that the Bill may perhaps not be committed and will have a smooth passage through the House.
On Question, Bill read a second time, and committed to a Committee of the Whole House.