- `(1) The Secretary of State may make regulations requiring such persons as are specified in the regulations to supply to such authority as is so specified such information as may be so specified with respect to transplants that have been or are proposed to be carried out in Great Britain using organs removed from dead or living persons.
- (2) Any such authority shall keep a record of information supplied to it in pursuance of the regulations made under this section.
- (3) Any person who without reasonable excuse fails to comply with those regulations is guilty of an offence and liable on summary conviction to a fine not exceeding level 3 on the standard scale; and any person who, in purported compliance with those regulations, knowingly or recklessly supplies information which is false or misleading in a material respect is guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.
- (4) The power to make regulations under this section shall he exercisable by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.'. —[Mr. Freeman.]
§ Brought up, and read the First time.
10.12 pm§ The Parliamentary Under-Secretary of State for Health (Mr. Roger Freeman)I beg to move, That the clause be now read a Second time.
§ Mr. SpeakerWith this, it will be convenient to discuss the following: New clause 1—Register of Transplants—
'It shall be the duty of every hospital which transplants human organs to keep a record of every such operation, its date, the derivation of the organ, tissue type, blood group, relationship with the recipient and the name of the surgeons and consultants involved, and such records should be forwarded to the Regional Health Authority within a calendar month of the transplant.'.Sub-amendment (a) to new clause 1, at end insert`and the United Kingdom Transplant Service'.
§ Mr. FreemanNew clause 1, in the name of the hon. Lady for Peckham (Ms. Harman), seeks to establish the statutory recording of the details of all human organ transplant operations, involving either live or cadaver donors. It was tabled in a similar form in Standing Committee.
In Committee I said that we would come back at Report stage with a new clause to encapsulate the essence of the amendment. At that time we accepted the idea of making it a statutory requirement to record information concerning human organ transplants involving live donors. Since Committee stage, we have given further consideration to this matter and decided that it would be useful to have a complete record of transplants involving both live and cadaver donors. Leading representatives of the medical profession have also expressed to the chief medical officer their support for comprehensive mandatory records, and I know that some hon. Members are of the same opinion. New clause 6 sets out our proposals.
Proposed amendment (a) to new clause I would mean that the United Kingdom transplant service would also 564 hold the statutory records. That is impracticable, since UKTS is not a statutory body. In our proposed new clause, the authority which will keep a record of the information will be specified in regulations under the Bill. We intend that the authority for this purpose shall be the health authorities. We will also specify the precise requirements of information to be supplied in regulations.
The origins of the voluntary register to collect information about transplant operations go back far before the Human Organ Transplants Bill became necessary. Ministers agreed in principle to send out a health circular to initiate the register as long ago as 1986 and the medical profession also expressed their support for it. The arrangements to establish the voluntary register run by the United Kingdom transplant service were made before the decision was taken to include in the Bill the requirement to maintain a complete record.
It will be some months before the regulations come into force and, until then, the voluntary register will provide information on transplants. That time will also offer a valuable opportunity to see how a system of collecting information on transplants works and to bring to light any possible problems.
When the regulations setting up a system of statutory records are ready to come into force, we shall discuss with the medical profession whether it thinks there is any reason to continue the voluntary register and, if so, in what form. In Committee, we made a commitment to come back with a new clause, and I hope that new clause 6 fulfils that commitment.
§ Ms. Harriet Harman (Peckham)In Committee the Minister, in response to a new clause that we tabled, undertook to table a new clause today. I thank him for honouring that commitment.
We tabled new clause 1 tonight and the Government have tabled new clause 6. By my magnificent powers of deduction I believe that the Minister will not accept new clause 1, but will press new clause 6. New clause 1 has two advantages over new clause 6; the first is time, the second is specificity.
The Minister said that it will be a matter of months before the regulations come into force and that, until then, we shall have a voluntary register. He has said that, once we know how the voluntary register works, it will be possible to introduce the regulations. I am not satisfied that it should be in the lap of the gods as to when the regulations will be introduced to establish the register. I must press the Minister to give us some sort of maximum timetable for the introduction of those regulations. We are entitled to make such a request. He has not been sufficiently specific by just mentioning "months". I hope that he will tell us what the timetable should be—outside organisations interested in the Bill and in the register will demand nothing less.
New clause 1 would set up the register under statute. I do not believe there is any need for a long enabling clause that gives the Minister the ability to make regulations on all sorts of issues. Having talked to those organisations involved in the transplant programme, the Minister knows that there is a great deal of unanimity about the make-up and content of the register. I trust that the hon. Member for Newbury (Sir M. McNair-Wilson) will support me in that.
We do not need to make a big meal out of this, as it is fairly obvious what we want on the register. The Minister 565 need not bother himself with spending months examining the voluntary system and then drafting more regulations. If new clause I were accepted, the regulations would simply come into effect at the same time as the Bill. If new clause I were accepted, there would be no delay. We know what the specifics are, so we do not want to beat around the bush.
If the Minister insists on new clause 6, I would seek the minimum guarantee from him that all the points that are made in new clause I about what should be on the register are included in new clause 6. Such an undertaking would be helpful.
We are brimming with a lack of confidence in the Government's ability to get on with this, because we know that they are monstrously side-tracked with the impossible endeavour of trying to explain to the country the White Paper proposals. No one wants that White Paper, but the Government are trying to tell everyone that it is a terribly good idea. In the Department of Health, there is a political lack of impetus behind every other proposal. I do not want to see the Bill drift while Ministers slog up and down the country trying to persuade the people that the White Paper proposals are a good idea.
The Government's record on this issue is one of indecision and delay. The question of kidneys for sale arose as long ago as 1985 and the Government did nothing about it until a further kidney-for-sale scandal occurred at the end of last year and the beginning of this. Nearly four years had elapsed before the Government acted to make it an offence to sell kidneys. I am frightened that they may allow the establishment of the register to drift under the carpet with the legion of other issues while they remain frenetically concerned about the White Paper. Therefore, I ask the Minister to think again, accept our new clause 1 and take seriously any points made in its support, perhaps by the hon. Member for Newbury.
§ Sir Michael McNair-Wilson (Newbury)I thank my hon. Friend the Parliamentary Under-Secretary for bringing forward new clause 6 and fulfilling a promise which he made, as the hon. Member for Peckham (Ms Harman) said, as a result of a clause tabled by the Opposition and me. However, my hon. Friend's introductory speech was too short for me to grasp the finer points of what he was saying. As I understand it, the new clause means that the Secretary of State may make regulations—[Interruption.] Would it be possible for those making interruptions from a sedentary position to give me a chance to make a speech on this detailed point?
As I understand it, the new clause means that the Secretary of State may make regulations requiring persons unknown to supply to an unnamed authority information which is not detailed, and that body shall keep a record of information supplied according to the regulations.
I recognise that that is an attempt to summarise the clause, and if my hon. Friend tells me that I have misunderstood it I shall give way immediately. However, if I have not misunderstood what he said, it seems that the first difference between his clause and new clause 1 is that I can understand new clause 1 but I cannot understand new clause 6.
New clause 1 lays down a clear-cut duty and seems to contain most, if not all, of what any of us would want to see in a register of transplant operations. The 566 Government's new clause is more obscure and is linked to an authority which dares not speak its name, or even to tell us where it will meet.
My hon. Friend seemed to imply that the authority was a regional health authority. If that is so, he will surely find that the Bill now becomes misleading. If in new clause 6 the authority referred to is a regional health authority, and in clause 2(3) another authority—as clause 2 (3) puts it,
The Secretary of State may by regulations provide that the prohibition in subsection (1) above shall not apply in cases where—(a) such authority as is specified in or constituted by the regulations is satisfied—I for one will find myself wondering which authority is which and how we shall know to which authority each clause refers. Will my hon. Friend clarify that point?
§ Mr. FreemanIt might be helpful to my hon. Friend if I described the authority under clause 2. This is the authority which will look at all live donations between non-genetically related individuals. That is its sole function, and I said in Committee that we would lay down the regulations. That authority deals only with whether the non-genetically related individuals should be permitted to have a transplant of a kidney, which is the only organ which can be transplanted from live patients.
I apologise if my hon. Friend could not hear what I was saying earlier. In new clause 6, we are dealing with a separate issue—the recording of live and cadaveric transplants. It is a recording of an event which has taken place. It is not prospective: it is historical. It is designed to meet the point that my hon. Friend and other members of the Committee raised. It is a comprehensive register of all transplants.
We have not reached a conclusion on whether the authority in question should be a regional or district health authority. Perhaps, if I catch your eye, Mr. Speaker, I shall develop that point at greater length at the end of this brief debate.
§ Sir Michael McNair-WilsonI am grateful to my hon. Friend for shedding light on the authority, but anyone reading the Bill after tonight's debate will still find the word "authority" in the clause and in the new clause, yet different authorities are meant. How will my hon. Friend clarify that so that there is no doubt in anyone's mind? I read the Government's new clause as referring to the authority mentioned in clause 2, so the speech that I subsequently prepared no longer makes sense. No matter; I have told my hon. Friend of my doubts and I am sure that I would not be the only person to draw the wrong conclusion from reading the word "authority" in the two versions.
I want to go a little further into why the new clause is worded as it is. As the hon. Member for Peckham asked, why is the statement to be voluntary—
The Secretary of State may make regulations"?That is not mandatory. Why was it felt necessary to begin with that open statement when, as the hon. Lady rightly said, the request for a mandatory register has been circulating for at least four years, if not longer? I find myself wondering whether the truth is that the regulations have not yet been put together by the Department.I also find myself a little uneasy about the assurances that we have been given that this voluntary statement will be turned into a mandatory register at a later date. I have 567 been sent a letter dated 6 June 1989 by Mr. Ross Taylor, president of the British Transplantation Society. Under the heading "Policing the Present Bill", he writes:
Since 1985 when the original troubles were first reported the British Transplantation Society has been trying to create a mandatory Register of all transplant operations, whether public or private, and covering all organs. We have repeatedly been told by the Department of Health that a mandatory Register is not possible because it would require legislation and we are repeatedly told that it cannot be incorporated in this present Bill. We believe very strongly that it should be incorporated in the present Bill and we can see very little reason why anyone should object to making a record of their transplant activity. We have all the documentation, all the computer work and all the arrangements in hand to establish a Register, but we are told that it will have to be a voluntary Register. If it is voluntary we may well miss the very few transplant operations which are the particular ones that we need to record. The Royal College of Surgeons of England has jointly agreed with the British Transplantation Society to supervise this register, but I don't think I am divulging any confidences when I tell you that the President-Elect of that College feels very strongly indeed, and has said so on many occasions, that the Register should be mandatory.I agree with Mr. Taylor and with the president-elect. I hope from the nod that my hon. Friend the Minister is giving me that he, too, accepts that position. Although we are being asked to pass a clause which is not mandatory—I cannot understand why it should not be—I hope that we can have my hon. Friend's assurance that by this time next year the clause will have set up a mandatory register.10.30 pm
If the clause does initiate the setting up of a register, who will keep it? I do not think that my hon. Friend the Minister told us that. Is the register to be made public in any way? Can hon. Members, for example, ask for a debate on the register? Will that be possible? Why should the register not be kept by the United Kingdom Transplant Service? The Minister says that it is not a statutory body, but it is the body which co-ordinates transplants in the United Kingdom. If not the United Kingdom Transplant Service, why not the British Transplantation Society? The president of the society is saying, "I have the equipment and the wherewithal."
It seems so obvious to me that that is the machinery that should be used to keep the register, to keep it within the hands of those who are most closely involved and who are most anxious that the ethics of transplantation should be maintained at the highest possible level. I have an article from the British Medical Journal of 1986, I think, which sets out recommendations on the use of living kidney donors in the United Kingdom by the British Transplantation Society. The recommendations could have been a model for any legislation that we have discussed in our deliberations.
I hope that my hon. Friend the Minister will give me a promise that the voluntary element in the clause will be translated into a mandatory register within 12 months. I hope also that he will seriously consider whether the United Kingdom Transplant Service or the British Transplantation Society should become the body to manage the register, to keep it up to date, and to be answerable for what goes into it.
§ Mr. FreemanI hope that I can give all the assurances that my hon. Friend the Member for Newbury (Sir M. McNair-Wilson) has sought. New clause 6 is the Government's response to a system that I was asked in Committee to introduce on Report. It is a mandatory 568 reporting system for health authorities covering all live and cadaveric organ donations. We shall introduce regulations—I am happy to respond to the hon. Member for Peckham (Ms. Harman), who asked for an assurance—under the new clause and under clause 2, which deals with non-genetically related live donations.
New clause 6 deals with the reporting system, and we shall introduce regulations as soon as possible—I hope that that will be before the end of the calendar year. The regulations will be debatable. We shall be specifying to whom the reports should be made. We still have not resolved whether it should be regional or district health authorities. We shall be specifying also what should be reported. I assure the hon. Member for Peckham that we shall bear in mind the text of new clause 1, which is specific on what should be reported.
The voluntary register is to be organised by the United Kingdom Transplant Service. It will be running for the balance of this year, for the six months prior to the coming into operation of the reporting mechanism under the regulations. For that period the voluntary register will be performing a valuable service. For the purposes of research, perhaps, clinicians will be more likely to turn to the voluntary register for greater detail than to the Department of Health. I am thinking of aggregate statistics that we might have from the regional and district health authorities under the reporting mechanism.
§ Sir Michael McNair-WilsonWho will keep the voluntary register?
§ Mr. FreemanWe will not frustrate or stand in the way of the continuation of a voluntary register, which could proceed simultaneously with the separate reporting mechanism envisaged under new clause 6. I well appreciate the argument that the voluntary register might provide the research data that clinicians need.
I shall now answer the points raised by the hon. Member for Peckham. I have dealt with the expected timing of the laying of regulations, which will be debatable. We need to consult the medical professions about what is specified in the reporting mechanism and to whom the report should be made. As to the hon. Lady's suggestion of a lack of impetus, I had hoped that she might congratulate the Government on their rapid progress. The Second Reading Committee was on Tuesday 16 May and now, in the first week of July, the House will—I hope—shortly be giving the Bill a Third Reading. I hope that we shall make rapid progress so that the other place can complete proceedings so quickly that the essential provisions of the Bill can come into force.
§ Sir Michael McNair-WilsonI am sorry to delay the House——
§ Madam Deputy Speaker (Miss Betty Boothroyd)Order. The hon. Gentleman has already spoken once, and under consideration I regret that I cannot allow him to speak again.
§ Question put and agreed to.
§ Clause read a Second time, and added to the Bill.