The purpose of the amendments is to probe what the Government mean by the word ''consent'' in line 41. We are talking about a non-heart-beating donation where there is a need to preserve organ function, normally of the kidneys, while appropriate consent, if I may use that term, is obtained to remove organs for transplantation. By inserting a canula into the veins in the groin and perfusing the kidneys—not exclusively the kidneys these days—with a cooling fluid, their function can be preserved, even though the heart is not beating and pumping oxygenated blood around, so that they can still be used for transplantation. I wish to have a short debate on clause stand part about that approach.
The clause states that the authority
''(a) to take steps for the purpose of preserving the part for use for transplantation, and
(b) to retain the body for that purpose . . . ceases to apply once it has been established that consent making removal of the part for transplantation lawful has not been, and will not be, given.''
There is no reference to what that consent is in relation to the appropriate consent given under clause 1. Do the Government mean unqualified consent or consent that they do not cross-refer in this part of the Bill, or do they mean permission, as we would understand it, from the appropriate person? Amendment No. 125 would allow them to say that, but if we are to have a consistent Bill, perhaps they should refer back to appropriate consent, such as that given under clause 1.
I am not sure whether such provision is appropriate to the architecture of the Bill. This is one place where consent is unqualified by any adjective and so there may be a question about its nature. Who will give that permission? Without cross-reference to another part of the Bill, the hierarchy of relatives who can give that permission will be in question. I am trying to be helpful with this probing amendment. In order to speed up progress, I will conclude my remarks there.
This is a difficult but necessary clause because it will allow organs that are currently lost to be salvaged. It is quite controversial, particularly among those who might be engaged in harvesting such organs, several of whom are concerned about the ethical and legal implications for them. It is important to get the notion of consent clear, so that that category of people can feel comfortable that what they are doing is fair and reasonable.
We have exhaustively defined consent elsewhere in the Bill, and I am not clear about the word ''permission'', which we have not defined, although the hon. Member for Oxford, West and Abingdon implied that there was a common-usage understanding of the word. I would therefore resist an amendment that would substitute the word ''permission'' for ''consent''. I seek your guidance, Mr. Hurst: I assume that we will have a clause stand part debate, in which we may explore other issues.
The Chairman indicated assent.
Will my hon. Friend the Minister consider in her reply another aspect of consent, which I do not think we have discussed? I am referring to consent from people with motor neurone disease who can neither write nor speak. However, there are other mechanisms, involving the alphabet and so on, by which they can transmit consent. We must be careful about the giving of consent by people with different types of disease. We do not want to miss any tricks at this stage.
We will resist the amendments. The hon. Member for Westbury touched on the issue of consent, which we debated quite thoroughly earlier. Although amendment No. 124 is designed to reflect the wording of part 1 of the Bill, it is unnecessary. It is clear from the Bill as a whole that the consent that makes removal of an organ or tissues for transplantation lawful is the appropriate consent required by part 1. On amendment No. 125, we argue that ''permission'' would, as the hon. Gentleman said, be at odds with the wording of the rest of the Bill. The consent to which the clause refers is that which makes the removal for transplantation lawful. We know from part 1 of the Bill that that is appropriate consent as defined in clauses 2 and 3.
My hon. Friend the Member for Norwich, North (Dr. Gibson) made the important point that the Human Tissue Authority will need to consider, and issue guidance to reflect, the different circumstances that people may face. Of course, people with motor neurone disease will face particular difficulties, and it is important that appropriate mechanisms are available to enable them to indicate that they want their organs or a relative's organs to be available for transplantation should they wish to do so. The authority will be able to indicate that in guidance.
The Minister has just said that consent means the consent referred to in part 1, but that is not obvious to someone reading the Bill because it does not say—when it could—that for the purposes of the clause, consent shall mean appropriate consent, and that is not cross-referenced. In tabling these probing amendments, I wanted to ask her why she has specifically not included that cross-reference. That would be an obvious thing to do, because everywhere else that consent is mentioned, a qualifying adjective makes it clear that it is appropriate consent or qualifying consent. Why is only the vague term ''consent'' in this clause?
The wording in this part covers two things: the appropriate person referred to and the fact that the act of obtaining consent has been carried out. The consent cannot be any other consent; the Bill cannot talk about permission. Throughout, the Bill refers to consent—the appropriate consent in terms of the person from whom consent should be obtained. It also refers to the fact that the Human Tissue Authority will issue guidance to help people to obtain that
consent. To change the wording to ''permission'' would be inappropriate and confusing in this part of the Bill.
Shall we forget amendment No. 125, which refers to ''permission'', and concentrate on the amendment that would change ''consent'' to ''appropriate consent'', or whatever is the appropriate terminology, as defined in part 1? I do not understand why in every other part of the Bill there is a cross-reference to ''appropriate consent'' as defined in clauses 2 and 3 in part 1, but just in this clause, where one would have thought there was a need to be specific, it is left as ''consent''. It might be implied that it is something other than what is in the rest of the Bill. Courts may have difficulty seeing what the Minister sees as obvious when they have to carry out a literal interpretation of the Bill.
I assure the hon. Gentleman that in drafting this part, we have been careful to ensure that we are not opening up any loopholes. The method that he suggests would cause greater confusion. I realise that he is finding that difficult to accept, but I assure him that we need to consider the thread running through the Bill, especially in this part when we are discussing transplantation. Obviously consent can be made by relatives as well, and we must ensure that we use the appropriate wording. According to our legal advice from parliamentary counsel and others, the Bill's wording is appropriate.
I am sorry to press the Minister on this point. She is saying that the wording is correct because she says it is correct and because that is her advice, and I find that hard to accept. I hope that she is saying it is correct because she thinks it is correct and that is her advice, but could she explain why it would be confusing or why loopholes would be created if there were a reference to appropriate consent as defined in part 1? What is being lost? As we shall discuss in the clause stand part debate, this is a controversial issue and people will want reassurance about what the Minister means by consent, versus appropriate consent.
I draw the hon. Gentleman's attention to clause 1(1)(c); it states that the removal of material from a deceased person is lawful with appropriate consent. The consent referred to in clause 44 cannot, therefore, be anything other than appropriate consent. I assure the hon. Gentleman that we have given thorough consideration to the correct wording to use in this clause. We know that this is the most appropriate way to express the consent to be given for transplantation. Having given the hon. Gentleman that assurance, I hope that he will seek leave to withdraw the amendment.
The Minister has just said that, because clause 44 refers to consent making removal of the part for transplantation lawful, that is all that is required to refer to part 1 of the Bill. However, I am not sure that that is as helpful as the Minister thinks. The Government have included these provisions in part 3 rather than part 1. I could understand it if they were in
the same part as those covering the definition of appropriate consent and the issue of qualifying relatives—that would flow naturally. However, some of the provisions and definitions in the Bill relate solely to a specific part, and repeat definitions cover other parts to clarify what does and does not apply to the rest of the Bill. The Minister has explained that she is confident that because the term ''lawful'' is used, the provision must refer to part 1, but she has not explained why it is not necessary, helpful or consistent to make specific reference to the phrase ''appropriate consent''.
I will not make much more progress at this point, but I hope that further explanations will be forthcoming. I am not trying to be difficult, as I am a strong supporter of the clause, but there is controversy around it, which is why I used amendment No. 124 to probe the Government's thinking. That said, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
I want to raise some ethical concerns about the clause. Its laudable aim is to increase the supply of organs for transplantation, but it has raised troubles in the mind of some of the clinicians who harvest those organs. The concerns are similar to those surrounding the separation of those who ask for consent for a post mortem from those who carry out the examination.
The idea troubles clinicians who work in accident and emergency departments, intensive care units, medical wards and coronary care units. As we understand it, the clause makes legal without consent the measures necessary in a non-heart-beating donor to preserve the organs within the dead body until consent can be obtained. That could involve ventilation and operations on the groin to insert cannulae in the femoral artery and vein to perfuse the organ.
An intensive care consultant from Leeds, Dr. Dominic Bell, who has written about the ethical aspects of non-heart-beating donation in the Journal of Medical Ethics, has written to me:
''Under the terms of Clause 44, elective ventilation could also be incorporated if instituted at the point of death, regardless of debate already existing as to the precise timing of death for the purpose of these interventions. These are not therefore minor undertakings and many staff in the arena would harbour ethical concerns about embarking on these particularly without explicit and detailed prior consent in today's climate.''
''Clinicians working in areas where donor recruitment takes place need not only resolution of the key ethical issues but also highly detailed prior consent before embarking on any manoeuvres that are solely for 3rd party benefit. Aspects within the bill relating to organ procurement need expansion and greater debate and public engagement before simply authorising by legislation.''
I will be grateful to hear the Minister's comments, and if she wants me to, I shall pass her the letter so that she can consider it more deeply.
My hon. Friend seems to be encouraging me to speak at great length, but I understand that he, like the rest of us, would like to finish early. With that in mind, I shall keep my remarks brief.
I am concerned about this clause because it opens up a new legal and ethical area, which is—judging from the remarks of the hon. Member for Wyre Forest—opaque, to say the least. The Minister must understand that people working in intensive care units in hospitals will be asked to do something that they do not currently do. It is important that she gives us a clue about what she understands by terms such as ''least invasive'' and ''minimal''. That is unclear at the moment—although we have a fair idea of what is involved, from the hon. Gentleman's description. It involves putting people on a ventilator, for example, if they are not already on one, to preserve organs prior to harvesting. As I said earlier in the debate on the amendment, that seems entirely reasonable. However, the thread running through the Bill is consent, and we must be clear about permission or consent and the mandate on which practitioners operate before they embark on organ perfusion or de novo ventilation. It really is a minefield. Allowing the clause to stand part of the Bill, and to be dealt with in such a summary fashion, is treading on very dangerous ground.
I should encourage the Minister to talk about the terms ''least invasive'' and ''minimal''. We have done the subject of consent to death. I was reassured by some of the remarks of the hon. Member for Wyre Forest, even though the hon. Member for Oxford, West and Abingdon seemed not to be. I should appreciate a description from the Minister of what will happen in practice under the measures outlined in the clause.
This clause is interesting because it is different from other measures in the Bill. I think that the Minister will say that it is valuable because of the need to increase the number of organs from non-heart-beating donors, which have shown to be very effective. In some studies, they are just as effective—in terms of the length of time that the transplanted organ survives—in saving and transforming life, particularly with the donation and transplantation of kidneys. Many people argue that we will make significant progress in tackling the huge shortfall of organs available for transplantation—and do something about the hundreds of people who die every year while waiting for an organ—only by increasing that form of donation. Although there has been plenty of correspondence on this issue, and it was included in the Government's consultation, it has not been the subject of a huge amount of public debate beyond that.
I would be grateful if the Minister could respond to a number of points. First, what is the origin of the authority? It is necessary to expand on what ''authority'' refers to. In the clause, the word is used as a noun meaning ''authorisation'', rather than ''an authority''. It is not clear who is responsible for ensuring that the people carrying out these activities are competent. Subsection (4) states:
''Authority under subsection (1) shall extend to any person authorised to act under the authority by—
(a) the person on whom the authority is conferred by that subsection, or
(b) a person authorised under this subsection to act under the authority.''
In a sense, that is circular, and it is not clear whether there is an authority in the sense of the Human Tissue Authority which is responsible for dealing with this matter. One assumes, since subsection (1) refers to a
''hospital, nursing home or other institution'', that those responsible for clinical governance and care standards in hospitals, nursing homes and other institutions will have an interest in it. It is important for the Minister to clarify that because it seems to suggest that such activity might be less well regulated by the Bill than other actions, even though it may be as controversial as, or more controversial than, other activities.
My second point concerns what the ''minimum steps necessary'' are. There has been no explanation of whether those minimum steps will relate only to cannulation of the main vessels in order to perfuse them with cold fluid, or whether elective ventilation of someone who is dead—as confirmed by brain stem death—might happen at the point of death or after death. The Minister should clarify that point, because it is currently recognised that elective ventilation of someone who is alive is not lawful. That has been examined in several cases, because elective ventilation is taking an action on someone that is not for their benefit, and therefore is not covered by the usual defence to a charge of battery. Moreover, as the Minister will be aware, there is a small risk in that process of producing a persistent vegetative state, which leaves the person in limbo. That is in no one's interest.
The correspondent of the hon. Member for Wyre Forest raised that point, among others, and, as the hon. Gentleman said, was concerned that, under clause 44, elective ventilation could also be incorporated if instituted at the point of death. That matter must be clarified, and I am not sure whether the codes of practice that are mentioned throughout the Bill will cover it, because the clause makes no specific reference to codes of practice. I regret that I have not looked through the Bill to see whether the codes of practice and the authority's remit extend to that matter. I suspect that they do not and, if that is the case, it will be necessary for clear regulations and codes of practice to be devised.
Thirdly, I hope that the Government will concede, although I suspect that they may not, that they are, for this purpose, endorsing a presumed consent. The
consent is presumed for this activity to take place, until subsequent checks are made. That is the view of many people who are examining this issue, including the correspondent of the hon. Member for Wyre Forest who says in his note that the clause, despite the protestations of the Minister regarding presumed consent,
''does constitute presumed consent, albeit for preservation techniques, not actual procurement.''
The Minister must acknowledge and deal with the fact that where the need is shown, and a good purpose is intended, it is legitimate to presume consent for an action until further considerations can be taken into account.
I would be grateful if the Minister could respond to the three points that I have raised.
I am sure that hon. Members will recall the debates about presumed consent on Second Reading and earlier in the Committee proceedings. I gave reassurances that there were provisions in the Bill that would increase the availability of organs for donation; the clause contains such provisions.
I will briefly address some of the main points that have been made. All hon. Members have raised the question of whether the clause extends the law. I want to make it clear that it does not make perfusion lawful; that activity is already lawful. The purpose of the clause is to clarify the current position. The provision allows a hospital or nursing home to authorise a member of staff to agree that preservation can begin after death until the wishes of the deceased, or those close to them, are known. That will not involve elective ventilation, which is and will remain unlawful. The clause will allow only the minimum preservation necessary after death. Elective ventilation can commence before death and would not be lawful under the clause. I understand hon. Members' points about that, but I hope that my explanation clarifies the position.
The Minister said that the clause will not make those activities lawful. Will she clarify on what basis the current practice is lawful? How does current law—statute or common law—restrict what is lawful only to the act of preserving organs for potential transplantation use, and not to other actions taken on a dead body?
I know that this sounds tortuous, but the current procedure of cold perfusion is lawful because there is no law against it. I realise that that sounds odd, but it is the case. We want to make it clear to people that they can undertake that activity. Just as embalming is lawful, so is cold perfusion.
With regard to the codes of practice issued by the authority, I assure the hon. Gentleman that the authority will ensure that only the least invasive procedures are used. The hon. Members for Wyre Forest and for Westbury raised the issue of intensive care unit staff, but the activity in question is carried out by transplant teams after death. As I have said, we are trying to clarify the law so that people have confidence that they can carry out the procedure, which can add
to the number of organs available for donation. The time in which consent is sought is short simply because organs will deteriorate.
I cannot envisage that it is practicable for perfusion to be carried out by a transplant team. Currently, it is carried out by the staff in the ICU or A and E department. I cannot envisage the transplant team being able to get to the hospital in enough time, unless the team happens to be idle in a major hospital. However, the procedure will be relevant to many people in smaller and district general hospitals without transplant teams. I am sure that the bulk of organs come from such situations and I remember the problems that we had with arranging transport.
I assure the hon. Member for Wyre Forest that we envisage members of the transplant team undertaking that activity because a certain amount of training will be needed.
I seek to help the Minister, which is why I wanted to intervene as soon as possible. There is some confusion, although not in the mind of the hon. Member for Wyre Forest I hasten to add, about controlled non-heart-beating donation and uncontrolled non-heart-beating donation. In many circumstances, death is liable to happen at a planned time and the appropriate steps can be taken. It is only in the uncontrolled situation, with a dead-on-arrival case in A and E, that people other than the transplant staff, such as A and E physicians and surgeons, may be required to take action.
The hon. Gentleman is right. I am assured that currently transplant teams, or others who are specifically trained for the purpose of carrying out the procedure, are always available.
I thank the Minister for clarifying that. The phrase ''or others'' is crucial. In Leeds the hospital that does the transplant is different from the hospital that has the A and E department, so it will not be the transplant team who carry out the procedure; it will be done by A and E staff who are trained in the procedure.
The important point is that proper training is available and that it co-ordinates with the work of the transplant team so that the person is almost part of that team.
I am aware that the Minister had moved on to deal with the point raised by the hon. Member for Wyre Forest, but I want to bring her back to the question of lawfulness. I should have thought that what is required is to make it explicit that the practice is lawful. Clause 1(1)(b) states that without appropriate consent
''the use of the body of a deceased person for a purpose so specified''
—in other words, transplantation—will not be lawful, and that is why clause 44 is necessary. If the Minister agrees with that, would it be useful—I suspect that she will say it would not be—to make it clear that the paragraph in clause 1 does not apply to the question of preserving organs for transplantation, even though most people would understand that to be the use of a body?
I am not quite sure that I completely follow the hon. Gentleman's arguments. The clause clarifies that cold perfusion is lawful, while making it quite clear that consent is required to proceed any further. This is a short procedure. The authority will ensure that it is the least invasive possible but it will make an important contribution to organ donation.
Dr. Murrison rose—
I know that the hon. Member for Westbury wants to intervene, but I have to say that I hope that the Minister is not proposing to finish her remarks there. I asked her three specific questions. One concerned the authority that is referred to and who regulates it. The second concerned whether codes of practice would be issued—
I am sorry if I missed that. Thirdly, I asked whether the Minister accepts that this is to a certain extent an issue of presumed consent, at least up to the point at which consent is required.
I think that I answered all those points in my remarks. First, I said that the codes of practice issued by the authority would state that the procedure had to be the least invasive. Secondly, I said that this did not involve presumed consent, but the carrying out of a short procedure to ensure that organs do not deteriorate until consent is obtained. Thirdly, the HTA will regulate the practice, but there is also the question of obtaining the authority to go ahead, perhaps from an individual.
I perceived that the Minister was about to conclude her remarks, so I thought that I should intervene briefly. Will she confirm that all she has in mind here is cold perfusion, not ventilation? Will she also say that she will rely on case law as a defence against a charge in the event that someone took exception to cold perfusion having been instituted? We understand that there is no statute law; that is fine. However, there must be case law for the assurance of those who will undertake the procedure. How many cases of cold perfusion have there been in, for example, the past 12 months or so?
Cold perfusion has been undertaken as a procedure for the past 10 years. I do not know the exact number of cases, but I can write to the hon.
Gentleman if he is interested. He asked about case law as a defence in respect of cold perfusion. Obviously, once it is lawful under the Bill, there will be statutory authority to do it. I am not quite clear what the situation would be if someone had indicated beforehand that they did not want the procedure undertaken. As far as I am aware, there have been no objections to it in the past 10 years. Cold perfusion is undertaken after death, and the results last only a certain number of hours before organs start to deteriorate.
I certainly endorse what the Minister has said. I believe that there was a case in Leicester in which someone sought to prosecute the doctors for undertaking cold perfusion, and there was a worry that the Crown Prosecution Service and the police would act. The clause is therefore welcome. If it turned out that someone had said that they did not want the procedure done to them, although that was not known at the time, the defence would be that the presumption was made that they would permit it, until their wishes were clarified.
No, a defence would be that the procedure is allowed under statute. It would not be a presumption; it would be what the law says. Having said that, I hope that members of the Committee will agree that the clause is important to ensure that we can assist in obtaining more organs for donation.
Question put and agreed to.
Clause 44 ordered to stand part of the Bill.