Human Tissue Bill

HL Deb 03 November 2004 vol 666 cc396-422

7.51 p.m.

Read a third time.

Clause 1 [Authorisation of activities Or scheduled purposes]:

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner) moved Amendment No. 1:

Page 3, line 3, leave out subsections (10) to (12).

The noble Lord said: My Lords, I reflected with my colleagues on the debate on the opposition amendments agreed to last week on Report, which sought to allow use of residual tissue without consent for education and training in research. As I have said before, we are a listening Government, and I recognise that some powerful points were made in support or the proposition behind the amendments. I also recognise that the amendments had broad backing from all sides of the House. At the same time the Government were also aware that, as drafted, the amendments agreed to had a very mixed effect, and that the amended Bill was likely to cause confusion to clinicians and researchers in the field.

Amendments to Clause 1 were agreed to that would allow use of residual human tissue for research education and training without consent, provided that the tissue was anonymised. Amendments were also made to Schedule 1 to allow use of residual tissue for research education and training without any consent or safeguards. Strangely, amendments made to Schedule 4, to allow use of tissue for DNA analysis in research, education and training without consent, would have the effect of requiring the tissue used for this purpose to be identifiable. Taken together, these amendments do not make sense and would have been unworkable.

Noble Lords will be pleased to hear that I am therefore now introducing amendments to remove those passed on 25 October and replace them with government amendments to achieve a similar but, I hope, more consistent and clear effect. The Government's amendments remove education and training in research techniques from Part 1 of Schedule 1, allowing that purpose to be subsumed within education and training in human health, so that it will be lawful to store and use tissue from the living for both those purposes without consent under Part 2 of Schedule 1. Amendments to Schedule 4 will similarly allow DNA analysis for education and training in research techniques without consent.

Noble Lords will notice that as a result of this, Part 2 of Schedule 1 does not now contain an explicit reference to education or training relating to research in connection with the disorders and functioning of the human body. That is because this activity is simply a sub-set of education or training relating to human health. It was necessary to single it out when the effect of the Bill was to include research training in Part 1 of the schedule alongside research itself, while the remainder of education or training relating to human health was in Part 2. However, now that we propose to include all education and training in Part 2 of the schedule, research training is simply re-absorbed into the general category of education or training relating to human health.

The two kinds of activity were mistakenly treated as needing separate references in paragraph 7 of Schedule 4, which deals with existing holdings of material for the purpose of DNA analysis, and so Amendment No. 26 corrects that. We chose this route to allowing education and training in research techniques without consent, rather than the alternative option among the opposition amendments of tissue anonymisation, for reasons of simplicity and clarity. Noble Lords spoke eloquently of the difficulty in distinguishing education and training in research from that required for clinical practice, so we considered it best to save further confusion by aligning the two. However, noble Lords should be in no doubt about the scope of this change to the Bill. It will not be a back door to research use of tissue without consent. It will not, for example, allow people to undertake research using tissue without consent, simply by involving a research trainee.

The activities of training and education in research techniques are distinct from carrying out research. Research, as we pointed out earlier in our discussions on this Bill, is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. It is not about showing medical students or technical trainees how to operate research equipment and learn techniques such as the staining of tissue samples. Storing and using tissue for these last activities will fall into Part 2 of Schedule 1 and may be done without consent. Storing and using tissue for research itself will remain in Part 1of Schedule I, requiring consent or, alternatively, anonymisation and ethical approval for the project concerned, whether or not a research trainee is taking part.

I hope that all noble Lords will welcome these amendments which fully meet the concerns expressed during debate in this House, so that we can all join in supporting the Bill as it goes forward to its final stage. I beg to move.

Earl Howe

My Lords, I am sure that I speak for noble Lords around the House generally when I say how grateful I am to the Minister for listening so carefully to the points made last week on Report, and for introducing these government amendments, which I for one very much welcome. They achieve everything that I had hoped that we could achieve. The objective, which I am sure that other noble Lords share with me, is that we should have a set of rules which are clear and workable for clinicians, researchers and teachers. We have arrived at that point, and it is to the Government's credit that they have listened so carefully. I am delighted that the main point of contention—perhaps the single largest point of contention that we were faced with when the Bill arrived in this House—has been so satisfactorily resolved.

Lord Jenkin of Roding

My Lords, this is a justification for the very long processes that we use in Parliament to put new legislation on to the statute hook. It is interesting that it has taken until the final stage of the Bill in the second House, after the argument has been advanced over many months in both Houses, before finally we have persuaded the Government that the change is necessary. I welcome the Government's amendments, as did my noble friend, but we need to recognise that that is why we have those processes for legislation.

Lord Turnberg

My Lords, I must also say how welcome the Government's amendments are and how grateful I am, and many others in the scientific community are, for the enormous amount of effort that my noble friend has put into bringing forward these amendments and making the Bill workable. This was one of the most difficult areas for the scientific community, and these amendments will make it much clearer what they can and cannot do. I take absolutely the point that this should not be seen as a back door into research without consent: indeed, I believe that it strengthens that requirement.

8 p.m.

Baroness Neuberger

My Lords, I should like to echo what noble Lords have said around the House and thank the Minister for this change, which has dealt with perhaps the biggest single objection to the Bill as it stood before Report stage. I know that the heads of medical schools, much of the research community and many of the specialist patient groups also are extremely grateful. I should also like to echo what the noble Lord, Lord Turnberg, said about this not being a back door to research using tissue without consent. It seems to me that that would be quite wrong. I think that noble Lords on all sides of the House have agreed that that should not be allowed.

Baroness Finlay of Llandaff

My Lords, I do not wish to detain the House with a long list of thanks. However, I should like to add my thanks and the thanks of those in the clinical academic community who are involved in training and education and see this as a very important group of amendments. We are most grateful to the Minister for all the negotiations and for listening, which has made this possible.

On Question, amendment agreed to.

Lord Warner moved Amendment No. 2:

Page 7, leave out line 13.

The noble Lord said: My Lords, you will recall that opposition amendments were proposed in Grand Committee and on Report to remove the power of magistrates to order a custodial sentence for offences under the Bill. I said then that we would look again at the point. I now propose government amendments that should meet the concerns expressed about excessive penalties available on summary conviction for these offences.

These government amendments remove the power of magistrates to order a custodial sentence where such a power has not previously existed or where the offence is triable summarily only. The effect of the changes is that offences that are triable either way relating to consent and misuse of human tissue at Clauses 5 and 8 of the Bill, to licensing offences at Clauses 25, 30 and 31 and to the DNA offence at Clause 45 will no longer attract custodial sentences on summary conviction.

Magistrates can at present order a custodial sentence in relation to most offences under the Human Organ Transplants Act 1989, which is concerned with trafficking in human organs. They will continue to be able to do so for offences transferred to the Bill from that Act.

Consequential amendments to Clause 58 relate to the position pending the coming into force of the Criminal Justice Act 2003, and consequential amendments to Clauses 51 and 59 relate to the position in Scotland and Northern Ireland.

I hope that noble Lords will agree that these amendments meet their concerns. As I have said before, the penalties are there to act as a deterrent to future misuse of human tissue and we do not expect cases to come to court. Only the most serious cases would warrant a custodial sentence and this will now be following a trial by jury. I beg to move.

Earl Howe

My Lords, while this particular issue is, I am sure, in the judgment of most of us, not as salient as the issue that we have just debated, my gratitude to the Minister is none the less great for the way in which he has listened to the arguments that I and others have put forward at earlier stages on the issue of judicial penalties. This is another set of extremely welcome changes to the Bill and will, I believe, send out the right balance of messages to the research community, without in any way damaging the message that the Government rightly wish to emphasise—that it is simply not acceptable to attempt to undermine or ignore the fundamental tenets of the Bill to which we all subscribe.

Baroness Neuberger

My Lords, I, too, should like to thank the Minister for agreeing to these changes. I know that they have been much welcomed by much of the research community, which was, I think, becoming rather nervous. Like the noble Earl, Lord Howe, I believe that it is important that we stick to the principle that those concerned need to take these issues seriously. But they were, I think, overly worried, and beginning to reach a position where they perhaps would not have done some of the research that we would wish them to do. So I thank the Minister most sincerely.

Baroness Finlay of Llandaff

My Lords, we know that we are faced with a national shortage of pathologists. I think that this amendment will go a long way to ensuring that we are able to keep on trying to attract people into this specialty. It is therefore extremely important that this group of amendments has our wholehearted support.

On Question, amendment agreed to.

Lord Warner moved Amendment No. 3:

Page 7, line 14, leave out from "maximum" to end of line 15.

On Question, amendment agreed to.

Baroness Hayman moved Amendment No. 4:

Page 8, line 26, after "Court" insert "or the Authority"

The noble Baroness said: My Lords, in moving this amendment I shall speak also to Amendment No. 25, which was helpfully tabled by the noble Baroness, Lady Finlay, to mirror my own amendment in relation to DNA. I tabled the amendment following the intervention that I made in our debate on Report where, fundamentally, we were looking at the issue of whether we should agree to an amendment that would transfer the responsibility for scrutinising applications, to dispense with the need for consent and/or anonymisation for research purposes when there was an overwhelming public interest so to do and it was not practicable to obtain consent or to anonymise.

The debate was essentially between the Government's view that these cases would be exceptionally rare and that it would not be onerous or inappropriate to involve the High Court in determining whether consent could be dispensed with in those cases and the view set out in an amendment. That amendment, which proposed to transfer the authority to make those decisions to the Human Tissue Authority, argued that, in fact, it might not be such a rare occurrence—there might be perhaps tens of these cases, or even more than 100, every year—and that it is important to develop an expertise that is available to the Human Tissue Authority, which is taking parallel decisions in other circumstances.

My suggestion was simply that—since we are currently discussing the regulatory power and the Government would have to bring forward regulations in which they could stipulate that, in the first instance, the High Court should determine these issues—there was nothing to be lost by allowing the regulations, in an enabling spirit, to confer this power either on the High Court or on the Human Tissue Authority. If the Government are right and this is a very rare instance, they can start with the High Court and see how things go. If they are correct in their analysis that very few applications come up, then the status quo can pertain, but none of us knows exactly what the circumstances will be. If we leave the Bill as it is and find that, in fact, it is a more common occurrence, we would be faced with the option of only the High Court having the powers. We would have to find parliamentary time for primary legislation in order to amend the Act.

My amendment is truly intended to be helpful to the Government Front Bench and to allow the Government flexibility, without in any way prescribing how they should deal with the issue and accepting that in the first instance they will deal with it as laid out in the Bill at the moment. I hope that my noble friend will be able to respond positively. I beg to move.

Earl Howe

My Lords, this is an extremely neat amendment that forces the Government to do nothing whatever that they do not wish to do. For that reason, I can think of no grounds for the Minister to resist it.

As the noble Baroness explained, the amendment would give the Government flexibility in the future. I agree with her that the High Court will, no doubt, be the chosen point of reference in the regulations, when they are first issued. I do not have a problem with that. As time goes on, if it transpires that there is a significant number of applications to the High Court under those regulations, it would be open to the Government to consider whether the Human Tissue Authority, rather than the High Court, might be a more appropriate point of referral for decisions of this kind. I hope that the amendment will commend itself to the Minister as a neat way forward, bearing in mind that none of us knows what the future holds. If we can, we want to allow for the two eventualities.

Lord Clement-Jones

My Lords, I support Amendment No. 4 and Amendment No. 25. Clearly, I need to go away rather more often, as the Government have demonstrated considerable flexibility between Committee and Report. I was delighted that all that happened in my absence. It was therefore with some disappointment that I read that the single act of inflexibility was failure to accept that there should be greater flexibility in Clause 7 as regards research tissue from a deceased person.

I have no doubt that the noble Baroness, Lady Hayman, is right. I agree with the noble Earl, Lord Howe, that this is a well drafted amendment. The Government have to make no commitment at all at this stage. The amendment would simply enable them, if experience showed that the High Court was not a suitable place for the matters to be resolved, to change it so that the Human Tissue Authority was designated by regulation at a future stage.

Reading the difference between the responses of the noble Baroness, Lady Andrews, in Committee regarding the first part of Clause 7 with the responses on Report is instructive. There is no reason why, on further reflection and in the light of experience, the Government might not come to the conclusion that the HTA would be better than the High Court, as they have done with living human tissue—rightly, in my view.

In Committee, the noble Baroness was at pains to say that the Government did not want a bureaucratic approach. That was in response to an amendment that put forward the idea of an advisory authority taking a view on these matters. The Government have clearly accepted that the HTA is the right way of going about this but, on the matters dealt with by the amendment, the High Court is going to be a far more bureaucratic way of dealing with them. I am sure that that will be demonstrated by experience, in terms of the type of expert witnesses required and the battery of lawyers that may well be required as well. The HTA could solve this in a much better way. There are many examples. The Human Fertilisation and Embryology Authority, which deals with other matters, is able to take decisions in a much more flexible way.

The Government's single reason for resisting that approach is that the cases are so exceptional that the only appropriate place to deal with them is the High Court. That again must be seen in the light of experience. At this stage, we do not know whether that will be the case, whether there will be quite a number of applications, or whether they will find proceeding through the High Court a problem in terms of timing and urgency.

I urge the Minister to reconsider the matter. All he has to do is indicate that the Government are prepared to keep their options open. Surely that is what all governments do.

Baroness Finlay of Llandaff

My Lords, as the noble Baroness, Lady Hayman, said, my amendment mirrors hers; she has already laid out the arguments for that. It would simply allow the Government to have flexibility. If many applications came forward, the Secretary of State could decide what was to be given as a power to the authority. That would not bind anyone into anything at this stage.

It is worth remembering that applications to the High Court are generally required where there are exceptional issues of life and liberty to be determined—where the consequences of decision-making are serious and grave. Quite a few requests may come forward that would not fulfil those criteria, but where the potential benefit to the health of the public of undertaking the research outweighs the risk of harm to the rights of the individuals concerned, the Human Tissue Authority may turn out to be the appropriate forum. It certainly would be less costly. The amendment would ensure appropriate expertise and independent scrutiny of an application, protect those from whom the samples had come, and allow the authority to consider the issues properly. The powers may never be needed, but if they were they would be in the Bill.

8.15 p.m.

Lord Jenkin of Roding

My Lords, in Grand Committee. I accused the Government of intransigence. I feel very much inclined to apologise and withdraw that charge, because of the large number of amendments that the Government tabled on Report and have tabled again today to meet the arguments advanced in Committee. I find myself wholly persuaded on this amendment by the arguments adopted and the case for flexibility. No one actually knows what the demand for the use of the clause might be. I would be able to withdraw the charge of intransigence with complete confidence if the Minister were to accept the amendment.

Lord Warner

My Lords, it is with some hesitation that I respond to the amendments; I do not wish to break the spell of harmony of our earlier stages. I welcome back the noble Lord, Lord Clement-Jones—our tabling the amendments on Report was nothing to do with his absence. I fully recognise the constructive thinking behind the amendments tabled by my noble friend and the noble Baroness, Lady Finlay. However, I hope that I can have a go at giving the grounds for the Government's position.

We accept that the amendments represent what might be described as a compromise approach, following Report. I understand where people are coming from in giving the Secretary of State the flexibility proposed in the amendments. However, underpinning the amendments is a belief that there could be a large volume of cases. Although I recognise the concern being expressed, it is that assumption with which I have to disagree.

The cases that we are considering in the context of Clause 7(4) are by definition rare. They will be ones where there is an urgent and immediate matter of public interest. That being the case, the High Court remains the appropriate forum for consideration. The noble Earl, Lord Howe, in speaking to his amendment on Report, said that the need for an order could arise quite frequently. He set out several scenarios in which he considered that one might be needed. Those were: where it was unclear whether a patient's previous consent was sufficiently broad to cover the research in question; where the consent was unclear because of a failure of record-keeping; where a patient with a rare condition can no longer be traced and anonymisation is difficult because all practitioners in the field are familiar with the patient; and where a person has died of a rare condition and has neither friends nor relatives who could give consent.

Those arguments fail to take account of several highly relevant points. First, the power in Clause 7(4) is certainly not intended to provide a back-up for failures in record-keeping. It will provide only for cases of overwhelming public interest. As my honourable friend said in another place when we brought the provision into the Bill, it is there primarily to deal with situations involving the deceased, such as the death of a person with an unknown virus having just arrived through Heathrow, or in a terrorist attack using biological material. These are highly unusual situations and would call on the need for an overriding public interest.

Secondly, the order provides for the only situation under the Bill where research using the bodies of the deceased can be carried on without consent. There has long been a clear consensus against the state requisitioning unclaimed bodies for research or education purposes. The current power, under the Anatomy Act 1984, to use such bodies has never been used and is now being removed. We should approach this issue with extreme caution. The noble Earl, Lord Howe, suggested that the most likely case would be regarding the deceased where there was no possibility of obtaining consent. Yet there is no evidence that routine cases of that sort would require research in the overwhelming public interest. In the light of Alder Hey and other events, the control mechanism in such cases needs to be at the highest level. That point was made to me forcefully in a recent letter from Professor Margot Brazier, the former chair of the Retained Organs Commission. Anxious about this and other amendments being proposed, Professor Brazier described them as "deeply disturbing", because they would erode the confidence that is being built around an ethical framework of consent.

Thirdly, in the case of tissue from living persons, other means are available for using tissue for research, without resorting to orders under Clause 7. These are: first and foremost, with the consent of the patient; secondly, in the case of incapacitated patients, under regulations that will be consistent with research allowed under the Mental Capacity Bill or clinical trials regulations; in all cases, with Research Ethics Committee approval and anonymisation; and, in cases of major public health concern, it would most likely fall within the public health monitoring exception.

Most typically, if consent has not been sought or given, then REC-approved research with anonymisation will be the norm. The noble Earl referred to cases of very rare diseases where all practitioners are familiar with the patient and the patient cannot be found. Is it really a frequent occurrence that there is a disease so rare that all patients are known to all practitioners by sight of their tissue samples, yet none of them knows how to contact the patient? Those would be extraordinary circumstances that are highly unlikely to occur.

This power will not be applied to everyday situations, but only to truly exceptional cases. It is not comparable to the situation regarding confidentiality. The number of applications made to PIAG is not a relevant comparison, because the court order is not intended to provide a fall back for all cases where, for residual samples, obtaining consent or carrying out research anonymously proves difficult. The Government have made clear their intention that the regulations that will come before Parliament will provide only for rare circumstances where the overwhelming public interest requires consent to be deemed to be in place. The precise circumstances in which it will be exercised are, by definition, not yet known. So there will not be a flood of cases. The regulations will simply not allow that.

I hope that my noble friend will withdraw her amendments and that I will not lose my growing reputation with the noble Lord, Lord Jenkin, for avoiding intransigence.

Lord Turnberg

My Lords, before my noble friend sits down, perhaps I may ask for clarification. He has made a good case in relation to deceased people and the need to seek permission for research in the circumstances that we are discussing. Those may well be rare in relation to deceased persons, but subsection 4(d) describes, the storage for use for that purpose of any relevant material which has come from a human body". Paragraph (e) also refers to "a human body". If that relates only to a deceased human body, the description given by the Minister would seem to be reasonable and rational. But if that relates to a human body that is living or dead—"living" being the operative word—would not that conflict with subsections (1) and (2) of this clause? I find that difficult to understand.

Lord Warner

My Lords, I was trying to deal with the two categories in my remarks, which I hesitate to repeat. The overwhelming point is that whatever the sets of circumstances, they will be rare and extremely unusual. Already there are a large number of ways of securing the use of tissue from a living body—the point my noble friend is making—in the ways I outlined.

My central point is that the powers in the Bill enable the Secretary of State to frame regulations which take account of those very rare circumstances which would go to the High Court. We must let time pass, but we are confident that because we are dealing with a very unusual set of circumstances in the cases covered, there will be no problem for the great majority of people. They are covered in the provisions throughout the Bill, living or dead. We are talking about a very unusual set of circumstances in which there may need to be an application to the High Court and the regulations will define those circumstances.

Baroness Hayman

My Lords, I listened carefully to what my noble friend said, but there is a circular logic to it; that the regulations will determine the number of applications and therefore ensure that it is small. Circumstances will actually determine the cases in which applications are made. I fully accept that at present none of us envisages that there will be a large number of such circumstances, but I am tempted to say that there are more things in Heaven and earth than in my noble friend's philosophy. It may have been prudent to allow a little flexibility to be available as a backstop if necessary. I do not believe that that would erode confidence in the system.

I hope that the Human Tissue Authority will build up confidence in it; that over time, through its decisions and the way in which it conducts itself, people will have more confidence in the authority as a specialist in this area than simply in an application to the High Court. Looking to the future, I hope that we shall see the Human Tissue Authority as an important player and, it is to be hoped, a respected one. However, my noble friend has not found himself able to move in this area and I do not want to destroy harmony. Perhaps he will not receive the accolades of the noble Lord opposite, but I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 8 [Restriction of activities in relation to donated material]:

Lord Warner moved Amendments Nos. 5 and 6:

Page 9, leave out line 3.

Page 9, line 4, leave out from "maximum" to end of line 5.

On Question, amendments agreed to.

Clause 11 [Coroners]:

Baroness Finlay of Llandaff moved Amendment No. 7:

Page 10, line 42, after "for" insert "current or future"

The noble Baroness said: My Lords, I am grateful to the Minister for his detailed letter addressing my concern over Article 2 of the Human Rights Act. Some issues warrant clarification as we do not have the revised coroners' rules before us. First, no one is talking about the retention of whole organs. No one would consider the retention of anything without that information being available to the next of kin.

I am deeply offended by correspondence that has suggested that I am in any way whatever trying to allow or defend the actions of Dr van Velzen and others. I am trying to protect human rights. I am trying to ensure that post-mortems properly sample to establish microscopic confirmation of macroscopic appearances; that the quality of every post-mortem is of the highest standard; that the findings are explained fully to the bereaved and that they are involved and informed at every part of the process; and that everyone has the right to justice. Secondly, we need clarification of exactly when the coroner is functus. If we are able to recognise that that may never be the case, then there is recognition of the ability to reopen an inquest.

8.30 p.m.

In retaining tissue, appropriate to the ability to revisit, the amount retained is sufficient only to allow the issues raised by a death to be addressed. In the majority of cases, that will entail blocks and slides. All other tissue should be returned to the body—if possible, prior to burial or cremation. If that is not possible, the coroner's consent form applies. That form, as it stands, states that, the coroner has legal power to order a full post mortem, including removal of body fluids and tissues for laboratory examination, and the taking of X-rays and other images". The form is designed to help relatives to understand what is involved in the post-mortem examination ordered by the coroner. It states: During the examination, samples of body fluids and tissues may be removed for laboratory examination. Tissue samples are made into blocks and slides for examination with a microscope. Any tissue remaining from this process (residual tissue) will usually be disposed of. Blocks and slides are kept indefinitely as part of the medical record or in case they are needed in the future for further tests relating to the cause of death or your partner or relative's treatment".

The form then goes on to record officially what has been agreed with the relatives about what will happen to the body and organs once the coroner's duties are complete. It also provides an opportunity to donate tissue or organs from the body for medical education or research. Those tissues are part of the record; they are not pieces of evidence, such as a shoe or a knife. The slides are as important as clinical photographs, the drug chart, the record of clinical observations or the results of biochemical analysis.

What makes a coroner satisfied that an inquest after post-mortem is unnecessary? That is a judgment on balance of probabilities at the time. If the pathologist finds a "natural cause of death" at post-mortem, we need to ask what that means. When the anatomical cause of death is a natural disease process, that does not per se, after Middleton and particularly after the tragedy of Touche, mean that the death itself is natural. The circumstances of the death can demonstrate culpability for failure to save life.

If there is a serial failure of care, or another Allitt or Shipman, it may be essential to revisit material in order to clarify the circumstance. If there has been a wrongful conviction, as I cited in example on Report, there must be the right to clear one's name. If a new genetic test comes to light, families must be able to test the sample and realise that the death was due to a genetic anomaly and not their fault. They deserve to be absolved of guilt.

Therefore, if the blocks and all slides are handed back to every family in that acute phase of severe bereavement, then the convicted person must have the right to ask the court to retain some tissue, even when an appeal has failed. And every bereaved relative in every case when fully informed consent is sought must, as part of the process of being fully informed, have it explained in detail that if tissue is not retained, then if a failure of care comes to light later, they may have no redress.

If this legislation is comfortable with that potential distress to the bereaved or to the wrongfully convicted, so be it. I have consulted widely and several sound legal opinions confirm my concerns. With the Bill as it now stands, I am concerned that human rights are not being respected. I beg to move.

Baroness Neuberger

My Lords, the hour is late but I do not wish to detain your Lordships for very long. I wish to support, in principle, the amendment of the noble Baroness, Lady Finlay, because we on these Benches have some concern about the kinds of cases in which a crime is committed by a family member to whom all the tissue is then returned and, therefore, no evidence remains. As the noble Baroness, Lady Finlay, cited, we are also concerned about a situation that may turn out later, if one were able to examine the tissue, to have been a case of medical negligence. Therefore, in principle, we support the amendment.

Lord Jenkin of Roding

My Lords, before the Minister replies perhaps I can ask a question. I shall be interested to hear the response to the amendment so ably moved by the noble Baroness, Lady Finlay of Llandaff. I found the Minister's letter on the subject of the coroners' powers very helpful in setting out the background which those of us not as familiar with these rules as we should be found very useful.

In that letter there is a paragraph that makes the point: Revisions to the Coroners Rules which govern these procedures are in hand, and will seek to clarify the functions and duties of both the coroner and the pathologist where material needs to be retained, and set out what information is to be provided to the family of the deceased, including options as to what should happen to the material once it is no longer required". The question that I hope the Minister will be able to answer is: when is that likely to happen? When will we see the revisions to the coroners' rules? From the letter, it sounds as though that may well go some way to deal with the important points that the two noble Baronesses have made. I would find it helpful to know when that is likely to happen.

Earl Howe

My Lords, I cannot hope to match, nor would it be appropriate for me to do so, the very powerful case put forward by the noble Baroness, Lady Finlay. On the assumption that the Minister does not feel able to countenance an amendment to the Bill, I very much hope that he will nevertheless take this issue away with him because it is a very real one indeed. It should be a matter not of affording the coroner wide extra powers, but rather of affording all of us a greater degree of confidence that miscarriages of justice will be less likely in the future. That is what this is about. As I say, I hope that the Minister can detect that there is a wide measure of support around the Chamber for what the noble Baroness, Lady Finlay, has said.

Lord Warner

My Lords, the amendment revisits one that we have debated at earlier stages. As we said then, it wholly undermines the fundamental principle on which the Bill is based. This principle can be enunciated clearly. Individuals, or those who were close to a person who has died, should have the right to determine the uses to which bodily material is put. It was the breach of that principle, especially in the retention of material following coroners' post-mortems, that gave rise to the need for the legislation in the first place. We cannot risk recreating that situation.

On an earlier amendment, I referred to a letter that I received this week from Professor Brazier, chair of the Retained Organs Commission. I wish to quote at greater length from his letter: In the Commission's meetings with well over a thousand relatives only a very few people were clear that if asked they would not have consented to the retention of tissue blocks and slides and even where a good case is made whole organs. They were however adamant that they should be asked. Extending powers to dispense with consent will simply be counterproductive and may result in further and damaging disputes between families and professionals". The letter was received unsolicited this week. We should pay regard to those concerns, voiced by a person who has sat through many discussions and negotiations with relatives affected in this respect.

I also received this week a powerful letter from PITY 2, the parents' support group set up following Alder Hey. The authors of the letter have allowed me to draw upon it. They register very specifically and in the strongest terms their objections to the amendment.

Of course the Bill provides for coroners to retain tissue for their legitimate purposes, but that is, by definition, for a finite period. Professor Brazier, like all of us, has no argument with that. It would include any cases where there might be concerns about the cause of death. In the case, for example, of a possible miscarriage of justice, we know that samples used in a prosecution are retained until a conviction is spent or an appeal is determined.

Let us be absolutely clear: the Bill does not inhibit the retention of material where it is, or may be, needed for a coroner's investigation, a police investigation or in connection with a prosecution, conviction or appeal. The stated object of the amendment—I am not altogether sure whether the amendment would achieve it—is to go beyond even those situations, and to retain bodily material for unspecified future purposes.

The noble Baroness, Lady Finlay, asked when the coroner was functus. He is functus while his authority under the Coroners Act is current; that is to say, when he is considering the cause or circumstances of death. What that might involve is further elaborated on in the coroners' rules. To respond to the question of the noble Lord, Lord Jenkin, I can say that those rules are being amended and will clarify what information should pass between coroner, pathologist and family. They will also make it clear that the family's consent will have to be sought for any retention after he has concluded his inquiries. I am advised by the Home Office that the coroners' rules should appear by the end of the year. The Home Office has been consulting the Royal College of Pathologists, coroners and others on the draft revised rules.

It has been suggested that forensic techniques may be developed so that cases could be reconsidered in the future. I have already written to noble Lords on that point. Clearly, any coroner's case might lend itself to that requirement, resulting in the retention of all tissue from the deceased in all cases. That is simply unthinkable. Where there is a legitimate state interest or concern, then, for coroners' or criminal justice purposes, material should and will be retained. But once those interests no longer pertain, the consent of the family must determine what happens with tissue or organs no longer required. To extend the coroner's purposes in that manner would be seen as a back-door way of recreating the organ retention scandal.

The noble Baroness has suggested that just small samples could be kept—without consent—that are maybe the size of a sugar cube. But we know that very young neonates have very small organs, so that might not solve the problem. We know that, for some people, it is important for religious and cultural reasons, and even simply for emotional reasons, that all parts, however small, are returned to the body. The debate is about whether people should have the right to consent over such matters. It is certainly a closed issue so far as we are concerned in this Bill.

8.45 p.m.

The noble Baroness, Lady Finlay, spoke to me before today's debate about the Department of Health model forms. I recognise that the current DoH model forms, published in early 2003, ensure that families are informed about the position of blocks and slides following coroners' post-mortems. They do not specify that consent is required. The point is that there is no statute requiring that at present.

However, the Bill will require consent for such retention in future. We are aware that the current forms and the guidance, which the noble Baroness cited, which, indeed, is on the website, will need to be revisited. I think that we are talking about the situation that pertained before this Bill and recognising that those forms will need amendments.

I must draw the attention of the noble Baroness to the fact that the Royal College of Pathologists' guidance states that once the coroner's interest has ceased, further use or disposal is subject to relatives' wishes". That is the current position.

I have written to noble Lords to explain this matter. I take seriously the concerns that the noble Baroness has raised. But the Bill's consent requirements do not apply when tissue is retained in accordance with the needs of the coroner in the context of his present remit and authority. We are not seeking to extend the authority of the coroner or to remedy any defects that there may be in the coroners' system. As I have said, any extension of the coroners' role is a matter for the Coroners Act and the Coroners' Rules.

While I am speaking, should like to put this on the record. At an earlier stage, the noble Baroness claimed that the Luce report on The Fundamental Review of Death Certification and Coroner Services proposed the retention of tissue following coroners' cases. It did not. On the contrary, Luce stated: We recommend that tissue or organs should never be retained for any purpose not directly stemming from the justification for a Coroner's autopsy, and in particular for teaching or research purposes, without the full and informed prior consent of the family". That is precisely what this Bill does.

We have discussed this issue extensively. I do not want to go all over that ground again, but I have tried to set out fully the Government's position. We understand where the noble Baroness, Lady Finlay, is coming from. I understand where other noble Lords are coming from. But this goes to the heart of the Bill. We do not think that there are grounds for making a move in that particular area. I urge the noble Baroness to withdraw her amendment.

Baroness O'Neill of Bengarve

My Lords, I should like to ask for a point of clarification. It seems that the principle of consent is not overriding in this Bill. On the contrary, we would not have the office of the coroner if the principle of consent were overriding. I think that the Minister has said that there is legitimate public interest in the coroner having authority to remove tissues for a number of very serious purposes.

If that is the case, why is it that the coroner cannot retain those tissues, if necessary in police custody, rather than in the custody of hospitals? We are not talking about those tissues being retained for research or for teaching: we are talking about them being retained for purposes of criminal justice. At the moment, I cannot see what it is that restricts the coroner's authority in time when, as we know, in some very sad and tragic cases, there may be a longer-term investigatory interest.

Lord Warner

My Lords, I clearly failed to get the point across, and I shall have another go. The Coroners' Rules and the Coroners Act determine the role of the coroner, the rules pertaining to the coroner and the circumstances in which the coroner can do various things. Those are defined in that legislation—subordinate and primary.

The Coroners' Rules are being amended as we speak, so to speak. This Bill has nothing whatever to do with the Coroners' Rules and the functions of the coroners. It recognises that there are circumstances in which the coroner functions, which relate to activities in this Bill. It would be outside the scope of this Bill to redefine the roles of coroners and how they perform their duties. That is a feature of alternative and different legislation.

For those reasons, I do not think that this is an area we go into in this Bill. If noble Lords have concerns over the Coroners' Rules as drafted and being consulted on, that is the area people should address if this is a criminal justice matter. This is not a criminal justice Bill.

Baroness Finlay of Llandaff

My Lords, I am extremely grateful to all those noble Lords who support the principles that I have been trying to explore, and for the way they have spoken tonight. I am also grateful to the Minister for his detailed reply, but I want to emphasise yet again that I do not believe that parents should not be informed. They should be informed and they must know what has happened. It is a terrible tragedy when a child dies, in particular for the parents. But if one of those parents was the person who caused the death, it is in that rare and exceptional circumstance that I am concerned about a wrongful conviction.

I certainly do not think that we should dispense with consent, and the forms currently on the Department of Health website try to provide an explanation and allow for consent. I would never suggest that the coroner should have access to tissue for education and research purposes. That is something for which consent should be given when the functions of the coroner are over. I am concerned that, when those functions are completed, this Bill then comes into play, and does so on those self-same blocks and slides. It is for that reason that I felt we needed to allow for any future interventions of the coroner.

I recognise completely what the Bill seeks to do and I am certainly not trying in any way to undermine the principle of consent. Indeed, I take exception to any implication that that is what I have been trying to do. In terms of the Luce report, I apologise to the House for having expressed it badly before: I felt that this applied only in relation to the purposes of the coroner, and certainly that consent should be sought for any other reason.

The hour is late and I realise that we yet have a chance to look at the revised Coroners' Rules and how the whole coroners' system is to function. In itself, that is outside the scope of the Bill. For that reason, I shall not test the opinion of the House, but I do think that this is something which is potentially very serious. I hope that I am completely wrong and that there will never be a miscarriage of justice, one in which people may want to prove their innocence. I hope that there will never be a serial failure in the NHS. With that hope, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 25 [Breach of licence requirement]:

Lord Warner moved Amendments Nos. 8 and 9:

Page 16, leave out line 37.

Page 16, line 38, leave out from "maximum" to end of line 39.

On Question, amendments agreed to.

Clause 30 [Possession of anatomical specimens away from licensed premises]:

Lord Warner moved Amendments Nos. 10 and 11:

Page 20, leave out line 36.

Page 20, line 37, leave out from "maximum" to end of line 38.

On Question, amendments agreed to.

Clause 31 [Possession of former anatomical specimens away from licensed premises]:

Lord Warner moved Amendments Nos. 12 and 13:

Page 21, leave out line 34.

Page 21, line 35, leave out from "maximum" to end of line 36.

On Question, amendments agreed to.

Clause 45 [Non-consensual analysis of DNA]:

Lord Warner moved Amendments Nos. 14 and 15:

Page 29, leave out line 39.

Page 29, line 40, leave out "maximum" to end of line 41.

On Question, amendments agreed to.

Clause 51 [Offences: Northern Ireland and Scotland]:

Lord Warner moved Amendments Nos. 16 to 18:

Page 32, line 1, leave out from "In" to "32(4)(a)(i)" and insert "section"

Page 32, line 1, leave out "and 45(3)(a)(i)"

Page 32, line 3, leave out subsection (4).

On Question, amendments agreed to.

Clause 52 [Orders and regulations]:

Lord Warner moved Amendment No. 19:

Page 32, line 21, at end insert—

"( ) Subsections (1) and (2) do not apply to any power of a court."

The noble Lord said: My Lords, this amendment corrects a drafting omission which should have been included in the Bill when amendments were made on Report in the other place introducing the possibility of court orders allowing use of material or DNA analysis in certain circumstances.

Clause 52 deals with the secondary legislation to be made under the Bill, including the parliamentary procedure and consultation processes which apply to it. Subsections (1) and (2) refer to, any power to make orders … under this Act". This is clearly intended to refer to secondary legislation only. However, as drafted, it could also apply to the powers of the court to make orders under Clause 7 and Schedule 4. It would be inappropriate for the clause dealing with secondary legislation to be applicable to the court, and the amendment ensures that that would not be the case. I beg to move.

On Question, amendment agreed to.

Lord Warner moved Amendment No. 20:

Page 33, line 6, at end insert—

"( ) Before acting under any of the following provisions, the Secretary of State shall also consult such other persons as he considers appropriate—

section 1(14);

section 6;

section 7(4);

section 10(9);

section 14(4);

section 16(5);

section 27(9);

section 33(3) and (7);

section 46(1);

section 54(10);

paragraphs 6(2), 12(2) and 13 of Schedule 4."

The noble Lord said: My Lords, the House will recall that opposition amendments in Grand Committee and on Report proposed that the Secretary of State should exercise his powers to make orders and regulations on a number of issues under the Bill only after, having consulted such persons as he shall consider appropriate". A number of noble Lords were not quite convinced by my assurances that this was not needed as consultation is customary before regulations are made. I said that I would consult colleagues and come back to the House on this matter.

I am now proposing amendments which respond on this point and make it explicit that the Secretary of State will be required to consult appropriate persons before making any orders or regulations which are subject to the affirmative resolution procedure. This applies to the more important secondary powers in the Bill—that is, the orders and regulations listed at Clause 52(4). I hope that this explicit statement on the face of the Bill meets the concerns expressed at earlier stages. I beg to move.

Earl Howe

My Lords, once again it is a great pleasure to thank the Minister for bringing forward these amendments. They amply respond to the concerns that I and others raised at earlier stages of the Bill. I very much welcome them.

Lord Clement-Jones

My Lords, I also thank the Minister. This clearly goes beyond the merely technical and is a conscious attempt to meet the argument—despite, no doubt, the views of the parliamentary draftsmen. The Minister is to be congratulated on bringing forward the amendment.

On Question, amendment agreed to.

Clause 58 [Transition]:

Lord Warner moved Amendments Nos. 21 and 22:

Page 34, line 31, leave out from "in" to "32(4)(a)(i)" in line 32 and insert "section"

Page 34, line 32, leave out "and 45(3)(a)(i)"

On Question, amendments agreed to.

Clause 59 [Extent]:

Lord Warner moved Amendment No. 23:

Page 35, line 30, leave out "51(4),"

On Question, amendment agreed to.

Schedule 1 [Schedule purposes]:

Lord Warner moved Amendment No. 24:

Page 38, line 20, leave out from "health" to end of line 22.

On Question, amendment agreed to.

Schedule 4 [Section 45: Supplementary]:

[Amendment No. 25 not moved.]

Lord Warner moved Amendments Nos. 26 and 27:

Page 53, line 2, leave out from "health" to end of line 4.

Page 53, line 21, leave out from "health" to end of line 25.

On Question, amendments agreed to.

Baroness Finlay of Llandaff moved Amendment No. 28:

Page 54, line 20, at end insert—

"( ) If the High Court is satisfied—

1. (a) that bodily material has come from the body of a living person;
2. (b) that it is desirable in the interests of another person (including a future person) to prevent mortality or significant morbidity, that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material is come ("the donor");
3. (c) that reasonable efforts have been made to get the donor to consent to the use of material for that purpose;
4. (d) that notwithstanding those efforts, a decision of the donor to refuse consent to the use of the material for that purpose remains in force;

it may order that this paragraph apply to the material for the benefit of the other person."

The noble Baroness said: My Lords, the amendment seeks to allow the right to life to be considered in the High Court in the very exceptional circumstance that a living competent person has refused the use of a DNA analysis on their tissue for the benefit of another, and his or her motivation for this seems to be malicious and to threaten the life or health of that other person. There needs to be a forum for their respective rights to be heard and an impartial ruling weighing up the balance of benefits and harms. Each must have the right to be heard in the narrow set of circumstances described in the amendment.

The issues have been well rehearsed at previous stages of the Bill. The practical problems are that under the Bill as drafted the competent adult has an absolute veto over the use of his or her genetic material and tissue, even when that prevents another person to whom he or she is genetically related from making an informed decision over whether to access potentially radical treatment. The absolute nature of the veto is arguably in breach of Article 2 of the Human Rights Act, which prohibits the intentional deprivation of life.

The use of the results of DNA re-analysis in the face of an individual's refusal should be a measure of extreme last resort, subject to the principle of proportionality and, as such, is likely to occur very rarely.

The amendment differs from that proposed at previous stages in that it acknowledges that reasonable efforts should at first be made to obtain consent to the use of the results of DNA analysis before an application to override refusal of consent is made to the High Court. This is an area where the intervention of the High Court is entirely appropriate, given that the refusal of consent may lead to serious injury or death. I beg to move.

9 p.m.

Earl Howe

My Lords, perhaps I may speak to Amendment No. 30, which is grouped with those of the noble Baroness. She has spoken powerfully on the issue, and the Minister kindly agreed to reflect upon it further, following our debates in Grand Committee and on Report. I should like to thank him for the letter he sent me during the past few days setting out his considered views on the subject.

Perhaps the simplest way to describe what divides us is to say that in the Minister's view, unlike mine, there can be no exceptions, in any circumstances, to the iron rule underpinning the Bill, which stipulates that. "No" means "No". In response to that, I totally understand the Minister's defence of the principle of individual patient autonomy, just as I enthusiastically support the key provisions of the Bill. Where I diverge from him is that I also think that we have a duty to look at the hard cases. The hard cases will almost certainly be very few in number, but they will occur. The Bill itself cannot legislate for them, but I am suggesting, as is the noble Baroness, that the courts should be allowed to deal with them.

In his letter, the Minister said that the law was not an appropriate mechanism for compelling people to perform what were essentially altruistic acts. I think we need to deconstruct that thought a little. The Bill, as the Minister will recognise, already makes provision for what he terms "enforced altruism", in the sense that tissue from living people can be used in research without their consent if it is anonymised. Indeed, given that we have allowed for wide exceptions to the consent rule, I am not sure how appropriate it is to refer to the Bill as facilitating altruism in the strict sense.

The point at issue is whether an explicit refusal to allow one's tissue to be used should be sacrosanct in all situations. The argument that I have been trying to put to the Minister is that it is possible to imagine situations in which such a refusal might be regarded by a court as inherently unreasonable. If my amendment were made, the line that the Bill would draw, therefore, would not be the Minister's line of absolute protection of one person's rights, but, rather, a line close to it which would be determined on a question of fact and judgment as to whether in all the circumstances of a case, the defence of those rights was reasonable when set against the rights of a close relative.

By accepting my amendment, we would be saying that, in some circumstances—we could define them fairly closely—the picture is not wholly black and white, and that as parliamentarians we should recognise that. When he wrote to me, the Minister countered that suggestion by saying that if a person's decision can be overriden, where, logically, should we stop? The answer, to put it simply, is that we can stop at any point we choose. There need be no slippery slope here.

The Minister's letter suggests that if my amendment were agreed to, we would find ourselves agreeing to the idea of forcibly removing a sample of tissue from someone so that it could be stored and used. I would not be in favour of that, nor have I suggested it; and certainly do not believe that it follows from my amendment, any more than it follows from the existing provisions in the Bill, where a court has made an order of some kind in the absence of explicit consent. What we are talking about are situations where a piece of tissue already exists and is being stored and which is readily capable of being subjected to DNA analysis but for the refusal of the donor to allow that.

The reasonableness of such a refusal should be capable of being examined by the court. Again, the Minister does not agree with that idea. He has highlighted situations in other contexts in which doctors defend the right of patients to make seemingly irrational decisions, such as refusing life-saving treatment, and has pointed out that this principle of common law is well established in the courts. I accept that, but the two issues are not in fact congruent in all respects. If a patient refuses life-saving treatment, that is a decision about what happens to his or her own life and what can be done to his or her physical person. It is surely not the same as a decision about a piece of residual tissue originating from him but no longer part of him, which is being stored somewhere in a laboratory.

The simple proposition that I seek to advance is that we should allow a court to come to a view, in particular cases, as to whether an outright refusal to consent is reasonable or not; for example, whether it is based on a perfectly proper and understandable wish for privacy about one's own genetic make-up; or whether, for instance, it is based purely on spite or the hope of financial advantage. I do not ask that the Bill makes such judgments; only that we should not deny people the right to ask the court to make them.

I do not see such a provision as undermining confidence in the Bill or the consent-based system that underpins it. I say that because this would not be a coach and horses. It is about people who are closely related to one another being allowed to argue competing cases before a judge in very narrowly defined situations. It is not about the generality of situations where there are competing interests; nor in particular is it about research or transplantation or teaching. It is not even about facilitating "the public good". I am not sure that the Minister fully acknowledged that aspect of the issue in his letter, but it is a key aspect. So few cases would fall within the scope of the provision that I have in mind that I fail to see how it would erode public confidence in the Bill as a whole, or even begin to.

For those reasons, I very much regret that the Minister has not been persuaded that there is a valid case here. If the noble Baroness and I have not persuaded him today, I hope that he may nevertheless be able to provide some words of comfort about the human rights aspects of the matter. He may be able to tell us that, notwithstanding the provisions in the Bill, there is scope to resolve difficulties of the kind that I have described through the courts by reference to and under the umbrella of human rights legislation.

Baroness Neuberger

My Lords, I rise to support the noble Baroness, Lady Finlay, and the noble Earl, Lord Howe, in these amendments. We have already discussed this issue at Report and before and I am also very grateful to the Minister for his letter. Equally however, like the noble Earl, Lord Howe, I have some difficulty with the reference to altruistic acts. I do not think that anyone is suggesting that it should be required that people have biopsies taken of their genetic material in order to benefit a close relative. That is when tissue is already being stored.

As the Minister knows from his previous life, dysfunctional families exist. In my ministerial pastoral experience as a rabbi—I do not mean "ministerial" in parliamentary terms—I have encountered dysfunctional families in which such issues have arisen. One family member did not know whether she should have a double mastectomy because she did not know whether other members of the family carried the BRCA 1 gene. That is common in Jewish families. Because the family had fallen out in a major way, she could not get the other female members of her family to co-operate. She ended up having a double mastectomy; it would have been better if she had been able to find out.

This is a serious issue. There are malicious people who will, for a variety of reasons, because of family relationships, refuse consent. It is a very rare occurrence, we hope—although it is not necessarily so. We believe that the matter should be able to be tested in the High Court. Like the noble Earl, Lord Howe, I hope that, even if the Minister cannot give us complete reassurance, he will at least give us some reassurance that he will address the matter or allow some reference to the Human Rights Act in this regard.

The Lord Bishop of Worcester

My Lords, when the Minister replies, will he make it clear whether it is the Government's view that a case of judicial review would lie in relation to the substance of the amendment? If there is a possibility that the courts might in any case be prepared to entertain an application for judicial review, it would be much better to have a provision in the Bill than to leave the matter in that area of chance. I speak from the position of believing that the right of consent is extremely important but that there is a gap somewhere between importance and absoluteness.

Lord Warner

My Lords, we discussed the issue on Report, and I undertook to look carefully at the arguments. I have done so, but we have concluded that this is a path down which we should not go. I wrote to noble Lords on the issue, so some of what I have to say may sound familiar. Some of it may help in extending the arguments in the letter.

The case was argued that there should be, in the Bill, a provision enabling the High Court to override the refusal of a person to consent to the use of their tissue for the purpose of gaining information that may be relevant to another person. The typical illustration given in this case was of family members who were estranged but where DNA analysis of a sample of one member might benefit the care of another. We know—there is no argument about this—that in almost all cases of heritable disorders people agree to the use of their tissue for these purposes, so the number of refusals is already very low.

I would not dissent in any way from what the noble Baroness, Lady Neuberger, said about a degree of dysfunctionality causing pain and grief in particular families, but it is worth hanging on to the fact that in many cases involving hereditable disorders, there is full co-operation. We learn from geneticists—the issues relate almost entirely to genetics—that the difficulty is not so much failing to find people, or outright refusals once people have been found, as problems in communication. The High Court, however, is not the way to resolve that, nor is overriding people's informed choices. That view was endorsed on the Opposition Front Bench when this question arose in another place. I refer the noble Earl, Lord Howe, to the remarks of Andrew Lansley, on 28 June, at col. 29 of the Official Report.

We are trying to develop a system in which people choose to consent to research and other matters that are for the public good. To provide for a mechanism of override would undermine the whole basis of the Bill. The confidence that we need to restore and promote in this consent-based system will be seriously jeopardised if we include provision for consent, once clearly expressed, to be simply set aside. That is what it amounts to.

I accept, however, that there may be a number of cases where, after constructive efforts have been made, people continue to say "No" despite the fact that use of the sample could potentially benefit a family member. I recognise that the noble Earl, Lord Howe, does not necessarily accept that I have made the correct linkage, but it is worth bearing in mind that there is case law on analogous cases and examples of the courts being asked to override people's wishes. In the case of Re MB, Lady Justice Butler-Sloss said that, a competent woman, who has the capacity to decide, may, for religious reasons, other reasons, for rational or irrational reasons or for no reason at all, choose not to have medical intervention, even though the consequence may be the death or serious handicap of the child she bears, or her own death. In that event the courts do not have the jurisdiction to declare medical intervention lawful". That situation is not totally identical to the one that the noble Earl cited, but I suggest that it is a relevant piece of common law. I think that it is worth reflecting on that fact.

A number of noble Lords have raised the issue of whether we are in conflict with human rights legislation by framing the Bill as it is without providing for an opening to the High Court. Certainly on advice, we have certified that the Bill is consistent with the Human Rights Act, and we are confident that it actually is as currently framed. Ultimately, however, I accept that any interested person who believes that their rights have been affected adversely would be free to challenge that view in the courts. It would be a matter for individuals to make that case to the courts in the specific circumstances that pertain.

We do not, however, believe that it is necessary to amend the Bill as proposed. We believe that the Bill as currently framed is consistent with the European Convention on Human Rights and the Human Rights Act. We also have to take cognisance of the common law in this regard.

A number of noble Lords raised the issue of whether altruism is an overriding consideration. A public-spirited approach is strongly to be encouraged. In setting out the terms of the Bill, we have tried to provide the framework in which people can engage fully with the public benefit in donating tissue for beneficial purposes. The Bill is quite clear on that. However, confidence is an important part in ensuring that that altruistic spirit is maintained.

Lord Jenkin of Roding

My Lords, before the noble Lord concludes his remarks, will he address the point that my noble friend raised on the issue of looking at bad faith and at reasons which, far from being rational or irrational, may in fact be extremely undesirable, such as someone refusing consent for reasons of spite or jealousy or even for financial advantage? Is the noble Lord saying that even in those circumstances there would be no right to go to the court?

Lord Warner

My Lords, Ministers are not the arbiters on common law. In the spirit of helpfulness to the House, I gave a quotation from Lady Justice Butler-Sloss. That quotation is very clear that people can behave irrationally in matters relating to their own body. We may not like that fact and disagree with it, but that is a judgment that has been made by a senior judge. It is not for Ministers—the noble Lord has been a Minister—to begin debating with the senior judiciary on their rulings in these cases.

I have already said that the Bill is compliant with the Human Rights Act. I have also acknowledged, and I shall repeat, that if people disagree on individual cases, it is their right in this country to take their case to the court and seek a judgment. No one is quarrelling with that but what we, as a Government, are saying is that we do not feel it appropriate to amend the Bill in the way that is being proposed in these amendments.

Baroness Finlay of Llandaff

My Lords, before the Minister sits down, can he clarify one small point from the letter that he helpfully copied to all the noble Lords who have been involved in the Bill? After he mentioned altruistic acts, he stated that any interested person may challenge in the court the action of a public authority, if he believes it breaches his human rights under the European convention. One of the difficulties we have here is that it would not be a public body, but it would be the person to whom he was genetically related, who is of ill intent, who would be breaching his rights. Therefore, I am not quite sure to which public body a person would refer if he wanted to put forward a point that would help in the making of a decision that would affect his health.

Lord Warner

My Lords, I was intending to be helpful in that letter. I have essentially repeated tonight the point that I made in that letter. I cannot give free legal advice, so to speak, on the Floor of the House on what might be available to individuals in some of the circumstances that might arise. But individuals would have to be adversely affected by the particular circumstances. If they thought that their human rights were infringed as a result, they could challenge in the court the Bill's compatibility with the European Convention on Human Rights. So, in that sense, I suppose that the public body would be the government of the day. It would depend on the precise circumstances with which a person was confronted and the strength of feeling that he had, or the confidence he had on legal advice, in trying to take a case to the court in the circumstances that affect him. I cannot answer what those circumstances would be. All I am acknowledging is that there is a right for people to challenge legislation in the courts, which is not in any way infringed by the Bill.

Baroness Finlay of Llandaff

My Lords, I am grateful to the Minister for his reply and to all the noble Lords, and the right reverend Prelate, who have spoken in this debate. I am grateful to the Minister for answering questions during the course of his response to this group of amendments.

This amendment is not a mechanism to override consent. It would not simply set aside the principle of consent and I have some concern that the Minister felt that it would. That would be to assume a High Court judgment. With the ability to go to the High Court that we were seeking, it would be for the High Court to determine in favour of or against the applicant. But there would be no assumption at all about how the High Court should go. The amendment would not set aside the principle of consent at all. It would be up to the High Court to decide whether it was appropriate consent or completely inappropriate withholding of consent.

I am slightly concerned that the example cited is thought to be directly relevant to these amendments because it involves harm to the mother, who has within her body the child whom she is carrying. So her decisions may be irrational, but they involve harm to her and her body in the process. We are talking about where a sample—usually blood—has already come out of somebody's body, is sitting in a test tube and is stored in some kind of refrigerator. No harm is going to come to that if somebody looks at it again for a very specific indication and no harm would come to the person from whom it came, other than that his or her pride would be dented. If they did not want to know any results at all from that subsequent analysis, it would be completely unethical to give results to them. If they decided that they wanted to know them, they should. It would also be completely unethical to give the results of the analysis overall to the patient, apart from the very specific point that would determine the way in which the decision was made that would affect their life and health.

There are some differences. I agree with the Minister that confidence is important. Within the amendments, we have tried to ensure that there is confidence that the Bill will respect a person's health needs, and that those health needs can be heard in the face of intransigence when there is a dysfunctional family. That said, the Minister has pointed out that someone can go back and look at the matter. Judicial review would certainly be a very lengthy, expensive and complex process. However, I will not test the opinion of the House, so I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 29 and 30 not moved.]

Lord Warner

My Lords, I beg to move that this Bill do now pass.

Moved, That the Bill do now pass.—(Lord Warner.)

On Question, Bill passed, and returned to the Commons with amendments.

House adjourned at twenty-seven minutes past nine o'clock.