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Lord Warner: My Lords, I have a terrible feeling that after listening to me, my noble friend Lady Hayman will feel that Ministers are generic and enduring.

I understand entirely the concern and reasoning behind this amendment, having discussed it in other guises on several previous occasions, and I am aware that assurances on this point have also been given in another place. The point that colleagues in the research community are making is that they should not be bound slavishly to go back to patients for further consent each and every time tissue is used for a new project, or for a novel use which may arise from time to time. I entirely sympathise with that view, provided that the patients in question are equally happy to donate their bodily material on that basis. I repeat that there is nothing in the Bill whatever to prevent tissue being donated on the basis that it can be used for any research project now or in the future.

I suggest to noble Lords that the wording of the initial consent is possibly the key here, bearing in mind also that the Human Tissue Authority will be issuing guidance in this area. Having spent some time looking at the considerable variation between some of the consent forms which are produced and signed, I think that this is an area to which the Human Tissue Authority will need to give attention.

However, I have enough humility to realise that not all researchers will necessarily read my golden words in Hansard or attend debates in your Lordships' House, and therefore they would like to see the matter spelt out on the face of the Bill. But there are very good reasons not to put unnecessary words into the Bill, and the proposed amendment is a good case in point. The effect of the amendment is to make "general and enduring" consent the only sufficient form of consent for the activity in question. Thus, if a person wanted to
 
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give a more limited consent—perhaps to research into a particular condition, to partake in a particular project or, more widely, to donate tissue for transplant to a particular person—that could well fall outwith the Bill and therefore be questionable in law. That seems to me to be an undesirable consequence and one which I assume is unintended by my noble friend.

However, the more general point is that, by not qualifying the term "consent" with any adjective—whether it be "general", "generic", "enduring" or "genuine"—all possibilities are left open and can be brought into play, depending on the circumstances. If we mandate that only "general and enduring" consent is permissible, then we shall also need to add in Clause 3 that consent may equally well not be general and enduring and we shall probably also need to list some other possibilities that come to mind.

I suggest that the only sensible way forward is not to qualify the term in statute but to allow flexibility in practice, coupled with the guidance of the Human Tissue Authority. I recognise that I am continuing the traditional ministerial onslaught on adjectives but I suggest that, when researchers stop to consider this issue, they will realise that this proposal may not be in their best interests.

We have been around this issue several times and I believe that the concerns of the research community on this point are entirely met by the Bill as currently worded. The research community would do well to wait patiently for the guidance from the Human Tissue Authority. Tinkering with the word "consent" by adding adjectives to the Bill risks producing outcomes that the research community would not like.

Lord Turnberg: My Lords, I am grateful to the Minister for his response, although naturally I am somewhat disappointed that he is unwilling to put these words on to the face of the Bill. I am moderately encouraged by his suggestion that we wait to see the guidance produced by the HTA. I am not very patient but I am willing to wait. With that, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 5 [Prohibition of activities without consent etc.]:

Earl Howe moved Amendment No. 11:

The noble Earl said: My Lords, in moving Amendment No. 11, I shall speak also to all the other amendments in this group. We come to a matter raised in Grand Committee by my noble friend Lord McColl—that is, the issue of criminal penalties. My noble friend argued then that a maximum three-year term of imprisonment for the type of offence that we are considering was inappropriate and disproportionate. Both my noble friend and I still hold to that view. However, the Minister's reply in Grand Committee gave me no cause whatever to think that he was likely to change his mind on that question—quite the reverse. Therefore, I have returned to another feature of this issue with which we on these Benches have, if anything, even greater difficulty.
 
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My noble friend Lord Jenkin underlined very effectively the point that I am about to make. We can agree or not about whether a term of imprisonment is an appropriate penalty for the offences detailed in the Bill and what the maximum term should be. A separate question altogether is whether we should empower a magistrate to pass down a sentence of imprisonment. If the offence with which someone is charged is serious enough to warrant a prison sentence, it seems to me that it should be heard in the High Court.

To try to argue that minor offences under the Bill should attract a prison sentence is, I believe, to lose sight of what is proportionate. No offence in this Bill—absolutely none—concerns physical harm to an individual. The nature of all the offences relates to infringements of privacy, individual autonomy and respect for the person.

I do not suggest for one minute that those are not serious matters, but I do suggest that the kind of minor matter likely to be tried in a magistrates' court under those headings is inherently less serious than some other matters commonly tried in a magistrates' court. For a magistrate to be able to send a doctor, researcher or clinician to prison for an offence that is not of the most serious kind seems to me inappropriate and wrong.

In Grand Committee, the Minister said that the Bill should send out a clear deterrent message. As I said, I disagree with the Minister as to the nature and extent of that deterrent message, but I am no longer arguing that point with him. The deterrent message in the Bill remains unaffected by the amendments.

The degree of seriousness attaching to the most serious offences under the Bill is equally unaffected because those will be heard by the Crown Court. If a magistrate who is called upon to hear a case believes that if the case is proven it is such as to warrant a prison sentence, then he or she is capable of referring it upwards. Therefore, I hope that the Minister will not reject these amendments. I believe that they give a better balance to the Bill and a better balance to the messages that it sends out. I beg to move.

Baroness Finlay of Llandaff: My Lords, we have a national shortage of pathologists. I know that in Committee the Minister said that the penalties are to act as deterrents but I submit that erasure from the register is the greatest deterrent. I am not going to plead that pathologists or clinicians are more special than anyone else, but why does a magistrate have the power to imprison?

By not practising, the public is protected from harm and the pathologist, when suspended, is prevented from repeating a harm, as well as being duly punished. If a major problem arises, of course it will go to the High Court and it is right that the High Court has punitive powers. I suggest that the only deterrence achieved by keeping imprisonment at the behest of a magistrate is the certainty that fewer people will enter the specialty of pathology through fear of being wrongfully convicted and fear of the trauma around that.
 
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We have 50 per cent of the pathology service that we should have and, at this rate, we may have none. Without pathologists, diagnostic accuracy will be almost absent. Do we really want to destroy pathological diagnostic services in the hope of deterring a potential unidentified wrongdoer in the future? Please may we have a sense of proportion and ensure that we attract bright, conscientious doctors to be pathologists and not drive them away by the threat of a magistrate being able to lock them up?

Lord Jenkin of Roding: My Lords, I agree with every single word that has been said by my noble friend Lord Howe on the Front Bench and with what has been said most eloquently by the noble Baroness, Lady Finlay of Llandaff, who has used her expertise throughout the proceedings on this Bill to huge effect.

The only point that I would add, and which I hope the Minister will take on board, is that it is perhaps this provision concerning the possibility of imprisonment from a magistrates' court that has sown the most hostility and suspicion among those who are engaged in medical research and related activities. The Minister would do himself and the purposes of his Bill a considerable service if he were to meet the arguments advanced and agreed strongly and firmly by most noble Lords, and I think that it would improve the Bill if he did so.


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