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Lord Clement-Jones: I thank the Minister for that interesting reply. It is good to be given the reasoned background. Of course there is a difference when considering current events. As the Minister said, the
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Second World War is still very much a part of people's consciousness, although that is perhaps not so true of the First World War.

I shall take advice, not from my personal "time team", but no doubt from a team of trained archaeologists to see what they make of the Minister's reply. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 52 not moved.]

Clause 16 agreed to.

Schedule 3 [Licences for the purposes of section 16]:

Lord Clement-Jones moved Amendment No. 53:

The noble Lord said: This is a probing amendment relating to the words in the schedule:

The Bill prohibits licences from covering more than one activity or one activity being carried out at more than one site. A researcher wishing to back up his collection at a second site would therefore need to hold two licences. That seems unnecessary both in terms of bureaucracy and cost. This amendment would lift that restriction. I beg to move.

Earl Howe: I endorse everything that the noble Lord, Lord Clement-Jones, has just said. Indeed, my Amendment No. 54 is very much directed at the same point. It does seem that Schedule 3 consciously sets its face against allowing one licence to cover more than one activity or more than one set of premises. I am not clear why we need to make work of that kind for apparently no purpose. It seems to be a case of creating paper and effort to no good purpose.

Lord Clement-Jones: I have not been explicit about Amendment No. 55; I should have mentioned that it relates to that point as well. It is not only related to place; it is also related to activity. The individual on a licence has overall responsibility for compliance, but that person would not necessarily direct or supervise all activities carried out under the licence. The early amendment therefore proposes amending the Bill to reflect that.

Lord Warner: These amendments all point in the same general direction, seeking to reverse the present sense of Schedule 3 insofar as it says that one licence may not cover premises at different places; may not allow licensed activities to be carried out under the supervision of more than one person; and may not relate to more than one licensable activity.

I recognise and share the good intentions behind the amendments, which seek to minimise bureaucratic burdens. I am extraordinarily sympathetic to those aims. However, I think that the Bill achieves both strength in its licensing approach and flexibility to ensure that the bureaucratic impact is indeed
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minimised. It is also trying to ensure that we have clarity of accountability for particular activities at particular premises.

Before I go into more detail on this, it is worth reflecting on the fact that, when one is talking about the cost, we are not talking only about the cost of issuing paper. The greater cost will be in the inspection function itself. Getting the inspection function right is likely to be the bigger cost, rather than the cost of issuing the pieces of paper.

The Government consider that the proposals in the amendments would seriously weaken the credibility and effectiveness of the Bill. Licensing will be at a level appropriate to the activity being carried out, but licences must relate to premises or, for practical reasons, the inspection system will not work well. A single collection might indeed be over a large number of sites and, if there was only one licence, they would all need to be inspected in relation to that licence. Accountability for problems at a particular site could well be difficult to establish if there was not clarity about the relationship between an activity, a site and a licence.

Under the proposed amendment, one site might need to be tied to a number of different licences. We think that that would be unmanageable from the perspective of both the authority and the bank itself, make inspection difficult and probably would be more expensive. It would certainly blur accountability.

Regarding the question of licences covering more than one activity, we had ourselves considered this point, and arrived at the conclusion that the least onerous solution is that which is presented by the Bill. The Human Tissue Authority will be able to deal with and issue licences simultaneously and use a single set of documentation. So there is no reason why, on a particular site, a series of licences could not be produced at the same time which show the licensed activities on that set of premises, with identification of the designated responsible individuals. That is what we are trying to achieve.

I emphasise again that the cost structure for charging for licences is likely to be governed much more by the volume and cost of inspection than it is by the issuing of pieces of paper. If an establishment carries out several licensable activities at the same location, as I said, they could be handled through a single application, a single inspection and a single document recording the various licences. If a licence for a specific activity were to be revoked or given up, under the Bill, that could be done without affecting the continuation of licences for the other activities at the same location. So there will be clarity about the particular activities that are being withdrawn and those which are being licensed and approved.

We do not believe that the general approach to the licensing system will be overly bureaucratic, but I can understand, because of the complexity, that people might at first blush think that it is. Indeed, we included a government amendment in another place, which is now Clause 43, which requires the Human Tissue Authority to adhere to best regulatory practice and to
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carry out its functions effectively, efficiently and economically. Against that background, I hope that I have been able to give the Committee some reassurance on this slightly complicated issue.

Lord Clement-Jones: I thank the Minister for that reply. It was helpful for him to be expansive in his reassurance and not just deal with the narrow points raised by the amendment. That will provide some reassurance and I thought that the reasoning behind the approach came through strongly. Clearly, we will need to reflect on some of the things that the Minister said about the impact. After all, it is the impact on those who are licensed that needs to be taken into account as well. In the mean time, I thank the Minister for that reply and beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 54 and 55 not moved.]

Schedule 3 agreed to.

Clause 17 [Persons to whom licence applies]:

Earl Howe moved Amendment No. 56:

The noble Earl said: If I may, I shall take Amendment No. 56 with Amendment No. 58, which is also in my name. I am concerned about the word "direction" in Clause 17. That concern is shared quite widely in the scientific and medical community, not least by the Academy of Medical Sciences, which has drawn the point to my attention. It relates to the description of the role and duties of the designated individual named in a Human Tissue Authority licence. Of course, someone must have overall responsibility for compliance with the duties of the licensee, but it is questionable whether that person should have the responsibility to direct or supervise activities carried out under his authority. That has an over-prescriptive flavour about it. The consequence might be that researchers would be encouraged to take out individual licences, rather than relying on organisational licences. That would increase the cost and administration.

I turn to Amendment No. 58. It is designed to draw attention to what I think is a perfectly understandable concern: that the designated individual under the Bill would not have any defence to any claim against him or her personally for a breach of a licence condition by a third party, even if the designated individual had complied with the conditions and taken all reasonable steps to ensure compliance by those third parties. That is what lies behind that amendment and I hope that the Minister will be sympathetic to the point. I beg to move.

Lord Warner: In responding to these amendments, it may help if I explain how the structure of the licences is to work. At the heart of the licensing system lies the notion of clarity of personal accountability, which is a key issue in this area.
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The trigger for licensing is the activity for which a licence will be required. For example, this includes the carrying out of a post-mortem, the storage of tissue and carrying out anatomical examinations. While it is the activity that triggers the need for a licence, the Human Tissue Authority in considering the licence must specify the premises on which the activity can take place. The applicant might be an individual or a body with legal personality, but the licence must also designate an individual who has the primary responsibility imposed by Clause 18 of ensuring that the practices carried out within those licensed premises are conducted in a suitable manner. This means, in essence, that they are compliant with the law, with any directions or regulations and conditions of licence and with the Human Tissue Authority's code of practice. The designated individual could, but need not be, the applicant for the licence. However, where the applicant for a licence is not an individual, the licence must still identify the designated individual.

It is important that the licence identifies an individual who holds those responsibilities so that there is clarity and transparency about the relationship between him and the authority. We are here copying the structure that operates under the Human Fertilisation and Embryology Act 1990, in which the person responsible under the licence has clear sets of responsibilities. We have observed that that system has operated very successfully for over a dozen years.

The designated individual will not be a person in a particular role within an institution; that is, it almost certainly need not be the chief executive of a trust, or the dean or vice-chancellor of a university. The designated individual will be a person who, in each case, is in a position to ensure that the activities carried out under the licence complies with the regulatory requirements to which I have referred. Indeed, I would suggest to the noble Earl that before someone becomes a designated individual, they would need to establish that they were able to bear and discharge the responsibilities which go with being such a designated individual. The system is constructed to ensure that people do not get into a situation where they become designated individuals who cannot discharge their responsibilities under the legislation.

The person might be a head of department, a clinician, a scientist or a manager. What is important is that it is a person who is in a position to secure that activities are conducted properly by people who are suitable to carry out those activities and that all the necessary requirements are complied with.

Amendment No. 56 would change the reference to other people having authority under a licence by virtue of their acting under the direction of a designated individual to persons acting under the authority of a designated individual. The effect of that would be to weaken the role and responsibility of the designated individual, on which I have placed great emphasis, and to weaken the overall control of licensed activities.

The problem with this is that we fully intend that the designated individual should be directly responsible for ensuring the proper conduct of the activities
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carried out under licence. That is clear from Clause 18, which lists the designated individual's duty. The activities under a licence are intended to be overseen by the designated individual and his authority should not be delegated broadly, as it might if this amendment were accepted. As I have said, we have followed the model of the Human Fertilisation and Embryology Act.

Amendment No. 58 takes a slightly different line in respect of the designated individual, and one that would clearly weaken the duties that are placed on the person under Clause 18.

I shall not labour the point too far, but we are emphasising that the designated individual is the person who will be identified in the licence as having the clear statutory responsibility. It is important that we do not blur accountability. This can become a particular problem when something goes wrong and leads to a situation which has often itself been contributed to by the blurring of accountability.

The noble Earl, Lord Howe, raised the point of whether a designated individual would have a defence against a third-party claim made against him. It is not clear that any of the responsibilities in the Bill give rise to duties towards third parties that might give rise to any such claim. If the noble Earl could give me some examples outside the Committee, I shall look into them, write to him and try to give him more reassurance.

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