Human Tissue Bill

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Dr. Murrison: Will the Under-Secretary confirm that just one licence fee would be involved?

Dr. Ladyman: Yes, in that, in setting that fee, we will be recovering the full cost of the application. However, it will not be a mechanism by which people can avoid the costs, if that was what the hon. Gentleman was looking for.

On the substantive point about he difference between this Bill and the Human Fertilisation and Embryology Act 1990, the hon. Member for South Cambridgeshire has a good point: there should be a mechanism short of revocation. One question is whether that requires sanctions short of revocation or whether it should be a matter of providing advice. In the latter case, whether or not that advice is accepted and acted on could inform the process of revocation.

If an organisation was not complying, it would be appropriate for the authority to explain to the organisation how it was not complying and what it was doing. In deciding whether to revoke the licence it would also want to take into account whether the organisation responded to that advice. Although there may not be a sanction short of revocation, I am not sure that the hon. Gentleman is right to say that such a sanction is needed. The response to any advice would be important.

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Mr. Lansley: I, too, am unsure whether sanctions are required. Another option could be for the authority to have the power to impose conditions on licences, not only when they were granted but subsequently. I am not sure whether paragraph 5 allows that, but that could be a suitable mechanism.

Dr. Ladyman: It is my understanding that, in paragraph 8(5), the schedule allows that to happen. The authority may also provide directions when it is in discussions with an organisation that might not be living up to best practice guidance or the high standards that have been set.

Having given those explanations, I hope that the hon. Gentleman agrees that the issues that he identified have been covered and that schedule 3 will be an important part of the Bill.

Question put and agreed to.

Schedule 3 agreed to.

Clause 14 ordered to stand part of the Bill.

Clause 15

Duty of the designated individual

Dr. Harris: I beg to move amendment No. 177, in

    clause 15, page 11, line 16, after 'on', insert

    'to do all that is practicable'.

The Chairman: With this it will be convenient to discuss the following:

Amendment No. 84, in

    clause 15, page 11, line 18, leave out paragraphs (a) and (b).

Dr. Harris: This is a probing amendment to clarify the position of the designated individual who does all that is practicable to comply with the terms of the licence but, for reasons beyond their control, is unable to comply, or ensure that people working with their authority comply, with the licence. I want to clarify whether there will be natural justice. How does the Under-Secretary envisage people being able to argue that they did their best to ensure that activities were undertaken in conformity with the licence?

11.15 am

Dr. Murrison: Amendment No. 84 is barking up the same tree as that of the hon. Member for Oxford, West and Abingdon, but it is a little stronger in its probing, because it would delete part of the Bill. Hospitals and many organisations involved in medical research will experience difficulty with supervision and the burdens that will be placed on supervisors. In practice, many such people will be remote from the individual who holds the licence, and it will be exceptionally difficult to achieve the kind of supervision that the Under-Secretary envisages.

The definition of suitable practices and persons is not given. I suspect that the Under-Secretary will say that that will be explored in the codes of practice, but that would leave it open for the word ''suitable'' to be interpreted in an undesirable way. If we are to put an onus on individuals who supervise, we need to give

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them a clear steer—I suggest that we do so in the Bill—about what we mean by the suitability of persons who may operate as subordinates to the licensee, and the suitability of practices. Paragraphs (a) and (b) are unhelpful in that they fail adequately to define, even for the casual reader, what is intended. For that reason alone, they must be candidates for deletion.

Dr. Ladyman: I do not agree with the hon. Gentleman. It is true that the person who applies for the licence need not be the designated individual. In my experience, which is of working in medical research environments, the two would be different people, because it would not be appropriate for people such as the head of department, the professor or the dean of the medical school to be the designated individual. They would neither have the necessary routine access to areas where procedures are carried out, nor be in and out of people's laboratories on a sufficiently regular basis. They might no longer have even the necessary hands-on experience to be the designated individual.

It would be beholden on the person who applied for the licence to ensure that the designated individual had the experience, time and access to do the job properly, because if they did not, the licence would probably be revoked. That would not be in the interests of the head of department, dean or professor. I say that as someone who, in all my career working in medical research environments, has come across very few heads of departments that I would not have wanted to see banged up. I feel strongly that there are few deans, vice-chancellors or professors who would not be improved by a good, solid dose of porridge. However, I must disappoint the post-docs of this world by saying that I do not think that the Bill will serve that purpose, because it has been devised flexibly and sensibly to allow the separation of functions between the person who applies for the licence and the designated individual. In my experience, the designated individual in most research environments will probably be the laboratory manager, because they have the most experience of what is going on in the organisation.

The Bill has been sensibly drafted. If we were to go down the route suggested by the hon. Gentleman, it would mean being far more restrictive, and imposing far greater burdens on the heads of departments and professors, which is much more likely to land them in trouble. I certainly would not advise the Committee to agree to the amendment.

As to the other suggestion, it is important that we maintain the principle in the Bill that the designated individual has to be a person with the experience, the access and the supervisory authority to carry out his functions appropriately. Were we to accept the amendment tabled by the hon. Member for Oxford, West and Abingdon and insert

    ''to do all that is practicable'',

the individual would have to decide for himself what was practicable, rather than do everything that he could to ensure that the functions were carried out properly.

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The designated individual should be in a position to identify areas in which he does not have the knowledge to ensure that the provisions are being properly enforced, and he should be able to call a halt to the proceedings until he is assured that things are being done in accordance with the law. It would set a poor precedent if he could just assume that things were going on in dark corners of which he was not aware. Having said that, if questions were to be asked, it would be a legitimate defence for the designated individual if he carried out his duties appropriately, understood the Bill himself, ensured that everyone concerned understood the licence conditions under which they were acting and understood what was required of them, and if he supervised them properly and ensured that their work was quality assured within the terms of the Bill. I urge the hon. Gentleman to withdraw his amendment.

Dr. Harris: In light of the Under-Secretary's comments I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 15 ordered to stand part of the Bill.

Clause 16 ordered to stand part of the Bill.

Clause 17

Appeals committees

Question proposed, That the clause stand part of the Bill.

Mr. Lansley: I understand that the decisions that are taken by the authority are those of the authority as a whole, therefore every member is equally responsible for them. However, although I would not expect it to be the subject of a change in the Bill, can the Under-Secretary assure us, for reasons of natural justice, that in practice the appeals committee would, whenever possible, be constructed of members who did not have a specific function in making the original decision that was to be the subject of an appeal? Within the obvious constraint of their all having been responsible for the decision, can we achieve that objective?

Dr. Harris: I am grateful to the hon. Gentleman for raising the setting up of appeals committees because it arose under the issue of appeals to professional regulatory bodies. I understand that the General Dental Council recently changed its regulations to ensure that they were compliant with the Human Rights Act 1998 and that members of the appeals committee are not members of the GDC. The appeals committee is therefore made up of people appointed for the purposes of appeals by the main authority—in this case, the GDC.

That has been set up as a model for other regulatory authorities. I know that that had to be done in response to questions about Human Rights Act compliance and fair trial. The suggestion made by the hon. Member for South Cambridgeshire may not go far enough. I should be grateful if the Under-Secretary

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could reassure us that there is legal support for leaving the Bill as it stands or for taking on board the hon. Gentleman's suggestion.

Dr. Ladyman: I can give both hon. Gentlemen the assurances that they seek. We have tried to ensure that the Bill and the procedures to be followed are compliant with the Human Rights Act. I understand that the conditions set by the hon. Member for South Cambridgeshire would be a requirement of

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compliance with that. There should not be a conflict of interests. We will reflect on the points that both hon. Gentlemen have made and, if necessary, we will discuss them further on Report.

Question put and agreed to.

Clause 17 ordered to stand part of the Bill.

        It being twenty-five minutes past Eleven o'clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.

        Adjourned till this day at half-past Two o'clock.

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The following Members attended the Committee:
Mrs. Irene Adams (Chairman)
Cohen, Harry
Davey, Valerie
Ellman, Mrs.
Francois, Mr.
Harris, Dr. Evan
Knight, Jim
Ladyman, Dr.

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Lansley, Mr.
Lucas, Ian
Murrison, Dr.
Naysmith, Dr.
Ryan, Joan
Taylor, Dr. Richard
Winterton, Ms Rosie

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