Schedule 3 - Licences for the purposes of section 13

Human Tissue Bill – in a Public Bill Committee at 11:00 am on 3rd February 2004.

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Question proposed, That this schedule be the Third schedule to the Bill.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I want to raise two points. The first relates to the structure of fees. Paragraph 4(f) of schedule 3 refers to the power given to the authority to seek fees. I think that at a later point fees can be required to be paid along with an application. There is also the power to pay additional recurrent fees at such time as the authority can direct. As I recall, a power of that kind can be expressed as it has been, or it can be expressed in the same form but with a requirement that the fees should not exceed the costs incurred. The fees should therefore be reflective of costs incurred. It would be helpful if the Under-Secretary assured us that the power, although expressed in this form, will be limited to the reimbursement of costs incurred by the authority in undertaking the licensing process.

Paragraph 2 reads:

''A licence shall not authorise the carrying-on of more than one activity to which section 13 applies.''

As I understand it, the licensing process means that a pathology laboratory that is responsible for post mortems and the removal of material, not only for post mortem purposes but for subsequent use for other scheduled purposes, and also a premise where material is stored for subsequent use, will be required to have three licences. I want to be sure that that is the case, as I am unsure why the Government consider it necessary to have three licences when one might suffice. I should like to be reassured about the burdens that might accrue from having to be licensed that number of times for what is, from the practitioner's point of view, one set of activities and one set of material.

Paragraph 7 gives a power to revoke licences. If I recollect correctly, this is different from the structure of the HFEA's power in relation to its own licensed clinics. Will the Under-Secretary tell the Committee how it is different? I also recollect that the HFEA anticipates that, in its submissions to the review of the 1990 Act, one of its intentions will be to give itself sanctions—short of revoking the licence—to impose on those persons who are failing fully or appropriately to discharge their responsibilities under the licence. I am not sure that I can see that here: the power to revoke a licence is here, as is the power to impose conditions when a licence is issued, but there are no intermediate steps by which the authority could undertake enforcement, short of revoking a licence.

The revocation of a licence could be quite a draconian power in cases of relatively minor breaches of the licence requirement. I assume that we are not getting into the territory of clause 22, where the licence

requirement has been breached altogether: this would apply to some one operating under the licence in good faith, or who is simply failing to meet their obligations as the authority would wish. There does not seem to be any process of iteration in which the authority can say to the licence holder, ''You may not be meeting the conditions appropriately—we want you to do this and we have sanctions to require you to do it, short of revoking your licence.'' That may be excessive. If we are going to review the HFEA at some point—perhaps a couple of years hence—I should be sorry if we had incorporated in the Bill a structure based on the HFEA which subsequently turned out, in the HFEA's experience, to be inappropriate.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

So far as the licence fee is concerned, the principle on which we are proceeding is only to allow cost recovery. One must accept also that the Government would not wish to subsidise regulatory bodies. Those operating or applying for licences must expect to cover the full cost of managing the licence process. We do not intend that the costs will go beyond the cost of recovering the licence fee.

As for the different licences that may be required, a licence can cover only one activity, so the application can be covered by a single process. Applying for several activities can be done on one form in one stage, but several licences might be issued. That will have benefits for the organisation, as it may want different activities to be managed separately. Its internal structure might mean that it is better to have different oversight of different activities to ensure compliance with the Bill.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

Will the Under-Secretary confirm that just one licence fee would be involved?

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

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.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

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.