Clause 12 - General functions

Human Tissue Bill – in a Public Bill Committee at 10:15 am on 3rd February 2004.

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Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 10:15 am, 3rd February 2004

I beg to move amendment No. 31, in

clause 12, page 9, line 38, leave out from 'remit' to the end of line 39.

One of the criticisms from outside bodies is that the Bill is complex and difficult to read. I hate to use the word ''bodies'' in this context, but there is no other word that usefully fits the purpose. This simple amendment seeks to remove an area of pedantry around the general functions, about which my hon. Friends and I are concerned. The amendment would remove paragraph (a)(ii) and rely exclusively on the preceding sub-paragraph in stipulating that the Human Tissue Authority should maintain

''a statement of the general principles which it considers should be followed''

in relation to ''the carrying-on'' of its activities. Although that is a small point, the deletion of that line would improve the way the Bill reads without removing any of its meaning.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

I join the hon. Gentleman in trying to remove words from the Bill. I, too, cannot see that the paragraph that would be deleted by the amendment adds anything necessary to the clause. I support the amendment.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

We would certainly expect the Human Tissue Authority to maintain a statement of general principles as a matter of good corporate governance, as do other arm's-length bodies that are associated with the Department of Health. We would not wish the authority to act in a purely ad hoc way and make up its principles as it went along. We would also expect the authority to take on board current Government policy on arm's-length bodies when it takes up its functions.

Clause 12(a) requires the Human Tissue Authority to maintain a statement of principles in relation to the activities that it regulates, such as post-mortem practices, anatomical examination, tissue-banking, the use and disposal of tissue and so on. In that way the authority will be able to demonstrate the principles against which it expects activities to be carried out, so that consistency can be maintained in a transparent fashion and stakeholders can recognise the common threads that will run through the various codes and licensing requirements. There has been extensive discussion and agreement about that.

At the same time, clause 12 requires the Human Tissue Authority to maintain a set of principles against which it will operate. Declarations might be made, for example, about taking a consultative approach and about guidance being based on best practice. The amendment—and some Committee members—questions whether that is necessary. However, to remove the second element of clause 12(a) would be unfortunate. It is important that the authority be seen to operate consistently and fairly. It would be helpful to all concerned if the principle against which the authority should be tested were known. I understand the points that have been made. However, we feel that this is a useful, practical tool for people to be able to judge the authority against principles not only in theory, but in practice. I hope that the amendment will be withdrawn.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health) 10:30 am, 3rd February 2004

I feel partly reassured. The general point made by the hon. Member for Wyre Forest in support of my amendment is important. As we have been told by a number of interested authorities, this is a complicated Bill. We feel that this deletion would have helped in a small way to make the Bill simpler. However, as this is not a big point, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

I beg to move amendment No. 5, in

clause 12, page 10, line 11, at end add—

'(2) In the exercise of its functions, the Authority shall have regard to—

(a) the desirability of securing and maintaining public confidence in the processes for retention, storage and use of relevant material for scheduled purposes;

(b) the desirability of securing the availability of relevant material for the scheduled purposes set out in Schedule 1; and

(c) the desirability of securing that those engaged in the activities related to the scheduled purposes in Schedule 1 are enabled to do so while incurring the minimum necessary burdens of cost and compliance with regulation.'.

Here we address an issue that might illustrate the differences between the way in which legislation is constructed today and how it was constructed in 1990. I understand that this legislation is reflecting, with some variation, the structure of the Human Fertilisation and Embryology Authority. In 1990, the practice was to set out what a regulatory body had to do. Now, the general practice is to say not only what a body has to do, but what duties it is seeking to fulfil and, more particularly, in addition to those duties what considerations should be reflected in its functions.

Regulators nowadays say, ''I do the things that the statute requires me to do.'' The motivation for the amendment is that in the absence of any specification of those considerations, there is a risk that the Human Tissue Authority would simply do the job that is required of it by statute and would be able to devise the manner in which it does that simply on its own account. It might, of course, take account of the debates that we have in Parliament, and it will be obvious to the authority that we are balancing—as we must—the considerations on the one hand of families and patients about the way in which they and their loved ones are dealt with and, on the other, the importance of obtaining the necessary relevant material for human tissues research, education, training and so forth.

However, the fact that we say such things in debate does not mean that it is inappropriate to present them in the legislation as considerations to which the authority must have regard. That is the purpose of amendment No. 5. Committee members will know that other regulatory bodies established over recent years have tended to have specific duties that they must meet. The Bill is constructed not around duties, but around a remit, activities and a licensing regime; none the less its duty is to regulate a whole range of activities. It is also true that regulatory bodies are given guidance about what considerations they must have regard to.

Under the amendment, the principal considerations that the authority should consider are

''securing and maintaining public confidence in the processes'' that it regulates. It should have regard to

''the desirability of securing the availability of relevant material for the scheduled purposes''.

Those two provisions are balanced. There is clearly a worry in the medical and scientific community about the future availability of relevant material. Those two

considerations are not in conflict, but they necessarily reflect different aspects of the same outcome. In addition, it should have regard to

''the desirability of securing that those engaged in the activities related to the scheduled purposes in Schedule 1 are enabled to do so while incurring the minimum necessary burdens of cost and compliance with regulation.''

That provision is slightly different from proposed subsections (2)(a) and (b). Those proposals are clearly implied in the original Bill and in our debates, and there is a risk that—in the absence of a requirement for the authority to have regard to securing the minimum necessary burdens of cost and compliance—the authority could take the view that it had no requirement to do so.

However, at no other point does the statute look to the regulator to minimise burdens. It should be the intention of the Government, when establishing regulatory bodies—especially when creating a more comprehensive structure of regulation—to make it clear that one of the ways in which the authority should behave is to secure its objectives with the minimum necessary burden of costs and regulation. Nothing under amendment No. 5 could lead to the conclusion that the authority should compromise its responsibility under the Bill to reduce burdens, but while meeting its obligations, it should minimise those burdens.

From my past experience, the amendment is a succinct a way of expressing in legislative form how an authority should think about how it fulfils its functions. As it is a ''have regard to'' amendment, it would not impinge or cut across the responsibilities of the authority. I hope that the Minister considers that the amendment accurately summarises for the authority the considerations that it should have. As regulatory bodies are creatures of statute, it is much better that we set out in the Bill the additional considerations.

Photo of Richard Taylor Richard Taylor Independent, Wyre Forest

Paradoxically, having tried to remove words from the Bill under the previous amendment, I am now trying to add words to the Bill under amendment No. 5, which I thoroughly support. It would spell out in one place three vital matters with which the Bill must deal. Obviously, we all want to restore public confidence. The availability of relevant material must be ensured, but I wish to refer to the burden, particularly on clinical staff.

On Second Reading, the Minister acknowledged that burdens must not be onerous. Let us envisage a busy consultant holding a clinic that is overbooked and running late. Relatives of a recently deceased patient come to the clinic because it is their only opportunity to do so. In such circumstances, he or she would have to break off from duties; in these days of lack of continuity, the consultant might be the only member of the medical staff who has kept in touch with the family throughout the whole difficult illness. Obviously, other staff members, such as nursing staff, can help to explain the consent form, but it must be a senior member of the medical staff who advises the family on completing the form and all its difficult bits. However simple the form is, it will take quite a time to

get through. I should like the Human Tissue Authority to bear in mind the tremendous importance of consent being obtained in the least onerous way, with it being possible for senior members of medical staff to be involved despite their other duties.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

I certainly understand the points made about the need for the minimum necessary burden of regulation and the point that the hon. Member for Wyre Forest has just made about burdens on front-line staff. Again, I draw him back to previous discussions, when we have said clearly that we want to build on best practice. We know that obtaining consent as he described can be done without being burdensome, which is the right thing to do. We have to make clear that the basis for the Bill is about getting that balance right. It is certainly part of the Government's overall policy—led by the Cabinet Office and the better regulation initiative—to ensure that legislation does not prove to be over-burdensome. The Human Tissue Authority will be regularly reviewed against such standards.

The effect of the amendment would be fairly limited. A duty to have regard to something that does not require a particular outcome is quite difficult to put in legislation. The word ''desirability'' would also be difficult to define. The difficulty is that, on many occasions, words put in legislation can turn sour as time goes on and the situation develops. Given that the Human Tissue Authority will have to have regard to many factors, listing a few would risk implying that others were less important or that the list was exhaustive.

The amendment is well intentioned in terms of supporting research, but it is unnecessary and might turn out to be unhelpful. Again, to make the authority a promoter of regulated activities would remove the balanced and neutral position that the authority must maintain to regulate fairly. Its role is not to promote acquisition, but to create the appropriate conditions for acquiring human material for scheduled purposes.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 10:45 am, 3rd February 2004

I must confess that I am worried that the Minister seems to be operating on the basis that we send the regulators away to a neutral environment where they conduct their regulatory activity almost without regard to the purposes for which the regulation was established. We know why the regulation was established. In practice, the authority will read all the materials that led to the establishment of the authority. However, when establishing the authority, Parliament should clarify key purposes for which it is established. When the 20 members meet, their debate can be conducted in a framework, rather than in the neutral, dispassionate way that the Minister envisages.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

Our task is to ensure that the legislation provides a comprehensive framework. The amendment would limit the ability to take a balanced view. It would almost imply that some duties are more important than others.

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

On that point—and it is the second time that the Minister has said that—the amendment is not designed to create any duties for the regulator. Those duties are to regulate the activities under the remit set out in clause 11. The amendment is designed to express considerations that the authority should bear in mind; they are not duties.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

Yes, but as I have also said, the addition of such words might be well intentioned but could limit the ways in which the authority can operate. The words of the amendment are not necessarily achievable and could be challengeable. That is the problem that we have with it. Clause 12(d) gives the authority the task of providing information about regulated activities to the public and to persons carrying on such activities. Through establishing a balance of lay and non-lay members of the authority, we have tried to improve public confidence in obtaining and using human tissue.

The purpose of the Bill is not only to set out the principles of consent, but to provide a framework in which research can take place. That can be done only as part of a regulated environment. I understand the hon. Gentleman's points, but his amendment would not achieve what he is trying to do. Therefore, I hope that he will withdraw the amendment.

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

When the Minister says that something is well intentioned, it sometimes sounds like an insult. The amendment is not only well intentioned; it is an accurate reflection of the considerations that Parliament would want to be included. It is not an exhaustive list, and there are dangers in trying to present it as such. It is a fair summary of the principal considerations that Parliament would want the authority to have in mind.

The Minister's comment that the amendment could be a hostage to fortune is an arguable proposition. I find it difficult to conceive of circumstances in which the authority would not balance the desirability of securing public confidence and available material with the minimum necessary burdens. We could have written that in a much longer form, but the objective was to reflect those purposes in as short a form as we could.

I suspected that the Minister would argue that the considerations were so self-evident that the authority would not need guidance on them. Without paragraph (c) of the amendment, there is a danger that when the authority comes to consider its activities and somebody in the HTA argues strongly that things should be done in a less burdensome rather than more comprehensive way, there will always be—because of the nature of the statutory regime—a tendency to go down the route of comprehensive regulation rather than what one might refer to as appropriate regulation.

It is all very well for the Minister to say—we shall discuss this point in one particular respect later—that the authority will be reviewed by the Better Regulation Task Force, but there is nothing in the Bill, or any other statute for that matter, that means that the authority must have any regard for the BRTF's views.

It can review all it likes, but the authority can say, ''We have a statutory responsibility, and in meeting that we cannot vary our decision, because we are set up to be comprehensive.'' Precisely the things that the Minister says about the comprehensive nature of the regime and the necessity for its integrity are likely to lead in the long run to a comprehensive and burdensome way of addressing the authority's responsibilities.

I focus on that point because paragraph (c) is the part of the amendment that is most likely to go out of the window. It is probably fair to say that paragraphs (a) and (b)—concerning public confidence on the one hand and securing availability on the other—are matters that any authority trying to meet such responsibilities would consider. Sometimes, it does no harm to recognise in an authority's statutory form the balance that it is required to strike. Although we will hold the authority accountable by examining what it does and ensuring that its activities are transparent, it should be aware that we must do so against the background of its requirement to try to balance those considerations. As the word ''desirability'' is not susceptible to definition, it would be subject to little challenge in the way that the Minister contends. Challenging the decisions of the authority by reference to its not having had regard to one of those considerations would in effect mean having to go to judicial review to say that absolutely no regard was had to the issue. If the authority made decisions without regard to any of those factors, it ought rightly to be subject to review because they are the factors and purposes for which it was established. If it leaves them out and is subject to challenge, so be it.

I am not in the least persuaded by the Minister's argument that the proposal is inappropriate. Her argument seemed to be that when we set up regulatory bodies it is very tiresome and potentially risky to tell them what they ought to do. That seems to me to be what we are here to do. During the last Session, I was concerned with the establishment of Ofcom, the new water regulatory body and the independent regulator for foundation hospitals. I would have to go away and look this up, but in none of those cases do I recall that, having defined what the regulator was intended to regulate, Parliament did not trouble itself to say why the regulator was doing it, what its duties were and what considerations it should have in mind. To varying degrees, that is what Parliament does when it sets up regulators. Therefore, I am not persuaded.

It is not my objective to divide the Committee. Wherever we can, I want us to proceed by consensus, so I will not press the amendment to a Division. However, the Minister may be sure that before Report I will marshal examples of the many cases in recent years in which the Government have set out not only the functions of a regulator, but the duties and the considerations to which a regulator should have regard. I will do that to demonstrate that such proposals are not generally regarded as a hostage to fortune. The Minister may have adopted the structures of the Human Fertilisation and Embryology Authority from 1990, but that has been overtaken by

the way in which we currently adopt best practice in setting up regulatory bodies. Unless the Minister chooses on Report to adopt some of that through Government amendments, we will return to the matter. However, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 12 ordered to stand part of the Bill.