Health Bill [HL]

House of Lords, 28 April 2009.

Report (1st Day)

Earl Howe (Conservative)

My Lords, it falls to me to open today's proceedings. With this amendment I shall couple Amendment 16 in this group. I take us to an issue which we did not debate in Grand Committee; the role and standing of the Statement of NHS Accountability for England in relation to the NHS Constitution. This statement was published alongside the NHS Constitution and the Handbook to the NHS Constitution on 21 January this year. In these amendments I am asking: is the statement an integral part of the NHS Constitution? If it is, why is there no mention of it in the Bill?

If you access the very helpful section on the Department of Health website which contains the NHS Constitution and you turn to the interactive version, you read the following words:

"This interactive version of the NHS Constitution is designed to help you navigate through all of the supporting information that you may need when reading the NHS Constitution. It consists of the following documents".

Below that there is listed the NHS Constitution, the Handbook to the NHS Constitution, and the Statement of NHS Accountability. It is important to note that the constitution is described as "consisting of" these documents. In other words, the constitution consists of more than the 12-page document carrying that title, and you do not have the constitution in your hand unless you are holding the three documents—four, if you include the Glossary of Terms. This is right and proper.

At the beginning of the 12-page document is the section headed:

"Principles that guide the NHS".

The seventh of these principles is concerned with accountability and commits the Government to making sure,

"that there is always a clear and up-to-date statement of NHS accountability",

to enable people to be clear about the system of responsibility and accountability for taking decisions in the NHS. This system is as important for NHS staff to understand as for anyone else. For one thing, if staff are legally obliged to have regard to the constitution, they surely cannot do that in the fullest sense without understanding and having regard to the statement of accountability.

That is the function of the statement of accountability, which also provides a very useful summary of the current structure of the NHS and what the bodies within it are tasked with doing. Just as there are cross-references between the 12-page constitution and the handbook, and just as it is not possible to understand one document without the other, there are also cross-references between the constitution and the statement of accountability. How might the statement be useful to a patient? If you were someone who was unhappy about some aspect of NHS services and were seeking to understand how best to impress upon the service that it needed to focus more attention on a particular matter, the statement of accountability would enable you to navigate your way around the NHS and its institutions. It is more than arguable that you would not be able to do that properly by reading only the handbook.

Why is it then that the Statement of NHS Accountability receives no mention in the Bill? If it is to be regarded as part of the NHS Constitution, as the department's website strongly implies that it is, we should be able to see mention made of it here, on a par with the handbook. Indeed, what is the difference between the status of the handbook and that of the statement of accountability? I beg to move.

Lord Walton of Detchant (Crossbench)

My Lords, the British Medical Association has said that it has been a vocal supporter of the concept of an NHS constitution. It is the BMA's belief that a clearly articulated set of values that reflect a shared consensus concerning the nature and purpose of the NHS will strengthen the public's trust in it. The BMA considers that a constitution, properly constructed, offers the means to maintain the public's confidence in the NHS and to safeguard its future.

However, the BMA has concerns with regard to the constitution's commitment to developing a responsive and accountable health service. Past experience and some evidence suggests that there exist significant failings in enabling patients, public and staff to engage in and influence meaningfully NHS decision-making processes. Recent examples of service redesign, involving poor levels of transparency and a lack of effective consultation reinforce this view.

The BMA continues to be a strong advocate of patient and public involvement as an integral and collaborative process that is essential to grow productive partnerships between patients, the public, health professionals and policy makers. Consequently, the BMA does not believe that the NHS contribution goes far enough in determining a framework that will better enable and safeguard local accountability for widening and strengthening the relationship between the health services at a local level and the populations they serve. I support this amendment.

Lord Darzi of Denham (Labour)

My Lords, Amendments 1 and 16 tabled by the noble Earl, Lord Howe, would place a duty on the Secretary of State to publish a statement of accountability, to review it every three years and to ensure that it continues to be available to patients, staff and members of the public.

I agree with the sentiment behind these amendments. The system of responsibility in the NHS should always be made clear and accessible to the public, the patients and the staff. As I explained in Grand Committee, it is critical that the public know how the NHS is accountable at a local level and how they can get involved.

During the formal consultation on the draft constitution, patients, the public and NHS staff told us that it would be helpful to produce a document that explains accountability and the roles and responsibilities in the NHS. The Statement of NHS Accountability, which was published alongside the constitution on 21 January, was a response to what we heard. It is a public-facing document that explains the roles, responsibilities and accountability in the NHS.

However, I do not believe it is necessary to place in the Bill the requirement to review and update the statement of accountability. This is because the Government have already committed to doing this through the NHS Constitution.

Principle 7 in the constitution explains that,

"the NHS is accountable to the public, communities and patients that it serves".

It says:

"The system of responsibility and accountability for taking decisions in the NHS should be transparent and clear to the public, patients and staff".

It goes on to commit that,

"the Government will ensure that there is always a clear and up-to-date statement of NHS accountability for this purpose".

Therefore, we have already committed to ensuring that the statement of accountability is always clear and up to date. Imposing a timeline on how often the statement must be updated risks being too prescriptive—at least once every three years may be too long to wait, or, conversely, the roles, responsibilities and accountability in the NHS may not change in one three-year period. By keeping the time flexible, we will ensure that it is constantly up to date and continues to be useful to the public, the patients and the staff.

I turn to the point that the noble Earl raised in relation to the interactive form of the Statement of NHS Accountability and the supporting document. I will certainly look at the interactive version that the noble Earl referred to, but I think that the intention was to say that the interactive guide, and not the constitution, contains a statement of accountability.

I hope that I have demonstrated that there is no need for extra legislation on the face of the Bill. The Government have already committed to publishing a clear statement on NHS accountability that is always up to date.

I turn to the point raised by the noble Lord, Lord Walton, in relation to the transparency of it. I made it quite clear, through the process of the NHS next-stage review in May last year, that any service redesign or reconfiguration has to be evidence-based, clinically led and needs to involve the local population and the public through the whole period of the consultation. Change has to be locally owned.

I hope that the service redesign concept that the noble Lord referred to is already covered within the statement of accountability. I hope, therefore, that the noble Earl is able to withdraw his amendments.

Lord Mackay of Clashfern (Conservative)

My Lords, before the noble Lord sits down, I wonder why the statement of accountability is not included as part of the constitution. It seems to be extremely important, and indeed the constitution reflects the importance of accountability. If you were stating the manner in which you should be accountable and the detail in the statement, I should have thought that it would be at least a candidate for being part of the constitution.

Lord Darzi of Denham (Labour)

My Lords, I am grateful to the noble and learned Lord, and I shall try to clarify the matter. Principle 7 in the constitution refers to accountability within the NHS, which is part of the constitution. At the time, we did not think of a separate public-facing document, and the Statement of NHS Accountability was the result of the consultation that we carried out with the public and the staff. That is why we published it alongside the constitution on 21 January this year. Although there is a reference to accountability in principle 7, the consultation made a strong case for publishing a statement of accountability alongside it. If that is still an issue, I shall be more than happy to look into it further.

Earl Howe (Conservative)

My Lords, I am very grateful for the support of the noble Lord, Lord Walton, and for the excellent points that he made. I am equally grateful to my noble and learned friend, who posed the key question very well. Reading the Department of Health website, I think that you would certainly be forgiven for thinking that the NHS Constitution was, in essence, a three-legged stool, consisting of the 12-page document, the handbook and the statement of accountability. I, for one, was very comfortable with that. Notwithstanding that, the Minister implied that the statement of accountability is not in fact part of the constitution. The question that that raises is: do NHS staff or the boards of NHS trusts have to have regard to the statement of accountability? It would appear that they do not, and I wonder what kind of message that sends out to them.

Lord Darzi of Denham (Labour)

My Lords, I am sorry to intervene but perhaps I may again read what principle 7 in the constitution says:

"The system of responsibility and accountability for taking decisions in the NHS should be transparent and clear to the public, patients and staff".

That statement is in the constitution.

Earl Howe (Conservative)

My Lords, that statement is certainly in the constitution but the content of the statement of accountability is not in the 12-page document. It is only when you read it that you understand what the accountability structure in the health service consists of. The Minister suggested that, because that statement was in the constitution under principle 7, it was not necessary to include it in the Bill. I am a little puzzled by that because the constitution refers to the handbook. It says:

"It"—

that is, the constitution—

"will be accompanied by the Handbook to the NHS Constitution, to be renewed at least every three years, setting out current guidance on the rights, pledges, duties and responsibilities established by the Constitution".

One could equally well argue that perhaps the wording of the handbook should not appear in the Bill because the pledge is already set out in the constitution. Therefore, we are on difficult ground here. I remain puzzled but this is not an issue that I intend to press. If the Minister can enlighten me further after these proceedings, naturally I shall be grateful. However, for now, I beg leave to withdraw the amendment.

Amendment 1 withdrawn.

Amendment 2

Moved by Earl Howe

2: After Clause 1, insert the following new Clause—

"Core principles

The Secretary of State may by regulations make provision as to the core principles of the NHS Constitution."

Earl Howe (Conservative)

My Lords, in moving this amendment, I bring us back to an issue that gave rise to a gratifying amount of debate in Grand Committee—that is, the question of whether Parliament should have some sort of say in the content of the NHS Constitution and, if so, to what extent. I do not need to remind noble Lords that we have a very curious situation at the moment. The NHS Constitution was signed off by the Prime Minister in person early in the new year amid publicity and expressions of mutual congratulation of a kind that one associates with an event of some importance. Important as the event was seen to be, the publication and adoption of the NHS Constitution have nevertheless been entirely divorced from any parliamentary process. I am one of those individuals who think that that is just wrong. The constitution is a document that is intended to underpin the values and the modus operandi of the entire NHS for the next 10 years, at least, and as such it has been promoted by the Government as a text of fundamental significance for both staff and patients. It is not just that Parliament has been given no say at all on the content of the constitution, which I find regrettable, it is also that without the stamp of parliamentary approval on what the document actually says, the substance of it completely lacks any sort of legal standing.

In Grand Committee the Minister cited two main reasons for not incorporating the constitution or any part of it in the Bill. He said that he did not want to set anything in stone and, equally, he did not want to create a lawyers' charter. I understand both those objections and, indeed, a number of noble Lords whose voices I always listen to weighed in on the Minister's side. I have therefore given renewed thought to the problem. By this amendment I suggest that there could be another way of achieving the objectives I have talked about; that is, by giving the Secretary of State a power to make regulations in which the core principles underpinning the constitution could be set out. That statutory instrument would be the direct link between Parliament and the constitution and would quite literally legitimise the content of the document. It would be up to the Government to specify what the principles would be, but if they happened to be closely related to the principles set out in the constitution itself, I am sure that we would all be satisfied with that.

That, I think, deals with the Minister's first objection, because, with a statutory instrument, nothing would be set in stone. If the Government wished in some way to amend the principles at the 10-year review point, they could do so without bringing forward primary legislation. The Minister may well say that I have not dealt with his second objection; namely, that by giving any element of the constitution the force of law, we run the risk of creating a lawyers' charter. I suggest to him that this is not a worry that he needs to entertain, provided that, in the statutory instrument, we restrict ourselves to principles as opposed to rights.

The difference between rights and principles in this context is an important one. There can perhaps be no better example in law of the significance of that distinction than the European Charter of Fundamental Rights. The noble and learned Lord, Lord Goldsmith, published a paper in February 2001 in which he very helpfully drew a distinction between individually justiciable classic rights, by which he meant the civil and political rights guaranteed under the European convention, and what he termed the social and economic rights covered by the charter, which are not really rights at all, but rather general principles which both the Union and European member states may not infringe when framing new legislation of any kind. The principles do not themselves give rise to rights, nor do they oblige member states to legislate in a particular way. They act as a means to ensure that any new legislation cannot be enacted in terms which violate the principles.

I emphasise the opinion of the noble and learned Lord, Lord Goldsmith, that no new rights are imposed on member states or their citizens by reason of the principles being included in the European charter. We perhaps need to remind ourselves that the UK is signed up to the charter. The parallel with the issue we are now debating is, I think, a direct one and extremely illuminating. These are the reasons why I believe this amendment, or one like it, poses no dangers at all, but rather gives us the best of all worlds—flexibility for the Government and a means by which the citizens of this country can be assured of Parliament's approval of what the NHS Constitution contains. I believe that that assurance is of fundamental importance and therefore I beg to move.

Lord Darzi of Denham (Labour)

My Lords, Amendment 2 would mean that the Secretary of State would need to make regulations to address changes to the principles set out in the NHS constitution. I understand that the noble Earl wishes to give a greater role to Parliament in determining the principles of the NHS. However, as I said in Committee, as acknowledged by the noble Earl, I do not believe that this amendment is necessary and will say why it carries a risk. The principles of the constitution were not dreamt up by the Government. They articulate the foundation on which the NHS has been built over many decades, and many of them have roots in primary legislation. Importantly, they were the result of full public consultation. Any changes to them would also require full consultation.

If the noble Earl's intention is to ensure that the Government of the day cannot tinker with the principles of the NHS behind closed doors, I can assure him that they could not. The Government would not be able to alter the founding principles of the NHS just by changing the wording of the principles in the NHS constitution, even if they did so following full consultation. That is because Parliament creates the underpinning legislative framework from which many of these principles are derived. For example, the second principle about access to services being based on clinical need, not ability to pay, is derived from Section 1(3) of the National Health Service Act 2006. If the Government of the day wished to change that principle—I can assure noble Lords that this Government would not—they would need to amend primary legislation with the consent of Parliament. Revising the NHS constitution would not be sufficient. Similarly, Section 72 of the NHS Act 2006 would have to be amended in order to change the constitution's fifth principle that the NHS works across organisational boundaries.

As the noble Earl mentioned, I was concerned in Committee that we should not make a lawyer's charter out of the constitution. Placing part of the constitution in legislation, whether secondary or primary—the principal part—brings with it an increased risk of litigation. I am sure that we all agree that we would not wish to see decision-making in the NHS become the preserve of the courts.

If the principles of the constitution were to be addressed in regulations, it would also create potential ambiguity with the rights, pledges and values set out in the constitution. I am very grateful to the noble Earl for addressing the issues about the rights and the examples in relation to the European charter. Those sorts of ambiguities have the potential to create litigation, which I am sure we would want to avoid.

It would be unusual and cumbersome to single out one part of the constitution to be treated differently from the rest when reviewing it. The constitution is a coherent whole and we have proposed a system for reviewing it involving full consultation. I think this is the right process for updating the constitution. Given my reassurances and the long debate we had in Committee, I still do not believe that we should separate the principles. I hope that I have reassured the noble Earl that any changes to the principles, which are historically underpinned by legislation, will obviously be debated in Parliament. I hope that the noble Earl will feel able to withdraw his amendment.

Earl Howe (Conservative)

My Lords, I am grateful to the Minister for his reply. He gave only a brief nod to the problem which I had been trying to identify in my remarks, which is, as I see it, that the model which the Government have chosen to adopt is that the content of the constitution—the principles, the values, the rights and the responsibilities—is totally detached from Parliament. I believe that that is simply wrong in principle. I realise that Ministers are well intentioned and extremely unlikely to change the principles set out in the constitution. However, for the reasons I outlined, the amendment offers a way of finessing the objections raised to the more explicit amendment which I tabled in Grand Committee. In my view, it bridges the gap which the noble Baroness, Lady Barker, referred to on that occasion.

The Minister said that in his opinion the amendment would carry the risk of encouraging litigation against the NHS. However, if the noble and learned Lord, Lord Goldsmith, was right in his analysis of the European Charter of Fundamental Rights in drawing a material distinction between justiciable rights and non-justiciable principles, it surely follows that the risk of litigation with a formula of this kind has to be more apparent than real. Nothing the Minister has said in his reply has persuaded me that the parallel I have drawn is incorrect

The issue I am raising is one of principle. It casts no aspersions whatever on Ministers but it is important, and I would like to test the opinion of the House.

Report (1st Day) (Continued)

Earl Howe (Conservative)

My Lords, I shall speak also to Amendments 7 and 8. I make no apology for returning to a matter that we debated at some length in Grand Committee—that is, the question of why the Bill contains no duty for NHS bodies and those delivering services on behalf of the NHS to have regard to the Handbook to the NHS Constitution. First, what is the handbook meant to be? In Grand Committee, the Minister made it clear that the handbook was the explanatory guide to the constitution. He said:

"It explains what the constitution means in practice, by setting out the law and departmental policy that underpin each right and pledge in the constitution". —[Official Report, 23/2/09; GC 21.]

That was absolutely as I understood the position. However, despite that, and despite the duty in the Bill for NHS bodies to have regard to the constitution, the Minister made it equally clear that it was not appropriate to extend that duty to the handbook. When comparing the status of the constitution and the handbook, the analogy that he drew was that between the Bill and the Explanatory Notes that go with it. However, the Explanatory Notes have no force in law; the Bill, when enacted, does.

I am still troubled by this. In the first place, I am doubtful whether the analogy the Minister drew actually holds water. The handbook is a statutory document; it is mentioned in the Bill, unlike the Explanatory Notes. I take us back to the departmental website. The part of the website devoted to the NHS Constitution makes it clear that the constitution consists of—I remind the House of those words—not only the constitution itself, but also the handbook. It also includes the Statement of NHS Accountability as well, but I shall not return to that issue.

If we look at the way this Bill is constructed, we should take due note of the heading to Clause 1: "NHS Constitution". Clause 1 introduces and embraces not only the constitution itself but also the handbook. I took that bracketing together to be an implicit acknowledgement that the two publications were legally and practicably inseparable for the purposes of interpreting what the NHS Constitution actually was. The Minister's reply indicated however that the handbook was not part of the constitution. He emphasised that,

"It is not a document that we intend should be legally taken account of by providers of NHS care".—[Official Report, 23/2/09; col. GC 21.]

If that really is so, we are left wondering what patients and staff are meant to think when they read it. It is explanatory, but at the same time, they do not have to have regard to it. If they do not have to have regard to it, they can ignore it, because nothing will happen to them if they do. Indeed, if they can ignore it, they do not even need to read it. That is the construction which people may well put on the Government's position on this matter.

The Minister put forward another reason in Grand Committee why it was not appropriate to create a duty to have regard to the handbook. He said that,

"the handbook is primarily an explanatory guide for patients, not guidance for the NHS".—[Official Report, 23/2/09; col. GC 22.]

I found that very odd. It is certainly true that the first part of the handbook is addressed to "you", by which is clearly meant, "you, the patient". But that is no less true of the constitution itself. The whole of the second section of the constitution is addressed to "you", which means everyone who uses the NHS. However, that fact does not prevent there being a duty placed on NHS bodies to have regard to the constitution. Again, the obvious question is, why not also the handbook? Equally, the Minister said in our earlier debate, and he may well repeat it today, that,

"the handbook itself does not create policy or law".—[Official Report, 23/2/09; col. GC 21.]

The implication is that its status is not of a kind that would put it on a par with the constitution. I accept that it does not create policy or law, but as I understand it, the constitution itself does not add to people's legal rights; it is a declaratory document, yet there is a duty to have regard to it.

We should perhaps bear in mind the handbook's opening sentence.

"The Handbook is designed to give NHS staff and patients all the information they need about the NHS Constitution for England".

Indeed, it is designed for rather more than that, because, as the noble Baroness, Lady Barker, pointed out in Grand Committee, there are sections of the handbook which qualify or place limits on the open-ended statements made in the constitution. A very good example, which the noble Baroness chose, was the right,

"to go to other European Economic Area countries or Switzerland for treatment which would be available to you through your NHS commissioner".—[Official Report, 23/2/09; col. GC 19.]

It is only when you read the handbook that you discover that the right can only be exercised at the discretion of the Secretary of State.

The constitution sets out the right to make choices about your NHS care, but it is only when you read the handbook that you are told about the raft of exceptions to that right. The handbook spells out exceptions to the right of access to your own health records and exceptions to the right to receive clinically indicated drugs and treatments recommended by the National Institute for Clinical Excellence. In a very real sense, a duty to have regard to the constitution which is not at the same time accompanied by a duty to have regard to the handbook risks, at best, confusion, and, at worst, downright contradiction.

I must press the Minister further on this point. How is it that a document which is to be treated, on the one hand, as an integral part of the constitution is at one and the same time not part of it? How can it make sense for there to be a duty to have regard to the 12-page document called the NHS Constitution, and yet for there not to be a duty to have regard to the fuller document which is meant to tell everyone how the constitution should be interpreted? I beg to move.

Lord Darzi of Denham (Labour)

My Lords, Amendments 3, 7 and 8 tabled by the noble Earl, Lord Howe, propose that the same list of bodies which are required to have regard to the constitution should also be under a duty to have regard to the Handbook to the NHS Constitution. It may be useful if I reiterate our intentions behind the purpose and status of the handbook. The noble Earl very eloquently described the debate in Grand Committee when I explained that the handbook is the explanatory guide to the NHS Constitution to be used by patients, public and staff. It is a reference guide for these groups, an explanation of what the constitution means in practice to help them understand it. Indeed, the very first sentence of the handbook reads:

"The Handbook is designed to give NHS staff and patients all the information they need about the NHS Constitution for England".

The words in the constitution are necessarily high-level. The handbook takes these words and explains them in further detail, making each right, pledge and responsibility more accessible and digestible to patients, public and staff. The handbook is the result of extensive research with patients, public and staff into what format would be most useful to help them understand the constitution. For example, the handbook explains to patients, as the noble Earl said, how they can make a complaint and explains in more detail what their responsibilities are. It summarises what a right means in practice, and its legal status, for both a patient and for a member of NHS staff.

The handbook is not guidance; it is an explanatory document and it is certainly not an instruction manual. The words in the handbook do not mean that the NHS has to do anything new or different. They do not express any new laws or policies, or new interpretations of existing rights or policies, which are not already in the constitution. They are merely a summary for patients, public and staff of the current situation regarding the law and departmental policy underpinning each entry in the constitution.

I understand the debate about whether we should have regard to the handbook as well as the constitution. My concerns are that the constitution summarises all the rights, pledges and principles of the NHS as we debated in Grand Committee. I am more than happy to look into what impact the handbook will have on the constitution itself. I do not want to dilute the constitution by inserting an amendment which gives more weight to the handbook. I hope I have reassured the noble Earl, as I did in Committee, of the purpose of the handbook. If the noble Earl is happy to discuss this at a later stage, then I am happy to take it away and bring the matter forward at Third Reading. I hope the noble Earl will feel able to withdraw the amendment.

Earl Howe (Conservative)

My Lords, I very much appreciate the Minister's comments and his explanation. I respect his position, but we are left with what many would see as an anomalous situation with regard to the functioning of the NHS. On the one hand, there will be a duty to have regard to the constitution but, on the other hand, there is no duty whatever to have regard to what the constitution means in practice. From a legal standpoint, we have in the handbook a statutory document which the Secretary of State has a duty to revise from time to time but the document has absolutely no standing or force if the Bill is left as it is. I am still baffled by that and my bafflement stems ultimately from the contradictory signals sent out by the department over the past few months in the contrast between what the Minister has told us at the Dispatch Box and what the department has said elsewhere, whether on its website or by means of the Bill's construction and drafting. Nevertheless, it is not appropriate to press the matter. I am happy to engage in further discussions with the Minister between now and the next stage of the Bill, and I beg leave to withdraw the amendment.

Amendment 3 withdrawn.

Amendment 4

Moved by Lord Morris of Manchester

4: Clause 2, page 2, line 4, at end insert—

"( ) the Advisory Committee on the Treatment of Haemophilia;"

Lord Morris of Manchester (Labour)

My Lords, I want first to thank my noble friend Lady Thornton for doing so much to make it possible for this debate to take place at a time when my dear and inspirational friend, the noble Baroness, Lady Campbell of Surbiton, can be with us. As she said so movingly and so memorably in the debate on the Archer report last Thursday, the history of the contaminated blood disaster is one of unspeakable suffering for,

"mothers, fathers, sisters, brothers, wives, husbands and friends ... seeing their loved ones die".—[Official Report, 23/4/09; col. 1614.]

When I announced the setting-up of the Archer inquiry in February 2007, 1,757 patients had died. Since then, of a patient group of barely 5,000, over 200 more have died in direct consequence of the use of contaminated blood in their NHS treatment. The noble Baroness, Lady Campbell, was herself widowed by the disaster, and I know that the House very much looks forward to hearing her speak again.

Today's is the third debate in which the case for my proposed new clause will have been addressed; and I will not be returning to questions dealt with in Committee and last Thursday. However, many of the questions then raised went unanswered due, not least, to pressure of time, and there are some that must be pursued today. I refer not only to questions of mine but to those of other participants, including the noble Lords, Lord Thomas of Gresford, Lord Corbett and Lord Rooker, and the noble Baronesses, Lady Campbell, Lady Barker and Lady Morris of Bolton.

The first unanswered question is whether it is now clearly understood by the department that the body for which my proposed new clause provides would be a statutory one. Correspondence between the department and the Haemophilia Society envisages a non-statutory body and is at variance with the intention of the Archer report. Thus it will be helpful if my noble friend Lord Darzi, in replying to this debate, can clarify the department's intended response.

I turn now to the urgency of the need for an updating of ministerial Statements to Parliament on the sombre threat of a third deadly scourge to patients dependent on NHS blood and blood products. The vCJD threat is increasingly worrying, a recent post-mortem on a hepatitis C-infected patient having found variant CJD in his spleen, thus totally undermining the Chief Medical Officer's assessment of the risk as "hypothetical". Specifically, we need to know the department's current figure for the number of patients treated with blood taken from variant CJD-infected donors. We need also to know what action Ministers have taken since the post-mortem on the implications of its findings. Further, how do they now assess the risk facing patients treated with blood taken from such donors, and what protection is now in place to safeguard recipients of donated blood?

As the noble Lord, Lord Thomas of Gresford, said, the issue of Crown immunity must also be pursued. The Archer inquiry's report raised it in commenting on the behaviour of the Blood Products Laboratory—the BPL—and said:

"In July 1979, the Medicines Inspectorate visited BPL. They reported that the buildings were never designed for the scale of production envisaged. They commented: 'If this were a commercial operation we would have no hesitation in recommending that manufacture should cease until the facility was upgraded to a minimum acceptable level'".

The Archer report then starkly stated:

"BPL was rescued by Crown Immunity"—

and went on that BPL's,

"existing plant continued production, relying on Crown Immunity to dispense with the requirements of the Medicines Act, but was able to meet only 40 per cent of the national requirements".

Thus, by the use of Crown immunity, a relic of feudal England, the lives of countless haemophilia patients were blatantly and gravely put at risk.

Speaking in the House on 10 March, my noble friend Lord Darzi, responding to me in exchanges about thalidomide, referred to,

"the tremendous amount of work that has gone into the marketing, testing and regulation of drugs, as encapsulated in the Medicines Act 1968, from which society has benefited greatly".—[Official Report, 10/3/09; col. 1059.]

There could be no clearer text than this for describing the enormity of the BPL's use of Crown immunity to dispense with all the requirements of that renowned and so vitally important statute; hence the need to reflect again in this debate on from whom the BPL was "rescued" by its use of Crown immunity.

First and foremost, of course, it was "rescued" from the afflicted and bereaved by the disaster, thereby denying them any prospect of legal redress, a denial made all the more cruelly unjust by the refusals of successive Governments to agree to a public inquiry. So they were left with no hope of any independent assessment of responsibility for their plight until the Archer inquiry was announced.

Crown immunity has now been abolished. It was ended by John Major's Conservative Government in 1991, and infected NHS patients ask why the present Government, who clearly have no intention of reinstating Crown immunity, cannot now review the claims of the victims contaminated by NHS blood from whom the BPL was "rescued" by Crown immunity. The noble Lord, Lord Thomas of Gresford, said in his speech last Thursday that he was sure that it would be possible for actions to be brought now if the Government chose to waive, dating back as necessary, Crown immunity. Have the Government, opposed as they must surely be to Crown immunity, considered this possibility?

Most of all, we need to know in this debate when the Government now expect to respond to the Archer report as a whole and how we can be sure that parliamentary time will be found for their response to be fully debated in your Lordships' House. Meanwhile, I hope that a positive response to this new clause—one giving a clear pointer to the Government's intentions vis-à-vis the report as a whole—will be forthcoming.

As I made clear both in Committee and elsewhere, the new clause can be implemented at no great cost but much to the relief of haemophilia patients who feel strongly that there must be no delay now in creating a statutory committee to advise government on the management of haemophilia, with patient and family representation. Of course there will be costs in giving full effect to the Archer report, but there will also be priceless benefits in enabling haemophilia patients to live fuller and more fulfilling lives.

Naturally, their principal desire is for closure with the Department of Health on their claims for just treatment. As the noble Baroness, Lady Morris of Bolton, told the House last Thursday:

"When we are ill, we have faith that the treatment that we receive will help to make us better, or will help us to manage the disease so that we can lead as full and dignified a life as possible. To receive treatment that leads to such tragic consequences is unimaginably cruel".—[Official Report, 23/4/09; col. 1628.]

Surely parliamentarians have no more compelling duty than to them.

It may, however, be said that, self-evident though the Archer report has made the case for closure, a time of deep recession is not one in which to expect it to be achieved. Yet some aspects of the current difficulties are frequently compared, not inappropriately, with those faced by Denis Healey—now my noble friend Lord Healey—when he was Chancellor of the Exchequer and had to resort to the IMF for support. Harold Wilson, then Prime Minister, in whose Government I served, said that it was a time for the broadest backs to bear the biggest burdens, but he needed no reminding that my responsibilities, as the first Minister for Disabled People, were for those with broken backs and even more handicapping disabilities. He and Denis Healey readily enabled me to introduce a severe disability allowance, the mobility allowance, the carers' allowance and many other benefits which both Harold Wilson and Denis Healey said later were the Government's finest achievements.

I hope that may put in some perspective the cries of alarm from anyone who thinks that acting justly to this small and stricken patient community is insupportable. Its claims are entitled to be seen as a priority of priorities and I know that my noble friend Lord Darzi will want to reply as helpfully as he can. I look forward to hearing him as we proceed.

Baroness Campbell of Surbiton (Crossbench)

My Lords, I am delighted to have the opportunity to speak in support of the amendment tabled by the noble Lord, Lord Morris of Manchester, who has made an extremely successful case for it. I ask noble Lords on all sides of the House to support this amendment, which, if passed by your Lordships, would establish a statutory committee to provide and give advice to government and haemophiliacs on health and support services.

This committee would undoubtedly improve the lives of those who have suffered from contaminated blood products. It would also bring together information for haemophiliacs and those who have cared for them into one place, with punch. I am not saying that there are no places to go for information, advice and support; the Haemophilia Society has done wonderful things. It is time, however, for a statutory committee that can really punch above its weight.

I shall not repeat my reasons for supporting the amendment. It is quite difficult for me to say these words, which take me back to an extremely difficult time in my life. Noble Lords will recall my connection with the haemophilia community and my experience, when my husband was contaminated in the mid-1980s, of trying to get coherent information and advice. If only we had had this committee then.

The committee would not be bureaucratic or cumbersome; it would be small and cheap to maintain. It would right a great wrong that has been done to haemophiliacs over so many years. Those who live with the complexities of their condition plus the consequences of contaminated blood—and all that that brings—should have the best information, support and advice. I believe that this committee would establish a modern response to a 1980s disaster and I urge noble Lords to support the amendment proposed by the noble Lord, Lord Morris of Manchester.

Baroness Howarth of Breckland (Crossbench)

My Lords, this is a difficult speech to make, because I have unutterable respect for both previous speakers and a great belief that such a committee might well be a positive way forward. I was going to speak about any section or interest that was added to this list because I feel that, if one group is added, I should bring forward a range of others who have an equal wish to be represented in the Bill. I find this difficult because the noble Lord, Lord Morris, and the noble Baroness, Lady Campbell, are wonderful advocates for this cause, but others of your Lordships might have advocated other causes had they thought that they might be added to the list in this part of the Bill.

Having said that, I hope that my noble friends will understand that I am not speaking against the need for an advisory committee; that need is a different issue from the consultation item under discussion, which is in a list in the Bill. If the need for an advisory committee was brought forward in another place, as I think will happen, I would be able to support it. It is with deep regret, then, that I feel unable to support my noble friends; it is simply because they are, as a technicality, making their argument in the wrong place. Should they put this forward at Third Reading, I would have to bring a long list of other people who would also wish to have their views heard.

Baroness Finlay of Llandaff (Crossbench)

My Lords, I intervene briefly after the powerful speeches made by the noble Lord, Lord Morris, and the noble Baroness, Lady Campbell. They made an important point. People have to trust the healthcare professionals who look after them; they have no choice but to trust the service to give them what they need. Therefore, at some future time, we might well be able to establish some grouping that would make representations for those who have, unwittingly and inadvertently, been the victims of a mishap that has occurred. If that is the case, such a committee should be included in this core list of bodies for which the NHS Constitution would be very important. Although the name outlined in the amendment may not, I fear, be right, the principle is correct. I wonder whether the Minister might be able between now and Third Reading to come back to us with some assurance that whatever comes in the future could be added to a broader grouping, and that the grouping outlined in the Bill may be a minimum, but not an exclusive, list.

Earl Howe (Conservative)

My Lords, it is not for me to speak on behalf of the noble Lord, Lord Morris of Manchester, but I think it might help the House to know—the noble Lord can correct me if I am mistaken—that the substantive amendment in this group is Amendment 40, and that the amendment that we are now debating is a pragmatic device, if I can put it that way, to ensure that we debate this very important topic at a time convenient to most of your Lordships. I say that only to address the point made by the noble Baroness, Lady Howarth, who was perfectly right in her observations about the list, but I do not think—if I read the noble Lord, Lord Morris, correctly—that that was his prime intention.

Like other noble Lords, I take my hat off to the noble Lord, Lord Morris of Manchester, for his principled and deeply felt stand on the plight of haemophiliacs in our country. In Grand Committee, as well as on Thursday of last week and again today, he cogently argued the case for treating fairly and compassionately those individuals, a dwindling band of people whose privations have been, and continue to be, so great. It would be a hard-hearted person who could read the report, so excellently written by the noble and learned Lord, Lord Archer, and not associate himself with the call that he makes for speedy and appropriate government action.

It was disappointing that the Minister was unable to throw any light on the Government's detailed thinking when she replied to the Motion of the noble Lord, Lord Morris, last week. She indicated then that she was pushing hard to be able to do so today. I hope that she can, or that her noble friend can.

Only last week, I was contacted by one of the people who received contaminated blood. She was not at all strident or pushy in her tone; she merely wished me to know that the hepatitis C which she contracted through no fault of her own as a result of the transfusion had now developed into full-blown cirrhosis of the liver. Her lifespan as a result can now be measured in terms of a few years at best. A liver transplant, she told me, is unlikely to be a practical possibility, not least because she has to take her turn in the queue. No allowance is made by the NHS for the fact that the NHS itself was the instrument of the serious illness which she now suffers from. Indeed, the attitude that she encounters in the NHS can be one of criticism, as if it were her own lifestyle that were to blame. That is a double insult.

It is the needs and wishes of that lady and individuals like her that most concern me here, rather than the business of attributing responsibility for what happened in the 1970s and 1980s. To be sure, it is important to establish what happened and why and to learn lessons for the future, but the immediate and pressing question is to ask what are the needs of the people who are now, many of them, very ill. What can and should we do to make their lives more bearable? As the noble and learned Lord, Lord Archer, recommended, we should look at ways in which access to NHS services for this group of people could be improved.

It is here that a committee of the kind proposed by the noble and learned Lord, Lord Archer, and now by the noble Lord, Lord Morris, could have a useful role to play. It is not the only way of dealing with the matter, but one factor in its favour is that it would provide the haemophiliac community with the sense that it was being listened to by a group whose remit consisted solely of haemophilia and related issues. As the committee would be only advisory, it would not usurp the authority of the Secretary of State, with whom decisions would ultimately rest, but its recommendations would clearly carry considerable moral weight.

I very much hope that the Minister will be in a position today to indicate the Government's response in more than just a cursory fashion to the proposals so cogently made by the noble and learned Lord, Lord Archer.

Baroness Wilkins (Labour)

My Lords, I strongly support the purpose behind this amendment, as set out by the noble Earl. The establishment of a statutory committee was one of the strongest recommendations of the excellent Archer inquiry. I support the amendment for its support of this recommendation.

Baroness Tonge (Liberal Democrat)

My Lords, I, too, add my support to the spirit of this amendment if not to its actuality—if that is the right word. I also add my support to the remarks of the noble Baronesses, Lady Howarth and Lady Finlay. I have just been to a meeting in the other place on brain tumours and research into brain tumours in children, which is greatly neglected. There are many groups who would like to be mentioned in this Bill, which is why we are reluctant to add this group. But—and it is a very big but—this saga has gone on for far too long. It is quite disgraceful that these people have not been dealt with justly and efficiently before now. I congratulate the noble and learned Lord, Lord Archer, the noble Lord, Lord Morris, and the noble Baroness, Lady Campbell, on taking every opportunity they possibly can to raise this issue. I admire them, I envy them and I try to be like them. I hope they will carry on campaigning and raising this issue until we get satisfaction for this group of patients.

Lord Darzi of Denham (Labour)

My Lords, I also acknowledge the moving speeches made by my noble friend Lord Morris and the noble Baroness, Lady Campbell.

Amendment 4 is a device to allow this important matter to be debated early in proceedings. I am grateful to the opposition parties for their help and support in facilitating this. As we heard, Amendment 40, tabled by my noble friend Lord Morris, is based on a recommendation by my noble and learned friend Lord Archer in his report published on 23 February. The report considered the supply of virus-contaminated blood and blood products and its devastating effect on the haemophilia community in particular from the early 1970s onwards until tests became available for Hepatitis C and HIV. We welcome my noble and learned friend's report and warmly thank him and my noble friends Lord Morris and Lord Corbett for the efforts they are making on behalf of the haemophilia patients and their families.

There is no doubt, as the noble Baroness, Lady Tonge, pointed out, that this group of patients has suffered tragic consequences as the result of the serious infections that were inadvertently transmitted via this treatment. I agree that it is important to ensure that these patients and their families are properly supported and to act to reduce as far as practically possible any further risk to all patients who need blood and blood products. There have been major advances in safer treatments for haemophilia. We have committed to making available synthetic products not derived from human blood for all those patients for whom they are suitable.

Haemophilia patients together with their clinicians and service commissioners already have influence in the selection, procurement and delivery of those products. This will continue. We entirely agree with the arguments in my noble and learned friend's report that it is vital for patients to be represented where decisions about good practice in healthcare provision are being made. This was the centrepiece of our strategy for embedding quality in the NHS and it certainly ran through my report, High Quality Care for All. Together with effectiveness and safety, patient experience is a guiding principle for high-quality healthcare.

We agree that it is vital to have strong mechanisms in place to provide independent expert advice on blood safety, and to recommend improvements. We have an established mechanism to do this through the expert scientific Advisory Committee on the Safety of Blood, Tissues and Organs, which advises the UK Administrations. The committee has patient representation and is developing effective means of communicating its advice for stakeholders and the public. Our view is that it is better to build on existing arrangements and expertise, rather than risk disrupting or duplicating those arrangements via legislation.

With this in mind, one option that we are actively considering, and have already discussed with the noble Lord, Lord Morris, is that together with the devolved Administrations we could build on the existing UK-wide partnership in the Haemophilia Alliance between patients, haemophilia doctors and others involved in their care, such as nurses, physiotherapists and social workers. The alliance is jointly chaired by the Haemophilia Society. We are considering a formal arrangement whereby the Government would seek advice from the alliance on matters relating specifically to the care of haemophilia patients, and meet with them at least twice a year. If this were pursued, we would, of course, meet the costs of these meetings. The Haemophilia Alliance has already established a commendable reputation by developing a national service specification for bleeding disorders, which has been welcomed by commissioners.

I assure noble Lords that my right honourable friend the Secretary of State is looking at the most appropriate means of strengthening representation for haemophilia patients and ensuring that advice is provided to those best placed to act on it for the benefit of patients. This is being considered together with the other recommendations from the noble and learned Lord, Lord Archer, for improving support more widely to the haemophilia community. I personally commit to do everything possible to ensure that the Government respond fully to the noble and learned Lord's recommendations in advance of the Whitsun Recess, if not the week before. Furthermore, we will of course assist as far as possible in securing a debate on the Government's response.

Finally, I turn to two points made by the noble Lord, Lord Morris, on CJD. First, since the announcement of the finding of the case, much careful work has been undertaken to ascertain the possible source of this infection. The information will be considered by the CJD incident panel, which will advise if further action is necessary. I remind the House that we have implemented many precautionary measures to reduce the risk as far as is practical and continue to monitor this area very closely. Secondly, on Crown immunity, I reassure my noble friend that the position is very different from what it was 20 or 30 years ago, but I am more than happy to look at what Crown immunity was 30 years ago and respond, giving the changes that have occurred since then.

I hope that the noble Lord will feel reassured by the steps that have been taken to consider the most appropriate way in which to involve those affected by haemophilia in decision-making and feel able to withdraw his amendment.

Lord Morris of Manchester (Labour)

My Lords, I think it was Aristotle—if not it ought to have been—who said that it is the essence of probability that some improbable things will happen. How could I possibly have suspected that my first duty now would be for me to thank the noble Earl, Lord Howe, for speaking so eloquently and with such attention to accuracy in responding to the noble Baroness, Lady Howarth? As he explained, I was simply taking the first opportunity to raise again an issue that noble Lords in all parts of the House see as one of priority and very considerable importance to the future of the National Health Service. The pledges we have had from my noble friend Lord Darzi on the imminence of a full response to the Archer report, and what he said about using his best endeavours to find parliamentary time for it to be debated, go far enough for me. I beg leave to withdraw the amendment.

Amendment 4 withdrawn.

Amendment 5

Moved by Earl Howe

5: Clause 2, page 2, line 6, at end insert—

"( ) specialised commissioning groups;"

Earl Howe (Conservative)

My Lords, in moving this amendment, I realise that I run the risk of crossfire from other noble Lords for seeking to add to the list in subsection (2). I am looking in particular at the noble Baroness, Lady Howarth, but luckily she is not paying attention. I am prepared to accept the risk because, when we debated the NHS Constitution in Grand Committee, I drew the Committee's attention to a remarkable omission, which is that nowhere in the constitution is there even a mention of specialised services. This seems to me quite extraordinary and I thought that we ought to return to the subject today.

It might be helpful if I were just to outline the way in which specialised services are commissioned in the NHS. What happens is that within each strategic health authority area, PCTs delegate responsibility for commissioning these services to specialised commissioning groups. In so doing, they pool their commissioning budgets. The point of doing that is to share risk and to ensure that the care that is delivered is of high quality. We are talking here about a very considerable range of conditions; for example, cystic fibrosis, complex disability, haemophilia, HIV, various neurological conditions and certain types of cancer. Serious burn injuries and spinal injuries also fall within the category of specialised conditions for the purposes of the national definition set.

Collectively the services involved account for 10 per cent of NHS expenditure and the treatment of hundreds of thousands of patients. The handbook to the constitution mentions these services only in passing. A short paragraph on page 15 talks about,

"the small number of people who suffer from rare conditions".

From his reply in Grand Committee, I rather took it that the Minister privately agreed with me that this was inadequate recognition of a category of services which he himself referred to as being the "jewel in the crown".

However, these services are important in another sense. We have to remember that the way in which the NHS commissions specialised services involves a diverse range of providers, many of them from the independent sector. That fact places even greater weight on the need for commissioning arrangements to maintain the standard of the services that are delivered, and, over time, to enhance them. Against that background, it is surely of great importance that the bodies required to have regard to the NHS Constitution should include specialised commissioning groups.

I understand that the PCTs participating in the specialised commissioning groups remain the statutory bodies, and the Minister may well say that my amendment is inappropriate for that reason alone. However, I would still argue that the quality and safety of specialised services is dependent on the effectiveness of the specialised commissioning groups acting on their behalf, which is why I am proposing an explicit reference to them in the Bill.

I hope the Minister will be able to give me a reassuring reply on this matter, which I do regard as significant, and I beg to move.

Lord Walton of Detchant (Crossbench)

My Lords, this is an important amendment. The reason that I think it is important rests on my knowledge of specialised commissioning services across a large range of different activities in the NHS, not least in my specialty of neurology.

I am at present serving on two inquiries being conducted by All-Party Groups. One is on Parkinson's disease; the other is on muscular dystrophy. We have taken a great deal of evidence already on services for patients with Parkinsonism, and have found, not greatly to my surprise, that there is a remarkable unevenness of resources and facilities for patients in different parts of the country, in relation to their medical care and also to the availability of specialist nurses, specialist physiotherapists and specialists in language and speech therapy.

In the case of muscular dystrophy and other neuromuscular diseases, the situation is substantially worse. My own research, many years ago, was based in Newcastle-upon-Tyne. I will give you a perfect example of what I am talking about. The most severe form of muscular dystrophy, the Duchenne type, affects young boys who have difficulty in walking and who, by the time that they are eight, nine or 10 years of age, are often confined to a wheelchair. When I started working in this field, many of them died in their early teens from complications such as heart failure or pneumonia. In the unit in Newcastle with which I am now very familiar, the range of services, including physiotherapy, treatment of contractures, prevention of deformities, respiratory care and specialised support for cardiac complications, has meant that the average age of death of boys in that unit, and indeed in other specialised units in Oxford, London and other parts of the country, is 31 or 32 years of age. I even know of one patient who is 41 years of age—admittedly on assisted respiration, but living a useful life. However, in certain parts of the country, and in one region in particular, a survey has shown that the average age of death of those patients is still 18 years of age. The standard of care is grossly uneven throughout the country.

The principles set out in the NHS Constitution are outstandingly good, but it is crucial that those responsible for commissioning specialist services should be in a position to take account of the crucial differences that already exist in services in different parts of the country. For that reason, this is a very important amendment that I warmly support.

Baroness Murphy (Crossbench)

My Lords, I cannot help but be sympathetic to the amendment of the noble Earl, Lord Howe, and recognise the points that have been made by my noble friend Lord Walton. However, this seems to me to come down to the matter raised by the noble Earl who is ultimately responsible for the commissioning of these services, which legally is the primary care trusts or another NHS authority. It seems that, while it is extremely important that the specialised commissioning groups should have delegated powers to make appropriate judgments on the commissioning of services, ultimately they take their powers from the legal responsibility of the bodies that purchase the services. This matter should really be dealt with by providing guidance to PCTs and other authorities responsible for purchasing. It is a matter of specifying which NHS body has legal responsibility, and adding to the list in this way is perhaps not very helpful.

Baroness Finlay of Llandaff (Crossbench)

My Lords, I would like to provide a contrast by strongly supporting the amendment. It neatly provides the device that I was looking for the last time I spoke. If we do not have specialised commissioning groups flagged up centrally, that would suggest that they are not absolutely core to the delivery of services for patients with rare and complex conditions, some of which may have arisen through mishaps. Different groups will need specialised services commissioned for them. It would seem extremely sensible to have them in the group, because the way that the provision is worded would leave it quite open for the different specialised commissioning groups as they evolve. We should also consider the collateral effect of not having this added to the list as advocated by the noble Earl, Lord Howe.

Baroness Tonge (Liberal Democrat)

My Lords, lists always worry me terribly, because when you have completed one you always think of something that should have been on it. I want to pose a question to the Minister before he replies: is there any group working directly or indirectly for the National Health Service that would not need to have regard to the constitution? Is there any need for a list, because it surely goes without saying that they should have regard to the constitution?

Lord Darzi of Denham (Labour)

My Lords, first, I declare an interest. I work in two NHS organisations that provide specialised services commissioned by specialist commissioners. I am sympathetic to the amendment and I understand why the noble Earl is seeking to ensure that we do not lose sight of specialised services. The NHS Constitution and the duty to have regard to it apply to specialised services as much as any other kind of NHS service, as adequately described by the noble Baroness, Lady Tonge. The Government remain committed more broadly to the collaborative commissioning functions of specialised commissioning groups, spending about £5 billion of the NHS budget every year on such services.

However, as pointed out by the noble Baroness, Lady Murphy, the amendment is not necessary, because it does not address the issue raised by noble Lords in this Chamber. Noble Lords passionately believe that we have a strong history of providing excellence when it comes to specialised services. I agree with them. The noble Lord, Lord Walton, gave one example and there are many examples of excellence across the country. We need to ensure that we have the adequate support and funding to continue to provide excellence in such services. But I do not believe that the amendment addresses that. It creates a regard by the specialist commissioners, who themselves are a consortium of primary care trusts. There is no such thing as specialist commissioners with their own separate governance structures: they are part of a consortium of primary care trusts. The duty would require primary care trusts to have regard to the NHS constitution when performing any NHS function, including the function of commissioning specialised services.

I hope that I have reassured the House that the amendment is not necessary. I support noble Lords who made a strong case for why the NHS needs to look at commissioning functions in greater detail. I hope that in High Quality Care For All we made a strong case for specialist providers—there are many in London and outside—and why such services should be supported and funded.

We also acknowledge that in these cases we also need specialist commissioners with the expertise in commissioning such services. I hope that I have reassured the noble Earl that specialist commissioners have not been overlooked and that he feels able to withdraw his amendment.

Earl Howe (Conservative)

My Lords, this has been a useful debate. Of course, I understand the point made by the noble Baroness, Lady Murphy, which in part I foreshadowed in my own remarks.

I would say to the noble Baroness, Lady Tonge, that it is as much the ability to be consulted on revisions to the constitution as the duty to have regard to it that prompted me to include specialised commissioning groups in this part of the Bill. As she will remember, Clause 3(5) refers to those bodies and groups of people who will be consulted when the constitution is revised. It was that ability to respond to this important constitution that I felt would have maintained the profile of specialised services.

The Minister's reply was slightly disappointing although not wholly unexpected as regards the appropriateness of this particular amendment. However, I took some comfort from the general tenor of what he said. He of all people will understand what is at stake here. We cannot afford a situation where the profile of specialised services and the priority that is attached to them are allowed to suffer. It would be particularly helpful to hear, either now or outside this Chamber, that there will at least be a separate assurance scheme for specialised commissioning groups within the world-class commissioning programme. If we had that comfort, my mind would be considerably eased on this issue. For now, I beg leave to withdraw the amendment.

Amendment 5 withdrawn.

Amendment 6

Moved by Lord Walton of Detchant

6: Clause 2, page 2, line 11, at end insert—

"(h) bodies concerned with the education of health professionals;

(i) bodies concerned with the support and delivery of medical and scientific research"

Lord Walton of Detchant (Crossbench)

My Lords, my noble friends and I have tabled this amendment for several important reasons. It is true that if one looks at the NHS Constitution, in Part 1 on the principles that guide the NHS, item 3 says that:

"The NHS aspires to the highest standards of excellence and professionalism—in the provision of high-quality care that is safe, effective and focused on patient experience; in the planning and delivery of the clinical and other services it provides; in the people it employs and the education, training and development they receive; in the leadership and management of its organisations; and through its commitment to innovation and to the promotion and conduct of research to improve the current and future health and care of the population".

Education and training are mentioned; so, too, is research. But people who work in the universities and medical schools who are involved in the education and training of all healthcare professionals—doctors, nurses and other members of the healthcare team—have expressed to me and others concern that not more is said about the crucial importance of the education and training of these individuals and of the necessity that the NHS should take full account of the needs of such education and training.

Equally, bodies concerned with research such as the Medical Research Council the Association of Medical Research Charities have felt that the NHS Constitution, which contains a number of very admirable principles, pays less than adequate tribute to the importance of research. As I have said often—and I know that the noble Lord, Lord Darzi, would agree with me—today's discovery in basic medical and scientific research brings tomorrow's practical development in patient care. There is no doubt that such research is one of the life-bloods of medicine in the UK and one of the great virtues of the National Health Service, which is something that does not exist in many other countries. Because of the nature of its organisation, it provides a wonderful situation for the conduct of clinical trials of new developments in medicine and in other branches of medical science.

It is very important that full account should be taken of the needs of education, training and research and more needs to be said. I accept the strictures that have been expressed by a number of noble Lords about lists and it is true that if one looks at this particular amendment one's first reaction on reading,

"bodies concerned with the education of health professionals",

and

"bodies concerned with the support and delivery of medical and scientific research",

should,

"have regard to the NHS Constitution",

is that yes, of course they must. But equally, it is important that the NHS as an organisation should take full account of the needs of the education of health professionals in all of their branches and the need to support the circumstances in which medical and scientific research can be carried out.

I will also speak briefly to Amendment 34, which is grouped with this amendment because it relates to the section in the Bill relating to prizes for innovation in the National Health Service. As the Bill currently stands, that clause refers to prizes for innovation. Innovation could be innovation in the design of new trolleys in the National Health Service or the design of items of equipment. It could mean a variety of different innovations which need not necessarily include components of research. For that reason, the Medical Research Council is particularly anxious, and deeply concerned, to see that particular clause, under which prizes can be awarded, includes the phrase "or research leading to innovation" as well as "innovation" itself. For that reason, I strongly wish to argue the case that these amendments are very important.

I am deeply grateful to the Minister for the letter he wrote to me expressing his feeling that perhaps there is already enough in the constitution to meet my concerns. He said that the NHS takes full account of the importance of the education of all healthcare professionals; of the way in which healthcare is nurtured by the results of research; and of the way in which the environment is provided in which research can be conducted. I find his letter extremely reassuring, but I am still not certain that that reassurance is, in itself, enough. For that reason, I beg to move this amendment.

Lord Patel (Crossbench)

My Lords, my name is attached to Amendments 6 and 34, and I support them both. My noble friend Lord Walton has articulated very clearly why these amendments are needed. I welcome the proposed innovation prizes, but recommend that the scope should be broadened to encourage the research that underpins innovation. I think these amendments are designed to do that. Innovation depends on research, and I know very well that the Minister is well aware of that in his own research and innovations.

It is important to recognise and reward the translation of basic and clinical research into innovative ideas and products that will improve healthcare. The NHS Constitution, in its principles, enshrines a commitment both to innovation and to the promotion of conducting research. During the previous debate, there was recognition of the need to develop a stronger culture in the NHS to support research and innovation. The Cooksey review, some years ago, examined the future of health research in the UK. It emphasised the importance of removing barriers to translational research and discussed the need for "pull" incentives to encourage demand for research leading to innovation. The review concluded that there should be proper rewards for translating research into innovation in health interventions.

The Cooksey review also highlighted concerns that the incentives for research to achieve an impact on health and health needs are not as strong as those to achieve academic excellence. Better incentives are needed to ensure that the best ideas are carried forward for patient benefit. Therefore, the criteria for the prizes should be developed to ensure they identify and reward early-stage research that has the potential to be transformative in an NHS setting.

During the Committee debate, my noble friend Lady Murphy raised concerns about the time frame in which the success of an innovation is demonstrated. This was shown in a recent report, entitled "Medical Research: what's it worth?", that was commissioned and independently produced by the Academy of Medical Sciences, the Medical Research Council and the Wellcome Trust. It estimated that the time lag between research expenditure and eventual health benefits is around 17 years. By including research as a criterion for prizes, it becomes easier to reward innovation in its early stage.

The noble Lord, Lord Darzi, during the Committee debate, stated that the awards could recognise,

"a scientific discovery that has had a huge impact on the NHS and patient care".—[Official Report, 5/3/09; col. GC 324.]

This amendment is intended to build upon that commitment by ensuring that the research and discovery process that underpins innovation is acknowledged in the Bill. I support this amendment.

Baroness Emerton (Crossbench)

My Lords, my name is also on the amendment; I support it, along with the eloquent speech made by my noble friend Lord Walton of Detchant. Coming from the nursing profession and professions not so steeped in history in the educational bodies, I would emphasise that we are, as a profession, "out of sight, out of mind". There is an unfortunate gap between service and education. That gap needs to be closed quickly to cover all the points that have been put in the NHS review by the Minister, concerning compassion and the values of the NHS. If this could be included in the Bill, it would help the universities to see—in undergraduate training, leading to post-graduate training—the importance of the values of the NHS, and to reinforce them. I strongly feel that "out of sight, out of mind" needs to be cleared, and hope the Minister will be prepared to take this on board.

Baroness Finlay of Llandaff (Crossbench)

My Lords, my name is also on these amendments, and I would like to speak in their support. I would also like very strongly to support the point made by my noble friend Lady Emerton. The NHS is dependent on the places where people are educated for the supply of its future staff. Therefore, it becomes absolutely crucial that, right from the day of entry into that educational process, students are viewed as part of the continuing spectrum of the workforce of the NHS. They are the potential workforce. The danger is that those who are organising educational courses can often view something such as the NHS Constitution as something extra that they have to include somewhere in their curriculum, rather than making sure that it is in embedded as a theme running through every aspect of the curriculum. I have seen this in some courses, where new pieces of legislation—and the Mental Capacity Act is one of those—have been added on as if they were bolt-ons, rather than underpinning the way every patient is approached at all times. Therefore, it is important to look at educational provision.

I turn to the second of these amendments. I fear that if we do not include original research, along with innovation, it risks being divisive. Original research may be the thing that triggers the subsequent innovation, and whoever undertook that deserves to be recognised for the work they did. It is also very evident that some of the more innovative and service-based research is coming from the healthcare professions beyond medicine, which are nursing and the allied healthcare professions. To encourage them to have a research approach, as well as to innovate in their practice, would foster the whole research agenda and drive forward the frontiers of knowledge. Therefore, I cannot see what there is to lose by including the words "or original research" in that amendment, but I can see that we stand to lose quite a lot by not including them.

Baroness Murphy (Crossbench)

My Lords, I hope noble Lords will forgive me if I seem to be turning into a legalistic nit-picker here today, because I am exceedingly sympathetic to what they are driving at. I am particularly sympathetic to Amendment 34 about the prize. Of course, it is an NHS prize, meant for the delivery of innovation in NHS care. Quite whether this is the right amendment to ensure that the right people get prizes for research, or whether it would need to be translational research done within the NHS, I am not sure. But I am very sympathetic to this amendment, even though it may be very difficult in practice to translate that into a part of the Bill.

The problem with Amendment 6 is that we have a definition of the discharge of NHS functions. Clause 2 relates to the duty to have regard to the NHS Constitution, and states that each of the bodies listed,

"must, in performing its NHS functions, have regard to the NHS Constitution".

Then an NHS function is described as,

"the provision, commissioning or regulation of NHS services".

In a way, those bodies are already articulated as to who does provide, commission or regulate services.

It all depends on whether or not universities and FE colleges discharge any NHS function by delivering educational services. Legally, they probably do not under the definition included in this part of the Bill. That of course is a pity, because I would particularly like to support the notion of my noble friend Lord Walton and the comments of my noble friend Lady Emerton about the crucial nature of getting the principles of the NHS Constitution into the training of nursing and other professions concerned with medicine, as well as medicine itself. To do that, those principles of care need to go right back to the beginning of training. This would be a marvellous place in the Bill to put that. It is also true that universities should deliver education and research with regard to healthcare.

I very much support the principles, but the way that the NHS Constitution is worded and who its functions should be discharged by mean that these amendments are not quite right. However, I am very sympathetic to what they are driving at.

Lord Turnberg (Labour)

My Lords, I apologise for not being here at the beginning, but I heard the vast majority of the debate on the amendments, which I support for all the reasons so eloquently put forward by a number of noble Lords. I know that the Minister needs no lessons from me about the importance of medical research. He is engaged in so much himself. I am sure that I do not need to remind him of the recent study that showed that it is possible to measure not only the value to people and patients, but the economic value, of medical research, whereby for every £1 that one puts in, one gets £1.39 out in economic terms every year thereafter, once the results of that research have been put into action. I know that the NHS Constitution refers to research. I am not sure that it refers to it at great length, but it does refer to it. Nevertheless, given that it is vital to future care, it should be included in the Bill, and I hope that my noble friend will agree.

Lord Sutherland of Houndwood (Crossbench)

My Lords, I support the eloquence of my various colleagues, my noble friends, who have put forward Amendment 6 in particular. I declare a disinterest; I am not and never have been a member of any healthcare profession, which may not be true of all the other noble Lords who have spoken, but I have some relevant experience as the head of universities which have incorporated medical and nursing schools, and I am an honorary fellow of one of the Royal Colleges. My experience is that healthcare and relevant education is always better provided the more closely integrated the two processes are. I have no doubt about that. This is perhaps less obviously true in times of plenty, but in times of shortage people disappear into their bunkers and silos, and the more that one can do in real and symbolic terms to integrate these two area, the better. Hence, I support Amendment 6.

Earl Howe (Conservative)

My Lords, with these amendments the noble Lord, Lord Walton of Detchant, has once again hit the nail on the head, and I very much support the case that he has put forward, especially in relation to education and training. There is a fundamental problem here to which the noble Lord alluded in tactful terms and the noble Baroness, Lady Finlay, drew attention to more explicitly. It is that many NHS organisations, if not the majority, do not regard education and training as part of their core business. They may pay lip service to them, they may be able to show that education and training are taking place, but for many organisations whose primary day-to-day preoccupation is to deliver services efficiently and effectively to patients, education and training are not in the forefront of their priorities.

Unfortunately, this is particularly true of foundation trusts. There are some notable exceptions to that generalisation which we could all name, but the letter of the law which states that foundation trusts must include education and training as part of their core mission does not tend to occupy centre stage in the deliberations of foundation trust boards. Nor is it something to which Monitor devotes a large amount of attention. I may be wrong in that perception, but there seems to be insufficient accountability for success or failure in this area.

We remember all too well what happened in 2006 when the NHS budget came under particularly heavy pressure. Trusts were told that they had to break even or do better, no matter what it took. Surprise, surprise, it was the education budget which was cut quite ruthlessly. I have a figure which came from the Nursing Times, which stated that strategic health authorities skimmed more than £70 million from education and training budgets during 2007-08.

The years ahead are likely to give rise to equal, if not worse, budgetary pressures. The education budget is an easy target, because the general public do not notice whether it is being spent or not, but the harm that cuts like that do over the long term is considerable. The training of staff is not something that you can abandon and return to from year to year; it is a long-term enterprise. The universities, whose core business is to deliver training, much of it in collaboration with the health service, are placed in an impossible position if the NHS decides to adopt any sort of stop/go policy.

I am told that the problem tends to be worse in trusts that are aspiring to become foundation trusts, because those organisations cut back on their costs to achieve the desired set of financial ratios, and the cutting of costs inevitably means cutting back on people, which in turn impacts directly on supervision ratios at ward level. That kind of economy has an immediate and obvious impact on the quality of training. Anecdotally at least, cuts are said to account for some of the high drop-out rates that there have been in nurse training, for example.

Equally, I am told that in primary care the quality of work placements is on the whole poor. Part of the problem is that doctors' surgeries have only a limited physical capacity, but the more fundamental issue is that for primary care practitioners, education is not a core part of their mission. There is no measure which impinges on a service provider for a failure to engage with the next generation of professionals. Yet, in a very real sense, NHS organisations owe it to themselves to be mentors and custodians of the next generation. They also owe it to us as patients, and we need to be very careful that this key function of the health service receives adequate recognition in the way that the NHS Constitution is applied. Those responsible for delivering education and training in healthcare must be held to account for their performance.

I hope that with his close knowledge of the NHS, the Minister will want to focus on the concerns which the noble Lord, Lord Walton, has raised, and that the Minister will also want to make sure that the opportunities presented by having an NHS Constitution with rights and duties within it are not missed.

Lord Mackay of Clashfern (Conservative)

My Lords, I strongly support Amendment 6 and the later amendment, not only in relation to the medical or surgical side of the profession but also in relation to nursing. In recent years, much more nursing training has been provided outside the NHS. In the olden days, the training was mainly in hospitals, but it is now in many cases quite substantially provided in universities. This leads to the difficulty that has been mentioned about the listed bodies. In Clause 2(2), we have the list of bodies, but what the bodies are to do is told to us in Clause 2(1), which says:

"Each of the bodies listed in subsection (2) must, in performing its NHS functions, have regard to the NHS Constitution".

Clause 2(3) defines what is meant by "NHS function". It means,

"any function under an enactment which is a function concerned with or connected to the provision, commissioning or regulation of NHS services".

I am inclined to think that most universities will be under an enactment of some kind. Under that enactment, they are providing education. That would be part of the provision of NHS services, because the education qualifying people to take part would fall into that category. The Bill does not say a health enactment; it just says "an enactment". I think that universities would qualify.

As an honorary fellow of some of the medical royal societies, I feel that these societies are in more of a difficulty, because most of them are not governed by an enactment; they are usually set up and governed by royal charter. Certainly, that is my understanding. Therefore, there is some slight technical difficulty about fitting them into the list. I have no doubt that, if the Minister was prepared to agree to accept this in principle, his advisers would quickly put in place the necessary adjustment to take account of it. I just mention it in case it might be overlooked—although I do not think that the Minister would overlook it—or looked on as a fundamental difficulty, because I think that it is a difficulty that can be overcome.

If the training of staff who are going to be members of the health service is undertaken by institutions other than NHS institutions, it is important that the spirit and ethos of the NHS and its constitution should be ingrained in them as part of the initial training. Therefore, I am strongly in support of Amendment 6. I also support the amendment on innovation, with which I have not noticed any technical difficulty.

Lord Darzi of Denham (Labour)

My Lords, we have heard from many Lords. Again, let me declare an interest. I am a university employee and still remain one. I can sympathise with the noble Lords, Lord Walton and Lord Patel, and the noble Baronesses, Lady Emerton and Lady Finlay, who propose that the list of bodies that are under a duty to have regard to the NHS Constitution be extended to include bodies concerned with the education of health professionals and with the support and delivery of medical and scientific research. In addition to this amendment, I understand that the noble Lord believes that it would be appropriate to require the same bodies to be consulted on the 10-yearly review of the constitution.

Amendment 34, which was tabled by the noble Lords, Lord Walton and Lord Patel, and the noble Baroness, Lady Finlay, would enable the Secretary of State to make payments to promote innovation or original research.

Both research and education are the bedrocks of high-quality patient care. I hope that I can provide noble Lords with reassurances in relation to some of the concerns that have been raised today. First, by way of context, I reassure the noble Lord that education and research are of vital importance to the NHS. In 2009-10, £4.6 billion was allocated to strategic health authorities for education and training, and health research commissioned by the NHS has reached £1 billion for 2010-11. High Quality Care for All, on which I reported in July last year, set out our commitments to the establishment of, for example, academic health science centres, which will bring together a small number of health and academic partners to focus on world-class research, teaching and patient care, bringing the NHS and research ever closer in the history of the NHS.

My report also sought closer working between the NHS and education institutions by proposing the creation of new health innovation and education clusters. These announcements will be made soon. These clusters will bring together many partners, across primary, community and secondary care, universities, colleges and industry. Bringing NHS organisations and higher education institutions together will promote learning and education between their members and will enable research findings to be applied more readily in improving patient care.

The noble Earl, Lord Howe, raised the issue of NHS budgets. We have on many occasions debated how we protect these budgets and, within the contexts of the health innovation and education clusters, some of the policy reforms that we are introducing will create more transparency. I remember on numerous occasions the noble Baroness, Lady Tonge, asking how we protect these budgets. The best way to protect them is to introduce transparency and a tariff system, where a budget will follow a trainee. That is the way in which we hope we will reform our education system, under the guidance and the support of Medical Education England from the medical perspective, and working with nursing colleagues to find a more transparent way in which we can allocate our education and training budgets.

On Amendment 6, I would like first to consider the NHS Constitution. The importance that we attach to both education and research is reflected in the third principle in the constitution, which states:

"The NHS aspires to the highest standards of excellence and professionalism ... in the people it employs and the education, training and development they receive ... and through its commitment to innovation and to the promotion and conduct of research".

In addition, although we have debated whether this amendment is necessary, I have to make the point that all education and training commissioned directly by the NHS is already covered by the legislation as drafted, as the noble Baroness, Lady Murphy, pointed out. Strategic health authorities and other NHS organisations will have to have regard to the constitution in everything that they do, including education and training. That should be included in commissioning education and training. However, the noble and learned Lord, Lord Mackay, always challenges me when it comes to issues of the law and I take the point that certain colleges, as far as royal charters are concerned, may not be able to do this. I will be more than happy to seek further legal advice and to bring this back when we come to the next phase of the Bill.

I turn now to the new bodies concerned with the support and delivery of medical and scientific research. Primary care trusts and other trusts can undertake, commission and assist in research. Any of this research would be captured, I believe, by the duty to have regard to the constitution in Clause 2. The current definition of "NHS function" in Clause 2(3) refers to,

"any function ... concerned with, or connected to, the provision, commissioning or regulation of NHS services".

I believe that this covers patient-facing research, where patients receiving NHS services are involved.

On consultation on the constitution on a 10-yearly basis, I again reassure noble Lords that many groups involved with research, training and education of health professionals contributed to the production of the final NHS Constitution, such as the General Medical Council, the Medical Research Council and the Academy of Medical Sciences. Their contributions were valuable and we shall of course wish to involve them in any further changes to the constitution, including the 10-yearly review of the constitution and any more minor revisions, where they are affected.

I now turn to the innovation prizes and the spirit in which they have been introduced. As I have said in the House before, I strongly believe that these prizes are intended to get the best minds in this country to focus on some of the challenges that will face us in the future, and those challenges will require major breakthrough discoveries. That is what I am referring to in relation to the prizes. I think that the noble Baroness, Lady Murphy, mentioned Peter Mansfield, who discovered MRI in 1967 in Nottingham. He was not recognised for his research until 2005, when he won the Nobel Prize. Many such discoveries occurred in this country, and their benefits were translated elsewhere around the globe before they had an impact on our NHS patients. Therefore, the drivers behind the NHS innovation prizes are major breakthroughs and major discoveries.

My noble friend referred to innovation prizes and the use of the word "research". This is a question of semantics. The definition of "innovation" is the successful development and implementation of new ideas, commonly divided into three stages: identification or invention, which is one area that we discussed in relation to research; growth, including adoption, testing and evaluation; and diffusion. However, if noble Lords still believe that we can strengthen the definition, I shall be more than happy to do so. In that respect, I am delighted to report that tomorrow we will be announcing the appointment of Professor Sir John Bell, the president of the Academy of Medical Sciences, as interim chair of the expert panel. I shall be more than happy to discuss the words "research" and "innovation" and to come back to the matter at Third Reading. I think that we all agree about the purpose of these prizes and about the very major role that universities and other higher education providers can play in relation to research.

I hope that I have reassured noble Lords that some of their amendments may not be necessary, but I am happy to seek further legal advice in relation to them and to come back at Third Reading.

Lord Walton of Detchant (Crossbench)

My Lords, as always, I am deeply grateful to the Minister for his comprehensive, thoughtful and helpful comments on these amendments. As he said, it is crucial that the interrelationship between NHS bodies and universities is close, as is made evident by the fact that 30 per cent of clinical academic posts in the UK are funded by the National Health Service.

However, there are still considerable anxieties, some of which were pointed out by the noble and learned Lord, Lord Mackay of Clashfern, my noble friends on these Benches and the noble Earl, Lord Howe. Despite everything that the noble Lord has said, certain NHS bodies seem reluctant to accept their responsibility in relation to education and research. For example, it has just been pointed out to me that, with regard to training around 95,000 students from this September in nursing, midwifery and the allied healthcare professions, universities have no information about the level of benchmark prizes to be paid by the strategic health authorities, and this is at a time when they are trying to finalise their budgets for the 2009-10 academic and university financial year. Therefore, there are continuing anxieties, although it was extremely helpful of the noble Lord to say that he would look again at the amendment on innovation prizes.

In the light of the Minister's letter and comments, when I first came to the House today, my feeling was that I should withdraw the amendment. Then, when I heard the speeches of many noble Lords around the Chamber, I thought that in many respects it would be much more sensible to test the opinion of the House. However, with reluctance, but nevertheless with gratitude for the way in which the noble Lord has presented the Government's case and for his willingness to reconsider the matter at Third Reading, I beg leave to withdraw the amendment.

Amendment 6 withdrawn.

Amendments 7 and 8 not moved.

Amendment 9

Moved by Earl Howe

9: Clause 2, page 2, line 28, at end insert—

"( ) The Secretary of State shall publish guidance providing for the meaning of "have regard to" in this section."

Earl Howe (Conservative)

My Lords, Amendment 9 is designed to take us back to one of the most perplexing aspects of this whole chapter of the Bill: what exactly it means to require bodies and persons to have regard to the NHS Constitution.

In Grand Committee, the Minister indicated in, I thought, a somewhat nonchalant way that there was a well established legal meaning to the phrase "have regard to". The trouble is that he singularly failed to tell us what that meaning is. Of course, we have all dealt with the phrase in other Bills and usually one can understand perfectly well what it entails. For example, the Local Government and Public Involvement in Health Act 2007 obliges a local authority to have regard to every local improvement target specified in a local area agreement. It is fairly obvious what a local authority should and should not do in compliance with that duty, as it is very specific. The Healthcare Commission had a legal duty to have regard to government policy in exercising its functions. What this meant was very clear: in everything it did, the Healthcare Commission had to bear in mind the Government's priorities in the delivery of healthcare and, as far as possible, to build those priorities into the ordering of its work.

With the NHS Constitution, we have something rather different. The constitution is made up of principles, values, rights, pledges and responsibilities. What does it mean to "have regard to" a set of values or principles? Who can say whether you have succeeded or failed in doing so? How indeed is a patient supposed to know whether a nurse or doctor, or the hospital as a whole, has had regard to them? The answers to these questions are not straightforward. I, for one, do not pretend to know what they are. The plot thickens when we come to consider the rights contained in the constitution. What does it mean to say that an NHS body must merely have regard to a right? The average patient who reads the constitution may well believe that a right is something that is guaranteed.

In Grand Committee, I proposed in an amendment that the Government should issue guidance to dispel potential confusion and to ensure that everyone in the NHS, and everyone working on behalf of the NHS, understood what was expected of them. The Minister did not like that idea, and other noble Lords thought that it was unduly bureaucratic. However, if the meaning of the phrase is not explained, there will be only one result, which is a free-for-all across the country in the interpretation that people place on it. If we land up in a situation in which "regard" for a principle or value is interpreted differently in different parts of the health service, that will instantly undermine the credibility of the constitution. It is almost an invitation for someone to issue a challenge via the courts. Who wants that?

The Minister needs to realise, as I am sure he does, that the consultation that took place last year on the NHS Constitution raised enormous expectations among NHS staff. Many people genuinely believed that the constitution was to be part of a new way of working in the NHS under which everyone—patients, the public and staff—would know what was expected of them and what they in turn could expect to happen. In the event, the very opposite appears to have occurred. People are confused. It is true, and of course very welcome, that David Nicholson has written to chairs and chief executives with some examples of what they should be doing to fulfil the new duty. However, examples are simply that; there is apparently to be no guidance on how, as a matter of law, the duty to have regard to values, principles and rights should be translated into the day-to-day behaviour of NHS staff.

Indeed, we need to ask who is bound by this duty. The Bill says that NHS bodies and organisations are bound by it. Presumably that means that the duty rests on members of the board—the people in ultimate control of the organisation—rather than on each individual member of staff. However, if that interpretation is right, as I believe it is, it will lead to some odd results. The board will be held to account for the way in which it fulfils the legal duty, but the people who actually deliver NHS services will not be bound by it at all. I cannot see the sense of that, nor can I see how it will be workable. How will the average patient understand that distinction?

We heard from the Minister that NHS bodies could fulfil the duty to have regard to the constitution by giving it "proper consideration". That sounds to me very woolly and feeble. It appears to bind an NHS body to do no more than consider what the constitution says before taking a given course of action. That is not much. Equally, I do not think that that is what people either wanted or expected. Most of us would surely wish that, at the very least, the values and principles of the health service could be relied on by patients and staff in virtually all circumstances, that patients' rights could be similarly relied on and that, when someone in the NHS is given a responsibility or a duty, you could take it as read that that person had that responsibility or duty. However, that understanding is, apparently, not correct.

Nothing can be taken for granted, because, quite deliberately, the constitution has been given no legal force of its own. In an extreme case, as an aggrieved patient taking an NHS body to court, you could use the constitution only as supporting evidence; you could not cite a breach of it as in itself an infringement of your rights. It is true that some rights within the constitution have a legal basis of their own, but some do not, as the Minister knows, and the task of proving that the NHS had failed to give a value or a principle proper consideration strikes me as being particularly difficult. Again, we need to bear in mind that this could be attempted only by means of judicial review, which is neither easy nor affordable for most people.

I am conscious that I have rather laboured this issue and I will now stop, because I should like to hear from other Members of the House and from the Minister, who I hope can throw some brighter shafts of light on to this question than we have had hitherto. I therefore beg to move.

Lord Mackay of Clashfern (Conservative)

My Lords, with great respect to my noble friend, this amendment does put a pretty heavy responsibility on the Secretary of State. Guidance as to what is meant by "have regard to" would either be extremely brief, or possibly, if it were extensive, a bit confusing, to say the least of it. I do not underestimate the skill in drafting available to the Minister, but I have seen some attempts at this kind of work and they are not always crowned with success.

The phrase "have regard to" is, as the Minister said in Grand Committee, a very common phrase. Indeed, my noble friend referred to it being in other statutes. It is a very common phrase in the law and I have been involved in arguing cases and sometimes deciding cases in which it was a crucial phrase. I will not be giving a definitive meaning for it, but I think what, in principle, it means, is that, in making a decision, you take account fully of all the provisions of the document so far as relevant to the issue in hand and you take account of them properly and seriously, not in a dismissive way.

On the example about duties, if a document confers a duty or a right—perhaps I should take a right, to simplify matters—if a document confers a right, I would suggest that, if you have proper regard to that document, you give effect to the right, unless there are some over-riding other considerations from other parts of the document which, in effect, reduce or modify the first expression of the right. On the other hand, if it is a value, you conduct yourself in accordance with that value and that is what "have regard to" means. It is a compendious phrase with very considerable legal lineage in which it is applied. I do not think there are many cases in which the judges have attempted to say what it means; they know how to apply it. I have tried to summarise what I believe is the way it would apply in this sort of situation. If the Minister is prepared to accept that the Secretary of State will give guidance, I wish him joy in that task.

Baroness Barker (Liberal Democrat)

My Lords, I take the opportunity to support the noble Earl, Lord Howe, and to note, as one always should, the words of the noble and learned Lord, Lord Mackay of Clashfern. Far be it from Members of this House to deprive members of the legal profession of a source of income which has been extant for a very, very long time, arguments over the phrase "have regard to" have made many a legal career. I take the point of the noble and learned Lord, Lord Mackay of Clashfern, in full part; because I think it would be difficult for a Secretary of State to give a full meaning to that. None the less, this document, this constitution, is going to sit alongside a whole range of other documents of varying degrees of legal importance which medical staff have to bear in mind every day in the course of their duties. I think the noble Earl, Lord Howe, is right to try to establish exactly where it stands in rank of importance, as against other laws and as against statutory guidance as well.

It is for the Department of Health to provide assistance to members of staff about how this document will work in practice and what practical difference it will make to their work. The Department of Health has been in this situation before. When the Mental Capacity Act was being argued in Parliament, a great deal of work went on, during the passage of the Bill and subsequently, to try to give examples to practitioners as to what the phrase "best interests" would mean. "Best interests" is, similarly, a legal phrase of some standing and contention, but nevertheless, in order to make what Parliament had passed become a reality for patients, the department did considerable work on that. We can argue about whether this constitution is going to be of the same import as the Mental Capacity Act and the guidance that went with it, but I think the noble Earl, Lord Howe, is to be commended for trying to find an answer to that question, because if he does not, we risk confusing staff when they come to make decisions in practice. The department has a duty to make sure that that does not happen.

Lord Darzi of Denham (Labour)

My Lords, Amendment 9 would commit the Secretary of State to publishing guidance on the meaning of the term "to have regard". I understand that the noble Earl is concerned that the NHS will be insufficiently supported in the interpreting of the duty to have regard to the constitution. I should therefore like to reassure noble Lords on this point. The department has already embarked on a programme of work to ensure that the NHS knows what will be expected of it when this duty comes into effect. The noble Baroness, Lady Barker, raised this issue and I hope I can reassure her over some of the activities within the department. First, the department has set up a state of readiness group, involving many important representatives, both from within the NHS—for example, SHA chief executives—and from outside—for example, UNISON. The purpose of the group is to understand how to help the NHS to be ready to embed the NHS Constitution and to establish ways of providing assurance that the constitution is taking effect. The group has had its first meeting and will continue to meet until the summer.

Another example of the support which the department is providing is a toolkit which will be made available to the NHS imminently. Among other things, the toolkit contains a guide for staff: suggestions about how to incorporate the constitution into organisations' annual reports, information for line managers and induction messages for new staff. These resources will enable the NHS to communicate the importance of the constitution to all staff and to explain what it means for them both as employees and for the way in which they provide care.

I am also aware that the noble Earl is concerned that the duty to have regard will mean that the constitution will not have any bite. I therefore remind him that much of the constitution is not new to the NHS. It contains many existing legal rights and where there are new ones, guidance will be published specific to those new rights.

I should like to clarify an issue about having regard to a right. A right in the constitution is a legal right; there is no such thing as a right in the constitution which is not underpinned by legislation. Similarly, the pledges reflect good practice and current departmental policy. Many are underpinned by existing performance mechanisms—in other words how we guarantee that these pledges are delivered. They are underpinned by existing performance mechanisms such as the operating framework. There is no possibility of them being ignored.

That leaves us with the principles, the values and the responsibilities. As I said, many of the principles are derived from existing legislation and do not represent a new way of working for the NHS. I do not think it would be appropriate to give guidance on how to have regard to the NHS's values or to patients' responsibilities, for example. In my view, the best guide that the department can give the NHS on what is meant by "having regard to the constitution" is the advice that the chief executive of the NHS has already given in his letter to the chairs and chief executives.

I sympathise with the noble Earl in relation to how we make this stronger. To produce formal guidance, as eloquently advised by the noble and learned Lord, Lord Mackay, on the meaning of "having regard to the constitution", the department would have to list every kind of action that an organisation would have to take to demonstrate that it has had regard. Even if I am surrounded by the best brains, I promise noble Lords that we will get this wrong. As I said in Committee, I do not believe that this is possible or appropriate and I will not repeat my comments here. I believe that the guidance is unnecessary from a legal point of view. As we have heard today, "to have regard" is established legal terminology. It has been used, as the noble Earl suggested, in previous health Acts—the Health and Social Care Act 2008, and the Health Act 2006.

I sympathise with what the noble Earl is trying to achieve. The challenge in the NHS is how to get the constitution embedded in the mindset of all of us who work in the NHS and how to disseminate that information to those who use the NHS. That challenge will be met only with dialogue across the system. I hope that I have reassured the noble Earl enough for him to withdraw the amendment.

Earl Howe (Conservative)

My Lords, I am very grateful to the Minister, the noble Baroness, Lady Barker, and my noble and learned friend Lord Mackay for taking part in this debate. My noble and learned friend indicated that it would be very difficult to formulate guidance. I do not doubt that he is right. However, at one and the same time, he had a pretty good shot at framing some of the main points which such guidance might contain. I do not think that it is a totally impossible business. Nevertheless, I recognise its complexity. My noble and learned friend drew out the point that the degree of regard which should be taken of different elements within the constitution changes in accordance with the matter in question. For example, a right is a right, as the Minister pointed out, and it is not enough simply to have regard to it; you have to implement it and honour it. Part of what would be teased out by guidance in the broadest sense is the scope for confusion and settling that.

The same applies to values. If one takes two of the values contained in the constitution, respect and dignity, one sees that they are meant to guide the NHS in all that it does. That is what we are told and what we would expect but what does it mean to say that the NHS merely has to have regard to them? Either it has those values or it does not. Equally, if we take the principle that the NHS aspires to the highest standards of excellence and professionalism, what does it mean to say that an NHS body merely has to have regard to that aspiration? Either it aspires to the highest standards of professionalism or it does not. If it does not, in what kinds of circumstances may it not do so? But for my noble and learned friend, those questions would have been left somewhat open by this debate; I think they are less open now than they were. For that, I thank him.

The Minister did not cover the issue of staff. Will individual members of staff within NHS bodies be bound by the duty to have regard to the constitution? I am not sure I understood whether I had got it right or not. As the Minister will remember from my opening remarks, I suggested that the Bill should be interpreted as imposing a duty on NHS bodies and organisations; in other words, the boards of those bodies, rather than each and every member of staff. If I am wrong in that I should be very grateful if the Minister would write to me. For now, with thanks to all noble Lords who have taken part in the debate, I beg leave to withdraw the amendment.

Amendment 9 withdrawn.

Clause 3 : Availability, review and revision of NHS Constitution

Amendment 10

Moved by Lord Darzi of Denham

10: Clause 3, page 3, line 15, at end insert "and bodies or other persons representing patients"

Lord Darzi of Denham (Labour)

My Lords, I shall speak also to Amendments 11 to 14 and 17. Amendments 10 to 14 propose that the Secretary of State is specifically required to consult bodies or persons representing patients, bodies or persons representing staff, carers and local authorities in any 10-yearly review of the constitution. The definition of carers and local authorities is set out. Amendment 17 requires that the Secretary of State explicitly considers the effect of the constitution on carers, in addition to patients, public and staff, during the three-yearly report.

In Grand Committee, we had an important debate about the role of carers, local authorities and other bodies in the functioning of the NHS. Many noble Lords spoke to amendments proposing that certain bodies be explicitly consulted during the 10-yearly review of the constitution, and that carers be included in the report on the impact of the constitution. I am grateful to them for their suggestions.

As I explained at the time, the Government believe that, as originally drafted, the legislation regarding the 10-yearly review of the constitution captured the bodies mentioned during debate. For example, the duty in Clause 3(5) to consult,

"such other persons as the Secretary of State considers appropriate",

during the 10-yearly review of the constitution would capture local authorities, and the duties in subsections (3) and (5) to consult "members of the public" would, of course, include carers. I also attempted to reassure noble Lords that, where any revision of the constitution affects certain bodies, it is fully our intent to consult them. Bodies representing patients and staff, carers and local authorities have been, and will remain, vital groups in shaping the constitution and any future changes to it.

However, I was struck by the force of argument in Committee and I promised to look again at the drafting of the clauses. I have considered further and am persuaded that there is a strong case for explicit mention of certain bodies in the Bill. It is for those reasons that I have tabled these amendments, proposing that the Secretary of State be explicitly required to consult carers, local authorities and bodies representing patients and staff, and to report on the impact of the constitution on carers.

Noble Lords will understand that legislation does not need to list every person and body to be consulted or reported on in detail. Referring to bodies representing staff and bodies representing patients allows us to capture bodies which were also mentioned in Committee, such as Local Involvement Networks, as mentioned by the noble Earl, Lord Howe, and trade unions and professional organisations, as mentioned by the noble Lord, Lord Campbell-Savours. We believe that these amendments strike the right balance. They ensure that carers and other bodies are represented and must be specifically consulted, while also respecting the concern raised in Committee about listing a large number of organisations in the Bill. I hope noble Lords are content with these amendments. I beg to move.

Earl Howe (Conservative)

My Lords, I thank the Minister for considering the points made in Grand Committee by noble Lords on all sides, and for having brought forward these amendments in response to those debates. They are extremely welcome.

Baroness Masham of Ilton (Crossbench)

My Lords, can the Minister give examples of bodies that might be representing patients? As the community councils are no more, there is a lack of bodies representing patients, and some patient organisations are very small and may not be able to do this without financial help.

Baroness Pitkeathley (Labour)

My Lords, I, too, thank the Minister for these amendments. They are entirely appropriate and I am glad that he has taken account of the strength of feeling all around the House. It is entirely right that carers, who are such major providers of healthcare but who also have special health needs themselves because of their caring duties, should be recognised as they are in Amendments 12 and 13. Carers everywhere will be extremely grateful for this recognition of their contribution and status. Amendments 10 and 11 are proof of the Government's proud record of support for patient-centred organisations; National Voices is only one of them. The NHS is infinitely more patient-focused now than it was 10 years ago, and for that the Government deserve praise.

Baroness Barker (Liberal Democrat)

My Lords, I, too, thank the Minister for the consideration that he has given to the points made so strongly and sincerely in Committee. I know that many of the groups that were active in putting forward amendments would wish us to put their thanks on record, too. Politically, this might be one of the most important parts of the Bill. I suspect that during the next five to 10 years the NHS will go through some major transitions, perhaps the most major in its existence, and that its purpose, scope and nature might become even more hotly contested and debated matters than they are now. It is therefore extremely important that we put in this legislation the right of these people to be involved at the heart of those discussions.

I do not wish to be churlish, but can the Minister explicitly assure me that the organisations representing patients in his amendments include former patients and carers of former patients? There persists in the NHS a feeling that all former patients want to complain. I do not think that that is true. Former patients and carers often have valid experiences and they are quite passionate about wanting the NHS to improve. I made the point in Committee and I wonder if it could be included in the reply.

Lord Darzi of Denham (Labour)

My Lords, I want to reassure the noble Baroness. The best learning we can get in the NHS is achieved by consulting former patients. LINks is one of many groups representing patients that might be consulted.

Amendment 10 agreed.

Amendments 11 to 14

Moved by Lord Darzi of Denham

11: Clause 3, page 3, line 16, at end insert "and bodies or other persons representing staff"

12: Clause 3, page 3, line 16, at end insert—

"( ) carers,

( ) local authorities,"

13: Clause 3, page 3, line 22, at end insert—

""carers" means persons who, as relatives or friends, care for other persons to whom NHS services are being provided;"

14: Clause 3, page 3, line 35, at end insert—

"(9) For the purposes of subsection (5), each of the following is a local authority—

(a) a county council in England;

(b) a district council in England, other than a council for a district in a county for which there is a county council;

(c) a London borough council;

(d) the Common Council of the City of London;

(e) the Council of the Isles of Scilly."

Amendments 11 to 14 agreed.

Clause 4 : Availability, review and revision of Handbook

Amendment 15

Moved by Earl Howe

15: Clause 4, page 3, line 41, at end insert—

"( ) Before any revision of the Handbook, the Secretary of State shall consult such persons (if any) as in all circumstances he may consider appropriate."

Earl Howe (Conservative)

My Lords, I want to point out a small error in the printing. The amendment should read:

"Before any revision of the Handbook, the Secretary of State shall consult such persons (if any) as in all the circumstances he may consider appropriate".

With this amendment I bring us back to the issue of who, if anyone, should be consulted when the handbook is revised. As the Bill stands, the Secretary of State may go ahead and revise the handbook without being under a duty to consult anyone at all. In Grand Committee a number of us questioned that. What it means, effectively, is that the Secretary of State has sole power to interpret the constitution as he sees fit. I realise that he would not do that in any way irresponsibly, but it was something that left some of us uncomfortable in the sense that it should be a collaborative process. It also means that those with the closest knowledge of how the constitution works, or should work, in practice have no say at all in the way that the manual to the constitution is drafted. They have no right to make a contribution to that process.

That seems, at the very least, short-sighted, but it is also wrong in principle. In reply in Grand Committee, the Minister made two associated points. The first one was that it would not be proportionate for the Secretary of State to have to consult on every minor change which might only be technical. The second one was that if the change was a more significant one relating to a policy issue, the Government would already have consulted on it, so there would be a lot of unnecessary extra bureaucracy if the Secretary of State also had to consult on the change to the handbook which brought the change of policy into play.

I understand both those arguments, but I accept the second one only up to a certain point. The purpose of consulting on changes to the handbook is not just to obtain people's views on changes in government policy. It is just as much to ensure that the information in the handbook is accessible, intelligible and workable. The Minister said in our earlier debate:

"The intention behind the regular reviews of the handbook is to assess whether the handbook continues to be fit for purpose for patients, public and staff".—[Official Report, 26/2/09; col. GC 155.]

If that is so, there is, at the very least, a prima facie case for involving staff, as well as patients and the public, in the review process. After all, there was consultation when the handbook was initially drawn up.

I am the first to want to avoid burdening everybody with unnecessary and pointless consultation. No one wants that. But I do suggest to the Minister that, from time to time, there could be a good case for consulting key stakeholders about changes being made to the wording of the handbook. This would not necessarily be when major changes of policy were in prospect, but rather when the practical implications of new or existing policy required explaining in clear and appropriate terms. This is one area of life where I do not believe that the Secretary of State or the Department of Health has a monopoly of wisdom. As it stands, the Bill gives the Secretary of State that monopoly. I, for one, am not comfortable about that, which is why I beg to move.

Lord Darzi of Denham (Labour)

My Lords, Amendment 15 proposes that,

"the Secretary of State shall consult persons ... as in all the circumstances he may consider appropriate",

on any revisions of the handbook. In our previous debate on Amendments 3, 7 and 8, which proposed that bodies be under a duty to have regard to the handbook as well as the constitution, I clarified our intentions behind the purpose and status of the handbook, although I promised that I would look at it again. Just as it would be incongruous to impose a duty on bodies that must have regard to the constitution also to have regard to the handbook, it would be disproportionate to impose a formal duty to consult on any revisions to the handbook. I agree with the noble Earl that any significant changes to policy or law that affect the handbook are likely to trigger consultation requirements in themselves, either by virtue of statute or because there will be an expectation that we should consult or comply with the Government's code of practice on consultation.

For this reason, we have chosen not to oblige the Secretary of State to consult again before amending the handbook, even for significant changes. The Secretary of State may need to make minor technical or legal changes to the handbook at any time to reflect current departmental policy or changes in the law. It certainly would not be proportionate to have to consult on a change of this kind. For the handbook to be useful as an explanatory guide for patients, public and staff, it is important that it should remain a live document that is constantly kept up to date. We want it to be as helpful as possible. A duty to consult on all changes, however minor, would impede this.

The intention behind the three-yearly reviews of the handbook is to assess whether it continues to be fit for purpose for patients, public and staff, as we debated in Grand Committee. For these reviews we will, of course, continue to involve on an informal basis those patients, public, staff and other stakeholders—as the noble Earl suggested—who were involved during the development of the handbook. We will do this to ensure that the handbook continues to be a relevant and useful document. This approach has been supported by stakeholders; one example is UNISON.

Again, I reassure noble Lords that the constitution cannot be amended via revisions to the handbook. Noble Lords will be aware of our previous debates. We have to ensure that the process for consulting on the constitution is robust. I hope I have reassured noble Lords that while we fully intend to involve patients, public and staff as necessary in each review of the handbook, we do not feel that it is necessary to impose a formal duty on the Secretary of State to do so. Once again, I hope I have reassured the noble Earl and that he will withdraw his amendment.

Earl Howe (Conservative)

My Lords, I am grateful to the Minister for his reply and I respect his position. I reworded the amendment that I tabled in Grand Committee to allow discretion for the Secretary of State not to consult on a particular change to the handbook if, in the circumstances, he felt that it was appropriate. This is not as sweeping an amendment as the one that we debated previously. I come back to the point that we need to bear in mind that the drawing up of the handbook that we have now was the subject of extensive consultation, so it is not altogether anomalous to suggest that revisions should be similarly consulted upon. Nevertheless, this is not a matter that it would be appropriate for me to press. I take note of what the Minister said and beg leave to withdraw the amendment.

Amendment 15 withdrawn.

Amendment 16 not moved.

Clause 5: Report on effect of NHS Constitution

Amendment 17

Moved by Lord Darzi of Denham

17: Clause 5, page 4, line 3, after "staff" insert ", carers"

Amendment 17 agreed.

Clause 7: Supplementary provision about the duty

Amendment 18

Moved by Lord Darzi of Denham

18: Clause 7, page 5, line 33, at end insert—

"(7A) Subsection (7) does not apply if—

(a) the provider does not have control of the premises, or

(b) the services are provided by means such that the persons receiving them do not do so at the premises."

Lord Darzi of Denham (Labour)

My Lords, the noble Earl, Lord Howe, tabled an amendment which we discussed in Grand Committee that sought to exempt two classes of premises from the requirement to display a notice about quality accounts. They were private dwellings and premises to which the public do not normally have access. I undertook to think further about this issue and come back on Report. Following further legal advice I agreed that we need to make the clause more explicit. The new provision would exclude certain premises from the requirement to display a notice. They are premises that the provider does not own or run, such as the patient's own home; or premises that the provider owns or runs but that patients do not directly access, such as a pathology lab. Our guidance will encourage providers to think about how they will publicise their quality accounts with patients whom they see off-site. I am very grateful to the noble Earl for his scrutiny, and for that of the Committee, in bringing about improvements in the drafting. I beg to move.

Earl Howe (Conservative)

My Lords, I thank the Minister again for his consideration of the points that I made in Grand Committee and for moving this excellent amendment. I really am very grateful to him.

Amendment 18 agreed.

Amendment 19

Moved by Earl Howe

19: After Clause 7, insert the following new Clause—

"Quality of data

(1) The Health and Social Care 2008 (c. 14) is amended as follows.

(2) In section 20 (regulations of regulated activities), after subsection (3)(j) insert—

"(ja) make provision as to the collection and analysis of data used in the preparation of quality accounts;"."

Earl Howe (Conservative)

My Lords, we had a useful and wide-ranging debate in Grand Committee about possible ways in which quality accounts might be quality assured, in the sense of their being subject to external audit or being otherwise validated for accuracy and reliability. The Minister, if I do not misrepresent him, expressed a good deal of sympathy with the concept of validation, but saw no need to insist on a formal audit as such.

I respect the Minister's point of view, and I do not propose that NHS bodies should be burdened with any additional regulatory requirements. However, I still see accuracy as one of the cornerstones for the success and credibility of quality accounts. My concern has been brought into sharp focus by the recent publication of the Audit Commission's report on data quality in the NHS, Figures You Can Trust. If noble Lords have not read this report, I respectfully recommend that they do. The Audit Commission's research—which was partly desk-based and partly involved inspections of several trusts—found that there is, to put it mildly, a great deal of room for improvement in the reliability of NHS data.

The error rate in clinical coding, for example, ranged from 0.3 per cent to 52 per cent, a range described by the commission as varying from excellent to wholly unacceptable. The average error rate was 9.4 per cent. The commission identified four main factors that it believes lie behind this. One is the training of staff; another is lack of involvement by clinicians; another is a lack of clarity in specific areas of the coding system; and the fourth is the quality of the source documentation and records. The reviews found that although trust boards devoted a significant amount of scrutiny to financial information, there was little evidence that they discussed or challenged the quality of other data. Indeed, the responsibility for quality assurance of data is typically delegated to information managers. The result of that is that many trusts do not have the knowledge or expertise at senior level to challenge the reliability of the data that are submitted to them. Not enough importance is attached to data quality at board level and there are no systematic programmes to enable trust boards to review the accuracy of such data. In general, the need to make sure that information is accurate is not seen as being an organisational responsibility of which everyone in the trust has a duty to take ownership.

Against that backdrop, it is not surprising that the commission sounded a warning about quality accounts. It said:

"If quality accounts are to have the same status as financial accounts and if patients and the public are to have confidence in the data that they contain, the quality of the data should be subject to internal and external review".

That is paragraph 56. It goes on to say that it does not think that this needs to be on the same scale as for financial accounts, which are subject to detailed internal and external audit,

""But we do consider that boards should put in place the kind of assurance programme outlined above and declare in their quality accounts that they have done so".

The assurance programme it refers to is the one currently being piloted in NHS North West for payment by results. There is an obvious read-across here to quality accounts because quality accounts, as the commission points out, will rely on accurate clinical coding and secondary-uses service data.

The report usefully suggests that commissioners of NHS care could play a much stronger role in scrutinising information provided to them by trusts, which is surely right. The same applies to strategic health authorities. We need think only of Mid-Staffordshire in that context. It also suggests that regulators have an important part to play in improving data quality in the NHS. The noble Baroness, Lady Young, was very quick to dismiss this idea when we debated it in Grand Committee. I was suggesting then, if noble Lords remember, that the Care Quality Commission should be given the task of auditing the accuracy of a trust's quality accounts. The noble Baroness did not like that idea at all—and I guess if she does not want to do it, it will not be done—but the suggestion that I made could be finessed if, instead of an audit role, we were to give the CQC the responsibility of assessing at the pre-registration stage how accurate and reliable an NHS body was in collating and analysing the data that it produced for its quality accounts. Competence in that area could be one of the standards that a trust had to meet before being allowed to operate. The amendment I have tabled makes this proposal, and I make it in all seriousness.

The importance of data quality in the NHS has never been higher. Leaving aside quality accounts, we have to think only of payment by results and the tariff system. But, at the same time, the problems identified by the Audit Commission could be considerably ameliorated simply by involving and engaging clinicians in the whole process. Generally speaking, that does not happen at the moment because much of the data that are currently collected relate to targets and processes rather than to clinical practice or the quality of care. I am sure the Minister will agree that the closer involvement of clinicians is inherently more likely when quality accounts come on stream because clinicians have a direct interest in making sure that the facts are not misrepresented. At the same time, the commission's report suggests that if a trust submits poor quality data, there need to be punitive consequences built in to the performance management process. So the answer lies in a top-down as well as a bottom-up series of initiatives.

I hope that the Minister will think carefully about these suggestions. I put them forward in a genuinely constructive spirit, although I realise that I may be at risk of being shot down again by the noble Baroness, Lady Young, when she reads Hansard. I hope not. For now, I beg to move.

Baroness Tonge (Liberal Democrat)

My Lords, the amendment highlights the reservations that I have had all along about quality accounts. Of course we want quality in the health service, and there should be some way of measuring the quality of its work, but unless these data are collected properly, unless they are the right data and unless they are properly audited by an independent person or persons, they are not really going to be worth while.

Of course, if we are talking about quality, we will have to involve the clinical staff. I am concerned that the clinical staff will be burdened with more bureaucracy and more forms to fill in. Instead of getting together and having proper clinical discussions about how their teams could improve their performances, which is how the noble Lord, Lord Darzi, referred to it when he introduced the subject, forms will be prepared by the department of quality and they will have boxes to tick. It will all descend to that rather banal level. I am very concerned about this. The principle is excellent and it goes without saying that we want quality in the NHS, but I am still totally unconvinced that this will have the right outcome.

Lord Darzi of Denham (Labour)

My Lords, Amendment 19, tabled by the noble Earl, Lord Howe, seeks to give the CQC a role in the data collection and analysis that go into preparing quality accounts. As I said in Grand Committee, I share the noble Earl's view that data used in the preparation of quality accounts should be of the highest standards. The question is how to reach that stage of the highest quality of data. That is where we differ. I believe that the only way in which we will improve the quality of our data is to have clinicians taking ownership of the data that they provide and a clear framework of safety, effectiveness and patient experience.

I assure noble Lords that one of the most gratifying things about High Quality Care for All is that it captures what drives clinicians. Quality is the organising principle of the NHS. We are introducing the process of clinicians taking ownership of the data and publicly reporting them following engagement with the clinical community across the country. The pride of any clinician is to publicly report the data on the care that they provide. I sympathise with the noble Baroness in relation to some of the challenges that measuring and collecting these data may bring. We are strongly encouraging the NHS to appoint further staff to help in the collection of these data and to improve the coding of many procedures and episodes of care that are provided through the NHS.

I also believe that we need analytical power, epidemiological support and statistical competencies in the NHS. That is why we will be announcing the creation of 10 quality observatories in the 10 strategic health authorities. The function of these quality observatories will be to collect and analyse these data and, more importantly, to give them weighting against age, social deprivation and the disease entity. The data in themselves need to be refined and analysed before they become useful. The purpose of collecting these data is to empower clinicians to use the measures against the standards in constantly engaging in quality improvement. That is what drives clinicians; that is the movement that we are trying to create on the back of that.

The noble Earl mentioned the north-west. He is right that the north-west has started a process of improving the quality of its data by working with external stakeholders. I believe that it has the best data collection system in the country. However, it did that by engaging its clinicians, who took ownership of the data. I suggest to the noble Earl that the NHS collects more data than any other healthcare system, but it does not have ownership of it. That is what will improve the quality. The regulator is not the person to do that, but the clinicians—those who are involved in care.

That comes back to the second point raised by the noble Earl in his amendment, on the quality assurance of the data. As I have suggested previously, I strongly believe that commissioners, patient representatives and local communities could and should challenge organisations on the quality of data. The noble Earl also referred to the Audit Commission, which said that commissioners have a strong role in ensuring quality assurance. I will also support that way of ensuring that those who commission the services will, based on the information from the providers, constantly appraise and encourage them to seek that external validation; that is their job, rather than the job of the regulator in the form of the CQC. When the noble Baroness, Lady Young, was concerned about this in Grand Committee, I sympathised with her because the regulator, who is independent, is there to ensure that core standards of care are maintained rather than to assure the data quality. I believe that the commissioners should probably be playing a greater role in that.

The noble Earl and I agree on the principles of improving data quality and I hope that I have reassured him that we have policies in which we can, at least, engage clinicians and provide them with the tools to make that happen. I hope that he will, therefore, be able to withdraw his amendment.

Earl Howe (Conservative)

My Lords, that was a helpful answer from the Minister and I thank him for it. We would all acknowledge that there is good practice, as well as less good practice, in this area, but there are no doubt problems to be addressed. How best do we do that? Part of the answer lies in encouraging accreditation, as I argued in Grand Committee; part of it lies in external review and in performance management. Most of all, however, the answer lies in better collaboration between clinicians, finance officers and business managers, with, as the Minister rightly said, clinicians taking ownership of data. The arrival of quality accounts creates a real opportunity in that sense.

Again, however, we should not forget about setting appropriate standards for data quality. The Audit Commission said in paragraph 57 of its report:

"Standards used for regulation and registration should include a requirement to ensure the quality of data and to submit accurate information. The current Standards for Better Health omits this. Use and submission of poor quality data should have direct regulatory consequences".

Therefore, it envisaged the CQC being involved in this area. Clinicians, as the Minister indicated, are likely to take ownership of the raw data for such things as patient outcome and mortality ratios. They are less likely to be closely involved in the statistical analysis of the data, an area where there is scope for things to go awry. We need to be mindful that there is a limit to the extent to which clinicians can oversee everything produced as statistics. Nevertheless, as so often, and in this area above all, I have confidence in the Minister wanting to get things right. I have no doubt that he is doing his level best to ensure that this part of the Bill will result in something that we can all value and be proud of, so I beg leave to withdraw the amendment.

Amendment 19 withdrawn.

Clause 8 : Regulations under section 6

Amendment 20

Moved by Lord Darzi of Denham

20: Clause 8, page 5, line 38, leave out subsection (2)

Lord Darzi of Denham (Labour)

My Lords, in moving Amendment 20, I shall also speak to Amendments 21, 35, 36 and 37. The Delegated Powers and Regulatory Reform Committee has recommended two changes to the Bill. The first relates to the procedure for exercising powers to create secondary legislation relating to quality accounts; the second relates to consultation by the trust special administrator on the draft report. These amendments act on those recommendations.

First, on quality accounts, the committee has recommended that the mechanism for exercising the powers in Clause 6(5) be subject to the negative procedure, including the first occasion on which the power is used. The powers in subsection (5) enable the Secretary of State to make regulations to omit prescribed providers or providers of prescribed services from the duty to publish a quality account. It would not be desirable to list the providers to be omitted for the time being from the requirement, as the policy with regard to these providers will change over time and the flexibility of secondary legislation is needed to ensure that they can be appropriately included or excluded.

We originally considered the affirmative procedure appropriate when the power was first exercised, since the intention is to omit specified providers from the ambit of the duty currently under consideration. The negative procedure was considered appropriate for subsequent amendments to those regulations, since the intention is that the power will, in most cases, then be used to extend the duty to publish quality accounts to those previously excluded. The committee considers that the negative procedure should provide an adequate level of scrutiny even on the first occasion. The regulations will be subject to public consultation before we bring them before Parliament and there remains, of course, the option for the Merits Committee to comment on them and recommend further parliamentary debate as appropriate.

On the recommendations relating to trust special administrators, new Section 65H of the National Health Service Act 2006, proposed in Clause 13, requires those administrators to consult certain persons specified in that section—for example, staff and staff representatives—on a draft report. Subsections (7)(c) and (10) of the new section currently permit the Secretary of State to prescribe in regulations additional persons from whom the trust special administrator should request a written response, or with whom they should meet. Amendments 36 and 37 change the mechanisms by which the power is exercised from regulations to directions. Amendment 35 is a technical drafting amendment to bring about consistency in wording.

Amendments 36 and 37 are in direct response to the Delegated Powers and Regulatory Reform Committee's recommendations that the mechanism for exercising the powers relating to consultation by the trust special administrator should be consistent for NHS trusts and PCTs. The committee took the view that parliamentary scrutiny was not necessary, favouring the approach that has been taken for PCTs. I am grateful to the committee for its recommendations and I beg to move.

Amendment 20 agreed.

Amendment 21

Moved by Lord Darzi of Denham

21: Clause 8, page 5, line 41, leave out "Subject to that,"

Amendment 21 agreed.

Amendment 22

Moved by Lord Palmer

22: After Clause 8, insert the following new Clause—

"Duty of providers to account for car park revenue

(1) Each of the bodies listed in section 6(2) must, in accordance with regulations made by the Secretary of State, produce a report in respect of each reporting period which accounts for the use of revenue raised from all car parks under their control.

(2) The report must contain the following—

(a) the level of revenue raised from each car park,

(b) a breakdown of how the revenue has been distributed, which clearly specifies if and how the revenue has been spent to directly improve healthcare provision,

(c) the tariffs charged in each car park, including any special rates for hospital staff or members of the public who have driven patients to hospital."

Lord Palmer (Crossbench)

My Lords, I apologise to the House that I was not able to give this amendment an airing in Committee. However, I feel strongly that it is absolutely wrong that people should have to pay a large proportion of their wage in car parking fees, particularly for the more menial tasks for which they get paid in hospitals, such as cleaning floors. This also affects those who arrive at a hospital to attend the accident and emergency department. You may, for example, only have a broken finger and so will put in enough money for the four hours that is meant to be the maximum time before you are seen. However, if it takes a little longer than that, you may get back to your car to find it clamped. As I have said, the main point of the amendment is for the Government to look favourably in particular on lower-paid workers within the National Health Service and those who visit people who are terminally ill or under conditions of accident and emergency. I beg to move.

Baroness Barker (Liberal Democrat)

My Lords, as the noble Lord, Lord Palmer, was unable to move this amendment in Committee, we did not get the chance to talk about it. I wish to give him some support, although I have no doubt that the Government will not. I know that the Scottish Executive have introduced measures of this kind; indeed, they have gone further and are bringing in measures to stop hospitals raising revenue from car parks. The amendment tabled by the noble Lord, Lord Palmer, does not go that far.

I support the noble Lord's amendment for two reasons. First, members of the public are angered beyond measure because they believe that they have no choice in many cases other than to take private transport to hospitals, when they are put in a situation where the NHS is making money from their disadvantage.

The amendment is important, secondly, because there are some patients for whom car parking fees at hospital are detrimental to their healthcare. Many years ago, when I worked in Age Concern, we did a study on non-emergency patient transport, which in those days was being cut back so severely that many older people were forced to make private arrangements to go to hospital. We called our report A Helicopter Would Be Nice, because that is what one of the people said to us. We found older people not going to hospital for appointments that they needed until they could arrange for their relatives to fly back from abroad to take them, or until they could rely on neighbours to take them. Time and again in our research, the stress of car parking and of taking people to hospital and having to run in and out of A&E departments to make sure that the parking meter was topped up came through as something that was not conducive to older people's health and well-being.

The noble Lord, Lord Palmer, has in a limited way hit on a big problem, which the NHS has a duty at least to examine. If all that it does is come clean about the amount of money that it is making from car parking, it would be a great step forward.

Lord Mackay of Clashfern (Conservative)

My Lords, I understood that it was one of the principles of the National Health Service that services provided should in general be free at the point of provision. A car park at a hospital is really an ancillary service. People do not go to the hospital for the sake of entertainment or anything of that kind; they go for the sake of receiving a service in the hospital. I commend to the noble Lord the good example north of the border, where, apart from in public/private partnerships, the Government have abolished car parking charges in the hospitals under their control. That is an example that would be well followed.

Lord Darzi of Denham (Labour)

My Lords, the noble Lord, Lord Palmer, has proposed a new clause that seeks to require trusts to justify their policies on charges for car parking. The idea has merit and should be given consideration, but it ought to be covered in guidance and offered as an example of an issue that could be of local concern. This would achieve the best fit with the way in which quality accounts are being designed, assuming that the noble Lord's intention is that the duty should form part of a quality account.

If providers wish to talk about car parking charges from a patient experience point of view, they are free to do so. I strongly encourage providers to do that, because it is clearly an issue of concern. I shall not try to address the comments of the noble and learned Lord, Lord Mackay, in relation to contrasting policies on charging north of the border and in England, because I am sure that we shall have opportunities to debate it. However, the matter is of concern to patients and it should be reflected through the patient experience matrix that we are developing with the health service. One's experience in a hospital is not purely one's experience in a ward or that of the care that one receives from a surgeon; it also includes one's experience of the environment and the car park facilities that might be available, as well as the costs associated with it. We updated the guidance on car parking charges in November 2008 and I shall be more than happy to send copies to noble Lords.

I reassure noble Lords that the income generated from car parking charges must be used to improve health services within a trust. It does not leave the trust; that is an important point to make. The whole process of designing quality accounts should be inclusive. Ideas must come from the front line, which includes patients, user groups and others at a local level.

I hope that I have reassured the noble Lord that it is our intention to measure all aspects of experience. I shall strongly suggest that this matter be part of the experience indicators that we are currently developing. If the noble Lord feels that I have addressed some of his concerns, I hope that that will give him the opportunity to withdraw his amendment.

Lord Palmer (Crossbench)

My Lords, I thank the noble Baroness, Lady Barker, for her support. I listened with great care to what the Minister said and I shall read it most carefully tomorrow in Hansard. He did not, however, respond to my point about lower-paid members of staff, who greatly concern me. The fact that people who earn not very much over and above the minimum wage have to spend a vast proportion of their income to park their cars is of great concern. I shall read carefully what the Minister said and may well bring this back at the next stage of the Bill. Meanwhile, I thank the Minister for his response. I hope that he will take on board the fact that there is a very serious point behind the amendment. I beg leave to withdraw it.

Amendment 22 withdrawn.

Consideration on Report adjourned until not before 8.37 pm.

Report (1st Day)(Continued)

Earl Howe (Conservative)

My Lords, I beg to move Amendment 23, which is designed to address a very straightforward issue, one raised with me by Diabetes UK. In Grand Committee, the noble Lord, Lord Darzi, spoke about personal health budgets and emphasised the Government's intention that these should always be voluntary and that exactly the same principle applied to direct payments. The question I want to raise with him is whether the wording in the Bill provides a sufficient safeguard against abuse of the voluntary principle. New section 12A says,

"make payments with the patient's consent",

which, at first blush, seems all right, but, if taken literally, the consent could be read as applying to the narrow issue of how the money in someone's direct payment budget is applied and spent. It might not necessarily prevent a situation arising in which a patient does not really want a personal budget at all but, against his better judgment, he is persuaded or pressurised into accepting one. There is a difference between the right to refuse treatment and the right not to choose a personal budget of any kind. The Minister's comments up to now have appeared to conflate the two. I have sympathy with the point made by Diabetes UK that the legislation should make it clear that personal health budgets of any kind—notional, third-party or direct payments—should remain voluntary, whether at the pilot stage or in the event that they are rolled out more widely. I am sure that the Minister will say that the wording in the Bill is adequate in this sense but, nevertheless, I would be glad if he would look at the matter again. I beg to move.

Baroness Barker (Liberal Democrat)

My Lords, I wish to speak to Amendments 25 and 31 in this group. As this is the first group of amendments on the subject of direct payments, perhaps I might reflect on the discussion in Committee. It would be accurate to say that we had an extensive debate—almost a full afternoon of one of our sittings in Grand Committee—during which the Minister was bowled question after question about direct payments, individual budgets, the principles underlying them, what the Government's intentions are, the extent to which individual health budgets might be brought into play in respect of different patients and different conditions and the limitations of the proposed pilots.

I thank the noble Lord, Lord Darzi, for his letter of 18 March in which he restated, to a large extent, the answers that he gave in Committee. However, detail is lacking and that continues to be a source of considerable concern to many of us on this side of the House who are supportive of the principle of direct payments but have considerable concerns about how they might be introduced and about the potential detrimental effects which they might have on the National Health Service and particularly on the provision of services.

Since the Committee, the noble Baroness, Lady Campbell, has been kind enough to arrange a meeting for all Peers, attended by the noble Baroness, Lady Thornton, at which she and several people from the disability organisations with which she has long been associated and academics such as John Glasby from Birmingham University set out the experience of disabled people. They talked at considerable length about what they consider to be the potential benefits to service users of individual budgets. It seems to be my misfortune throughout this Bill to refer to the noble Baroness, Lady Campbell, when she is not in her place and I regret that I have to do so again. It would not be inaccurate to say that although there was considerable support for the potential for direct payments at that meeting, again, when Members of your Lordships' House raised issues and asked questions, there were no answers. I find that deeply troubling.

That meeting gave rise to the tabling of Amendment 31, which, as noble Lords will see, bears a resemblance to an amendment tabled by the noble Baroness, Lady Greengross, in Committee in which she set out a list of conditions and services to which individual health budgets might apply. The purpose of both these amendments is to probe the Government's intentions on the extent to which direct payments will be introduced in the NHS. It is of considerable interest and should give rise to a degree of concern that many of the organisations that have supported the principle of direct payments or individual health budgets have expressed their support on the understanding that they will be available to a small minority of patients who suffer from long-term conditions, and that there will be adequate advice and support for any person who has an individual budget. Neither of those two statements can be made with any certainty, given what is in the Bill and our discussions so far.

Amendment 31 refers to two particular conditions, both of which, in different ways, highlight some of the potential issues associated with individual health budgets. In Committee some noble Lords expressed the view that palliative care services, given their place in the National Health Service and the fact that they are largely supplied by independent organisations, principally charities, should be funded through direct payment. But the major providers of hospice care in the country have a very different view. By definition, palliative care—end-of-life care—is provided to individuals but it cannot be predicted when any particular individual will need it. At the moment part of the function of the NHS is to study populations and the incidence of conditions, and to make an assessment of the level of service needed to deal with them. That process runs right through to budgeting. There is an attempt at the heart of the NHS to address issues such as pooling of risk and equity of service. If palliative care came to be primarily funded by direct payments, the ability of providers to predict and provide a certain level of service would be extremely difficult. It might signal the end of the provision of palliative care within the NHS and I want to establish whether the Minister can envisage that as a consequence of the introduction of this policy.

At the meeting arranged by the noble Baroness, Lady Campbell, noble Lords who were interested in the subject discussed at considerable length the benefits of this service, and there are benefits. In Committee we discussed the fact that services can be more personalised and more effective for individual patients, and can contribute to greater health outcomes. At the meeting noble Lords—particularly the noble Baroness, Lady Cumberlege, who, I am sorry to see, is not here to take part in this debate, although she talked in Committee—saw that maternity services would be a good candidate for individual health budgets. Maternity services are required, usually, with about nine months' anticipation of the need for them arising. They are planned on the basis of population studies. Thinking about the matter in greater detail, within the NHS there is at the moment a considerable move towards midwife-led units, on the basis that the majority of deliveries are uncomplicated and routine. However, there are always births that do not go according to plan and in which there is a sudden and urgent need for a woman to be referred to a consultant obstetrician.

The reason for suggesting that maternity services should be included in the pilots for individual health budgets is to test the point that I raised in Committee. To what extent has the Department of Health analysed the risk of turning some services, which may be elective, over to individual health budgets, and to what extent might they then jeopardise acute services because of the coexistence of the two? Amendment 25 suggests that it is the responsibility of the department to set out much more clearly than it has done to date those conditions and circumstances under which direct payment may, must or must not be made available. It is essential not only to the future of the policy but to the expectation that will be placed on it by NHS staff and, most particularly, by users. Both amendments signify a degree of frustration on my part that, having had detailed discussions about these matters over the last three months, we are no further forward in understanding just how radical this policy is intended to be and just what its potential implications are for NHS providers and patients.

Lord Darzi of Denham (Labour)

My Lords, this set of amendments deals with consent and the services and circumstances in which direct payments might be used. I turn first to Amendment 23, moved by the noble Earl, Lord Howe. It would require that a patient's consent to receiving a direct payment is "prior and informed". It is important to emphasise that personal health budgets, including direct payments, will be entirely voluntary. That is one of the core principles outlined in our policy document, Personal Health Budgets: First Steps. Of course, consent is enshrined in the very first sentence of this legislation for direct payments. No one should be forced to have direct payments if they do not want to, and I do not believe that anyone could be forced to accept such payment.

More generally, I agree with the noble Earl that people should give valid consent before they receive any form of care. If they are not able to do so, the consent should be obtained from someone acting legally on their behalf. That is fundamental to healthcare, and a legal right, as we have made clear in the NHS Constitution. However, the notion of consent already implies that the person is informed. Expanding the definition of consent will not, in practice, increase the protection that this Bill already offers. I remember debating this in Committee. Although I take the point that the noble Earl is concerned about, I cannot find a better word to cover this being a voluntary scheme. That is well known to the people coming into it. Finally, before even accepting it, they have to obtain consent. I hope I have provided reassurance to the noble Earl on his amendment.

Amendments 25 and 31 were tabled by the noble Baronesses Lady Barker and Lady Tonge. Amendment 25 seeks to limit the services for which direct payments may be made and Amendment 31 would promote the use of direct payments for maternity services but would rule out end-of-life care. I hope to persuade the noble Baronesses that these amendments are not necessary.

It may be helpful if I start by giving an update on how the pilot programme has developed since these clauses were last discussed in this House. In Personal Health Budgets: First Steps we invited PCTs to submit expressions of interest in becoming a pilot site to test personal health budgets. Since then, we have received more than 70 applications from every strategic health authority area, covering a range of services and conditions. Many PCTs want to focus on people with long-term conditions, people who are receiving NHS continuing healthcare or people with mental health needs. We have also received proposals to explore how personal health budgets could be used, for example, to support carers for stroke services. Around a dozen applications included proposals for end-of-life care, while one PCT expressed an interest in using personal health budgets for maternity services. I am sure that will please the noble Baroness, Lady Cumberlege.

Lord Campbell-Savours (Labour)

My Lords, which authority was that?

Lord Darzi of Denham (Labour)

My Lords, I am not entirely sure. I shall be more than happy to come back and say unless my noble friend knows which one it was. We felt that it was a creative proposal and I have no doubt that it will be looked at quite carefully.

It is too early to say exactly which proposals will go ahead. We are delighted by the enthusiasm and the range of innovative ideas that we have seen. We are looking forward to working with as many sites as possible to develop viable proposals and we intend to feed back shortly to all PCTs that have applied.

Initially, the pilots—and I remind the House that these are pilots—will test only the models of personal budgets that are allowed under current powers. Subject to the passage of this Bill and the making of necessary regulations, there would be a further stage in the process to decide which pilot site would be authorised to use direct payments.

As I said in Committee, we are looking to build on the enthusiasm for personalisation in the NHS, so we do not intend to set too many prescriptive limits on the circumstances in which people could use direct payments. The Bill already gives power to exclude services or groups of people. This is something that we might consider where there is a particular risk of abuse: for example, for people who are under compulsory drug or alcohol treatment orders. As I said in Grand Committee, we intend to consult on this in the normal way with draft regulations.

However, across the NHS there are, of course, many services, such as accident and emergency and other acute services, where direct payments will not be appropriate. I do not think it is necessary to list these and exclude them all in regulation. We want personal health budgets and direct payments to be used where they make sense, relying on the judgment of local PCTs, individuals, patient groups and the voluntary sector.

On the specific questions about end-of-life care, clearly this is an area with particular sensitivities. However, there may be great potential for personal health budgets, although not necessarily delivered through direct payments, as per the applications we have received recently. For example, some PCTs have suggested that personal budgets might allow patients to receive a more flexible range of support, or allow a quicker and more responsive way of adjusting a care package to a patient's changing needs. It is also worth remembering that another person—for example, a carer—can receive direct payments on behalf of the patient. This would mean that people could have the extra flexibility of direct payments while not creating an additional burden at a very difficult time.

I am sure the noble Baroness will agree that some of the policies that we have come up with over the past 18 months are all to improve quality and caring on the end-of-life pathway, in relation to the national strategy. This could be one enabler in relation to that pathway. Rather than making conclusions now about which services are suitable or unsuitable for delivery through direct payments, we would prefer to explore a range of proposals and to build the evidence base through those pilots. If evaluation reveals the need to rule out a specific service, the Bill already provides the power to do that. With these reassurances, I hope that the noble Baronesses will not press their amendments.

Baroness Barker (Liberal Democrat)

My Lords, before the Minister sits down, does he agree that there are legitimate reasons, other than the incapacity of individual patients, to rule out particular services from individual health budgets? If, because of this policy, it is possible that provision of a particular service within an area would cease and that that can be predicted now, is it right that that particular area of service should not be included in a pilot? That is the point I seek to make. For example, that could apply on specialist services such as palliative care, where there are only small numbers of people and the level of need for that service cannot be predicted regularly. The Minister's answer is important. I feel so strongly that this is of importance, not just to these pilots but to the future of the NHS, that I would be willing to test the opinion of the House on it.

Lord Darzi of Denham (Labour)

My Lords, I am not entirely sure what the question is. If it is whether a highly specialised service might be destabilised by the concept of direct budgets, I do not think that will change the demand to affect the supply. At the end, the demand will remain the same. It is about the method of payment, and whether the PCT is paying a provider or the patient is holding the direct budget. In my experience of those rare diseases, most patients feel much more empowered to buy their own services—because they are, firstly, expert patients—and that is the purpose of that. If this might be a reassurance, I do not see the situation arising where the supply of a service could demise because the payment method had become direct payment rather than being a direct commission from a PCT. If that were to happen, I can reassure the noble Baroness that the providers of such services will remain, because the local demand will be the same.

Earl Howe (Conservative)

My Lords, this has been a useful debate, and I thank the Minister for his reply. His assurances were welcome. He may like to know that it is not only Diabetes UK that has expressed concern to me about the voluntary principle of direct payments; the RNIB is equally concerned. Its worry is that PCTs might make certain long-term healthcare services available only via a direct payments route. In other words, the patient would have no choice in the matter. Whether that is likely is a matter for debate, no doubt, but the RNIB is clearly worried about it. In those circumstances, the proposed constitutional rights that the Minister has referred to would not be easily enforceable. The RNIB would be much reassured to see the right to refuse direct payments explicitly expressed in the Bill. However, while I have sympathy with that I do not propose to press the point tonight, unless other noble Lords think differently. I beg leave to withdraw the amendment.

Some noble Lords objected to the request for leave to withdraw the amendment, so it was not granted.

Lord Dubs (Labour)

My Lords, I am a member of the Joint Committee on Human Rights, and this amendment stems from some work that the committee has done, which we published in our 11th report on 15 April. The issue is again about payments. Under this Bill, the Secretary of State is enabled to discharge various statutory functions under the National Health Service Act 2006 by making direct monetary payments to patients in appropriate cases, initially through pilot schemes. As the Explanatory Notes say:

"This gives patients receiving direct payments for health care similar rights to those enjoyed by patients accessing services from NHS organisations or from private sector organisations commissioned by PCTs".

So far, that is good. The issue is whether the provider of these services would constitute a public authority under the Human Rights Act 1998. Why is that in doubt? It is in doubt because a number of court cases culminated in a judgment by the House of Lords in YL v Birmingham City Council and others in June 2007. As our report says:

"By a majority of 3 to 2, the Law Lords ruled that the person concerned could not bring a claim against her private sector care home under the HRA, in relation to the infringement of her right to respect for her private life and home under Article 8 ECHR".

As a result, the Government introduced an amendment to the Health and Social Care Bill in the last Session to put that right, but the question is whether the new arrangements on payments are also covered. The report of the Joint Committee on Human Rights states:

"In their joint evidence to us, Help the Aged and Age Concern argued that private bodies providing health services funded by direct payments should be considered as providing public functions, but"—

and here is the key point—

"'it is not clear whether in practice they will be'. They recommended that legislation should clarify the position, given 'the overall uncertainty about the HRA status of private healthcare providers'.".

I think that is a reasonable doubt, given the previous House of Lords case.

The Government have argued that it is unnecessary, and there is a straight conflict of view there. We on the Human Rights Committee believe that it is necessary and that there should be an amendment to this Bill for the avoidance of doubt. The recommendation is,

"that the Bill be amended to make it absolutely clear that it is intended that NHS services funded by direct payments and provided by independent bodies are functions of a public nature for the purposes of the HRA 1998".

I beg to move.

Lord Mackay of Clashfern (Conservative)

My Lords, there may be a small question about what the status of such a person would be in terms of the European Convention on Human Rights. The Human Rights Act is domestic legislation and there is, ultimately, the possibility of going to the court in Strasbourg. I am not sure that this would necessarily be sufficient. I may be wrong about this—I am not sure—but I raise the question whether this would be sufficient to make the provider a public authority within the meaning of the Convention on Human Rights, which is a different document in some substance from the Human Rights Act.

Lord Darzi of Denham (Labour)

My Lords, the amendment tabled by my noble friend Lord Dubs on behalf of the Joint Committee on Human Rights would highlight the fact that NHS services funded by direct payments—whoever provides them—are functions of a public nature for the purposes of the Human Rights Act 1998. I hope to persuade my noble friend that there is no need to make this explicit in the Bill; and furthermore, that to do so might cause confusion and have an adverse effect on how other health services are provided. This is not to deny the need for greater clarity about what constitutes a public authority under the Human Rights Act. The Government are aware of concerns raised by the Committee on this matter, and remain committed to consulting on the issue in due course.

The Committee previously sought clarification on whether the Government considered that private providers of health services funded through direct payments were to be treated as public authorities under the Human Rights Act. I will reiterate the Government's position. We do consider independent providers of healthcare to be public authorities, for the purposes of Section 6 of the Human Rights Act 1998, when they are providing services under the National Health Service Act 2006. The duty of the Secretary of State to continue to provide a comprehensive and free health service under the Act is a core public function. The Government consider that all independent providers of healthcare that provide services in fulfilment of that duty are carrying out a public function, and therefore that they are all public authorities for the purposes of Section 6 of the Human Rights Act.

The Government do not consider that any distinction can be drawn between the situation where the Secretary of State directly enters into a contract with an independent provider of healthcare services—as permitted by Section 12 of the National Health Service Act 2006—and the situation where a patient enters into a contract with an independent provider of healthcare services under the proposed legislation. In both cases, the services will be provided under the National Health Act 2006, and in fulfilment of the Secretary of State's duties. Similarly, an independent provider of after-care services under the Mental Health Act 1983, whether commissioned by a primary care trust or providing the services under a direct payment arrangement, will be covered by the Human Rights Act.

The Government also note that the costs of services provided under the proposed direct payment arrangements would still be met from public funds. The Government note that there would still be a strong public interest in ensuring that the services were properly provided. The Government do not, however, believe that it is necessary to state this in the Bill, which is what the amendment seeks to achieve. To state explicitly that providers of healthcare procured by direct payments were carrying out public functions for the purposes of the Human Rights Act could cast doubt on whether independent providers of health services acting under other relevant sections of the National Health Service Act were exercising functions of a public nature.

The judgment in YL v Birmingham City Council 2007 does not alter the position. It did not determine the position of any function other than those specifically considered by noble and learned Lords. For example, the noble and learned Lord, Lord Mance, explicitly stated that he,

"would leave entirely open the position of those operating in different areas of health and education services".

The provision made in Section 145 of the Health and Social Care Act 2008 was necessary only because of the judgment in the YL case. It was intended to ensure that, notwithstanding the judgment, some social care and accommodation that is publicly arranged under the National Assistance Act is a public function subject to the Human Rights Act. The approach was deemed sensible by a range of stakeholders at the time, and no subsequent court judgment has led the Government to consider that independent providers of national health services are not public authorities for the purposes of the Human Rights Act.

In the light of these explanations, and of the Government's intention to consult on the issue of what constitutes a public authority under the Human Rights Act, I hope that my noble friend will withdraw his amendment.

Lord Dubs (Labour)

My Lords, I am grateful to my noble friend for that explanation. What the Government seek to achieve and what I seek to achieve are clearly the same. The question is whether I share the Government's confidence that, if the matter were to be put to the test of the House of Lords in its judicial capacity, the House would come down on the side of the Government or take the same view as it did in the YL case. I am not a lawyer: I am not qualified to answer some of the detailed legal questions, but my understanding is that there is a little doubt about that. If there is no doubt, that is fine and I hope that I am proved wrong. However, given the persuasive nature of my noble friend's arguments, I beg leave to withdraw the amendment.

Amendment 24 withdrawn.

Amendment 25 not moved.

Amendment 26

Moved by Baroness Barker

26: Clause 9, page 7, line 16, at end insert—

"( ) as to the mechanisms by which a patient, or (if different) the payee may appeal against the amount of direct payment or how it is calculated;"

Baroness Barker (Liberal Democrat)

My Lords, the amendment would insert into Clause 9 something that is omitted from new Section 12B. That is a provision for the Secretary of State to make explicit the mechanisms by which a patient, someone on a patient's behalf if they lack capacity or the payee can appeal against the amount of a direct payment or the method of calculation. The Bill provides that the Secretary of State may in regulations make provision about the amount of a direct payment, but there is no indication anywhere that an individual person may have recourse to a means of appeal.

That absence of a means of appeal puts individual health budgets on to a different basis from the provision of direct healthcare services. If a patient is provided with a particular course of treatment under the NHS, they have a means within the current system of raising the issue of their treatment and questioning it. The amendment asks not that individual budget holders be able to determine the level of their payment but that they have a means of appeal. There are a variety of reasons why that should be so. In the new world of a plethora of providers of services to individuals and individual providers of individual services, it could be that the level of costs goes up. That which may be deemed to be a reasonable amount in order to provide a service that has hitherto been a direct provision by the NHS may simply not be possible when it is provided on a small scale without some of the efficiencies and economies of scale—one of the things that NHS patients currently benefit from.

This is a reasonable amendment. It is a matter to which we have not hitherto paid any attention and I therefore beg to move.

Lord Campbell-Savours (Labour)

My Lords, I will speak to Amendment 29, which is grouped with the amendment moved by the noble Baroness, Lady Barker. In Committee, there was much debate about direct payments and the impact that they may have. While I appreciate the assurances provided by my noble friend about the safeguards that will be put in place, I have remaining concerns that the fundamental impact that direct payments will have on health services and staff delivering those services has not been fully realised.

UNISON, the union with which I have a non-pecuniary relationship and which I support in amendments in this House when I agree with its positions, recognises and supports the need for National Health Service services to be responsive and able to provide more tailored support to some patients. However, there are still concerns within the union that the introduction of direct payments may have a damaging impact on the delivery of health services to the wider population that have not been fully considered.

During consideration of the Bill in Committee, noble Lords raised their concerns around the potential circumstances that could arise if a direct payment budget ran out and a sufficient safety net was not put in place.

This is a concern both in dealing with the patients who might be turned away from essential care if their direct payment runs out and in relation to the risk that the NHS might be left to foot the bill in situations where a patient spends their direct payment inappropriately. This would, in effect, leave the National Health Service, in the view of UNISON, having to pay twice for the same person's care.

I welcome the Minister's comments in Grand Committee, where he provided some reassurances about safeguards to avoid such scenarios occurring; we debated these issues at some length at that stage. However, concerns still remain. It remains the case that there is no detail on this in the Bill and no firm mechanism to reassure those of us with concerns that it will be addressed within regulations. There is a real possibility that, if a patient exhausts their budget, they will either have to pay to top up their care, which I am told is wrong in any event under the Bill, or the NHS will be left to foot the bill. My concern is that, without the inclusion of any safeguards in the Bill, the risk remains that such scenarios could arise. This amendment would provide some security to those of us who are concerned that this significant change to the delivery of healthcare has yet to be fully scrutinised.

Earl Howe (Conservative)

My Lords, Amendment 27 in my name follows on from the remarks made by the noble Lord, Lord Campbell-Savours. It indeed brings us back to the issue that we debated in Grand Committee, which is the need to guarantee that nobody is denied access to NHS treatment purely as a result of having a personal budget or being in a direct payment scheme. When he replied to me in Grand Committee, the noble Lord, Lord Darzi, assured me that the worry about someone running out of money and therefore not being able to access the care and treatment that he needed was not well founded. The situations that he described were ones where either there was inadequate resource allocation in the first instance for the defined care package or where a personal health budget might turn out to be inappropriate. However, those situations are not the only ones that are relevant to the underlying concern.

The noble Lord referred to the safeguards outlined in the department's guidance document, Personal Health Budgets: First Steps, but we know that this is not a definitive book of rules; it is, as he said, a framework within which the policy can develop further. The guidance states:

"Setting the budget at the right level will be one of the major challenges to be addressed during the pilot programme".

I do not doubt that that is right, as we know the process for budget allocation is still under development. It goes on to say:

"Once at least an indicative budget is set, the next step is to draw up a detailed care plan designed to meet the individual's agreed health and well-being outcomes".

With all due respect, that seems to address the problem from the wrong starting point. Unless a detailed care plan is developed prior to resource allocation, how can one identify an appropriate budget?

My worry on this score is underlined by the Explanatory Notes, in the part that covers new Section 12B(5). This makes it clear that goods and services purchased by the patient directly should nevertheless be regarded as goods and services provided by the Secretary of State. It then says:

"This means that in prescribed circumstances, but only in prescribed circumstances, the Secretary of State could be considered to have fulfilled his duty to provide a service described at new section 12A(2) by making a direct payment".

This caveat suggests that there may be circumstances in which a service user would not be able to access services through the NHS if their budget had proved insufficient. I should be grateful if the Minister could reassure me that this is not an interpretation that should be placed on those words.

It is perhaps not difficult to see why these issues are causing concern for organisations such as Diabetes UK, because, in that instance, diabetes is not a condition that would appear to lend itself readily to a direct payment scheme. The Minister will know about the Year of Care programme; its aim is to define the differing needs of diabetic patients across the spectrum and then to pin down how much it would cost to deliver different packages of care that will enable each of those patients to manage their own care in an appropriate way. Evidence from the Year of Care pilots indicates that the task of calculating the allocation of personal budgets for people with diabetes will be difficult. A lot of work has to go into assessing and costing out different needs, but the key concern is unpredictability. Even if someone's diabetes appears to be well managed and stable, there is always a chance that something will happen that throws everything out of kilter.

Diabetes is complex and progressive. Having a personal budget or receiving a direct payment that is meant to cover the entire package for your diabetes runs the serious risk that the budget may run out, thus exposing you to having to put up with a level of care that simply does not meet your needs. It really is a case of saying that what should come first for diabetic patients—indeed, all patients of any kind—is making the right choice of treatment for an individual, based on that person's clinical needs and preferences. The budget allocation should follow on from that.

That is why there is a fear—here, I return to Amendment 23—because patients need to understand exactly what they are letting themselves in for when opting for a personal budget or signing up to a direct payment scheme. Some conditions and some patients will be tailor-made for both, but others decidedly will not be. I shall not ask the House to vote on my amendment, but I should like the Minister to consider whether we need to beef up the Bill by building in an explicit statutory duty on the NHS to ensure that no one is denied treatment simply because they have opted for a personal budget or direct payment.

Lord Darzi of Denham (Labour)

My Lords, Amendment 26, tabled by the noble Baronesses, Lady Barker and Lady Tonge, proposes that there should be a way for people to appeal against decisions on their direct payments. I agree with the sentiment behind this amendment that people should be able to complain and seek redress if there are problems with the services that they receive. Indeed, the NHS Constitution sets out the right to have any complaint about NHS services dealt with efficiently and investigated properly. However, I would be concerned by the idea of setting up an additional complaints or appeals system specifically for direct payments.

In the first instance, we hope that concerns can be resolved locally and informally. We would expect PCTs to discuss any concerns that people have, either about the size of the budget or the mechanism used to set it. We would encourage PCTs to be flexible to meet individual needs, while ensuring the fairness of the system as a whole. If a patient still has concerns, they are entitled to make a complaint, just as with any other NHS decision about which they are unhappy. NHS complaints procedures have recently been reformed to make the system more efficient and certainly more robust. Ultimately, patients may also ask the Health Service Ombudsman to look into their cases. Clause 10 extends the role of the ombudsman to cover services delivered through direct payments, precisely to ensure that people are suitably protected. It is worth reiterating that services paid for by direct payments are NHS services; patients are covered by the complaints procedure protecting patients receiving traditionally commissioned services. It is, therefore, unnecessary to create a new route of appeal or complaint, which might also prove costly and burdensome.

I turn now to Amendment 27, tabled by the noble Earl, Lord Howe, and Amendment 29, tabled by my noble friend Lord Campbell-Savours. These deal with the related situations of whether patients can receive other services alongside a direct payment and what happens if a direct payment budget has run out. I understand these concerns that people might be turned away from the NHS if they have exhausted their budget, or that the NHS should be forced to spend more money inappropriately. However, I assure noble Lords that this should not happen. As I have said before, and as we said in our Personal Health Budgets: First Steps, no one should ever be denied the care that they need. That is a core principle of our policy.

In addition, direct payments will often be for just one aspect of a patient's care, or even one element of that patient pathway. Patients will still be able to use other traditionally commissioned services where that is appropriate. Direct payment should be used only when there is a likely benefit and it will be wholly voluntary.

In Committee, I emphasised that there were several safeguards in place to protect against the budgets running out. First, the personal health budget would be offered to people only in circumstances where their needs could be assessed and the budget calculated for them. Clarity on how we calculate such budgets is one of the requirements. Getting the calculation right will be important. We were pleased to see that a large number of the pilot applications that we received contained proposals for designing resource allocation systems. Many PCTs are aiming to build on the approaches already developed by local authorities. Others intend to develop their own mechanisms for assessing individual needs. There is a long way to go, but the pilots should produce valuable learning.

The second safeguard that we intend to have is a pre-agreed care plan for how the money would be spent. I take the point raised by the noble Earl, Lord Howe: the care plan must come first, before you calculate the budget. I could not agree more, although, in reading the Bill, I am not entirely sure whether there is an order that might be, in a way, adding confusion. The clinician, in partnership with the patient, must decide on the care plan and then calculate the budget.

Thirdly, there should be regular monitoring and review so that the budget can be adjusted in line with a significant change in the person's conditions. Diabetes is a good example. It would be very unfortunate to see a diabetic patient progress in their illness into some of the morbidities of diabetes that we are ultimately trying to prevent. If the patient's condition changed and they required an ophthalmologist to check their retinopathy or a renal physician to check their nephropathy, the budget should be adjusted to accommodate that. Alternatively, the patient may opt out and receive these extra treatments without a direct payment. I am confident that these safeguards will avoid problems arising for the recipient of direct payments or for the other patients and services.

I remind the House that these are pilots. The purpose of having pilots is to learn from them. We will certainly be empowered by the knowledge base from them. These are very innovative areas and I strongly believe that we need to be the leaders in innovations and in empowering patients through direct budgets. I hope that I have reassured noble Lords and that they will feel able not to press their amendments.

Baroness Barker (Liberal Democrat)

My Lords, I thank the noble Lord, Lord Campbell-Savours, and the noble Earl, Lord Howe, for their support on this theme. It was immensely helpful that the noble Lord, Lord Darzi, made the statement that he did about clinical assessment having to come first and having to be a wholly separate process from financial assessment. It is a point that was the subject of extensive research by CSCI in the report that it produced earlier this year into individual budgets in social care. It wrote extensively about the need to have, first, an assessment of need as it is found in social care followed by a separate assessment of files. That is not a new issue. It has not arisen simply because of the existence of individual budgets; it has been a running issue throughout health and social care for some considerable time. However, given the way in which individual health budgets and direct payments are going to come in, I think that there is potential for great confusion.

I must admit that I am slightly disappointed with the noble Lord's response to my amendment regarding appeals. I cannot help but think that, by their very nature, individual health budgets and direct payments will bring questions of cost and expense to the direct notice of patients in a way that has not happened before. By and large, with the exception of some areas such as NHS continuing care, discussions on financial transactions have not been conducted with patients, although they will be now. I hesitate to suggest that it may be naïve to think that this issue will not arise, but I think that not having an obvious system by which it can be addressed is another flaw.

I bow to the more extensive experience of the noble Lord, Lord Darzi, but I shall be astonished if the NHS complaints procedure is capable of handling the fallout from the introduction of individual budgets. Nevertheless, I note what he said and, in due course, we will see what happens. On that basis, I beg leave to withdraw the amendment.

Amendment 26 withdrawn.

Amendment 27 not moved.

Amendment 28

Moved by Lord Campbell-Savours

28: Clause 9, page 7, line 23, at end insert—

"( ) as to the conditions that must be met to protect staff providing services which direct payments are used to secure"

Lord Campbell-Savours (Labour)

My Lords, we know that the impact that the proposals for direct payments will have on staff is significant. In particular, the introduction of this more individual-centred delivery of healthcare will have a significant impact on workforce planning, especially where a patient embarks on a course of treatment that conflicts with professional opinion. Furthermore, if in the future direct payments create circumstances in which staff are employed directly by patients rather than by healthcare providers or the National Health Service, it is important that they are offered the same workforce protection and support to which other staff are entitled.

This amendment is a retabling of one from Committee stage. It calls for provision to be made in regulations to provide a level of protection for staff involved in providing services. UNISON has thousands of members working in the health service. Perhaps I may draw the House's attention to the fact that it represents more than 450,000 healthcare workers and 300,000 social care workers employed in the National Health Service and local government and by private contractors, the voluntary sector and general practitioners. Many of those thousands of members working in the health service will be in the front line of implementing these proposals, and therefore clearly they will be affected in a major way by this legislation.

In Committee, the Minister recognised that the success of personal budgets and direct payments will depend on staff and that,

"the development of personal budgets will require significant cultural changes at all levels of the NHS, which should not be underestimated".—[Official Report, 2/3/09; col. GC 237.]

Given the extent of this culture change, surely there needs to be a level of protection in the Bill. We need something greater than a reassurance that, if staff engage during the pilot process, they will be properly protected and supported during such a period of change. We need regulation if staff are to be fully protected. I beg to move.

Lord Darzi of Denham (Labour)

My Lords, this amendment aims to ensure sure that implementation of direct payments for healthcare is fair for staff. Clearly, there is no argument here in principle, but I am not convinced, as I said in Committee, of the need for setting this out in the Bill. Amendment 28, tabled by my noble friend Lord Campbell-Savours, deals with the issue of protecting staff who provide services funded by direct payment. As we discussed in Grand Committee and set out in Personal Health Budgets: First Steps, the successes of personal budgets and direct payments will depend on staff, those who support, agree and monitor care plans and budgets and those who deliver such services. This is a lesson that came across clearly from the evaluation of individual budgets in social care.

It is vital for all staff that they have terms of employment that are legal, reasonable and fair. All of those who directly employ staff will need to understand their responsibilities. Several PCTs have already been considering ideas to ensure that individuals and carers have the information and support they need to manage staff responsibly. We are keen to support that. While most staff would not argue with the aims of personalisation, its delivery will require a significant mindset shift. We have already touched on the cultural change, as pointed out by my noble friend. Staff should be involved and engaged as much as possible in steering the implementation of personal health budgets and direct payments and in developing appropriate training. In our assessment of the pilot proposals so far, we have therefore been looking for evidence that frontline staff and unions are directly engaged.

It is vital that the pilots help us to understand fully the implications for staff, including around their employment status, their conditions of work, and the skills they need. I have no doubt that my noble friend will agree that these pilots will provide us with wonderful learning opportunities that we can take back to our stakeholders, such as the trade unions, and work out a reasonable proposal for the future. I want to reassure noble Lords that our evaluation programme will specifically look at the implications for staff of personal health budgets, including those involving direct payments, and if there is a case for putting specific safeguards in place, the legislation already gives us the power to do so. Therefore, I do not believe at this stage that an explicit provision in the Bill is necessary.

I hope that the explanation I have given, including the fact that further safeguards could be set out in regulations, will provide enough reassurance that my noble friend will agree to withdraw the amendment.

Lord Campbell-Savours (Labour)

My Lords, I am grateful to my noble friend for the recognition he has given to the role of staff in the National Health Service and I know that the unions appreciate the value of the dialogue that he has with them on matters of this nature. However, I am sure they will want to consider his comments further prior to Third Reading. On that basis, I beg leave to withdraw the amendment.

Amendment 28 withdrawn.

Amendment 29 not moved.

Amendment 30

Moved by Baroness Barker

30: Clause 9, page 7, line 23, at end insert—

"( ) as to the production every three years of an independent research report into the effects of direct payments on provision of health services and health outcomes"

Baroness Barker (Liberal Democrat)

My Lords, in moving Amendment 30, I want to turn again, in a slightly different way, to what was the theme of our discussion at Committee Stage and has been again today. This is the fact that individual payments and their potential effects on healthcare systems, on the level of healthcare services and healthcare outcomes are all great unknowns. I hope, as do other noble Lords, that they are a positive benefit, but there are a great many uncertainties about the principles and practice that will surround their introduction.

Much of the supposition made by the Department of Health is based on very limited evidence of pilots which have been run in social care. It is worth pointing out that the pilots for direct payments and individual budgets in social care happened at a time when health and social care funding was at an unprecedented level of growth. That is unlikely to be the case when these services are introduced within the NHS.

I also want to direct noble Lords' attention back to the IBSEN research which we quoted extensively in Committee. It is one of the most tentative and circumspect research reports that I have ever seen. In Committee, I drew noble Lords' attention to the cost and cost-effectiveness of individual budgets in social care. The cost and cost-effectiveness of services in social care is very largely determined by salary level and the availability of staff. Given the change in the economy, the availability of social care staff may increase. There has been a horrible shortage of them for several years. Salary levels may go down, which might mean that this becomes a much more cost-effective way of delivering services. For those and similar reasons, which could bear repetition although I do not wish to detain the House, it is reasonable to say that this policy, even on a pilot basis, is built on a whole series of assumptions for which, as yet, there is very little evidence.

My amendment is worded deliberately. It talks about,

"the effects of direct payments on provision of health services and health outcomes".

It does not talk about the provision of those health services which will be funded by individual budgets. I return to a point that I have made several times before. Services for those with long-term and chronic conditions may be provided by the providers of acute services. By changing the funding patterns for part of what they do, one may potentially jeopardise the funding for the acute service. I make it clear that I am not talking about the impact on those conditions for which people are eligible to receive an individual budget; I am talking about the wider impact on health services and health outcomes.

Why should I propose that there be research every three years? First, I think that that is a long enough period in which to detect changes. Secondly, it is a sufficiently long period of time in which the effects of other relevant policy changes can be thrown up. It is also a similar timescale to that of a Comprehensive Spending Review. The position of health spending and the overall effects on the health service is a direct contributory factor to determining how people will have to use their individual budgets. Finally, a three-year timetable would take the process of research out of the political timescale as regards a change of Government. I believe that this is potentially one of the policies which will have the biggest impact on the provision of health services and health outcomes. It is therefore only right that it should be subject to regular independent review. I beg to move.

Lord Campbell-Savours (Labour)

My Lords, I will be very brief but I think this is quite an important amendment. I did not think it was so important as little as three or six months ago but it is particularly important now. This Bill was born in a time of relative affluence when the National Health Service saw huge increases in expenditure. We are going into a period which may be very different indeed. There are going to be all kinds of new pressures exerted on health service budgets with people crying out from every section of the health service for an increased share of the cake. A matter of only months ago we may not have thought that this would be a problem in the future. This needs regular review over and above pilots. Over the next couple of weeks before Third Reading additional consideration should be given to the principle behind this amendment. I know my noble friend will have to reject it now, but I appeal to him to ask his civil servants and his department to consider the period that we are going into and the new pressures which none of us, at this stage, is able to predict with any certainty.

Lord Darzi of Denham (Labour)

My Lords, Amendment 30 tabled by the noble Baronesses, Lady Barker and Lady Tonge, would create an expectation that direct payments would continue to be independently reviewed every three years, even after the pilot phase has concluded. Let me try to convince noble Lords why I do not believe that is necessary. I would be the first to say that any innovation such as this has to be evaluated, and I could not agree more with the noble Baroness that it needs to be a rigorous evaluation. It could have a tremendously positive impact on the patient and also on the health service. We will be speaking later about how we are calling for bids for independent evaluation. The question here is how long we keep evaluating something once we have had an independent evaluation of the pilots. We do not evaluate anything else independently in the health service. It all comes under our normal evaluation of our commissioning structures. If these pilots are successful, direct payments will be evaluated through the performance management of PCTs and their commissioning function will be evaluated as part of the world-class commissioning programme.

Maybe I misunderstood what the noble Baroness, Lady Barker, was suggesting. I will take back the issue of the behavioural change that might arise from providers and patients in relation to direct payments. That should be considered by the independent evaluating committee. I will never accept the idea of an independent rigorous academic evaluation without taking into account the behavioural change that the noble Baroness referred to.

The area I do not agree with is the impact of direct budgets on healthcare funding. This is innovation and innovation can save money. If we look at the evidence base of small pilots run in the US and from talking to stakeholders, including patient groups and the voluntary sector, we are constantly reminded of the amount of waste in the system. If the patient is empowered to make these decisions and have control of the payment, what cost savings might arise from that? Remember the wonderful example told by the noble Baroness, Lady Campbell, about her mattress. Let us remember the mattress story. The PCT was encouraging her to spend £3,000 and she found the same brand on the internet for about a tenth of the price. Let us have an open mind about this, which is the purpose of the independent evaluation. I hope I have made the case for why the Government see independent evaluation as important. Once we evaluate this independently, we have to make a call. Are direct payments going to benefit patients or do we need to decide what suits who based on our evaluation of the pilots? I hope I have reassured the noble Baroness enough to allow her to withdraw the amendment.

Baroness Barker (Liberal Democrat)

My Lords, I thank the Minister for one of the politest and most thoroughly considered responses that I have ever had to an amendment. I thank the noble Lord, Lord Campbell-Savours for his response, too. I hope the Minister will accept that I accept that individual budgets can bring about cost savings and be more efficient. I am not as convinced as he is that they will automatically be more effective and efficient. Even the noble Baroness, Lady Campbell, who was a bit embarrassed about the example of her mattress, had the grace to concede that a physiotherapy service in which the physiotherapist goes to somebody's work to provide physiotherapy at a point and place convenient to the person receiving the service might have a higher unit cost than one that is run for the benefit of several people from a traditional NHS facility. Let us not take one example and from it extrapolate savings that may or may not arise across the NHS.

I want individual budgets to succeed. A critical part of their success will be their being subject to full, rigorous and independent review. I suspect that the process will have to carry on way beyond pilots. Pilots are carried out by people who are enthusiastic and work extremely hard to make sure that they are a success. That may not be the case when they are rolled out, as I am sure that they will be, throughout the whole of the NHS. I thank the Minister and beg leave to withdraw the amendment.

Amendment 30 withdrawn.

Amendment 31 not moved.

Consideration on Report adjourned.