My Lords, I shall speak also to Amendments 2 to 10. On Report, the noble Earl, Lord Howe, tabled an amendment to ensure that Parliament is given an opportunity to scrutinise any changes to the guiding principles set out in the NHS Constitution. In the government amendments that I bring forward now, we have accepted the principle of the amendment but suggest an alternative form of wording to ensure that it fits with the existing clauses. These amendments require the Secretary of State to make regulations, under the negative resolution procedure, to address any changes to the guiding principles set out in the NHS Constitution.

Although they may look extensive, the amendments are minor and technical. They make it clear that regulations must be laid whether principles are changed as a result of the 10-yearly review of the constitution or as a result of more periodic revisions. To achieve that, they make clearer the distinction between a review and a revision, and correct cross-references.

Any changes to the guiding principles in the future would already require consultation, as we set out in the Bill from the start. However, I have listened to the concerns of the House about the role of Parliament in determining the guiding principles, and the amendments address those concerns. I hope that noble Lords are content with these amendments and I beg to move.

My Lords, I very much appreciate the Government’s acceptance of the underlying principle of the amendment carried by your Lordships on Report, and of course I accept the reformulation proposed by the Minister.

The fear that some people had that an amendment of this kind might open the floodgates to litigation against the NHS was never one that I considered to be well founded. I still do not believe that. It would have validity if the scope of these amendments were to extend more widely than they do—if, for example, they were to embrace specific rights. However, in so far as the guiding principles are already underpinned by existing primary legislation, there cannot reasonably be a fear that, by linking the constitution directly to the parliamentary process, we will be creating the potential for a lawyers’ charter.

As I said, I am most grateful to the Minister for having given this matter his close consideration and for having brought forward these amendments. I hope that they will be accepted.

My Lords, I strongly support what has been said. It is extremely good that the Minister has felt able to modify the Bill in this way. A lawyers’ charter is not a particularly fearsome prospect for me. However, the best protection against lawyers’ charters is clear drafting, and these amendments are clearly drafted.

My Lords, these amendments clarify our intentions around supporting patients and reviewing the pilot schemes. Having listened to the excellent debates on Report and in Grand Committee, I promised to consider these issues further, and I have consulted the noble Baroness, Lady Barker. I hope these amendments address noble Lords’ concerns.

Amendment 11 would make it more explicit on the face of the Bill that the NHS should make arrangements to ensure that patients, or people receiving direct payments on someone else’s behalf, are able to access advice, information, and other support. As I have said in earlier debates, having proper support in place is vital for the success of this policy, and support could be delivered in many ways. The pilot proposals we have received contain a range of innovative ideas. We want to allow for flexibility rather than prescribe a particular approach.

The amendment will allow our regulations to be broad enough to allow innovation to flourish, while ensuring that people are well supported. It will also allow patients to buy support services using their direct payments. Some people have suggested that PCTs should commission and pay for support services centrally. Others have proposed including an element within the personal health budget to allow patients to choose the support that is right for them. It is likely that different approaches will work in different circumstances, and this amendment gives us the flexibility to test both.

Amendment 12 clarifies how we intend to evaluate direct payments. The first part highlights our objective to commission and publish an independent evaluation. Noble Lords may know that the department recently published a detailed invitation to tender for the evaluation of the personal health budgets pilot programme. We hope to have a team of independent researchers in place by the summer.

I emphasise that every pilot site will be involved in the evaluation. In practice, it is likely that a representative subset of the pilots, chosen by the evaluation team, will be examined in great detail, while the other sites contribute information. This will give both breadth and depth to the analysis.

The evaluation will, of course, specifically consider the effect of direct payments as a mechanism for delivering personal health budgets. The findings of the evaluation will be published. Moreover, before the Government can extend direct payments more widely, each House of Parliament must give its express approval, through the affirmative resolution procedure.

The second proposed new subsection in the amendment allows the Government to specify in regulations some of the issues the review should address. These include reviewing the administration of the schemes, the effect of direct payments on the cost or quality of care, and the impact on the behaviour of patients, carers and providers.

I know that the noble Baroness, Lady Barker, is particularly concerned about the potential effect of personal budgets on other services, particularly the effect on smaller specialised service providers. The amendment is deliberately worded in a general way to emphasise that we intend to examine the effect of direct payments both on the people who receive them and on those who do not. Our invitation to tender makes that clear.

Amendment 13 is a technical amendment, reflecting the addition of these paragraphs in new Section 12C. We have listened to the points raised in the debate and I believe that these government amendments respond to them. They provide explicit reassurance that we intend there to be a proper support in place for people receiving direct payments, and that the evaluation should be rigorous and independent. I commend these amendments to the House. I beg to move.

My Lords, I thank the noble Lord, Lord Darzi, for tabling these amendments. They are the product of intense discussions between the department and myself. I am most grateful that we have achieved a resolution of matters which although technical and boring are of great importance to the working of this policy. I am delighted to be able to do so in the presence of the noble Baroness, Lady Campbell, because those who sat through our discussions will see her hand in this amendment in the inclusion of the word “support”. She took me to task on my original proposals and she made them better. I am therefore pleased that this represents a victory for her, too.

I do not want to restate the arguments we had during previous stages. I am pleased that the noble Lord has seen the importance of requiring primary care trusts to pay attention to the provision of these services, not least because in the department’s own advice and guidance to commissioners, it talks about reliance on existing services such as the CAB. When these pilots take place, those services will be going through a great deal of upheaval and may not be readily accessible to people.

As regards the review, I thank the Minister for his explanation and for sharing with me the detailed spec for the review process. However, I seek clarification from him on one point. He talked about the wording of the amendment, enabling the research to focus not only on those patients who receive direct payments, but also on those who do not. I would welcome his confirmation that the wording of the amendment is such that it would not be a matter of looking only at those patients who do or do not receive direct payments for the same service, but looking at the impact of a service which is funded by direct payment on other parts of the health service. That is the point that I have been trying to make for the past week.

I am under no illusion that it will be an extremely complex piece of research. The noble Lord, Lord Darzi, talked about the need to research the cost of direct payments, but to research the cost-effectiveness of direct payments will require a level of monitoring and accountancy, and sophistication in those, which is as yet unseen. We need properly to be able to answer the question, “Does the move towards direct payments and individual budgets not only benefit patients in terms of the outcomes of those services, but decrease reliance on other services in the NHS?”. That is a critical part of the issue. From what the Minister has said, I believe that he will be able to give me a satisfactory answer. With that in mind, I thank him very much for the work that he has done to get us to this point.

My Lords, these amendments immensely strengthen this part of the Bill, and reflect a key part of the concerns raised at earlier stages from all parts of the House, including mine. Like the noble Baroness, I very much welcome all these amendments, especially Amendment 11, which seems to address an aspect of the direct payment scheme that is likely to prove central to its uptake and success, namely the provision of,

“information, advice or other support”,

for those who decide to try that scheme. I hope that these amendments will be accepted.

My Lords, I am grateful for the support that these amendments have received. To clarify the issue raised by the noble Baroness, Lady Barker, the tender for the evaluation is based on five broad areas: the effects on individual outcomes, including carers and informal carers; the behavioural change on both individuals and NHS staff; finances and cost-effectiveness; system effects, including impact on staff and other existing services, and how personal budgets have been implemented. It covers a wide range of services, so I very much hope to have reassured the noble Baroness.

My Lords, on Report, the noble Lords, Lord Walton and Lord Patel, and the noble Baroness, Lady Finlay, tabled an important amendment that sought to make it clear that innovation prizes would encompass research. It has always been our intention that prizes would include research; innovation is a broad concept, of which research is a vital part. The purpose of the innovation challenge prizes is to recognise and promote excellence in innovation, including research. I am grateful to the noble Lords for our useful discussions on the matter and hope that this amendment puts that important point beyond doubt. I beg to move.

My Lords, I am very grateful to the Minister for that, and for the opportunity that he gave us to meet him and members of the Bill team last Thursday. I was concerned to express the fact at Second Reading—and again in Committee and on Report—that the responsibility of the National Health Service for the education and training of healthcare professionals was not formally acknowledged in the Bill. However, after our discussions I am sufficiently reassured that any revision of the NHS Constitution and other issues would take full account of the needs and concerns of those involved in such education and training. In the light of those assurances, then, the amendment that we had considered tabling for Third Reading has proved unnecessary.

At the same time, I expressed the concern that had been conveyed to me—not least, by the Medical Research Council, the Wellcome Trust and the Association of Medical Research Charities—that the word “research” did not formally appear in the Bill. All innovation is, in many respects, dependent on research. Whether the innovation is physical, social, behavioural, scientific, or whatever its nature, achieving it depends on a background of inquiry and research. For that reason, I believe that the amendment meets our concerns precisely, and I am delighted to see it now come into the Bill.

My Lords, I do not wish to reiterate the words of my noble friend Lord Walton, except to add my thanks to the Minister for having listened so attentively and worked with us to make sure that “research” appears in the Bill. For the record, I also thank him for his recognition that research might originate outside England—for example, in Wales—but result in excellent innovation in England, and that Welsh researchers would not be denied credit simply because their research was done on the other side of Offa’s Dyke.

As we have come to the end of the government amendments to the Bill, I take this opportunity, on behalf of all patients waiting for transplants and on behalf of their families who struggle with the difficulties of transplants, to thank the Minister and the Bill team most sincerely. Although not directly relevant to the amendment, the guidance on the preferential donation principle, which I introduced earlier, is now being taken forward. I have had the privilege of being able to comment on the confidential draft guidance and it looks satisfactory. When linked to the training of transplant co-ordinators, I think it will greatly improve donation rates. I hope that those families with the rare situation which I outlined will ensure that the wishes of the person who died are respected. I am most grateful to the Minister and his team.

My Lords, Amendment 15 seeks to enable health trusts to develop private health services outside the private patient cap on condition that they are, in all the circumstances, in the interests of the National Health Service. I must declare an interest as the chair of a mental health foundation trust in east London and I make it clear that my own trust will not plan any changes in its own practice whether or not this amendment becomes law.

The new clause leaves the private patient cap in place, although I believe that as soon as possible it needs to be replaced by a new framework. As we debated in Committee and on Report, the cap varies from one trust to another. I shall not repeat our earlier debates; suffice it to say that the cap is well recognised to be illogical and unhelpful. By providing for exceptions, the amendment opens up an opportunity for rational decision-making as long as the interests of the NHS are served. Introducing that one principle into the Bill is something to which all sides of the House would subscribe.

I hope that proposed new subsection (4B) in the amendment will enable Ministers to introduce regulations which will extend important principles to all private patient service developments, and not only to services developed over and above the level allowed by the cap. Examples would include the principle that private patient services will not be subsidised by the NHS and the principle that those services will not dilute or adversely affect the core values of the NHS. In my view, both are crucial principles but they are absent from the 2006 Act.

A further powerful argument in favour of the amendment is that it will enable the NHS to benefit from the considerable export opportunities provided by our highly respected NHS clinicians. We can ill afford to squander that opportunity. The amendment would protect the NHS, while increasing flexibility. I beg to move.

My Lords, I cannot add very much to what the noble Baroness has said. The virtue of this amendment, as drafted, is that it would allow the Government to make changes to the rules governing the private patient income cap at a time entirely of their choosing. It would not tie the Government down and it would allow Ministers to reformulate these rules in whatever way they decide, as long as any changes conform to the key principle spelt out in the amendment. In the absence of any likely legislative vehicle for making a change of this kind, at least in the near future, I hope that the amendment will be considered seriously by the Government.

My Lords, I very much hope that my noble friend will reject this amendment for the reasons which were very carefully put by a number of us in Committee. These are incredibly sensitive matters for the House of Commons. When the original legislation went through, undertakings were clearly given by Ministers in the Commons to our Back-Benchers which enabled them to vote for the whole principle enshrined in foundation trust status. I hope that my noble friend is not tempted in any way to re-enter that discussion. If these matters are to be considered, it should be on the back of primary legislation which starts in the House of Commons, where Members can then consider them in Committee and they can be dealt with comprehensively before they enter this place. I hope that my noble friend will not take this opportunity to amend the law in any way in this area.

My Lords, I support the amendment, to which I have put my name. I declare two interests. I was the Minister who moved the offending clause in the 2003 Act in this House. As I said on Report, I repent my sins. I do so again. I will explain why I differ from my noble friend Lord Campbell-Savours. First, I must declare an interest as an adviser to the General Healthcare Group, which is a private hospital. It is in no way asking me to support this amendment; I have had no conversations with the General Healthcare Group about it. I am doing this because I think that the legislation, as framed, is wrong and detrimental to the NHS.

Why do I think that? First, the world has moved on since we passed the legislation in 2003. There was a different set of circumstances then. We now know that foundation trusts are an important part of the NHS landscape. They have proved very successful. If you look at the Healthcare Commission’s ratings, foundation trusts are in many ways extremely successful because of the excellence of their services and their management of financial resources. There were, if we are honest, doubts about foundation trusts at the time that this legislation was passed. Some of those doubts were expressed in the issue of a private patient cap. That is no longer the context in which we are dealing with this.

The cap itself has been arbitrary. It chooses a base year when people were in different positions in terms of their private incomes. The consequence of that definition has been that whether particular trusts are caught by the cap is almost random. I do not make a major claim about this, but it has in a few cases prevented an NHS trust getting foundation trust status because its business case depended—partly because of its international reputation—on growing private practice, usually from overseas earnings that would benefit the NHS. Legislation that is supposed to protect the NHS is, in my view, damaging it. We are moving into a financial climate where the NHS—if I may put it as gently as this—will need every penny that it can get to meet public expectations, which always continue to rise in our modern world, and some of the demographic challenges that it will face. It seems a bit of an own goal to restrict the ability of NHS trusts to marshal their activities, without detriment to NHS patients, so that they can generate some income from this.

My noble friends have said that the case is now under judicial review at the High Court, so it is difficult to deal with this; we should wait for the judgments and then move the legislation that may need to be put in place. I have always found that the courts welcome clarity from the Executive about what their policy intents are. This is not to prejudge the case that is before the High Court, and which was, as I recall, taken apart by UNISON. However, it would be helpful for the Government to be absolutely clear about where they stand on this issue. The issue seems to be one of making it very clear that there is a public acceptance that the present cap is arbitrary and unfair; and that there is a willingness on the part of the Government, at an appropriate time, to make changes that will make it fairer and will not stop the NHS benefiting from raising income from private patients—without detriment to NHS patients—which could provide extra income to develop NHS services. I would like much more clarity on this issue because the worst of all worlds would be a judicial judgment which is more restrictive than what we have at the moment, and that cannot be beyond peradventure. We need to be clear about the Government’s position so that we do not end up with an even more restrictive cap and no legislative opportunity to change things back, even to where we thought they were in 2003.

That is why I support the amendment. I hope that we will have some reassurance from the Government on this issue.

My Lords, during our earlier deliberations I had a great deal of sympathy with the position put forward by the noble Lord, Lord Campbell-Savours. My name is on the amendment and the reason for that is very simple. We could debate how foundation trusts operate in great detail and at considerable length—as we did during the passage of the legislation to which the noble Lord, Lord Warner, has just referred—but, ultimately, proposed new subsection (4A) contains the key point, that any private-patient work must be in the interests of the NHS. However long we continue to debate this issue in great detail, I am persuaded that that is the critical point, and the fact that we have agreement across the House on it is important. Another important point is the arbitrary nature of the way in which the cap is working and the problems that it creates for mental health trusts in particular. Those two factors alone were sufficient to convince me that this is a move forward in the right direction.

My Lords, does the noble Baroness accept that this relates not only to mental health trusts? This is a Trojan horse that could be used by a future Government to completely undermine whole areas of the National Health Service. I am astonished to find her name on this amendment.

My Lords, I support the amendment because, as the noble Lord, Lord Warner, said, we are in a very changing world. I shall refer only to the area of cross-border healthcare. The present amendments are opening up our thinking to the changes happening in health services. At the moment we have a minimal cross-border healthcare system but the European Union and the Commission are looking at developing it and that will be an added complication. Anything that frees up health trusts’ ability to think through the provision of alternative ways of developing their services would be helpful. I therefore support the amendment.

My Lords, I, too, strongly support the amendment. My attitude may be coloured by my personal experience, but I look back to the time when Mrs Castle, later Baroness Castle, attempted to remove all private beds from all National Health Service hospitals. I was a whole-time NHS consultant with a personal chair and I had a major research unit studying neuromuscular diseases in Newcastle-upon-Tyne. In that city there were three major hospitals, each of which had one private bed. The result, to my great regret, was that I could not admit to hospital patients who were referred to me from other countries—patients from Australia, and even two from the United States—to take advantage of my unit’s facilities for research and investigation. There were no private beds to which I could admit them and no private hospital in that city had anything like the facilities necessary for that particular purpose.

This cap was based on private income in hospitals in 2003, but the world has moved on since then. Particularly within our foundation hospitals, but also within our university departments, there are professorial units with innovative procedures and treatments that are being rapidly developed and could prove to be not only extremely important for patients—after all, let us not forget the large number of patients in the UK who are insured for private medical care—but also a very attractive possibility for patients coming to this country from overseas who must by law be private patients if they are admitted to hospitals in the National Health Service.

The present cap is proving to be outdated, illogical and detrimental to processes which could benefit the NHS by bringing in substantial additional finance to support its work. The amendment is cleverly phrased to indicate that:

“The Secretary of State may by regulations make provision for exceptions”.

It rests with the Secretary of State,

“subject to the principle that any such exception must in all the circumstances be in the interests of the National Health Service”.

That is a very satisfactory way to frame the amendment and I support it strongly.

My Lords, I would like to ask a question because of what the noble Lord, Lord Campbell-Savours, said. Are there not very strong safeguards in this amendment to protect the National Health Service? I travelled back from Mauritius once with a young child whose face was covered with a terrible cancer. Would it not benefit that sort of patient to be given treatment in our hospitals, because their countries do not have the facilities? We must be a humane country.

My Lords, Amendment 15, tabled by the noble Baroness, Lady Meacher, and supported by the noble Baroness, Lady Barker, the noble Lord, Lord Warner, and the noble Earl, Lord Howe, seeks to maintain the existing rules governing the private patient income cap for NHS foundation trusts. The amendment would allow the Secretary of State to make regulations to permit exceptions to the general rule. An exception could be permitted only if it was in the interests of the NHS to do so. The regulations can specify other conditions and principles on which such exemptions may be permitted.

The Government recognise the concerns which have been presented to us. We have also listened carefully to the views expressed in debate, not least that caps set by reference to historical income levels appear increasingly arbitrary. The Government sympathise with and understand the intention and spirit behind today’s amendment.

In our previous debates on this issue I made clear the Government’s desire for a wider debate on the cap. Following the outcome of the judicial review on the current legislation, it is our intention to begin a review to address precisely how to strike the right balance between protecting NHS services for NHS patients and allowing NHS foundation trusts the flexibility they need to operate effectively in the best interests of patients. This would mean a review of the cap and appropriate action to follow.

I turn to the specifics of the amendment. It is quite right that to change the cap would require primary legislation. However, I have genuine concerns about the approach that the amendment takes and about rushing into any quick legislative fix. I would like to take a few moments to set out some of the issues raised by the amendment and explain why a broader review following a clear process would be a better and more practical route to take and be in the best interests of the NHS.

As your Lordships know, this is a complex policy area. The fact that we have already discussed it twice, in Grand Committee and on Report, highlights both the range of views that need to be taken into account and the difficulty of crafting legislation.

The amendment would enable the Secretary of State to make exceptions to the current cap. However, it would not remove the cap’s underlying principle that the private income of a foundation trust should be restricted according to levels set in 2002-03. The Secretary of State would be able to use regulations under the amendment to create exemptions to the cap; for example, to allow mental health foundation trusts to carry out private patient work. However, legal advice is that those regulations could not be used to such an extent that the effect of the underpinning primary legislation was nullified. In short, we could not use exemptions to get rid of the underlying rule. The level playing field which was described in Committee by the noble Baroness, Lady Meacher, with a new system having an equal impact on both NHS and foundation trusts, would not be achieved.

As noble Lords will be aware, a judicial review is currently considering what income counts towards the cap. The Government are an interested party in the legal proceedings, so I will not comment on the interpretation of the current provisions. However, noble Lords will wish to be made aware that, even if this amendment were accepted, there would still be the issue of what income counts towards the cap. The court will give a judgment on that issue.

We might best describe this as a quick-fix solution, and I understand why people would be tempted by it, but it would not address the issues and underlying problems with the cap that we have discussed. We need a wholesale review of the underlying rule. The Government believe that the best way to reform the cap would be to create a new test or set of principles that would apply equally to all foundation trusts, reforming the rules so that they are clear, logical and work well. We are keen not to replicate the current situation with the cap from the 2003 Act by bringing in new primary legislation without first discussing and testing it thoroughly with the NHS—the people who will put the new arrangements into practice.

We have heard in our discussions the wide range of views on the issue. Key stakeholder organisations inside and outside the NHS should be given the opportunity to contribute to a debate on the design of the new framework which should begin as soon as the judicial review is complete. We should not try to reach a consensus quickly on what the future framework should look like without consulting foundation trusts from the outset. The reform of rules that impact directly on them, in the context of an evolving health policy framework, needs to be considered in the round.

We agree that private patient activity should not lead to a poorer service for NHS patients and that private income should subsidise NHS care and, therefore, be used to improve and widen NHS services. We also agree that NHS foundation trusts must above all preserve and promote the values of the NHS. We therefore need to go through a clear, fair, practical process to develop fully the best policy solution before we legislate—which we will of course do at the first opportunity once the approach has been agreed.

I repeat our commitment to take forward a review following the outcome of the current judicial review. This is the most sensible way of making sure that any new approach reflects the views of those affected and enables us to test those practical solutions. With this assurance in mind, and with thanks to noble Lords for the valuable contributions they have made to the discussion, I hope that the noble Baroness will withdraw the amendment.

My Lords, I thank the Minister for her comments. I recognise that the amendment does not answer all the problems that the cap poses for the NHS—that is inevitable. However, the amendment does enable—quickly—some opportunities for rational decision-making that are not there at the moment.

The amendment clearly places in the Bill a principle that has the support of all sides of the House. I have been given assurances that there are people in the Government who do not have a problem with it, because it is going in the direction that the noble Baroness, Lady Thornton, indicated the Government want to go in. We are saying, “Let us take a step forward in the direction that the Government want to go”.

When the Government are able to institute a review, we would all hope to be involved in it, contribute to it and support it. Then, if possible, a consensus can be found through a good consultation process in which all the issues can be resolved, and a set of principles wider than we are able to deal with today can be put into a future Bill. However, that is all for the future. There is no upcoming health Bill, and the issues are too important to leave for an unspecified opportunity in the future. NHS foundation trusts up and down the country are struggling with this. In my view, having the principle in the Bill will affect how people operate. We have boards of governors and members councils out there that will be watching this and will know that the principle is in the Bill—if we can get it in the Bill. Personally, as somebody who passionately believes in the NHS and NHS patients, I want—and we want—that principle in the Bill. Therefore, I wish to test the opinion of the House.