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Incidentally, it is not just the pharmaceutical industry that is a key sector for the Government in relation to skills upgrading and working in a global economy more successfully. In the United Kingdom, we are developing a professional grade of regulator—the people who do this stuff and do it well—that is beginning to become world renowned. I am talking about the quality of those people’s work and the systems that they use.

[The Sitting was suspended for a Division in the House from 4.15 to 4.25 pm.]

Lord Kirkwood of Kirkhope: I was concurring with the noble Lord, Lord Warner, and the noble Baroness, Lady Cumberlege, about the quality of the NHS and, indeed, the quality of the regulators who serve the NHS. That world-class quality is something that we should be proud of and hope to develop.

Of course, it is true that, as the noble Earl, Lord Howe, mentioned in his powerful introductory remarks, equality of access and lack of consistency are the key questions here. NICE is not the only appraisal system that we have in the United Kingdom. I have already said that the value of the NHS to this country is immeasurable, but it is an NHS that has core central principles that are consistent throughout the nation states of the United Kingdom. It is an NHS that is changing and diverging, quite properly, through the devolved legislatures in Scotland and Wales. New systems are now being looked at and developed and there is a degree of constructive divergence, which I think impinges on the work of NICE.

At the outset, I echo noble Lords’ words in saying that I have a high regard for the quality of the work at NICE and for the people who carry out the multiple technology appraisals. They have established a world-class standard for doing that. I do no want to go into too much detail, but noble Lords may know that in Scotland we have the Scottish Medicines Consortium, which does things differently, and in Wales there is the All Wales Medicines Strategy Group. These three different systems are rotating and operating together, but I think that it is now time that we had another look at how they are all gelling—if, indeed, they are all gelling—where the gaps lie and how those gaps can be addressed.

Noble Lords probably all know that NICE deals only with the medicines, techniques and procedures that are referred to it—that is, something like 20 per

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cent of the new medicines that come on stream. Therefore, 80 per cent of medicines are left outside the NICE appraisal net. NICE has done roughly 130 appraisals since it was set up in 1999, but multiple technology appraisals take nearly two years on average to complete and cost a quarter of a million pounds each. By definition, the scrupulous way in which NICE carries out those appraisals means that there are pressures in the system.

I can illustrate that very easily. There is a drug called Alimta that deals with mesothelioma. It is a single medicine in its class; it is the only one available. I had better be careful that I do not sound as though I am being Scottish and triumphalist about this because that is not the case. I am talking about different systems and I understand perfectly well that NICE is a different system from the Scottish Medicines Consortium. They have evolved from different backgrounds, so I am not saying that one is right and one is wrong. However, Alimta was available to the ship workers at Rosyth who were clearing out some of the ships that the Royal Navy was decommissioning and who had been exposed to asbestos for many years. They had access to that drug in July 2005. On the other hand, the ship workers in the shipyards in Southampton got access to Alimta only earlier this month after NICE had taken nearly 1,000 days to appraise it. That cannot be right and it must be a matter of concern to the Government.

4.30 pm

If the Government are prepared to listen to evidence from the Committee this afternoon, perhaps I may adduce, in support of my case, the Office of Fair Trading report produced in February 2007. The Office of Fair Trading is obviously more concerned about price structuring, which is understandable, but under the heading, “The medium term”, the report states:

So it would be carried out in England, Scotland and Wales. The next sentence states:

That is the part that is missing. It is not that NICE is not doing the right thing or that the SMC is doing something better; it is that there is an absence of co-operation at a local level. The noble Earl, Lord Howe, has referred to this and I can think of many examples that are well known and well founded.

I do not think that that has changed. Certainly in my former incarnation as a Member of the House of Commons up to the last election, I discovered to my horror that hospital prescriptions are all recorded on paper. There is no IT in the primary care system. If you go to your GP and you are prescribed a drug, it is all carefully taken down, analysed and evaluated. Summaries are made to which GPs can refer to ascertain whether prophylactic treatments for certain conditions have proved effective in other patients before deciding whether or not to prescribe them. If you go into hospital and get the same drug, the paper prescription goes into a cardboard file. Therefore, the possibility of

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evaluating cost-effectiveness, as advocated by the OFT, is somewhat diminished. The OFT introduced the excellent idea of value-based pricing for the first time in 2007 and the Care Quality Commission should embrace it as an important part of its primary work.

For all these reasons, there is an urgent need to engage deeply the Care Quality Commission in some of the work of medicines appraisals currently carried out by NICE, the Scottish Medicines Consortium and the All Wales Medicines Strategy Group.

The noble Lord, Lord Warner, is right to say that cost is a significant factor. It is true that the Scottish Medicines Consortium works on a much smaller scale, but it is working within an NHS context because its members are derived from within the NHS and not from clinicians and academics outside it. Indeed, the SMC holds the pharmaceutical industry deliberately at arm’s length and treats it with some suspicion. The SMC is scrupulous about not being influenced in any way, shape or form and about retaining its objectivity.

A great deal of work can and should be done. On costs—and I am not trying to say that because the SMC is Scottish it is therefore the best—the SMC has an annual budget of less than £1 million compared with the NICE budget of £30 million, but there are many issues on which we can learn and share best practice and co-ordinate in a way that is not possible at the moment. These systems were set up in 1999-2000 and it is understandable that it is only now that we can start to get a grip on how they have developed, how they are working and how they can be improved. We have the chance to do that with this amendment.

If the Government are not willing to accept the amendment—I would be amazed to hear a constructive, common-sense reason for not accepting it—perhaps between now and Report they will consider a proposition that has been put to me which makes perfect sense. It derives from the fact that the Scottish Medicines Consortium, which was formed in 2001, took the view very early on that a NICE MTA would always supersede anything done by the SMC. The time has come for the Government, following what the OFT said about value-based pricing, to recommend that NICE should confer the status of NICE guidance on all Scottish Medicines Consortium advice on medicines that are not in the NICE work programme—the other 80 per cent of new treatments. If the Scottish Medicines Consortium thinks that medicines are good enough using single technology appraisals, not multiple technology appraisals—doing it faster, cheaper and in the context of an NHS where primary care trusts are already taking advice from the Scottish Medicines Consortium website—surely that could be formalised. Perhaps the Care Quality Commission needs to do this, but someone needs to investigate the positive prospect of getting some of those medicines and techniques into patients’ and users’ hands faster but safely. There are ways of doing that, of which that is one.

The Government were solicitous yesterday about suggestions from all sides of the Committee. I do not know what the noble Lord, Lord Darzi, was told when he was taken back to the office by his hard-faced officials, who are allegedly sometimes sitting behind

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him, but I hope that the Government will think seriously about this. Amendment No. 21, in particular, is very hard to argue against. It is of great importance to me and I hope that the Government will treat it seriously, think about it carefully and give us a clear answer. The noble Earl, Lord Howe, was absolutely right: the response to the Select Committee report, which says that this is something for the Care Quality Commission to do in future, is completely inadequate for the purpose and for the importance of the task that he is trying to address with this important amendment.

Baroness Masham of Ilton: Following the noble Lord, Lord Kirkwood, who is an expert in making suppositories, I must declare an interest because I use them. I use two every second day, which is a very important part of my life. I just want to say in support of this important amendment that, if we can do away with the postcode lottery, many people throughout the country will be greatly relieved.

Baroness Thornton: As the noble Earl, Lord Howe, outlined in his opening and powerfully argued remarks, which of course I take very seriously, the amendments all in some way seek to ensure that the importance of guidance and technology appraisals produced by the National Institute for Health and Clinical Excellence is explicit in the Bill.

The Government established NICE nine years ago to provide independent, authoritative advice to the NHS on the clinical effectiveness and the cost-effectiveness of new and existing treatments and, by doing so, to help to tackle variations in prescribing practice, as has been ably described by my noble friend Lord Warner. As mentioned by the noble Lord, Lord Walton of Detchant, whom we are delighted to see here, NICE has made a great success of that challenging brief, developing an international reputation for its work and improving its performance in recent years, and remains at the heart of the Government’s plans for driving forward quality improvement in the NHS.

I know how valuable NICE guidance is in supporting evidence-based decision-making. I therefore fully understand the desire of Members of the Committee to include specific mention of material produced by NICE in the Bill and genuinely appreciate the intention to support NICE that lies behind that. However, we cannot support the amendments. I will explain why for each in turn. It is the classic situation, as the Committee will realise as I go through, of what you put in the Bill and what you put in guidance, and testing which of those we think will be most effective. At the moment, we think that the words in the guidance are the most effective way.

Amendment No. 21 would amend Clause 2 to require the new commission in everything it did to have regard to the consistent application of NICE’s technological appraisals and other guidance as a means of providing equity of access to treatments and medicines. NICE guidance is of course an important and authoritative source of advice for the NHS on issues of clinical effectiveness and cost-effectiveness. I welcome the spirit of the amendment in underlining that fact. However, the amendment is very specific and what it

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would prescribe is not appropriate as an overarching factor that the commission should have regard to in carrying out its work. Factors that the commission should have regard to are not intended to be a list of specific sources of advice and guidance from specific organisations.

To ensure that flexibility is maintained, the registration requirements on which we are currently consulting are the appropriate place to deal with this issue. I have ensured that a pile of these documents is available at the door and I urge noble Lords who have not read the document from cover to cover to do so. I appreciate it particularly because it is written in plain English. Indeed, our first proposed registration requirement is,

The commission can take account of the relevant NICE guidance, specifically including NICE’s interventional procedures guidance, to ensure that the most appropriate treatments are being provided across all registered providers of care.

Our consultation document gives examples of how this proposed requirement is intended to work. The requirement on page 57 states:

Let us remind ourselves that, where registered care providers fail to meet registration requirements, the commission will be able to use the full range of its enforcement powers. This seems to be a more appropriate means to address the intention behind Amendment No. 21.

Amendment No. 71 refers to NICE guidance and technology appraisals produced by NICE in relation to standards. Standards in Clause 41 are to be used by PCTs and registered providers as brief common descriptions of aspects of healthcare quality, with the intention of informing improvement effort. I agree with the remarks of my noble friend Lord Warner and the noble Lord, Lord Kirkwood, in this respect. We want wide consultation and discussion on the detailed content of these standards. The Bill, therefore, contains a statutory requirement for these standards to be consulted on and kept under review.

Given our commitment to an open consultation on these standards, we would not want to make specific provisions in advance of the consultation process. NICE will, of course, be an important contributor to this consultation, and material produced by it is very likely to inform the development of specific standards. It is certainly not our intention to undermine NICE’s work by setting out a standards regime that is inconsistent with its guidance.

Amendment No. 88 relates to special reviews. Again, while appreciating the spirit of this amendment, I am unable to support it. Clause 44 already makes provision for the commission to carry out general service reviews, more specific reviews into particular matters and investigations into specific aspects of care. The commission will be free to take account of anything that it reasonably considers is relevant. The provisions as drafted would

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enable the commission to carry out reviews of the nature proposed by Amendment No. 88, which is, therefore, unnecessary.

Baroness Howarth of Breckland: While the noble Baroness is on that point, could she say what the timescale is for that consultation and whether the report from it will come during consideration of this Bill?

Baroness Thornton: I shall let the noble Baroness and other Members of the Committee know the answer to that. While I was reading, I was asking myself, “When does this start and end?”. I do not have the answer in front of me. I apologise for that.

Amendment No. 56 would make express provision in the Bill that, when issuing its registration guidance, the commission may look at compliance with guidance issued by NICE. Therefore, this provision is not needed, because Clause 19(3) already allows the commission to refer to provisions in other documents, including those issued by other bodies.

I was struck by the wisdom of the remarks of the noble Baroness, Lady Cumberlege, but I shall have to return to her specific question. I am grateful for the opportunity that this debate has given me to clarify how the work of NICE relates to the provisions in Part 1. I welcome the support for NICE and its work. I hope that I have been able to reassure the Committee that the Government remain committed to ensuring that the work that NICE carries out remains at the heart of the future development of the provisions of the National Health Service and that noble Lords will therefore feel able not to press their amendments.

4.45 pm

Earl Howe: I thank all noble Lords who have taken part in this debate, which has been very good. I thank the Minister for her full answer. There was a lot that was helpful in what she said, although I confess to being disappointed that she does not feel able to build something like these amendments into the wording of the Bill. The problem with the consultation document is that, although it contains a great deal of good stuff—if I can say that—it is only a consultation and we do not yet know how much or how little of it the Government are hoping to adopt in the end.

However, it is encouraging that some noises are being made in the direction of meeting the concerns that I have been articulating. I felt that the amendments were in large measure going with the grain of the Bill and of government policy, as I know that part of that policy is that the uptake of new medicines should be encouraged and assisted. I hope that we will see flowing out of this consultation something more concrete than just a set of aspirations. I will read carefully what the Minister has said between now and Report. We may have to return to this, but in the mean time I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 21A not moved.]

Earl Howe moved Amendment No. 22:



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The noble Earl said: We come to an issue that is central to any understanding of how the Care Quality Commission will set about its work and what kind of organisation it will be: its autonomy and the extent to which it will be able to operate independently from Ministers and the Government. I come from a simple starting point. If the Care Quality Commission is to be a body in which the public as well as public services have confidence, it needs to be seen as being, so far as is reasonably possible, free of political bias and political interference.

We all recognise that a public body of this sort cannot escape the realities of life; it cannot fail to have a sponsoring department, nor can we ask it not to co-operate with that department or with Ministers if it is to fulfil its remit. I am not troubled by that thought. Equally, I am not troubled by the thought that there should be a reserve power of direction for Ministers in the event that, for whatever reason, the commission is seen to be failing to carry out its statutory functions. The Bill provides for that in Clause 78.

There may also be circumstances where, for a compelling reason, Ministers believe that a particular issue warrants the commission carrying out an urgent special review. In Clause 44, the Bill will oblige the commission to conduct a special review if the Secretary of State so requests. I am less happy with that clause than I am with some others because it could conceivably be open to abuse in the form of political grandstanding, but in the overall scheme of things these provisions are not too problematic.

The issue of operational independence hangs on more complicated and more subtle considerations. We see in Clause 2(4), which is the focus of the amendment, a provision that says:

The Minister will no doubt point out that that is a form of words lifted directly from the 2003 Act, which set up both the Healthcare Commission and CSCI. So why should we worry about it? I accept that a clause such as this would give rise to little concern if other provisions in the Bill made it clear that ministerial direction was not the only thing that would determine the way in which the commission set a course for itself and defined its purpose in life. However, as we have already seen, the Bill is silent on the objectives that are to govern and underpin the commission’s way of working. Its way of working will be largely decided for it in advance because regulations drawn up by Ministers will determine, for example, the requirements that have to be met for the purposes of registration in Clause 16 and for deregistration under Clause 13. The commission does not even have the freedom to set its own performance indicators when conducting its periodic reviews. The Secretary of State has the power to devise them for himself.

It is often said that operational independence flows in part from having some measure of financial independence. We see in Clause 81 provisions enabling the commission to charge fees for performing its various functions. But it is the Secretary of State who will be

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in control, because the level of fees, the basis for charging fees and the manner in which fees are to be levied will all be subject to his approval. Therefore, at this stage, we do not know how much freedom will be afforded to the commission in that very practical sense.

Schedule 1 tells us that the appointment of the chair and members of the commission is to be in the gift of the Secretary of State. The Minister may say that there is nothing sinister in that but, looking back to our earlier debate on the salary of the chair of the commission, we have already seen an advertisement, which appears to suggest that the commission’s chair will have a status equivalent to that of a medium-ranking official in the department. It is as though the commission itself is being viewed by the Government as little more than a division of Richmond House. If noble Lords think that that is fanciful, they should look at Schedule 4, which covers the commission’s inspection programmes and frameworks. Paragraph 5(3) says:

What is that if it is not direct operational control from the centre? That is just one example. The requirement for the Secretary of State to give approval to proposals or actions by the commission features numerous times in Part 1 of the Bill.


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