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The Minister of State, Department of Health (Mr. John Denham): We had a lengthy debate on the new clauses last night and important issues have been raised, although some of those were fully explored in Committee. I shall try to deal with some of the issues that were raised in last night's debate.

The casual observer of the debate might think that the Bill is about the establishment of the National Institute for Clinical Excellence, which has been established in the proper way as a special health authority. Given the way in which the Bill intermeshes with other reforms that the Government are carrying through, it is understandable that hon. Members have sought to debate NICE and its relationship to other health reforms.

As we have made clear on numerous occasions, NICE will play a key role in modernising the NHS and driving up standards within it. The intention is that the national institute will issue authoritative guidance to health professionals, and help to ensure the faster and more uniform uptake of clinically effective and cost-effective treatments. New clause 14 tabled by the Liberal Democrats deals with a number of separate issues. Subsection (1) would require NICE to hold its meetings in public. It is entirely right that there should be openness and transparency in the workings of NICE. During the debate on the establishment of NICE we made a commitment to extend the Public Bodies (Access to Meetings) Act 1960 to incorporate the National Institute

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for Clinical Excellence. We are doing that. We are currently preparing a statutory instrument to ensure that NICE will be subject to the 1960 Act. In practice, that means that meetings will generally be open to the public, but allows them to be excluded where publicity would be prejudicial to the public interest by reason of the confidential nature of the business or for other special reason.

Mr. Simon Hughes (Southwark, North and Bermondsey): I am grateful to the Minister for his helpful remarks. On the qualification point, which I understand, can he give us an assurance that if there are to be times when NICE will meet in secret for the reasons that he has given, a record of the meeting and its conclusions will be available to the public at a later stage? I understand that occasionally a meeting may need to be held in secret.

Mr. Denham: I am sure that normal procedures with regard to publication of records of meetings of public bodies would apply. I imagine--the matter is probably worthy of further examination--that if the information would be of great commercial importance to the companies whose products were being appraised, great care should be taken by me this evening not to give the impression that the position of those companies would be lightly undermined. I am sure that normal procedures for public bodies would otherwise apply.

Subsection (2) of new clause 14 would require NICE to publish an annual report, and would require the Secretary of State to lay the report before Parliament. It has also long been the Government's intention that NICE should publish an annual report, and that, as is common practice, the report should be made available to Parliament.We do not need primary legislation to do that. It will be achieved through directions issued by the Secretary of State.

The national institute is a special health authority established in secondary legislation under the National Health Service Act 1977 and, accordingly, directions are the appropriate way forward. Subsections (3) and (4) confuse the role of NICE and the guidance that it will issue with the way in which priorities are set in the NHS. That goes to the heart of part of the debate last night.

By developing a consistent body of guidance on the clinical effectiveness and cost-effectiveness of different treatments and procedures, NICE will play an important role in tackling unjustified variations in access to treatment and it will provide valuable information on which clinicians, the Government and others in the NHS will make their decisions. NICE will, we believe, help to ensure that the most clinically effective and cost-effective treatments are widely available, without the delays that have accompanied the introduction of effective treatments in the past. However, we do not intend that NICE should become a substitute for the decisions that clinicians and others must take. That was the point raised by the hon. Member for Buckingham (Mr. Bercow).

Ministers are accountable for setting overall priorities for the NHS and, on occasion, for setting specific priorities--for example, the priority that we attach to the coronary heart disease national service framework. We have also given a particular priority to smoking cessation. Ministers are and must remain accountable for those decisions. On the example of smoking, as we discussed

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in Committee, there is a substantial body of work on the clinical and cost-effectiveness of smoking cessation. As it happens, that guidance predates NICE, but is the sort of guidance that might be issued by NICE in the future. I believe that it is right that we should establish NICE to make such information available. I also believe that it is right that in such a case it is the Government who set the priorities.

However, not all such decisions are taken by Government. Clinicians must also take important decisions about the treatments that are best for their patients and, in so doing, they want information about clinical and cost-effectiveness. NICE will provide that information, but NICE has no power to determine what decision is taken in each individual case. If a drug or treatment were ruled out on the NHS, that could be done only by the Government, and therefore by Ministers, as is the case at present.

The Liberal Democrats seem to want to transfer both the general responsibility of Government and the specific individual decisions of clinicians to NICE. That is what I understand to be the role of the patients forum that the Liberal Democrats want to establish. That is not the role that we intend NICE to play. I do not believe that it is the role NICE should play, whether it is advised by a committee of patients or not.

Of course, patients and their representatives have an important role in shaping the way in which NICE approaches its task. That is reflected in the way that patients are represented on the partners council. Through the council patients will help to ensure that the guidance that NICE issues is as good as it can be, and that NICE produces its guidance in a form that all groups can best understand. We want the information to be accessible to patients as well as to clinicians, and they will help to ensure that the voice of patients and other important stakeholders will be heard at the heart of the national institute.

Mr. Bercow: The hon. Gentleman said a moment ago that only the Government would be in a position--ultimately, I presume he means--to rule out the provision of treatments. Assuming that in some circumstances the national institute might judge that a particular treatment was not cost-effective and should not therefore be provided, is the hon. Gentleman referring to a situation in which NICE has one view and the Government have another? If so, is NICE obliged to accept some form of collective responsibility, or is it entitled to make it clear that although it defers to the Government, it disagrees with the Government's decision?

Mr. Denham: The point that I was making is straightforward. Perhaps I can best deal with it by turning to new clause 4, which covers it. As I said in Committee, NICE will operate within a framework agreement set by the Secretary of State.

We are committed to ensuring that that framework, and any other guidance from the Secretary of State, is open and transparent. It will be clear where the Government have given guidance, if they did so. We made it clear in the appraisal document, "Faster Access to Modern Treatment", that there may be circumstances in which NICE concludes that a particular procedure should not generally be available on the NHS, because of its lack of clinical or cost-effectiveness or because alternative procedures are simply and clearly more effective.

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We would expect health authorities, primary care groups and primary care trusts, NHS trusts and clinicians to take full account of such guidance, but it is important to make it clear that NICE will have no power to reach and impose a decision on what is or is not available. If, having read NICE guidance, Ministers concluded that it should be enforced by regulation, it must remain the responsibility of Ministers to take such a decision and be accountable for it.

Mr. Philip Hammond (Runnymede and Weybridge): The Minister has several times used the phrase "cost-effectiveness". Can he elaborate on what he means by that? When he asks NICE to consider various treatments for the same symptom or disorder, it is clear how he will measure the cost-effectiveness, but how will he measure the cost-effectiveness of a treatment for cancer against the cost-effectiveness of a hip replacement?

8 pm

Mr. Denham: The point is that it will be for NICE to make the judgments and to explain how it has reached the judgments that it will provide on particular treatments or interventions. If it compares different approaches to treating a particular condition, it must also explain how it has assessed those approaches, one against the other, and reached its conclusions. That is the role that we will look to the national institute to play in making the appraisals that we have asked it to make. Professor Michael Rawlins, the widely respected chairman of the national institute, will play a role in developing the methodologies that will enable that to be done effectively, which is one reason why we want substantial expertise to be available to the national institute.

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