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Lord Thomas of Gresford: I am afraid that I disagree with what the noble and learned Lord says. I believe that the Secretary of State should have a power to override only where such secondary legislation, whether by order or by regulation, amends primary legislation that has been passed at Westminster. I cannot see that any government would countenance giving the National Assembly a free hand through secondary legislation--by order or by regulation--to amend that which Westminster has passed. It is only in those specific, unusual circumstances that the Secretary of State would have that power.

If the noble and learned Lord looks at Clauses 3 and 4, he will see that, where there is a proposal to amend primary legislation--for example, to make insertions into Schedules 2A and 2B--the consent of the Secretary of State is required. I am not adding anything new. That is already there. I do not believe that there is anything wrong in principle with that, but I believe that that useful mechanism could be inserted into every Bill that affects Wales, that relates to the National Assembly and gives it that power. It is not a power to make major alterations or to make whatever alterations they want; it is simply a power to make such alterations as the Government at Westminster agree are necessary and to put them into effect without joining the queue of parliamentary time.

Lord Williams of Mostyn: I understand that. That is a perfectly understandable objective. I simply indicate that the mechanism produced at the moment will put more shackles on Cardiff because in relation to wholly devolved matters Cardiff will still have to come to the Secretary of State cap in hand. I believe that that is the law of unintended consequences.

Lord Thomas of Gresford: I disagree. This is not the first time that I have disagreed with the noble and learned Lord. We have had many a battle. In that spirit, for the moment, and only for the moment, I seek leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clauses 6 and 7 agreed to.

Clause 8 [Commencement, short title and extent]:

[Amendment No. 21 not moved.]

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Clause 8 agreed to.

Schedule--[Persons and arrangements subject to review]:

Lord Roberts of Conwy moved Amendment No. 22:

    Page 8, line 8, at end insert--

"Any police authority in Wales."."

The noble Lord said: I beg to move this amendment and with it speak to Amendments Nos. 23 to 26. These are indicative in the sense that they concern various bodies who have responsibilities for children and young people and those listed in Schedule 2B. I shall not go through each and every amendment, but their arrangements for dealing with complaints, disclosure and advocacy should surely be subject to review. I beg to move.

Baroness Farrington of Ribbleton: The amendment to be brought forward by the Government at Report will empower the commissioner to consider and make representations to the Assembly about any matter affecting the rights and welfare of children in Wales, and will allow him a locus in respect of those which have no functions within the Assembly's devolved fields of responsibility. This will of course include all those covered in this group of amendments. I hope that, in the light of this assurance, the noble Lord, Lord Roberts, will feel able to withdraw his amendment.

Lord Roberts of Conwy: I am delighted to beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 23 to 26 not moved.]

Schedule agreed to.

In the Title:

[Amendment No. 27 not moved.]

House resumed: Bill reported without amendment.

National Institute for Clinical Excellence

7.23 p.m.

Baroness Cumberlege rose to ask Her Majesty's Government whether the progress being made by the National Institute for Clinical Excellence in their appraisal of Beta interferons and glatiramer acetates is satisfactory.

The noble Baroness said: My Lords, I am very grateful to the noble Lords and the noble Minister who have agreed to take part in this debate. As your Lordships will recognise, there has been a degree of uncertainty concerning the business of the House because of concerns over the general election, and I have received a number of letters from noble Lords who are very interested in this subject but who expected the debate to be held later in the spring. I want to mention that because, although we are a select band here tonight, it is a small band and I would not like your Lordships to think that this is an issue which does not interest many people.

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The subject of glatiramer acetates and Beta interferons, which are licensed drugs and available to very few on the NHS, has been a very long-running sore. There are 85,000 people in the United Kingdom--that is a large number--who suffer from multiple sclerosis. This is a condition which I know is well known to noble Lords, but I should like to remind the House that multiple sclerosis is a most terrible condition.

First, it is unpredictable, and unpredictable in two ways. The relapses are unpredictable. Sufferers may undergo relapses of one month's duration, or six months or two years: they never know when one is coming. The second unpredictability is the severity of the attack. It can be mild; it can be very severe, and leave lasting damage. It causes chronic pain and physical disability of frightening proportions, and not just physical disability, but memory, mood, understanding and perceptions can be affected.

The average age of diagnosis is between the late twenties to the mid-forties, and that means people of working age and young parents endeavouring to bring up a family. As a consequence of the disease, they can lose their jobs, their livelihoods, and their families are affected. The physical and, in particular, the mental effects can cause break-ups in marriages and wreck relationships. It is a disease that destroys lives and life.

The one hope that sufferers have is through the new range of therapies--Beta interferons and glatiramer acetates--which reduce the number of relapses and the severity of the disease. They delay the progression and leave people less disabled and more able to cope with life and face the future. These drugs are licensed, but only a very few people can get them on the NHS. As a consequence, some sufferers have been known to sell their houses to buy the drugs privately.

I think this is a nonsense. It is unfair, it is unethical and it is unnecessary. On 6th August 1999 the department referred glatiramer acetates and Beta interferons to NICE for appraisal. Both therapies were to be assessed separately. On 6th December last year NICE confirmed its intention to issue separate determinations early this year. Suddenly, just before Christmas, on 22nd December, NICE announced that it would couple the medicines together again and undertake further economic modelling, thereby delaying the issue of guidance for many more months.

This caused utter misery and anger among MS sufferers. They feel they are being toyed with and not taken seriously. Some of them fear that the delay will mean that their condition will have deteriorated so far as to prevent them benefiting from the drugs.

The cost-effectiveness and clinical benefits of glatiramer acetates are clear. Coupling them with Beta interferons means that some MS patients who would have benefited from this drug are being denied it. The Health Minister in another place, John Denham, was asked on 6th February why glatiramer acetate was being treated as a Beta interferon when chemically and pharmacologically it is different. It has been tested for eight years and has been shown to reduce relapses by 70 per cent. The Minister made no reply, but I hope

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tonight that the Minister, who has had notice of this question and indeed of all the questions I am going to ask tonight, will be better briefed and give us a straight and unequivocal answer.

On 22nd December--that was the date of the bombshell announcement of further delay--the reason given for the delay was that it would allow NICE to commission, construct and evaluate new economic modelling. The results are to be considered by the appraisal committee in July. This will mean that the whole guidance process will have taken well over two years--27 months, to be exact. That is 27 months of further misery, fear and despair for MS sufferers, and for products which have been shown to be safe and clinically effective through the licensing system.

There is anger, and there is no confidence, first, that this process is at all necessary, and, secondly, that it will bring results. In fact there is a body of opinion which now labels NICE simply as a rationing body and a front for Ministers, who do not want to be seen taking responsibility for denying people their vital medication. To quote a spokesman for the Health Economics Consortium, which has been commissioned by NICE to undertake this work, the new model will still leave a "massive amount of uncertainty".

So it is not clear that NICE's appraisal committee will be better informed or more able to reach a judgment based on cost-effectiveness, since no threshold for cost-effectiveness has been discussed. Therefore I should like to ask the Minister: what is the threshold for cost-effectiveness? Is this an arbitrary measure, and who decides what it should be?

Glatiramer acetate has a known annual cost of 6,650 per patient per year. That is two-thirds of the cost of Beta interferon. Does the Minister believe that it would be reasonable for NICE to give positive guidance that at least this therapy is affordable at an additional cost to the NHS of 14 million over two years, benefiting more than 4,000 MS patients? Does he not agree that it is a drop in the ocean compared with the annual drugs budget of 5 billion to 6 billion a year and that the cost far outweighs the benefits?

The cost of treating MS patients with either drug must be offset against the cost of not treating patients with these drugs. Does NICE take into account the cost to the country of relapses and increasing disability; costs in terms of people unable to work; costs of social security, housing and unemployment benefits; and the costs of hospitalisation and so on?

The clinical efficacy of the Beta interferons and the glatiramer acetates is not in dispute, yet the new NICE process is seeking to elucidate the size of the clinical benefit. On 30th March, NICE requested the sponsors to provide raw patient data within four or five working days' notice and understandably it is concerned that this information should be used accurately and fairly in the new model. Yet no reassurance has been given to it on those counts. The request from NICE is surprising, as robust clinical data over eight years for

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glatiramer acetate has already been submitted to NICE. This clinical experience is surely a better source than some theoretical academic model.

In 1997, the department issued an executive letter, EL(95)97, instructing health authorities to fund Beta interferon for MS pending the NICE appraisal. Glatiramer acetate was not included and repeatedly the department has been asked to re-issue an update of this executive letter. My noble friend Lord Howe pursued the matter vigorously on 6th March and tonight he may well want to revisit the subject. Why is the department not updating and re-issuing the executive letter to include glatiramer acetate? Is this an attempt to deny patients their treatment?

I am sure that that is not the case, so can the Minister give us an undertaking tonight that that will be done and the blight which now exists will be lifted--lifted for those who benefit from both Beta interferons and glatiramer acetates?

Finally, why, when the Minister stated in this House that the whole purpose of NICE is to conduct a rigorous process, is the Health Economics Consortium asking for patient data at such short notice, without being clear what it will do with it? NICE has appraised drugs for Alzheimer's disease, motor neurone disease and obesity where there is similar uncertainty about costs and they are now available to the NHS. Why has it taken such a uniquely rigid view in relation to MS drugs? Is it acting under instruction? Eighty-five thousand people and their families await the answer.

7.33 p.m.

Lord Addington: My Lords, I was attracted by the subject when the MS Society pointed out to me that, although many people suffer from the disabling disease, which over time reduced their capacity to live full lives, a drug was available which will stop that. Such information leads one automatically to ask questions. We must carefully examine the situation in which people are suffering from a condition because the intervention which could prevent the suffering is being denied to them. Even though that delay may be for only a short time, we must examine the matter carefully. The idea that we can act now to stop such suffering brings me to this debate.

The first absurdity is that, although MS can be prevented by the intervention of these two drugs--and I take the noble Baroness's point that they work for different sections within the group--they are not being prescribed. The second is that if prescriptions are being withheld on grounds of cost, why are not other costs such as social security and outside support services taken into account?

NICE's memorandum of understanding states that certain concepts should be borne in mind. Paragraph 11 of that document, under the heading "Appraisal methodology and criteria", states that NICE should take into account,

    "the broad balance of benefits and costs",


    "the effective use of available resources".

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However, that suggestion is not explained; it is very broad. Paragraph 10.i of that document brings the matter into stark relief. I obtained a copy of the document from the Internet and was interested to read the footnote to that paragraph. It states:

    "The wider benefits of treatment (such as a reduction in disability which allows continuation of employment) can be taken into account on the benefit side of the equation but should not simply be treated as an offset on the cost side".

That statement is most worrying. First, it appears to express the view, "This is our budget. We are dealing with our budget and, although we will pay attention to the budget of another part of Whitehall, we will not pay close attention to it. We will merely make sure that our column of figures adds up correctly". If that is the case, any attempt at joined-up government has crashed into a heavy obstacle because the whole picture is not being taken into account.

We are saying that someone can be allowed to deteriorate both physically and mentally--and we probably knew that that was happening--and that great damage can be done to their personal life although we can do something about it. We are also saying that the cost will not be shared between departments. Some people in full employment may be able to pay for their treatment but others will not.

There is a problem and I believe that we deserve a full answer tonight. I apologise for not having given advance notice of the quotation but, as the noble Baroness said, words of wisdom previously indicated that this debate would not take place. Furthermore, I admit that when I first read the document I had not noticed the small "1" indicating a footnote.

The fact has been exposed that an odd series of calculations is going on, and the process is not the clearest I have come across. Other drugs are involved, one dealing with obesity. I was attracted to that because the definition of obesity is height over weight and I am sure that I and everyone with whom I played rugby last Saturday would be entitled to its benefits. But clearly the drug can help prevent a condition becoming worse. It will help people to lose weight, which is important, because obesity is damaging.

The principle of prevention is accepted. If we cannot obtain a clear picture of what is happening in this case, we have real problems. Can the Minister give us an insight into the thinking behind the procedure, because the principle described is worrying? It seems strongly to suggest that what is associated with the cost is more important that the amount spent. I accept that there must be a degree of rationing, in that in saving one person we cannot allow thousands of others to suffer. That has always been a reality. However, if with the technology that is available we cannot easily make calculations, manoeuvre funds and take a broad view, we have a major problem.

7.40 p.m.

Lord Clement-Jones: My Lords, I thank the noble Baroness, Lady Cumberlege, for raising this very important issue in a short but significant debate tonight. I shall not repeat the history of the NICE

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appraisal of either Beta interferons or glatiramer acetates which was very ably set out by the noble Baroness and amplified by my noble friend, and both put some extremely pertinent questions. We heard that the original circular is not being observed and we must wait until later this year for the NICE determination. We have also heard about how those two determinations have been put together. It is deeply depressing that here such a small proportion of MS sufferers compared with those in other western countries receive both drugs despite clear evidence of their clinical effectiveness.

Since NICE started work in 1999 some of the defects in its appraisal process, such as lack of openness on appeal, have been cured, but other core problems have not been. The key is the scientific basis of the appraisals. Nothing has fed the public's distrust of NICE more than the Beta interferon and (if I could pronounce it as easily) the glatiramer acetate affair. It feeds the belief that essentially NICE is engaged in a rationing exercise and that that approach underlies all its appraisals.

In the case of NICE, the process was acknowledged to be flawed by the appeals body. Certainly, the catalogue of the different ways in which the appeal was flawed was quite extraordinary: the ignoring of disability data; real doubts that the long-term benefits were fully considered; what was called the perverse enshrinement of inequality--the decision that it was right to allow only those who already were in receipt of the drugs to have them--and failure to give due weight to clinical need and to make a transparent comparison with alternative uses of NHS resources. The catalogue was considerable and culminated in breach of an EU transparency directive, which was no mean feat for a determination by an official body.

Quite apart from that, the Beta interferon appraisal raises fundamental questions about how NICE will accommodate access to drugs for rare diseases. In particular, concerns have been expressed to me about the appropriateness of cost economic evaluation in the treatment of low prevalence diseases. NICE appears to be in direct conflict with the so-called orphan status of the drugs involved in this case. Just as in the United States, the EU recognises the problems of patients who suffer from rare diseases.

The issue of so-called orphan products is dealt with by the Regulation on Medicinal Orphan Products which was agreed last year and the Programme for Rare Diseases agreed by the EU in 1999. The regulation underlines the need to support research into, and the development and availability of, orphan medicinal products. The criterion adopted by the EU is to accord orphan status to products which are of benefit to those who suffer from conditions which affect no more than five in 10,000 people. The noble Lord, Lord Hunt, recognised the value of that approach only in September last year in his announcement of new partnerships to further the development of drugs for rare diseases. He said:

    "We must get the right medicines to the right people at the right time. The regulation on orphan medicinal products is based on the principle that those suffering from rare diseases have as much

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    right to proper care as anyone else. I want to see more research and development so that rare diseases can be diagnosed, prevented and treated".

Those are excellent sentiments but the development and production of such drugs are not sufficient to ensure that people who suffer from rare diseases receive treatment. Such drugs must also be made available within the National Health Service. The problem is that the superimposition of standard cost-effectiveness criteria onto the assessment of a drug for a rare disease is not always appropriate. Are the traditional quality of life, cost-effectiveness or clinical effectiveness analyses applicable to an orphan drug? How can existing treatments be compared when the orphan designation implies that there are no satisfactory methods of prevention or treatment of the condition?

Conventional health economics techniques are based on the availability of a wide range of comprehensive data needed for the appraisal. In the case of rare disorders, often for practical, ethical and scientific reasons it is impossible to provide equivalent comprehensive data. Innovative products which treat rare diseases are often by their nature unique and cannot, therefore, be assessed by the use of traditional cost-effective assessment methods.

Is multiple sclerosis a rare disease? Are Beta interferons and glatiramer acetates orphan drugs? The total population of those who suffer from relapsing remitting MS (RRMS) is 3.8 per cent per 10,000, so clearly it falls within the EU category. In the US, MS is classified as a rare disease and Beta interferon is categorised as an orphan drug. The fact is that Beta interferon is the first orphan drug to have undergone a cost and clinical effectiveness appraisal by NICE, which has considerable implications.

Despite the EU regulation, the conclusions drawn by NICE in its appraisal contrast sharply with the conclusions reached by the European Medicines Evaluation Agency (EMEA) in its marketing authorisations for the same products. This raises the question whether NICE is dealing with orphan drugs in the appropriate fashion. EMEA is responsible for assessing the quality, safety and efficacy of drugs before authorising them to be marketed in the EU. It has established compliance with these standards 13 times in its authorisations for the marketing of Beta interferon in particular--I do not have the background information for glatiramer acetate--saying that these drugs have,

    "proven useful in the treatment of multiple sclerosis, for which there is no specific treatment available so far".

In contrast to EMEA, NICE finds it virtually impossible to balance its remit to ensure the availability and effectiveness of pharmaceutical products with its requirement to have regard to affordability and cost-effectiveness by the NHS. That is particularly acute when one looks at rare diseases and effective but expensive treatments such as Beta interferon and glatiramer acetate. Clearly, we need changes to the system so there is proper recognition of the issues which surround rare diseases and orphan

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drugs. Like the EU, we need recognition of the specific nature of rare diseases and a different appraisal system for orphan drugs such as Beta interferon and glatiramer acetate. The cost of the illness and the burden of the disease must be properly taken into account in relation to these orphan drugs.

Currently, however, precisely the contrary seems to be happening in NICE with its commissioning of additional economic modelling of the costs and benefits and, as the noble Baroness, Lady Cumberlege, pointed out, its call for the drug companies to release patient-specific data. In the meantime, those who want Beta interferon must come up with 11,000 to 13,000 a year, and those who want glatiramer acetate must find upwards of 6,650. They should not have to bear that cost much longer, and I look forward to hearing what the Minister has to say.

7.49 p.m.

Earl Howe: My Lords, among the many benefits to spring from a postponed general election is the survival on the Order Paper of this evening's Question, tabled by my noble friend Lady Cumberlege. She has not only raised an extremely important set of issues; she has also done so in a masterly way. There is little that needs to be added by me to the powerful case that she has made.

If there is one conclusion to be drawn from what my noble friend has said, it is surely that this is a matter of shame for the Government. If it is not a matter of shame, then it certainly should be. We are in a situation that I am quite sure Ministers did not ever wish to see but which is nevertheless entirely of their own making, a situation in which, as a direct result of structures and processes that the Government have put in place, many hundreds of individuals with MS are not receiving the drugs that they need to keep their condition under control. I do not believe that that is a comfortable position ethically for Ministers to find themselves in, whatever the case may have been for establishing the National Institute for Clinical Excellence and its current remit. To me, it is a worse situation, from a moral perspective, than the postcode lottery. However much the Minister and I may deplore the postcode lottery, as we both do, no one believes that Ministers of either party ever sought to engineer it.

Indeed, it was with the worthy aim of tackling the postcode lottery and speeding up access to new drugs that NICE was originally established. What could be better, the argument ran, than to have definitive and independent assessments of drugs and treatments whose clinical and cost-effectiveness were in doubt or dispute? What could be better than to set up an expert body to cut through sometimes conflicting evidence and to furnish doctors with impartial and up-to-date advice? I do not believe that anyone could argue with those aims because they are self-evidently in the interests of both patients and the NHS. It is the way that those aims have been pursued in practice that has led to all manner of difficulties--and perhaps none

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more unfortunate than in the case of Beta interferon and glatiramer acetate or, as I find it easier to say, Copaxone.

As my noble friend said, these are licensed drugs that have a proven history of efficacy. They have been used successfully over many years throughout the world. In that sense, they are not new drugs, though it is true that Copaxone has only recently received its UK licence from the Medicines Control Agency. As we have heard, they are of benefit to perhaps half of those patients afflicted with the relapsing remitting form of MS, estimated as a group to represent about a quarter of all MS patients. Yet there is a huge variation in prescribing rates in different areas of the country. Some health authorities will not fund the drugs at all. Others will do so, if only to a limited extent. As the noble Lord, Lord Clement-Jones, pointed out, the UK as a whole compares unfavourably with many of our EU partners with regard to the number of patients receiving Beta interferon or Copaxone. Only 2 to 3 per cent of MS patients in this country receive either drug, compared with 12 per cent in Germany, France and Italy and as many as 21 per cent in Austria.

As I have said, there is no doubt about the efficacy of these treatments. The guidelines from the Association of British Neurologists are unequivocal. They state:

    "The ABN considers the evidence that the drugs are effective in a subgroup of patients with clinically active relapsing remitting MS to be conclusive. The beneficial effects can be clinically important, and in the absence of alternative disease modifying treatments, treatment should be available to this well defined subgroup (approximately 10% of patients) in all parts of the UK ... Such a provision of treatment would meet an important clinical need in a debilitating neurological disease, would represent best clinical practice based on current evidence, and would be in accordance with standard clinical practice elsewhere in the EU".

Even before those guidelines were published, the previous government took the rare step of issuing an executive letter requiring health authorities to allow Beta interferon to be prescribed to those patients who might benefit from it. Despite that letter--number 95(97)--the referral of Beta interferon and Copaxone to NICE in August 1999 had an immediate and damaging effect. Doctors stopped prescribing the drugs to new patients and those health authorities which might otherwise have been influenced to adopt a more generous policy on funding the drugs had a cast-iron excuse not to do so. That excuse was made all the stronger by, at that time, the commonly shared understanding that the NICE appraisal was likely to take only a matter of months to complete. Indeed, NICE indicated in August 1999 that it anticipated issuing guidance no later than the following August.

As we have heard, that prediction was seriously inaccurate. For a whole variety of reasons the evaluation of Beta interferon and Copaxone has turned out to be much more of a complex exercise than was originally anticipated. The issue of NICE's final appraisal determination was put back to October 2000, then to Christmas, then to January 2001. Just before Christmas NICE announced, all of a sudden, that it wished to commission an entirely new economic

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model to inform its evaluation of the drugs' cost-effectiveness. Following that announcement, it was made clear in another place that the long-awaited guidance would not now be issued until November 2001, a full two years and three months after the appraisal process first began.

For that delay to arise for any reason is serious enough. For it to happen as a consequence of NICE perceiving the need to go through a learning process after more than a year of deliberation strikes me as appalling. I am sure that NICE will have excellent answers to that criticism, which the Minister will no doubt present to us this evening. But my bet is that they will be answers that seek to justify NICE's procedures purely within the terms of its own remit. In other words, the quest for an accurate and reliable model of cost-effectiveness will be held up as being for the greater good of all in the longer-term.

If the Minister says anything like that, as indeed he appeared to do when last we debated this matter on 7th March, then I need to put it to him that the plot has been lost. There is a human dimension to this issue. As the MS Society put it recently:

    "Coping with the original timetable caused distress; doubling the length of the appraisal is causing despair among people who fear that while it goes on they may become too disabled ever to benefit from the drugs, even if NICE's eventual decision is positive".

The flaws associated with the NICE process are many, and I have not time to cover them all. But perhaps the most obvious is the unintended consequence of what is increasingly referred to as blight--the blight that is imposed on whatever treatment NICE is evaluating, pending issue of the final determination. I have spoken about the damage to patients. But we should also bear in mind the damage to the pharmaceutical industry. Increasingly, NICE is being seen by the industry as a fourth hurdle between it and the market place; a hurdle above and beyond the three established and accepted hurdles of safety, quality and efficacy on which a licensing decision by the MCA depends.

That negative view of NICE by the pharmaceutical industry and its potential consequences should not be underestimated. The "blight" imposed on a drug that is undergoing NICE appraisal extends in commercial terms far beyond the confines of the UK. It affects overseas markets for that drug and therefore world-wide revenues. To the extent that it engenders a loss of confidence in the UK as a base for foreign investment, it could well lead in the future to a decline in the UK's position as an international centre of excellence for pharmaceutical research and development. The more that the multinationals see this country as erecting barriers in the way of innovation, the less enamoured they will be about using the UK as a launch-pad for new treatments and the more they will be tempted away by the operating environments of rival countries.

I may say that that sense of frustration among pharmaceutical companies is already apparent in their criticisms of NICE, as to its perceived lack of transparency and its unwillingness to enter into any kind of dialogue with industry once an appraisal is

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underway. There is little confidence either that NICE contains the specialist expertise in-house appropriate to a proper understanding of each appraisal. That attitude of confusion and uncertainty contrasts markedly with what I have found to be the industry's view of the comparable system in Scotland, which is generally seen as open, transparent and consultative. I believe that there are lessons to be learnt from that comparison.

I began by saying that the regrettable situation highlighted by my noble friend's Question is, indirectly at least, of the Government's own making. As long as NICE continues to function in the manner that it does, with its existing remit, I do not see much scope for matters to improve. However, I do believe that for Beta interferon and Copaxone there is a partial remedy at hand, if Ministers choose to take it.

When we debated this issue on 7th March the Minister said in reply to a question from me that the department's executive letter 95(97) is still in circulation and the prescribing of Beta interferon should continue in line with what is stated in that letter. As I have said, there is abundant evidence that that is not actually happening--a fact that was, I believe, emphasised at a meeting last week between the Minister's right honourable colleague in another place, Mr Denham, the MS Society, the MS Research Trust and the Association of British Neurologists. Many doctors are being put in an impossible position.

I do not expect the Minister to give an undertaking to me here and now, but I would ask him seriously to consider the issue of further guidance to health authorities, reminding them that Executive Letter 95(97) still applies until such time as the NICE judgment is available. Guidance of that kind, which could also cover Copaxone, would I believe constitute an unequivocal signal from the Department of Health that the needs of MS patients should have primacy. It would also be an undoubted earnest of ministerial good faith to counter what I am bound to say have been some fairly mixed signals in recent months.

I look forward to hearing what the Minister has to say in reply.

8 p.m.

Lord Hunt of Kings Heath: My Lords, first, I thank the noble Baroness, Lady Cumberlege, for having raised this issue. I suspect that all noble Lords are a little surprised to be debating this matter tonight. I agree with the noble Baroness that we have held perhaps three or four debates on NICE over the past few weeks. The matter is one of intense interest among many Members of your Lordships' House.

I should like to say in particular to the noble Earl, Lord Howe, that of course I understand the human dimension behind the Question put by the noble Baroness, Lady Cumberlege. Equally, I am only too aware of the issues that undoubtedly have to be confronted by the unfortunate people who suffer from multiple sclerosis. However, I would have to say that many different concerns have to be considered here.

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I believe that there are two recurring problems which the NHS has had to face over many years: first, the issue of postcode prescribing, which I believe to be increasingly unjustified and indefensible within a national service; and, secondly, the slow take-up of innovative, proven medicines and techniques. That has been a factor of the NHS going back over many years. I believe that, far from the concerns expressed tonight by noble Lords, NICE is the best way forward to ensuring that authoritative guidance is made available to the NHS on the most effective and cost-effective drugs and treatments.

I believe also that we are receiving broad support from the service in taking this approach. What is abundantly clear is that the NHS, just like any other healthcare system in the world, has to set priorities and has to make choices. The issue lies in how those choices should be made. My contention is that the establishment of NICE brings much greater certainty, clarity and confidence to that process by providing authoritative assessments of the current state of medical knowledge on particular treatments and conditions. It undertakes the very important task of helping health professionals to keep abreast of the latest knowledge as well as removing the smokescreen of scientific uncertainty that has sometimes masked arbitrary and unfair funding decisions.

I recognise that the NICE process brings many of those dynamics out into the public arena and I understand why, when faced with those dynamics, they can cause concern to individuals who perhaps would have preferred the smokescreen of postcode prescribing and the slowness of uptake of innovative medicines and treatments. But, surely, in taking the NHS forward, it is preferable to use an approach such as that adopted by NICE, which can be informed by the best evidence available, and which in turn can advise the health service on what is both effective and cost-effective. That is as relevant to MS as it is to any other disease.

The noble Baroness, Lady Cumberlege, very appropriately and graphically, described the major and adverse impact--the terrible impact--that MS can have on a patient's quality of life, in particular during relapses. Of course I well understand the potential that many people see in Beta interferon and, more recently, glatiramer acetate which, as the noble Baroness pointed out, has been licensed more recently as a treatment for the disease. But we cannot ignore the ongoing debate about the identification and targeting of treatment on those patients most likely to benefit. Equally, I believe that it is important that no one should raise excessive expectations about the ability of these treatments to combat multiple sclerosis. It was because there appeared to be uncertainty about the appropriate use of Beta interferon, which was reflected in different prescribing patterns across the country, that we asked NICE to conduct an authoritative appraisal of the evidence on disease-modifying drugs for MS.

The noble Baroness asked why glatiramer acetate is treated in the same way as Beta interferon when it is chemically and pharmacologically different. She is

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quite right to say that these two drugs are different, but what they have in common is that they are both disease-modifying treatments for MS and we think that glatiramer acetate should be subject to an appraisal by NICE. The evidence demonstrates that, for patients with the relapsing and remitting form of MS, the drug reduces relapses by around 30 per cent as compared with the placebo. In its recently issued new guidelines, the Association of British Neurologists suggested that the magnitude of the effect of both therapies on the relapse rate in the relapsing and remitting form of MS appears comparable.

The noble Baroness went on to raise the issue of costs. I should say to her that the issue here is one of cost-effectiveness, not affordability. We have NICE to advise on clinical and cost-effectiveness and to issue guidance to the NHS on which treatments have the greatest potential to improve patient care. An entirely separate set of decisions is reached by Ministers as regards the overall level of resource and affordability.

I fully accept that the process under which NICE has conducted this appraisal has not been without controversy. It is unfortunate that the leaking last year of its provisional assessment led to widespread speculation at a premature stage in the process. It is true, as noble Lords have mentioned, that appeals were submitted which were then upheld in part by NICE's appeal panel. The record of NICE's appraisal committee meeting held on 13th December details how carefully the matter had been considered. It also highlighted the dilemma faced by the committee.

On 22nd December, NICE announced that it would extend the timescale for its appraisal of these drugs to enable further research to be undertaken on their cost-effectiveness. NICE has advised that this additional work has been undertaken to resolve critical differences in the economic models supplied by manufacturers and independent researchers. The commissioning, construction and evaluation of the new modelling will take around six months. That process will be transparent and the results will be made available to the parties involved, along with the appraisal, by summer 2001. Based on that, we expect NICE to produce its authoritative guidance by November, subject to any appeals. Until NICE publishes its guidance, I cannot pre-empt what it might say.

Of course I understand the concerns of MS sufferers who are worried about the delay in the production of NICE's final guidance on those drugs, but ultimately it is vital that the integrity of the NICE process is maintained. It is critically important that NICE is able to review all the evidence and attempt to reconcile differences between the interested parties. We want the institute to do a thorough job and to produce authoritative guidance.

Surely it is understandable that NICE wishes only to issue guidance when it considers that it is able--to the best of its ability and in the light of data available to it--to address the issues upon which it was established to assist the NHS, including, as I have said, advice on both clinical and cost effectiveness.

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I have been asked about the methodology used by NICE to make those judgments. It is a matter for NICE itself to develop its own working methods within the broad guidelines laid down by Ministers and set out in the directions and in its framework document. The directions require NICE to take account of any guidance on the resources likely to be available.

NICE has made clear that it is not committed to any single methodology but that it applies judgments to each individual appraisal topic in the light of the evidence on clinical and cost effectiveness. I should say to the noble Baroness, Lady Cumberlege, that we have not indicated a threshold, either directly or otherwise, to the institute. We are committed to a review of NICE, starting this summer, and methodology is one of the issues that, no doubt, will need to be considered in that review.

Both the noble Baroness, Lady Cumberlege, and the noble Lord, Lord Addington, raised the issue of the account that NICE should take in its assessment of what one might describe as the wider costs and benefits to society. This matter was raised earlier today during the debate on a Starred Question in relation to anti-TNF drugs. As I said then, we have required NICE to assess evidence on all the other clinical and health-related benefits of treatment and to judge whether, on balance, they would represent a cost-effective use of NHS and personal social services resources.

As the noble Lord, Lord Addington, informed the House, NICE has recently issued more detailed guidance to manufacturers and sponsors on the way in which they should submit evidence on appraisals, and the issue raised by the noble Lord will be specifically covered. It is open to NICE to take into account a wider range of factors, and it is open to those who submit evidence to include evidence on a wider range of factors.

The noble Lord went on to raise the issue of productivity. The guidance states that changes in productivity, such as increased availability for work, may be a consequence of health gain resulting from the use of a technology. As the noble Lord said, any such monetary estimates of benefits should not be subtracted from the estimates of healthcare resource costs. However important these wider social factors are--I agree that they are important; NICE has stated that it is prepared to consider them, and it is open to people providing evidence to NICE to make submissions covering those areas--it is also important to note that it is not valid to say that the treatment in that sense is somehow cost neutral. Very often, for instance, the costs of NHS treatments are up front and very real, while the possible savings to the rest of the economy may often be downstream and speculative. There is, in practice, no mechanism--at least in the short term--for using savings elsewhere in the system to offset NHS costs.

That does not mean to say that there is not considerable force in the arguments put forward by the noble Lord, Lord Addington. As I said, it is a factor which can be considered by NICE--and no doubt we

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will look at the issue in the review--but it is not an easy issue to deal with. We have to be wary of being too simplistic in our arguments in that area.

The noble Baroness, Lady Cumberlege, asked about the difference between the way Relenza and drugs for Alzheimer's disease were treated. Again, this is a matter for NICE, but my understanding is that in those cases there was a much lesser range of uncertainty about the clinical and cost effectiveness of these drugs from the evidence available from a number of different parties. This is clearly not the case in relation to Beta interferon.

The noble Baroness asked about the requirement and request for patient data. My understanding is that NICE gave notice to the manufacturers in December last year that it would be requesting patient-level data from the clinical trials. Last Friday, members of the health economics consortium, which had been commissioned to develop the cost-effectiveness model for NICE, gave a detailed presentation of their proposed approach. The need for patient-level data and the uses to which it would be put were clearly described at the presentation.

I turn now to the suggestion that far from being a rigorous process to allow us to ensure high-level consistency and the fast introduction of proven and innovative techniques and treatments, this is a rationing tool. If that were the case, I doubt very much that Nick Timmins, in an article in the Financial Times a few months ago, would write:

    "So far the view that NICE is there purely to ration is hard to sustain. Its first 15 significant decisions have saved the NHS about 70 million. However its recommendations for wider use of some treatments has boosted NHS spending by at least 205 million. Many thousands of patients should now be receiving potentially life saving treatments they were previously denied".

Surely that is the point. If NICE was simply a crude rationer, many more of the techniques and drugs that it has been asked to consider would have been ruled out. The fact is that NICE has ruled in many drugs and treatments at a cost to the National Health Service.

I turn now to the question of guidance. As the noble Earl, Lord Howe, suggested, this was issued in November 1995 in EL 95(97). This was in advance of market authorisations being granted for Beta interferon drugs. At that time, Beta interferon was licensed only for relapsing remitting MS. The circular asked purchasing authorities and providers to develop and implement local arrangements to manage the entry of such drugs into the NHS, in consultation with other interests and, in particular--I stress this--if prescribing was considered appropriate for it to be undertaken through hospitals. This guidance remains in place.

In addition--this is relevant to glatiramer--the department issued health service circular 1999/176 in August 1999. This asked National Health Service bodies to continue with local arrangements for the managed introduction of new technologies where guidance from NICE is not available at the time the technology first becomes available. These arrangements should involve an assessment of all the

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available evidence. I believe that the combination of the executive letter and the substantive guidance in 1999 is all that is required to ensure that appropriate policies are agreed and implemented within the NHS.

I heard what the noble Earl said about blight. I repeat what I said earlier today: if specific cases are brought to my attention where it is clear that NHS bodies have not gone through the processes that they need to go through, I shall look into them.

The question was raised as to whether the advice issued by NICE is put into effect. My right honourable friend the Secretary of State for Health has announced that we shall introduce explicit monitoring so that we know that every health authority and trust is taking full and proper account of each NICE appraisal. I repeat: there would no point in the NICE process unless we were confident that its recommendations were being implemented by the NHS.

On the question of the pharmaceutical industry, I heard what the noble Earl said. I have had the pleasure of chairing the joint task force between the Government and the industry. I understand the issues raised by the industry in relation to NICE. I can say that after 12 months of constructive discussion it understands our viewpoint as well. We have agreed that as part of the review process we shall pick up again the issues raised by the industry. I believe that we have to balance on the one hand the concerns of the industry and on the other the clear evidence that the impact of NICE so far has been to lead to greater expenditure on drugs than would have been the case had we not brought NICE into being.

I agree that the pharmaceutical industry is a major contributor towards inward investment in the UK in terms of jobs. It is responsible for 23 per cent of all commercial R&D investment in this country. The whole purpose of the working group that we established is to ensure that the UK continues to be competitive in attracting R&D investment and other investment from the industry.

I listened with great care to the comments made by the noble Lord, Lord Clement-Jones, about orphan medicinal products. I am grateful to the noble Lord for repeating my words of some weeks ago. I fully accept that drugs for rare conditions will tend to be more expensive than those for common conditions because the cost of research and development has to be recouped over a much smaller number of sales. On that basis it is likely that orphan drugs will tend to appear less cost-effective judged by the yardsticks that are sometimes used, such as cost per life year.

We are sympathetic to the needs of those who require orphan drugs. We must also accept that difficult choices will still have to be made between providing very expensive treatments benefiting only a few and providing effective treatments offering a substantial health gain to a larger number of patients. That is where NICE can advise us on what will always

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be very difficult issues. But that does not mean that NICE will mechanically apply a fixed cost-effectiveness yardstick to all treatments it is asked to appraise. Equally, I do not believe that NICE can ignore the question of cost-effectiveness altogether, even for treatments for rare disease.

This has been a good debate in which a number of concerns have been raised about the operation of NICE. The review will be commencing within a relatively short time. We shall need to pick up the kinds of concerns that have been expressed during this debate. At the end of the day, I am convinced that NICE provides us with the most effective way of ensuring that the right decisions are made in relation to cost and cost-effectiveness and that this will speed

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up the introduction of new treatments and new techniques that are found to be effective. That is far better than postcode prescribing and a situation of patchy provision throughout the NHS.

Medway Council Bill [H.L.]

Returned from the Commons with the amendment to which the Lords have disagreed not insisted on.

Criminal Defence Service (Advice and Assistance) Bill [H.L.]

Returned from the Commons agreed to.

        House adjourned at twenty-four minutes past eight o'clock.

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