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30 Apr 2008 : Column GC59



30 Apr 2008 : Column GC59

Grand Committee

Wednesday, 30 April 2008.

The Committee met at quarter to four

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) in the Chair.]

Health and Social Care Bill

(Third Day)

The Deputy Chairman of Committees (Baroness McIntosh of Hudnall): Before we begin, I remind the Committee that, if there is a Division in the Chamber, the Committee will adjourn as soon as the Division Bells are heard and will resume after 10 minutes.

Clause 2 [The Commission’s functions]:

Earl Howe moved Amendment No. 21:

“( ) the need to provide equity of access to medicines and other therapeutic treatments through the consistent application of guidance and technology appraisals produced by the National Institute for Health and Clinical Excellence.”

The noble Earl said: I wish to move Amendment No. 21 and speak to Amendments Nos. 56, 71 and 88. We come to an issue that to the veterans of health legislation over the past eight or nine years will not be new: equity of access to medicines and other approved treatments. In January this year, the Health Select Committee in another place published its report on the National Institute for Health and Clinical Excellence. The report made a number of recommendations about the implementation of NICE guidance and the uptake of medicines that NICE has approved. The problem here is a serious one. At present there is no consistency round the country as to the uptake of NICE-approved therapies. Some PCTs go to considerable trouble to build NICE guidance into their plans, whereas others do little more than pay token regard to it, if that. The result is what is often referred to as the postcode lottery for medicines, although the analogy with the lottery is not a particularly good one.

I could give many examples to illustrate the lack of consistency to which I referred. I shall mention just a few, starting with osteoporosis treatments. NICE issued guidance in January 2005 strongly recommending that women aged 75 and over who have suffered a prior fragility fracture should be treated with osteoporosis therapy. However, a recent survey undertaken by the NHS Information Centre found that the worst performing quartile of GP practices could demonstrate that only 18 per cent of eligible patients received care in line with this part of NICE guidance. The best performing quartile could demonstrate that only 32 per cent of eligible patients received the care that NICE guidance recommended. The same NICE guidance also recommends that women aged between 65 and 74 who have suffered a prior fragility fracture be referred for a

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DEXA bone density scan to assess future fracture risk. Here the picture was even worse. Even the best performing quartile of GP practices could demonstrate that only 12.5 per cent of eligible patients received care in line with the NICE guidance.

On prostate cancer, NICE issued the guidance Improving Outcomes inUrological Cancers in September 2002 and set a December 2007 deadline for its full implementation. However, the latest available data show that seven of England’s 30 cancer networks were not on course to have implemented the guidance by the deadline—a full five years after the guidance was issued.

Herceptin was recommended by NICE for use in women with HER2-positive advanced-stage breast cancer in March 2002 and for use in women with HER2-positive early-stage breast cancer in August 2006. Previous audits show that the implementation of NICE guidance has improved over time, but significant variations in usage around the country remain. The latest data, adjusted for incidence, show that the seven best performing cancer networks in England provide around 65 per cent of eligible patients with Herceptin but that the seven worst performing cancer networks provide it to less than 35 per cent of eligible patients. The failure of some cancer networks to implement this NICE guidance is why England, on average, lags a long way behind the European comparator countries in the use of this medicine.

My final example is rheumatoid arthritis. A class of drugs called anti-TNFs was recommended by NICE for the treatment of this condition in March 2002. Even now, many years later, problems still remain in implementation. In 2005, the Audit Commission said that anti-TNF therapies were among the three treatments approved by NICE that PCTs most frequently failed to make available to patients. In late 2006, the British Society for Rheumatology said that half of rheumatologists were reporting funding restrictions relating to anti-TNF therapies. An investigation by the All-Party Group on Inflammatory Arthritis found that less than 60 per cent of PCTs were offering anti-TNFs to patients in accordance with NICE guidance.

What did the Select Committee say about this? Two of its recommendations are especially pertinent in this context. In Recommendation 26, it said:

In recommendation 27, it said:

It was interesting that NICE itself was enthusiastic in its response to both these recommendations, particularly the first.

The Government’s response was more cryptic. They referred to the Healthcare Commission’s annual health check, which relies in part on self-declarations by PCTs and trust boards and in part on inspections, the implication being that this process is working entirely without problems. They then go on to say:

I hope that the Minister will not think it unfair of me if I say that the Government’s policy and intentions do not emerge very clearly from that answer. What role do the Government intend the CQC to play in relation to NICE guidance? Do Ministers agree with the committee that PCTs should play a larger part in making sure that NICE guidance is implemented and that they should receive help in doing so, if necessary from the department itself?

The question that is begged in all this is: what action counts as implementing NICE guidance? In other words, how little do you have to do as a PCT to claim correctly that you have implemented it? For me, and I suspect for many of us, NICE guidance ought to be defined as the minimum standards for healthcare providers to meet. We surely cannot say that a PCT has correctly ticked the box of implementing NICE guidance when only a small proportion of eligible patients actually receive the recommended treatment.

In response, the Minister may repeat what previous Ministers have said, which is that all this is down to local decision-making. I understand the point, but we have a rule, in the form of a direction of the Government’s own making, that NICE guidance should be regarded as mandatory and subject only to the clinical judgment of doctors in individual cases. If you ask patients what they think they can expect from the NHS in some of these treatment areas, the answer will usually be that they are completely confused. The NICE guidance on atypical medicines for schizophrenia is currently binding because it is guidance, but it is being revised and looks set to be turned into non-binding guidelines. The NICE guidance on medicines to treat ADHD will shortly mutate into guidelines but, unlike the guidelines on atypicals, they will retain a binding requirement on PCTs to provide funding. The NICE guidance on osteoporosis treatment is being reviewed with the intention of incorporating the appraisal in an osteoporosis guideline; here again, unusually, the guideline will remain subject to the ministerial direction on funding.

No wonder there is confusion. Among other things, the amendment would provide an opportunity for patients to get a clearer picture on the implementation of NICE guidance because, with a more transparent evidence base, there is a much better basis for patients and carers to exercise more informed choice on the treatment options available to them. We also have here an opportunity for Parliament to strengthen good governance in healthcare, to raise standards and to enhance equity of access to treatment for patients. It will be possible for the Government and NICE through the Bill to get NICE decisions on medicines universally implemented, leaving the Care Quality Commission to ensure that the guidance is consistently applied locally. I beg to move.

Baroness Meacher: I shall speak briefly to Amendments Nos. 71 and 88 and to endorse the excellent contribution of the noble Earl, Lord Howe. You could not get a more eloquent description of the situation and the incredible importance of the amendments.



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I just want to make one point: NICE guidelines are not restricted to medical treatments. I want to refer to the NICE guidance on therapeutic treatments for depression and anxiety. Any service-user survey of people with mental health problems puts right at the top of user priorities the availability of therapeutic psychological treatments. NICE guidance was issued clearly specifying the evidence-based psychological therapies that should be available to people with depression and anxiety. The Government then committed £70 million for a three-year rollout of training across the country to ensure that the evidence-based treatment recommended by NICE would be available to people across the country.

No mental health intervention would do more for the general mental health—the well-being, if you like—of people in this country than the implementation of those NICE guidelines. Yet we are finding that it is nigh on impossible to ensure that PCTs across the country take on board the Government’s policy. If I may say so, even the strategic health authorities are producing guidance to PCTs that is all over the place. It is not consistent; it does not fully take on board the Government’s policy. Therefore, even in the information going out to PCTs there is confusion—there is basically anarchy—and I cannot imagine what will happen at the PCT level. I add my few words to those of the noble Earl, Lord Howe, in giving strong support to the amendments. I very much hope that the Government will produce their own amendment to give rise to the outcome that we want.

Lord Walton of Detchant: I give warm support to the amendment. About 35 years ago, when I was dean of the medical school in the University of Newcastle upon Tyne, I chaired a committee established to appoint a professor of clinical pharmacology. We appointed someone who was at that time the youngest professor ever appointed in the medical faculty in Newcastle—Professor Michael Rawlins. Sir Michael, as he now is, has become the distinguished chairman of NICE, and that organisation has done a wonderful job over many years in defining the cost-effectiveness of medicines and other forms of intervention in the practice of medicine. The problem has been that, although the guidance that it has produced has been extraordinarily clear, very competent and based on solid evidence, that guidance has not, as the noble Earl, Lord Howe, made clear, been implemented widely across the country.

This is not an absolutely restrictive amendment. It would be subject to Clause 2(3), which states:

and here Amendment No. 21 would add—

I cannot see any way in which the Government could conceivably object to this helpful amendment. If implemented, it would, in general, help with the removal of the postcode lottery; it would assist the uptake of new medicines; it would encourage innovation; it would define the new commission’s competence in respect of

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NICE and external review groups; it would ensure uniformity and consistency across the country of the implementation of NICE guidance; it would help to define clearly the status of NICE guidance including technology appraisals; it would, I hope, ensure that some elements of the NICE clinical guidance were made mandatory; and it would broaden NICE’s remit to incorporate carer costs, social care services, worker productivity gains and other wider benefits and costs. These would be the major advantages of the implementation of this group of amendments, which I warmly support.

4 pm

Baroness Cumberlege: I, too, put my name to these amendments and I endorse what the noble Lord, Lord Walton, has just said. I do not often pay tribute to the Government, but I do on this occasion: NICE has been one of their great successes. It is interesting that, although NICE cannot be exactly replicated in other countries, because they do not have the same connections or sockets or whatever makes the NHS work, NICE is nevertheless now giving advice and support. Indeed, it is founding an international consultancy to help other countries. As the noble Lord said, it has done a very good job.

Of course, NICE is not universally popular; we know that. On occasion it disappoints industry or it disappoints patient groups that are fighting for the drugs that they feel their members need. NICE does not seek popularity, but it strives to make sensible judgments within the parameters in which it has to work. As my noble friend said, however, one of the drawbacks and frustrations has been the lack of implementation, of which he gave some good examples. I co-chaired the All-Party Osteoporosis Group and we heard a lot of evidence, but my noble friend has covered that. Another example is the three cycles of IVF for women who want to have a baby; that has not been implemented across the country. Then there is rheumatology and the drugs that my noble friend mentioned.

We have to be practical, though. Until fairly recently, PCTs have been strapped for cash; in my area, they still are. They have to set their priorities locally. It would be fair to the population, to patient groups and to the pharmaceutical industry if more information were to come from PCTs, when setting their priorities, if they cannot make something a high priority because they have a lot of calls on their resources. It would be better if they could tell the general public and if there were a means—we suggest that it could be through the Care Quality Commission—of saying where their priorities were and where their needs, as they see them, were to be met. On occasions when they have to introduce a drug and cannot afford it immediately because it is new and expensive and all the rest of it, they should say how long it will take to introduce it within their patch. They should say who needs that drug and how they will make an assessment according to the need. This is a plea not only for some oversight by the Care Quality Commission, as the Healthcare Commission has already taken that area pretty seriously, but for transparency. The local population should know what the different priorities are in their area.



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Our pharmaceutical industry—and I declare an interest in that I am not a shareholder in it—is number one in trade surplus rankings. It is an important part of our national economy. It employs some 73,000 people. It spends £9 million every day on research and development and it has discovered 20 per cent of the world’s top medicines. For a small country, that is fantastic.

I chair the Association of Medical Research Charities. We have to be careful to avoid discouraging the pharmaceutical industry, as a result of some of our mechanisms, from investing as much in research. One of the difficulties that it faces is that it takes some 10 years to produce a new medicine. If at the end of that time that medicine is not allowed to be prescribed, there is an issue that needs resolving. There is a simple issue about the funding of the NHS for these expensive drugs. I may well be wrong, but I believe that there is a £1.8 billion surplus in the NHS. Can the Minister tell us where that money is and how it will be spent?

Baroness Murphy: I support the amendment. Others have spoken with great clarity on how nice NICE is. I am a great fan, too, but this group of amendments is important on the grounds of clarity of regulation. We should be giving the Care Quality Commission the tools to enable it to improve the quality of health delivered to the nation. One of those tools is the guidance produced by NICE. That is one of the fundamental tools available to PCTs and everyone else to tell us in what direction treatment should be going. It is crucial that the Care Quality Commission should be tied into a system in which it is testing the delivery of the very best and raising standards. For that reason alone—clarity of regulation—this group of amendments is worthy of consideration.

Lord Warner: I wish to make a few observations, but first I should declare an interest in that I was the Minister responsible for the pharmaceutical industry and NICE between 2003 and 2005, when of course everything worked perfectly in this area.

The noble Baroness, Lady Cumberlege, made an important point about the pharmaceutical industry. When NICE began—I, too, believe that it is one of the Government’s great achievements and a real success story—the pharmaceutical industry was less than thrilled with it. Part of the deal was that NICE should produce certainty. When new drugs were presented to NICE, its set of recommendations sometimes went against the industry’s interests and the industry was not always thrilled by that. But part of the deal was that, when drugs were approved, there was an expectation that the decision would be implemented and that the drugs would be used across the country.

If we are honest—and I can speak only from my experience—we must recognise that we have struggled to reconcile issues in this area. It is right that, after NICE has made its pronouncement, the drugs and, in particular, the technology appraisals should be implemented across the NHS. But we have often had thrown back at us the issue of local priority setting down at the PCT level. That argument has some legitimacy. We ended up with a situation, certainly when I was a Minister, where we wove into the standards that were produced, following the standard-setting

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provisions of the 2003 Act, requirements for authorities to adhere to NICE guidelines and findings on technology appraisals and on national service frameworks. For some time, the Healthcare Commission has been able to inspect against those standards in its rating of health authorities, so there is a link at the moment.

However, under Schedule 15 to the Bill, the standard-setting powers in the 2003 Act are abandoned. We will have a new set of standard-setting provisions and we will need to see what those are at some time in the future. For all I know, the Government may proceed with the same set of standards or amend them in some way. The standards provide for the current commission to inspect against NICE guidelines and to have some expectation of the guidance being implemented.

This is not an easy area. There is great strength in the amendments on standards and on functions but, before we get too carried away, it is worth dealing with the issue of the cost of implementing NICE guidelines. One of the factors taken into account in bunching a group of referrals to NICE is what the cost is ultimately likely to be for the NHS and how that relates to the totality of the budget. NICE guidelines and technology appraisals up to the end of 2007-08 have cost about £1.5 billion. However, we are spending more than £10 billion a year on pharmaceuticals of one kind or another, so the NICE recommendations are a relatively small part of the total spend. We should be a little cautious about feeling too sorry for local PCTs that say that they cannot afford to do the job. Given the amount of money that has gone into the NHS in recent years, we should not be overly sympathetic about that.

There is an issue about how we can make the system work more effectively. The provisions in the Bill may help, but we will still need to truck away on these issues, as we have been doing for the past few years.

Lord Kirkwood of Kirkhope: The noble Lord, Lord Warner, is an experienced hand in these matters and his words are wise and worthy of careful study. It is now sensible to investigate again a number of issues around NICE and its costs and I think that the Care Quality Commission will be in a good position to enable that to be done. I commend the creativity of the noble Earl, Lord Howe, in tabling this amendment, which I think is irresistible in relation to the commission’s functions.

My interest in pharmaceutical matters started when I was trained as a graduate at Heriot-Watt pharmacy school. I spent my summer vacations making industrial-scale chemicals for Boots the Chemist; I became an expert in the industrial-scale manufacture of suppositories, which I fear is likely to be put on my tombstone. In the context of the quality of healthcare, my stints behind the dispensary desk at Boots in Shandwick Place in Edinburgh suggested to me that there is considerable confusion about the route of administration for suppositories; perhaps the Care Quality Commission could look at that as a matter of urgency.

We had some high-quality debates yesterday in Committee. The weight of influence and experience in Committee is rooted in the care side, but this set of

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amendments is equally important. The noble Lord, Lord Warner, and the noble Baroness, Lady Cumberlege, are right to talk about the pharmaceutical sector and, indeed, the health service itself.

If I am interested in anything, it is in trying to get people off benefits and into work. When one goes around sister European nations and, in particular, America, one realises that the jewel in the crown of what is available to us in the United Kingdom is universal free healthcare, because it does not provide a disincentive from getting into work. In America, if you try to tempt people away from benefits into work, the block is always that they say that they cannot pay for their healthcare. We should celebrate what the health service does. Of course it can be improved; in my view, this Bill goes some way towards doing that.

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