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The noble Baroness, Lady Verma, was concerned about cover for teachers during the training. Cover is essential and we have included it in the cost of the training. It is anticipated that about 12 days' training will be needed outside the classroom, and cover will be built into the funding provided for that. There were concerns about the approach promoting a two-tier system. Newly appointed SENCOs will be the priority, but as greater clarity on the numbers emerges, we will look with the Training and Development Agency at the scope within assigned resources for supporting SENCOs who have been in post for longer. An enormous amount of work has been undertaken by the TDA, and as the numbers become clearer we can consider revising the scheme.

The noble Baroness, Lady Verma, and the noble Lord, Lord Addington, were interested to know how we will be reviewing the regulations. We will do so through the TDA, which will examine the scheme after a three-year period. The noble Baroness, Lady Verma, asked about who had developed the scheme. It was developed by the TDA and there was significant consultation with specialists involved-head teachers and SENCOs alike. We will also look at the TDA to monitor the take-up of places. Already 700 have been taken up, with 2,000 more to be taken in January. That is a significant number. Our aim is to improve the skills, knowledge and confidence of a group of people who are key to the outcomes for children with SEN and disabilities. From 2010, the school workforce survey will help us to keep track of SENCO qualifications. That will give us a running commentary on how things are going.

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I welcome the recognition expressed by the noble Lord, Lord Addington, that there have been improvements over the years, and I echo his clear statement that not enough has been done. None of us in government, or in this House, would for one moment think that enough had been done, but we are very much committed to making further improvements. Twenty per cent of pupils in maintained schools have SEN or disabilities-a significant number of children and young people. A school's special educational needs co-ordinator has a vital role to play in meeting those needs. The SENCO also forms an important point of contact within the school for children with SEN and their parents. I can say that from personal experience when working with my daughter's SENCO.

Serious concerns about the perceived low status of SENCOs within schools were expressed in the July 2006 report of the Education and Skills Select Committee. As a result of that committee's recommendations, there is now a requirement in law for maintained schools to designate an SEN. Hitherto, there had simply been an assumption that that would happen-here we return to the noble Earl's concern about a lack of consistency. Regulations laid last November established a requirement for SENCOs to be qualified teachers. It does not mean that all staff working with SENCOs must be teachers, but the SENCO must be a qualified teacher. That is essential if they are to have the necessary authority to negotiate with qualified colleagues on differentiated provision geared towards children's individual needs. This is about raising the status of SENCOs.

That in no way hinders non-teacher members of the SENCO team from continuing to play an important role in supporting the SENCO function. A further recommendation of the Select Committee was that SENCOs should receive appropriate training. Noble Lords here today have recognised that that is important and the right way to go. We know that some SENCOs have received very good training and I take this opportunity to commend the efforts of schools, local authorities and the individuals in this regard. However, there was no obligation to undertake such training, and it was therefore possible to take on the role of SENCO with little or no professional preparation. I do not think that that is the right way to go.

Some SENCOs have received little preparation for their important role and some say that they have received no training at all. If we want to ensure effective educational provision-we are all agreed that we do-for children with additional needs and abilities, we must provide SENCOs with the training and professional skills they need. We believe that the best way to improve the skills of the workforce and boost parental confidence is by requiring those new to the role to obtain the nationally approved qualification within three years. We consulted on the regulations earlier this year. The majority of the respondents, who included SENCOs, head teachers, local authorities, governors, teacher unions and SEN organisations, supported the proposals now before us. The course should normally take one year to complete on a part-time basis, assuming that no credit is given for prior qualifications or experience, but the time could be shorter. Our draft regulations proposed a three-year

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period of latitude to obtain the award so as to make allowance for the individual circumstances of post-holders and schools-for example, those with caring responsibilities. We believe that that will provide latitude there, a point which concerned the noble Baroness, Lady Verma.

We will also examine ways to ensure that SENCOs who have been in post for some time benefit from the new training resources developed under the other work that the TDA is doing on our inclusion development programme, to which I have already referred. We know that it takes time for SENCOs to grow into their role. The new training is intended to enable those with less experience to get up to speed as quickly as possible. That is why we are not requiring those who have extensive experience or are working as a SENCO already to undertake the training. Instead, we leave it up to head teachers' discretion whether SENCOs who have been in post for more than 12 months should be encouraged to take the course. SENCOs do an important job, as we all agree. They deserve our support, as do the children that they work with.

The Government agree with the recommendations of the Select Committee, and we have taken action to address its concerns. The regulations, the professional training courses approved by the TDA and the funding that we have earmarked for the next two years will ensure that all SENCOs new to the role will receive the training and support that they need to perform a demanding and valuable job. I therefore hope that noble Lords will support the initiative.

Baroness Verma: My Lords, I thank all noble Lords for contributing to this short but very important debate. We are all agreed that SEN teachers play an incredibly important role, as well as often being main classroom teachers. I still feel very concerned because, reading the SI and the committee's report, my opinion is that when this is rolled out, those teachers will be expected to have that qualification, even though they have been SENCOs for a very long time. I have listened carefully to the Minister, and I shall read Hansard carefully. I hope that she is assuring us properly that only new people coming in will need that qualification-ruling out completely those who have been SENCOs for a long time-and evaluating them only on what may be their weak areas. Otherwise, I fear that we will lose a whole group of teachers.

Baroness Morgan of Drefelin: I fear that I have not been as clear as perhaps I could have. It is the new SENCOs who are required to have this training. For those who have been in post for some time, it will be at the discretion of the head teacher. If a SENCO has been in post for some time, it is possible that they will want to do the course, and of course that will be available to them, but it is important that I am clear that the discretion of the head teacher will come into play.

Baroness Verma: I thank the noble Baroness for that clarification. I just want to make sure that we are all singing from the same hymn sheet: that we want to support SEN as best as we can, without taking teachers

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away from the classroom. The noble Baroness said that it would take 12 days outside the classroom. That does not really take into account the work that would be needed to be done outside the classroom and outside their other duties. Has she estimated what timeframe will be needed? I know that she is saying that it is over a three-year period, but I am still slightly worried that it will be an extra burden for SENCOs to deliver that in the way that the Government expect. As I said, I shall read carefully what the Minister has said.

Motion withdrawn.

Health: Medicines

Question for Short Debate

2.13 pm

Tabled By Earl Howe

Earl Howe: My Lords, I am raising an issue which to the casual reader of the Order Paper may look rather abstruse but which is in fact the very opposite; and it is an issue which has far-reaching implications both for patients and for the NHS. Medicines are used off label when they are not licensed for the particular indication to which they are applied. There are two main reasons why a license may be absent. It is either because the illness is so rare that the manufacturer is unable to recruit enough participants to take part in clinical trials; or else it is because the manufacturer has come to the view that the potential market is so small as to make the costs of conducting trials uneconomic.

Many cancers, particularly some of the rarer cancers, are treated with a medicine used off label. There are also a number of less common auto-immune conditions for which the treatment is unlicensed. Rituximab is licensed to treat rheumatoid arthritis, but doctors also use it to treat vasculitis, which is a disease affecting the blood vessels. Infliximab is licensed to treat Crohn's disease, ulcerative colitis and ankylosing spondylitis, among other conditions, but it is also prescribed off label for the treatment of Behcet's disease, which is a most unpleasant complaint that can involve ulceration and extreme exhaustion. Micophenolic acid is licensed to prevent organ rejection after a transplant, but it is additionally used to treat psoriasis and lupus.

The use of those treatments outside their licensed indication is widespread because some clinicians believe that the unlicensed treatments can lead to better patient outcomes than licensed treatments, where those exist. Ironically, the fact that doctors may develop a strong belief in the efficacy of an off-label use can make it harder to conduct any registration trials necessary to secure an extended licence. That is because they would deem it unethical to randomise patients to a control arm of a trial if they are already convinced that doing so would not be in those patients' best interests.

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As the Minister will know, NICE assesses the use of medicines only in their licensed indication. Because of that, there can be no NICE guidance for a drug's off-label use, and hence no mandatory funding direction at national level. That inevitably means that decisions about the funding of treatments outside their licensed indication are left to local discretion. That fact is one which works to many patients' disadvantage. Although in a given PCT, the requests that come forward may be quite few, the treatments may often have a relatively high unit cost, which can throw budgets into some disarray. There may be little or no published information on the effectiveness of the treatments requested, which means that commissioners often have little to go on, and the decision collapses into a calculation of raw cost rather than a more considered assessment of clinical and cost effectiveness.

The commissioners at PCT level are typically not specialists, and many find it hard enough to make informed decisions about relatively common conditions, let alone rarer ones. There is something of a vicious circle here, because funding for treatments is not made available, as there is little published evidence in support of them, and that itself perpetuates the paucity of information.

The result is an extraordinary amount of duplication in each of the 152 PCTs, which must each develop their own processes and maintain their own advisory committees to determine whether to fund a particular treatment. The people who suffer most, of course, are patients. For those who need off-label medicines, the postcode lottery is a stark reality, and health inequalities are accentuated, not least because the most articulate and well informed patients will typically negotiate their way through the system to secure a positive outcome.

The Minister may have read the report published recently by the Rarer Cancers Forum, called Off Limits, which looked into the way in which acute trusts and PCTs determine requests for off-label use of medicines. There were some alarming findings in that report. Nearly a third of hospital trusts which responded to the audit said that they had no protocol in place for off-label treatments. That is a serious matter, bearing in mind that for cancer in particular, chemotherapy is a process which administers toxic substances into the bloodstream. Because there is a relative lack of evidence about the safety and efficacy of an off-label treatment, commensurately greater care needs to be taken over it. There are wide variations in attitude about this issue from trust to trust. Some trusts appear actively to discourage off-label use, while others acknowledge that it is a necessary ingredient of high-quality patient care. Perhaps the surprising thing is the number of trusts that do not appear to distinguish between on-label and off-label use at all and do not keep records of the requests they get. As they are vicariously liable for the outcome of off-label treatments, this seems a somewhat reckless attitude.

Among PCTs, the picture is, if anything, worse. Almost three-quarters of PCTs reported that they operated protocols for determining off-label funding requests. However, 42 per cent do so by using the exceptional case process, despite the fact that the

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National Prescribing Centre has said that this absolutely should not happen. Three PCTs-North Staffordshire, Oldham and Western Cheshire-said that they had a policy of never funding off-label treatment requests. This is arbitrary and unjustifiable. It may also be illegal in the context of the NHS Act. Perhaps the Minister would care to comment on this. It is certainly a situation that appears to run directly contrary to the NHS Constitution.

At the heart of the problem is the absence of an information base about the uses of off-label medicines and the clinical outcomes achieved thereby. Somehow this needs to be overcome. I say that not least because of the need to guard against inappropriate off-label treatments. Perhaps the most worrying instance of this is the overuse of antipsychotic medicines in care homes to treat dementia. The Psychiatric Bulletin published a study two years ago that brought this issue to the fore, as did evidence presented to the All-Party Parliamentary Group on Dementia last year. Not only do such medicines carry safety risks, they also have unpleasant side effects, and there is clear evidence that people with dementia derive only limited benefit from them. The Department of Health is about to publish a report into this subject, and we await it with interest. I hope that it will cover two issues in particular: the need for care home staff to receive training in dementia care and the need for those to whom antipsychotics have been prescribed to have that prescription formally reviewed by a doctor on a regular basis.

It is uncomfortable for me to admit that, in the context of off-label treatments, the split between purchasers and providers and the competition that exists between them serves to frustrate the delivery of the most effective care to patients. My own view is that the only way to tackle these difficulties satisfactorily is to put in place a collaborative commissioning arrangement, perhaps across each strategic health authority area, which combines the skills of both hospital specialists and PCT commissioners. A single commissioning committee, perhaps not unlike that which deals with specialised conditions, could be established in each strategic health authority to examine requests for off-label treatments. This would drastically reduce waste and duplication at PCT level, and it would also allow different local health economies to pool their expertise. However, the real benefit would flow over the medium term because once a certain number of requests for an off-label treatment had been reached, the committee could form a consensus opinion about that treatment, and that in turn could be used as a means of informing funding decisions in the future. Consensus opinions reached in this way could be made available to NHS Evidence, which would act as a conduit to inform decisions elsewhere in the country. Of course, there would need to be a mechanism for updating the content of a consensus opinion to take account of experience and any new research that emerges.

I very much hope that this idea, or something like it, will commend itself to Ministers. I say this more in expectation than in hope, because in the department's paper published in November last year, called ImprovingAccess to Medicines for NHS Patients, it did seem that they had in mind some kind of collaborative arrangements

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for making decisions about the off-label use of medicines. My firm view is that this dimension of drug prescribing in the NHS has been overlooked for too long. Someone needs to champion the whole issue and come up with a completely new model that is designed to ensure that patients across the country receive speedy and appropriate access to the medicines they need.

2.25 pm

Lord Kirkwood of Kirkhope: My Lords, I am pleased to follow the noble Earl, Lord Howe, who, typically generously, shared some of the briefing that was made available to him. I am grateful for that. I am a trained pharmacist. I did a degree a long time ago in the days when pharmacists were trained to roll pills-that shows how long ago it was-so my pharmacy is not as modern as it should be. However, I am also a recently appointed lay member of the General Medical Council, which gives me an interest in this debate. I congratulate the noble Earl on this debate. The timing is absolutely right. He is correct that this subject has been overlooked for too long. I was quite surprised when I looked at some of the material. This is not the area of public policy in which I specialise, but there are so many different, overlapping issues that need urgent attention that the time has come for it. I hope the Minister can give us some comfort in that direction.

I shall go off-label in the debate and make two quick points. First, overprescribing in the NHS is still a problem. A sentence of reassurance from the Minister would be helpful. Secondly, we all understand that the escalating costs of the drug bill are a problem for us all. However, I do not think this issue is predominantly about cost. If everything recommended by the noble Earl was brought into being in good order in a reasonable time, it would not cost a lot, but it would improve the pathways of care for some patients throughout the whole United Kingdom-I shall come back to that point. I do not think the Government can hide behind the fact that this will cost a lot of money, because it should not.

In addition to the important areas that the noble Earl, Lord Howe, referred to-rare cancers and the antipsychotics issue that the Alzheimer's Society perfectly properly raised with us-there are other cases and circumstances that the Government are already aware of. I shall refer to one of them, although I am sure there are others. It is the question of Lucentis versus Avastin in the treatment of age-related macular degeneration. It is a particularly interesting case because the same company produces an expensive drug that treats colon and breast cancer and the even more expensive Lucentis, which is properly licensed for the treatment of wet AMD. There are practitioners who believe in soul and conscience and their best clinical judgment that the cheaper product would be as efficacious, but they cannot get past the bureaucracy of the extra cost for the NHS for the reasons that the noble Earl suggested. It is right to say that in rare conditions, such as rare cancers, you cannot get the critical mass to get statistical validity for the trials that are necessary for the licence. There are also perverse incentives for pharmaceutical companies within the licensing system. I do not blame them. Why should they license another drug when they have a more expensive licensed drug

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on the market? It would cost them money to do so. There are issues around the licensing system that we need to look at.

However, equality of access is the main burden of the noble Earl's powerful evidence to the House this afternoon. I concur with him. There are quite indefensible variations of treatment. I commend the Rarer Cancers Forum, an organisation of which I was previously ignorant. Its report is extremely well argued and well researched and repays careful study. It is very clear about the impact on patients who are suffering from rarer cancers. I did not realise that rare-cancer sufferers are quite a proportion of cancer sufferers. It is important not to forget that.

The noble Earl made a very important point about NICE. It is hamstrung and cannot do much about this issue without a new look at the whole thing. I also agree that the lack of NHS protocols to ensure the clinical governance of off-label treatments is not satisfactory and needs attention. The report demonstrates that there is a wide variety of practice in the NHS, which is not satisfactory.

Some NHS trusts have vicarious liability, and as a member of the GMC I know that it has no rules with a locus in this argument. The GMC, in any case, is not responsible for licensing or for determining price efficacy or anything else. There is, however, some pretty clear guidance in Good Medical Practice, a GMC publication, which is supplemented by a document called Good Practice in Prescribing Medicines, which also sets out quite clear guidance on how medical practitioners should conduct themselves when they prescribe a medicine for use outside the terms of its licence. They must, for example:

"Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative",


"Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help in which case the necessary information must be sought from other sources".

It is perfectly possible, legal, right and proper that people using their medical judgments-that is why they are trained-should prescribe off-label medicines for treatments that they think are appropriate, but they should not be doing so casually and without being properly cognisant of the regulatory environment that is all around them. It is unsatisfactory for trusts not to support the people whom they employ to discharge these important responsibilities as medical practitioners.

There is a difference in practice north and south of the border. The Scottish Medicines Consortium is light years ahead of and much better organised than the situation in England, due partially to the fact that it operates on a much smaller scale and can get these things done an awful lot more expeditiously. I make the point facetiously. Nevertheless, we in Scotland seem to be more fleet of foot and able to move more expeditiously in determining some of these things. If the Minister has the briefing, will she reassure the House that there is dialogue, as I hope there is, between professionals, if not Ministers, about all this?

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Secondly, there is an international body of opinion and experience on which we can draw. The noble Earl made an important point about treatments for psychosis and drew very interesting comparisons between how we and our sister European nations deal with some of these technical problems. Arguably, their best practice could be looked at and we could benefit from that.

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