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If we want to take politics out of the NHS and allow clinical experts to make decisions on our behalf, why does a matter still have to go to the Department of Health for the Minister to make a decision on the referral? Surely, such decisions are for NICE to make, and to make a lot earlier. For example, it could make a decision as trials come towards their end—there is no need to wait for them to finish—and then refer the matter to the Minister. It could then be referred back to NICE. NICE should be engaged at the latter part of trials, which would speed up procedures all the way through.

We have had an excellent debate and some passionate and informative speeches from people who are much more knowledgeable on the subject than me. I encourage the Minister to look again at the procedures and to use whatever powers she still has to ensure that NICE introduces such a procedure as soon as possible, to ensure that people do not use the lack of NICE guidance as an excuse for not making the procedure available throughout the country. She should also consider the shortages relating to clinical expertise. Please give people with this disease the opportunity to have a better and longer life. Although the disease is, sadly, incurable, we can still give sufferers much better life experiences.

10.34 am

The Minister of State, Department of Health (Dawn Primarolo): I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on securing the debate. I pay tribute to him for his work as chair of the all-party group on motor neurone disease and to the valuable work that is undertaken by the Motor Neurone Disease Association.

I also congratulate the hon. Member for Montgomeryshire (Lembit Öpik), who spoke in a very quiet but assertive way about this important subject, and the hon. Member for New Forest, East (Dr. Lewis), who said that he felt out of his comfort zone because he was relatively new to the subject. I do not think he was out of his comfort zone at all given the eloquence with which he spoke. He made some very moving points about the huge contributions that Lord Cheshire made.

Many of the points my hon. Friend the Member for South Derbyshire made about the process of considering guidelines for non-invasive ventilation for motor neurone disease are valid. I agree with him and other hon. Members that NICE undertakes an incredibly important and delicate process of assessment for the NHS. Over 10 years, it has made considerable progress, but the job is not finished. In responding to the debate, I want to explain—as the hon. Member for New Forest, East asked me to do—what lies behind the decisions, and what the extenuating circumstances are for the long delay in referring this topic. Such a delay is deeply regrettable and something for which I am personally sorry. My hon. Friend is entitled to an explanation of some of the consequences that lie behind the delay. I will outline how I intend to help the matter proceed.

My hon. Friend is right that the topic was originally put forward for NICE guidance in 2006 and finally referred to NICE as a short clinical guideline topic in November 2008. It might be helpful if I say a little about NICE’s clinical guidelines programme, and recap briefly on the process whereby topics for NICE are chosen.


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NICE’s clinical guidelines programme is the largest such programme in the world. To date, NICE has published more than 80 clinical guidelines, addressing major disease areas such as mental health, cancers and cardiovascular disease, and a further 40 guidelines are in development.

However, even a programme of such world-leading scale cannot develop guidance on every topic where it might be of value. NICE’s work has to be prioritised, and a clear process is in place for that to happen. That touches on the point made by the hon. Member for Hemel Hempstead (Mike Penning) about how topics get referred. Topic ideas may come from a dedicated horizon-scanning team, which actively identifies new

drugs and technologies. Anyone can suggest a topic for NICE guidance using the suggestion form on NICE’s website, and many groups and individuals do so every year. Suggestions are then sifted to ensure that NICE guidance is appropriate and does not duplicate existing work. Topics are then prioritised by one of seven multidisciplinary consideration panels at NICE before being considered by a small group chaired by the NHS medical director, which makes recommendations to Ministers. The process was introduced in 2006 and is designed to be as open as possible while dealing with the large number of suggestions that NICE receives each year.

In this case, the topic selection process took far too long to consider the guidance suggestion. The reasons behind that delay, as I understand it, were threefold. First, when the topic was suggested for NICE’s work programme in 2006, there was a backlog of hundreds of topics awaiting consideration. The changes made to topic selection arrangements in 2006 were designed to address that situation but the backlog took time to clear.

Secondly, there was a discussion between interested parties on whether the topic would be most suitable for NICE’s short clinical guidelines or for its technology appraisal work programme. That was important in ensuring that the product NICE developed for the NHS was the most appropriate to support the delivery of care to that group of patients, but the process took too long. There are many complexities, and I do not want to go back over them.

Mike Penning: Will the Minister give way?

Dawn Primarolo: I should like to give the three reasons for the delay before I give way. To make it absolutely clear, I am not condoning the delay, but Members are entitled to know what actually happened, what we have done about it, and what happens in future.

As I said, the deliberations are necessary to ensure that NICE addresses the guidance topic through the appropriate route and develops the kind of advice that the NHS needs. In this instance, that took too long.

Thirdly, internal staffing problems in NICE played a significant role in the delay. It would not be appropriate for me to go into detail, but I assure my hon. Friend the Member for South Derbyshire and all other hon. Members that lessons were learned to ensure that, if at all possible,
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such a thing never happens again. Ministers can never say never but, with all due certainty, I can say that it will not happen in future.

The cumulative effect of those three events meant that it was not until November 2008 that the topic was referred to NICE. As I have made clear, I am not condoning that; I am explaining the situation to hon. Members because they are entitled to an explanation.

Mike Penning: I thank the Minister for her description of what was happening, and I realise that she is not condoning the delays. What was the period between the committee referring the matter to the Minister and the Minister referring it to NICE? If the Minister cannot answer that question today, perhaps she could drop me a line.

Dawn Primarolo: As I understand it, the period was very short indeed. The role of Ministers is now to formalise the work that pre-dated the request for them formally to refer something to NICE. I was not personally involved in this case, but in others where I have been involved, we would be talking about an incredibly short period.

Mr. Todd: The Minister is helpfully explaining what has happened. The Motor Neurone Disease Association was in regular contact during the nearly three years of delay, trying to find out what was happening and what the delay was, so it was not a case of saying, “Well, we have told them once, and now we are waiting for something to come out of the other end of the tube.” It would be helpful if the Minister described the review process that presumably happens when there are such repeated contacts.

Dawn Primarolo: I will be happy to write to my hon. Friend on the detail. However, I understand that the discussions did not involve the MNDA pressing the question why a decision had not been made. Rather, there was an interaction with the association about what the process and its outcome should be. Of course, I will look into it further.

My hon. Friend has written to the chief executive of NICE about the time taken to refer the topic decision and I am assured that he will receive a full reply very shortly. I have asked to be copied in when the reply is sent because, undoubtedly, lessons can and will be learned from the process, although, ultimately, the rate at which NICE can develop guidance will depend in large part on its guidance capacity.

The hon. Member for Hemel Hempstead asked how long it took the Minister to refer the matter. The submission went to the Minister on 20 November and it was referred on 26 November—in the same year—which is what we would call a reasonably prompt turnaround.

The topic has now finally been referred to NICE’s short clinical guidance work programme. It has ensured that the topic will be in its work programme at the earliest opportunity. As my hon. Friend the Member for South Derbyshire mentioned, NICE expects to commence work later in 2009, but I will return to that matter. The issue is NICE’s guidance production capacity. Although NICE is an extremely valuable body and the resources that we have made available to it have grown considerably since it was established 10 years ago, any Government
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would need to consider the balance—the need for proper resourcing of NICE and the prioritisation of funding for front-line services.

I do not condone the delay, but NICE fulfils an incredibly important, delicate and often difficult function. It has to prioritise topics for guidance and strike the right balance between the speed of guidance development and accuracy to ensure that it is robust. At the same time, it must also confront the sheer scale of medical innovation and clinical care and the flow of new ideas, evidence, treatments and drugs that are constantly emerging.

The Government recognise the importance of timely NICE guidance both for patients and the NHS, as well as the need to build NICE capacity and expand it in new areas of activity. That was a central message of last year’s next stage review. As well as reducing the time it takes NICE to produce guidance on new drugs, we have worked with it to introduce the shorter clinical guidelines process, which is specifically designed to allow NICE to tackle guidance topics that do not need a full clinical guideline. So far, it has published short clinical guidelines on a range of issues.

The Department of Health is working with NICE to see whether it is possible to expand the capacity of the short clinical guidelines programme, through which the topic is being addressed, which could mean that it is able to start work earlier than is currently planned. I will ensure that my hon. Friend is kept fully informed of progress as we seek to move the discussion forward. My colleague, Lord Darzi, is looking at the issue with a view to identifying further action for the Department to take in the near future.

Dr. Julian Lewis: I thank the Minister for the comprehensiveness of the account that she is giving. In her work with NICE on the possible expansion of the short clinical guidelines procedure, will she especially raise the point that, as my hon. Friend the Member for Hemel Hempstead (Mike Penning) indicated, separate consideration ought to be given to cases of this sort, when we are not talking about drugs but about relatively simple physical procedures? There should be an accelerated consideration of such cases, because the prospect of adverse side effects is vanishingly small.

Dawn Primarolo: I confirm that that is precisely what the introduction of the short clinical guidelines programme seeks to do. One of the reasons for the delay of the referral—I gave the three reasons earlier—was uncertainty about which programme the topic should have been in. I am trying to provide information, but the House will not gain anything if I look back and say, “The delay may not be to do with the Department or NICE,” or, “So and so did this or that, which caused a delay.” The urgent questions to address in this debate are: what were the delays, were they reasonable—I do not think that they were—what lessons have we learned to ensure that the same situation does not arise again, and what are we doing to ensure the timely consideration not only of this case, but of other short clinical guidelines programmes?

Lembit Öpik: Before the Minister comes to what I imagine will be her concluding remarks, may I say that I am encouraged by what she is saying? If she is saying, in effect, that the NICE system is to start considering the opportunity costs of not making quick decisions—not
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just on motor neurone disease treatments but on other things as well—that is encouraging. If she is also saying that the informal conversations that she is having about non-invasive ventilation recommend that NICE might wish to make a judgment about the benefits of delay versus the benefits of immediate implementation, given the very small risks that have already been described, she is saying something that everybody in this Chamber, the Motor Neurone Disease Association and victims of the disease want to hear.

Dawn Primarolo: I am not putting myself in the place of the clinical experts on whom I as a Health Minister rely absolutely. The hon. Gentleman knows from discussions on the Human Fertilisation and Embryology Bill, for instance, and from the good research that can now be done with embryonic stem cells, that we depart from the best clinical and scientific advice at our peril. I shall not do that today. The process that he just described is the one that is supposed to be in place and that works now. Looking back to 2006, when this particular case started, a number of things happened that, regrettably, slowed it down. I believe that the changes made should ensure that does not happen on any referral in future.

However, that still leaves us with the important question that the hon. Gentleman and others asked: when will NICE consider the issue? I told him what NICE said originally. All the issues are priorities. NICE is not picking and choosing. I hear what the hon. Gentleman says about high priority, but he knows as well as I do that the national health service treats some 1 million people every 36 hours. All the complexities that our staff must handle and the fantastic things that they can do with the help of science, drugs and technologies—some of which he mentioned in relation to motor neurone disease—make choosing priorities a difficult job. They are all of equally high priority, but we are taking them forward.

The hon. Members for New Forest, East and for Montgomeryshire expressed concern about the thousands of patients who, they said, had died prematurely and in circumstances that all of us would want to alleviate, as a result of the delay in developing guidance on the topic. I understand their perspective absolutely, and I respect the passion with which they spoke on the matter. The hon. Member for New Forest, East went on to answer his own question. If there is good evidence that a treatment works well and it appears to be a good use of resources, the NHS should not hide behind the lack of guidance from NICE, as the hon. Member for Hemel Hempstead mentioned. We have made that clear repeatedly to the NHS.

Most of the services delivered by the NHS have not gone through NICE, but the NHS does not say, “We’re not going to do this because NICE hasn’t considered it.” NICE is about trying to reach more sensible and equal decision making across the NHS. The Government have always maintained that the absence of NICE guidance on treatment does not mean that individual PCTs should decline to make funding decisions on individual treatments based on assessment of the evidence. I have written to primary care trusts on that subject. Lack of guidance alone is not an acceptable reason for not funding treatment. I have made that clear.

The hon. Member for New Forest, East complimented his health service on its performance in that respect and
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on the excellent services provided in Southampton. We have made it absolutely clear what is expected, how NICE should play it and what the Government’s role is, and we will continue to do so.

Mr. Todd: That relates to the point that I raised when intervening on the hon. Member for Hemel Hempstead (Mike Penning) about the unevenness of distribution of expertise on a disease that is not prolific. Many people will not encounter motor neurone disease more than once or twice in a clinical career. Partly for that reason, we must address it through a NICE process, but it is worth making the point that the Minister is making. The remedy lay in the hands of the NHS all along, as Southampton illustrates.

Dawn Primarolo: I agree absolutely with my hon. Friend. Most neurologists—there are some 900 of them in the UK—are involved in the diagnosis of MND, and many are involved in multidisciplinary local MND teams. The vehicles do exist, but NICE guidance would undoubtedly help. That is why the association requested that such guidance should be undertaken.

I have done my best to reassure Members about the prioritisation process now and to explain why the situation occurred. The hon. Member for New Forest, East asked why it took so long. I have tried to explain that. He asked whether it was acceptable. I have explained that I do not think that it is. He also asked whether the treatment was prioritised. I have explained that NIV is, and that we are taking it forward.

In conclusion, to encapsulate where we are going now, I congratulate my hon. Friend the Member for South Derbyshire once again on securing this debate. I thank him for the powerful arguments that he has made. I do not pretend for a moment that the handling of that important guidance topic has been in any way satisfactory, and I have outlined some of the factors at work, although they are no excuse. I hope to be able to reassure him that I acknowledge the regrettable problems that have occurred and that we and NICE have learned lessons from the experience. NICE will be progressing the topic at the earliest opportunity and, as I have promised, I will ensure that my hon. Friend is kept fully informed of developments. I leave it to him to tell me whether he will pass that information on to other hon. Members who have taken part in the debate, or whether he would like me to do so.

Mr. Todd: I will gladly pass the information to other members of the group and those interested in the issue.

Dawn Primarolo: In that case, I am grateful for the opportunity to explain the position and how the Government intend to take things forward. As I said, delays occurred and I have explained why, but I do not condone them. I hope that the House is satisfied that I intend to take the matter forward with great vigour to ensure that the situation is addressed.


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