Hansard (KC) 14-Oct-08

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Rare Medical Conditions & Drug Availability

14 Oct 2008 : Column 210WH

Rare Medical Conditions 11 am Dr. Doug Naysmith (Bristol, North-West) (Lab/Co-op): As always, Mrs. Humble, it is a pleasure to serve under your chairmanship. I am grateful to Mr. Speaker for granting me this debate, as it will provide a welcome opportunity to discuss with my colleagues the needs of patients who suffer from rare and complex medical conditions.

I emphasise that the Government’s commendable policy of making the national health service more locally accountable should not prejudice the interests of people with such conditions, as they have requirements that need to be planned and provided for regionally and sometimes nationally. Many of these conditions are severe, genetically determined and sometimes life threatening. They include cystic fibrosis, some myelomas, Gaucher disease, paroxysmal natural haemoglobinuria—PNH—and muscular dystrophy. However, many of us, or our friends and families, could need specialised services for severe burns, spinal injuries or serious mental health problems, to take only a few examples. Those living with rarer cancers often encounter similar problems receiving care as do those with other rare medical conditions. Examples include some brain tumours, soft tissue and bone cancers, and HIV-related malignancies such as Kaposi’s sarcoma.

The point of listing these conditions is to emphasise the fact that rare conditions and specialised services are not unusual curiosities, but are to be found at the heart of what makes our NHS special. For that reason, those of us with an interest in the treatment of rare and complex conditions were delighted by the Government’s decision to ask Sir David Carter to review the commissioning of specialised services. In an impressively coherent report, published in 2006, Sir David recommended that 10 specialised commissioning groups should be set up at regional level to plan and procure services catering for populations of more than 1 million, and that the constituent primary care trusts should pool budgets to pay for the procured services.

Indeed, on 8 January, the Prime Minister said:

“as the cost of ever more effective technology intervention rises and there is little advance knowledge of upon whom the cost will fall, it is more important than ever to pool the risk and share the cost of those interventions fairly across our whole population.”

That risk-sharing aspect of the NHS was one of its fundamental features when it began 60 years ago. Another feature apparent then was a commitment to research and the development of new treatments and technologies. That makes it all the more bizarre these days that when effective treatments become available, often developed within the NHS, they are sometimes denied to patients on the ground that they cost too much.

Considerable progress has been made towards implementing the Carter reforms in the two years since publication of the report, and that should be recognised. However, specialised services seem to have a habit of moving to the periphery, and there has been a worrying lack of recognition of the Carter principles in a number of recent Department of Health documents. For instance, there is no mention of them in the next stage review final report or in “High Quality Care for All”, nor are they mentioned in the draft NHS constitution. Furthermore, 14 Oct 2008 : Column 211WH because small patient numbers requiring individual services means that the cost of treatment tends to be high, it puts rare and complex conditions in the thick of the current debate about top-up fees and the like.

As my hon. Friend the Minister knows, I am a strong supporter of the National Institute for Health and Clinical Excellence, and a firm believer in its role as an arbiter of the clinical effectiveness and cost-effectiveness of medicines—and, I hope, increasingly of other forms of treatment. However, if we used cost-effectiveness as the sole criterion for decision making, the NHS would rapidly lose public support—for example, palliative care could instantly be discontinued, and heart and liver transplants could be at risk. Indeed, NICE’s citizens council has constantly found that large majorities are in favour of society taking care of those in greatest clinical need. The Secretary of State’s directions for NICE cite clinical need and innovation as factors to be taken into account alongside clinical effectiveness and cost-effectiveness. However, the directions on clinical need and innovation are not explicitly recognised in NICE’s recently revised document on social value judgments. Surely all the Secretary of State’s directions should be adhered to when decisions about the funding of treatments are taken by NICE, PCTs and other bodies?

On the subject of exceptional cases and exceptional case panels, procedures for assessing exceptional cases were originally established to consider the funding of treatments that could be of debatable clinical benefit, such as tattoo removal, breast enlargement or hair transplants. In order to receive funding, patients had to establish clear clinical benefits, such as the alleviation of severe suicidal depression. However, with the advent of new high-cost treatments for a number of rare conditions—for example, some of the rarer cancers that NICE cannot assess because a drug has not been licensed or because it is waiting in a queue—primary care trusts are increasingly using exceptional case procedures in order to assess whether or not such patients should receive treatment.

The clinical benefit of such treatments is often not in doubt, which means that it is difficult for patients to prove that they are exceptional. In many such cases, it is clear that the procedures are being used to assess whether the treatments are cost-effective—something that they were not designed to do and which they are ill-equipped to undertake. That is not satisfactory, and the Rarer Cancers Forum has pointed out some of the drawbacks. For example, 3,000 patients make a request for exceptional funding every year, of which a large proportion—2,200—are approved. However, those patients first have to navigate a confusing system that has no common term to describe exceptional cases to help the panels that assess them. Indeed, exceptional cases are varyingly referred to as “underfunded” or “non-normal” treatments, or even “case-by-case” requests; and the panels are sometimes referred to as “priorities panels”, or “commissioning advisory groups”.

There are huge variations in the number of exceptional applications made to PCTs and in the proportion of applications that they accept. One PCT received 180 applications over 20 months, whereas another received only one. Likewise, some PCTs approved all applications and others approved none. There are differences in how PCTs deal with exceptional case procedures: some have panels to assess treatments and others do not; some of those panels are dominated by administrators, and others 14 Oct 2008 : Column 212WH include a majority of clinicians. In addition, some PCTs use social criteria, such as whether a cancer patient has children, in order to determine whether a case should be approved; and others do not.

We need to make improvements to ensure that the NHS does not progressively become a body that fails to provide health care based on clinical need rather than ability to pay or some other criterion, and that applies particularly to patients with rare and complex conditions. Despite the rapid recent growth in NHS spending, affordability will always be an issue. The NHS will always have a limited pot of money, and we have to accept that it cannot fund everything. However, the existence of a NICE threshold for cost-effectiveness, which has changed little for 10 years, must be contributing to the current pressure for top-up fees.

Some positive things are happening, which should help in future. For instance, some substantial savings for reinvestment will be made from a generation of blockbuster drugs that are due to come off-patent in the next few years. The Department of Health and the pharmaceuticals industry have recently come up with a few innovative approaches to risk sharing that enable patients to access new products earlier in their life cycles.

It is easier to draw attention to problems than to provide solutions, and I am conscious that I have done the former so far, so I shall conclude by listing a number of things that I believe need attention if we are to put things right. The aim is to introduce fairness and transparency into the current systems for specialist commissioning.

First, I hope that the operating framework that is due out later this month will help to complete successful implementation of the Carter report on specialised commissioning. Secondly, the NHS’s proposed right of access to local services should be extended to include specialised services. Thirdly, the Secretary of State’s directions to NICE on clinical need should be actively adopted by NICE and throughout the NHS when taking decisions that affect the funding of treatments. Fourthly, the Department and NICE should explore ways in which to recommend a treatment for use in the NHS, even when it does not have product licence, on the basis that it can be used to treat a biologically similar condition. I realise that proposal is complicated, but it is worth exploring.

Fifthly, there is a need to encourage collaborative working between PCTs, which is already happening in many places. A poll by the NHS Confederation in June showed that more than three quarters of NHS organisations believed that PCTs should work together nationally or regionally when deciding which expensive drugs or treatments should be offered to patients. Finally, as the Select Committee on Health has frequently recommended, it would be helpful if NICE evaluations could be speeded up. I know that there is a willingness in both the Department and NICE to do that, but progress, interestingly, is remarkably slow.

I look forward to hearing what my hon. Friend the Minister has to say on those very important matters.

11.12 am Steve Webb (Northavon) (LD): I congratulate the hon. Member for Bristol, North-West (Dr. Naysmith), my constituency neighbour, on securing this important 14 Oct 2008 : Column 213WH debate and on the thoughtful, measured and well informed way in which he opened it. I agree with the thrust of what he said, and I am grateful for the opportunity to participate. I have recently been made aware of the work of the Rarer Cancers Forum by meeting a constituent who is affected by some of the problems that the hon. Gentleman spoke about. Briefly, I should like to describe my constituent’s experiences and draw some conclusions about how the system is working or, more to the point, not working.

My constituent, Robert Derrick, is in his mid-60s; he is a father and grandfather who lives in Charfield in my constituency with his wife, and who runs a small business. He could be any of us. Last year, he saw a surgeon in Gloucester because it was clear that something was not quite right. The surgeon suspected bone cancer, but in June 2007, he was diagnosed with kidney cancer and had a kidney removed. In October 2007, he had a knee and part of a femur removed. He went through the wars but, interestingly, made a good recovery. He still runs his business, which I believe involves transfers for vintage motorbikes, and he is keen to go on doing so. We have a correspondence, and I met him and his wife on Friday. He has had kidney cancer, but one would not necessarily recognise that he was ill.

In June 2008, he was admitted to Gloucester hospital bleeding from the lungs, and was diagnosed with inoperable metastases on both lungs, at which point the system started to go wrong. The family spoke to the consultant, who told them that they can have two drugs, one on the NHS and one not. The drug that is available on the NHS is called Interferon. In Mr. Derrick’s circumstances, it offers a poor quality of life and works for only one in six people; it might, with luck, give him another six months. The consultant said that Sutent, the other drug, should work well. The family wrote to me to tell me that their impression was that the consultant had told them that Mr. Derrick could expect to lead a normal life on Sutent, so there is a huge contrast between the drugs.

Sutent and associated treatments cost £4,000 a month—no-one pretends that that is not a lot of money—and the family were told that the NHS would not pay for it. The consultant said, “Every time I get a patient who would be appropriately treated with Sutent, I fax a request to Gloucestershire PCT, but it has told me to stop doing that because it has an exceptional funding process.” If the consultant referred everybody who he thought would benefit from the treatment, by definition, they would not be exceptional, so the PCT told him to stop making requests. He replied, “All my patients are exceptional, so why should I look at 10 people who come through my door and privately make a decision to pick this person or that because they are somehow more exceptional than the other nine? That is not why I came into medicine.” When Mr. Derrick and his wife went to see him he said, “There’s no point me even applying for this drug, because the PCT will just say no.” Understandably, the family were unhappy.

When approached, Gloucestershire PCT said, “You haven’t asked for or applied for the drug, in this case, for this patient, so we haven’t yet refused.” Having been told to apply, we did so. The family wrote in, the consultant said why Mr. Derrick would benefit and I 14 Oct 2008 : Column 214WH wrote letters of support. The PCT had a meeting and decided not to fund the treatment, which is probably not surprising. However, the meeting was held behind closed doors, and had I not told the family what date the decision would be made, they would not have known. They were not allowed to send anyone along, did not know who was making the decision, and there is no accountability for what happens behind those closed doors. Making what is literally a life-or-death decision behind closed doors, unaccountably, is a problem.

When the decision was made and the family came to see me on Friday, they said that they had not yet had an explanation from the PCT. I phoned the PCT on Thursday night, and was kindly sent a copy of the letter that explained things, which they were about to post. In the letter, the chief executive of Gloucestershire PCT wrote:

“Whilst sympathetic to the patient’s condition”—

Mr. Derrick smiled at that pathetically weak phrase and said that it was the first time that he had had any sympathy from the PCT. We know that funding cannot be provided for everything and everyone, but we should all be treated with humanity and sympathy. The letter continues:

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“the symptoms described are, unfortunately, not uncommon in patients requesting this treatment and are therefore not considered exceptional in that they will be experienced by other patients in the county. We therefore regret that we feel unable to grant funding”.

In other words, Mr. Derrick was not different enough to warrant funding.

NICE preliminary guidance concludes that Sutent is not cost-effective. However, there was uncertainty whether NICE had taken account of the fact that Pfizer provides the first course—four weeks of tablets and two weeks off—free of charge. NICE did not factor that into the costing of the drug, because the Department said that it was not sure that it was national, robust or rigorous. However, I believe that Pfizer confirmed that the first month is free to the NHS, so NICE could take account of it when it revises its guidance. Will the Minister assure us that it will? The first month being free to the NHS should be taken into account in the costing. Pfizer has also provided further clinical data. I hope that NICE has a more favourable cost assessment when it revises its judgment and that it recommends the treatment. I asked NICE whether it can speed up the process, because until the guidance is revised, PCTs throughout the country will use the preliminary guidance and probably say no in most cases. I also contacted Pfizer to see whether my constituent can go on a clinical trial or something.

Mr. Derrick told me that it is not the illness that gets him down, but the battling—the constant lobbying and letter writing, uncertainty and waiting. It would be unfair to say that the people making the decisions are faceless, but they are in the sense that they sit behind closed doors. The problem is that people do not know who is deciding their fate.

Not only is the drug available in most other European countries but it is also more expensive. This is not a case in which a drugs company is making vast profits by charging huge amounts in this country. The drug is cheaper here than elsewhere. Most other European countries pay for it, and some PCTs have approved its being prescribed, but not my constituent’s. That is the root of the problem.

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Let me share with the House a few words from Mr. Derrick’s daughter. She wrote to me and has given me permission to quote from her letter. As an Opposition MP, I do not have the right to place something in the Library, but I would love to place this letter there because it is so powerful. Her letter is headed:

“Robert Derrick, Not Cost Effective.”

It includes a photograph of him with his grandchild. His daughter says that

“it all depends on where you live. If you live in one place in Britain it definitely is OK to let you go. If you live in another it certainly is not, and in some, you just need an assertive family and a really good lawyer, and if you don’t have them, then oops yes, it’s OK to let you go too.”

She goes on to say:

“The differences don’t stop there. If you can prove you are exceptional, then you might be in with a chance of staying alive. But surely we are all exceptional. It’s a funny thing. You have to show you are different to everyone else who is the same as you, i.e have this horrible disease. So you can’t win.”

She talks about the difficulty of battling the disease, and says that a patient cannot enjoy what is left of their life.

“No, you have to find the energy and the will to fight, do research, hassle doctors, MPs, journalists and anyone else who will listen to you to try and get them to understand that you do count, that it really is immoral and barbaric to let you die like this.”

She says that the drugs are costly, but that does not amount to much in the great scheme of things.

“Is it really too much for Dad to expect the best available treatment, one that his neighbours are getting?”

I know that it is easy for me to say that Mr. Derrick should just get his drug. The Minister has a fixed budget and has to allocate it. My argument is that if the public’s priorities were really getting through in the NHS, they would want Mr. Derrick to have his drugs at the expense of other things the NHS spends its money on. If the public was actively involved—even locally in Gloucestershire—and were asked to list their priorities, I believe that this case would be one. This case is not about localism. I believe in localism and that the health service should respond to local needs. However, this is not about that. Mr. Derrick’s needs are not different because he lives in Gloucestershire; he would have the same needs wherever he lived. Localism is not relevant in the provision of a treatment because, morally, it should not matter where a person lives. What should we do? I believe that the system is cruel and inhumane because it has the random element of where a person happens to live. The system is not working and it is not what the public wants.

The hon. Member for Bristol, North-West raised the crucial issue of the cost threshold NICE uses to evaluate drugs. It is about £30,000 for a quality-adjusted life year. I know it is not quite as simple as that, but that is the figure that appears in the Sutent judgment. As the hon. Gentleman said, that figure has not kept pace with the costs of the NHS and its medicines since NICE was introduced. If that one change was made—if NICE was asked to adjust that threshold to reflect what has happened since it was created—and the Sutent appraisal was redone in the light of the fact that the first treatment is free and of the latest clinical evidence, that could just make the difference. It would not make a difference for some drugs, but it would for this one.

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I understand that the Minister cannot say, “Yes, of course, this gentlemen can have this drug.” However, this is not a choice between two drugs, one of which is quite good, and one of which is very good, one of which is fairly expensive and one of which is very expensive. It is a choice between treatment that will prolong Mr. Derrick’s life, perhaps for a good long period, and his death. It is not that there is a treatment that works and a treatment that does not. There is only one effective treatment, and the NHS does not pay for it. That is wrong. The NHS does not pay for the treatment because of where Mr. Derrick lives. If he lived somewhere else, it would pay for it. I ask the Minister to look again at the threshold that NICE is using and objectively assess whether it should be increased because of NHS inflation and drug price inflation, and to let us know how quickly it can be done, to benefit not just my constituent but many others.

11.24 am Dr. Ian Gibson (Norwich, North) (Lab): It is a pleasure to see you in the Chair, Mrs. Humble. I should like to congratulate my hon. Friend the Member for Bristol, North-West (Dr. Naysmith) on setting us down the track on this important issue and covering lots of ground, which will save us getting into it, because we absolutely agree with him. He has the facts at his fingertips. I can sense a whiff of socialism in the air around this place. It is apparent, if one is in the right wind direction. I am aware, though, that there are hon. Members here who do not like that. On Radio 4 this morning, I heard a Republican denying that what was happening in America had any semblance of socialism. He said that recent events were a little episode that will suddenly disappear and then we will get back to good old strong capitalism again.

We are seeing that in the health service too. Last night, I was with the Minister at a party on the 29th floor of a building not far from Millbank. Many people were talking about the information that patients were getting now, not just through websites and internets but from individuals. They said that the balance of power was swinging in the health service. Jonathan Miller described it as a revolution. He said we were moving towards a situation in which doctors, GPs and consultants would have to find time to listen to the patient. Sometimes the patient knows what is happening, can understand it and should be put in a position in which they can say clearly, “This is having a good effect.” They understand that doctors should not be as omnipotent as the system often makes them. That is important. Some of what we are talking about today is part and parcel of that process.

The hon. Member for Bristol, North-West has delimited many of the things that are happening. I have reason to congratulate the Government. A consultant at Guys called me to say that the Government had used a special system, on which the Minister will elaborate, for paroxysmal nocturnal haemoglobinuria. A special commissioning group had decided to extend the system to a group of patients in this country, and various strategic health authorities had come out and said that Eculizumab must be available on the NHS. What a way forward. At last, amazingly, something is happening that will make a difference to people’s lives. I am not talking about millions or even thousands of people, but individuals 14 Oct 2008 : Column 217WH and groups of people, who, politically, punch well beyond their weight in numbers. They are not 3,000 beekeepers coming down to make a noise about bees. Those patients might be numbered in fives and tens, but they have a huge influence on the process.

It is not just MPs and Ministers who play a part, but people across the country. That gives confidence to other groups to take similar action. Therefore, people who punch beyond their weight can have an effect. We must ensure that when we implement this system, there are no delays and no postcode lotteries, whereby one place gets the drug and another does not. Those days are past. That nonsense is surely over. After all, NICE was inaugurated to prevent such behaviour. Ever since, there have been problems relating to finance, the way in which people make their judgments, and who is on the committees that make such judgments. One of the issues that my hon. Friend the Member for Bristol, North-West touched on was that the people on the committees are often hidden away and we cannot find out who they are. Some committees are made up of administrators, some have a few clinicians, and others have a large number of clinicians. It is no surprise that there are huge differences across the country and they must be eliminated.

I want to carry on the Sutent argument. For my sins, I have to chair the rarer cancers forum, whose meetings take place in here, in dining rooms and so on, and who are an amazing organisation of people. They are enthusiastic, determined and knowledgeable. They have recently published a well researched, well documented report called “Taking Exception”, which is a must-read for the Health Committee. The way forward is for groups of people to come up with things that are not contained by the rules of this House. Such people come together from different parts of the country and produce new and exciting ideas. We tend to get trammelled by the pathways that operate in this place.

This morning I phoned a friend of mine who has just been given Sutent by NHS Norfolk. His name is David Blackett, and I met him at a football competition at Tasburgh; he was not a bad player in his time. He has kidney cancer. He wanted the drug, and he has been paying for it. He has funded it himself, and it is costing an arm and a leg: the house, the insurance and other things have had to pay for it. On top of that, there is the top-up issue—the Government are holding an inquiry into it—which means that people who self-fund are not allowed to use other NHS facilities. It creates a huge political dilemma about a two-tier service that must be eliminated quickly.

The issue arises only because decisions are made not to give people the prescription drug Sutent. Why was it given in David’s case? It was partly because of the inquiry being held into the need for top-up fees, but also because his doctor stood up in front of the committee with two pictures, one taken before Sutent and one after, and said, “Just look at that cancer. There it is then, and here it is now.” There was a huge difference.

Steve Webb: I am fascinated by what the hon. Gentleman says. Is there not a contrast between the PCT that he just described, where doctors can go in and argue the case, and the example that I described, where the proceedings are entirely closed off from the patient?

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Dr. Gibson: Absolutely. It is important that the patient should be there, too, to see that he is being well represented by his GP and that they have talked together. David has a friendly GP and consultant who have allowed that. In some places, the consultant’s word is good enough; in other places it is not, and the administrator must sign the claim form and so on. All sorts of different systems operate. No wonder there is great confusion. I am pleased that doggedness can make it happen, but we must stop this nonsense, as the hon. Member for Northavon says.

Dr. John Pugh (Southport) (LD): Although I warm to the idea of PCTs having to give explanations for their decisions, is it not also the case that some PCTs would simply be out of their depth and unable to make extremely complex decisions on rare conditions?

Dr. Gibson: Absolutely. That is why I started by saying that the Government had created a special commission to represent different PCTs across a region. There is no reason why there could not be an East Anglian regional determination for such matters. Why is it important? It is because of the number of exceptional cases. My hon. Friend the Member for Bristol, North-West has already quoted the numbers, but of maybe 5,000 cases a year, only 800 are refused. One wonders whether some of those refusals come about because of some doggedness in a PCT or in individuals, or whether the wrong people are involved and so on. The numbers are not astronomical, but let us say that those 800 all paid top-up fees. I am sure that good administration and good judgments about how the system operates and who is involved could greatly reduce that number until it became fairly trivial.

Dr. Naysmith: My hon. Friend is making a good case, but the PCT special committees called to consider exceptional cases used to vary greatly. A member of the trust would be brought in who happened to be in the office that day, and two or three of them would sit around and make a decision. Then, the next time a decision had to be made, different people would make it. It has been recommended that that should change, and it has changed in Bristol PCT, although I do not yet know about South Gloucestershire PCT. It is important to have much more continuity if we are to get standard and reproducible decisions.

Dr. Gibson: It is true that that is improving in places, but by gosh, people have to fight to make it happen. Some lawyers are active in that field. I will not name them, but they have attended debates here and hammered away at MPs. They do not do it for profit; they just take the case and fight it, and it has been hard. One of them just wrote to me. He congratulated the Government and told me what was happening in Scotland—I will leave that out—but he had just heard that

“Hampshire PCT now refuse to allow any patient involvement in their whole decision and appeal making process...in Manchester one PCT insists on a signature from a trust manager in any application before it is considered and the consultant application route is not enough.”

There are still major differences. It is not rocket science; it is just about equality. There are terrible inequalities in how assessments are made that would easily be eliminated by a bit of action from Government or strategic health authorities.

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We talk too much about drugs. In my socialist mood, I would nationalise the drug industry. Everybody laughs when I say that, but at every union and Labour party conference in the 1970s, one had to say that or get booed, and anyone who said it would be cheered to the echo. If we are nationalising banks, why do we not start thinking about nationalising other things? But that is enough heresy in this place for one morning. We do not hear much of it, but it is a thought. Drug companies are merging anyway, and if they do not get their evil way, they get the hump and threaten to go to Ireland, Europe and so on. The first drug NICE ever considered was made by SmithKline Beecham, as I think it was called at the time, which threatened to go to Europe if it did not get its evil way. There are all sorts of political pressures like that, and in cases such as the ones that we are discussing, the drug companies have some questions to answer.

I think that the next few years—the next few weeks, even—will be quite exciting. It is high time that things happened. Many of our constituents are wary of the process because they do not understand it, and it is our job to ensure that it is simple. Many things could be said about the issue. It is not just about cancer; it is about technologies becoming available. People can do things such as blood sampling, treatment for diabetes and so on at home. Those technologies need to be assessed, and I accuse NICE of not taking other technologies as seriously as it takes drugs. An inquiry is probably needed; the Health Committee may have something to say about it. We may need a separate arm of NICE to push along other technologies such as stents for heart problems. An exhibition is held here every year, although hardly any MP goes to it, of all the new, modern gizmos that allow people to assess their own health, take measurements, save GP time and so on. It is an exciting time and NICE is at the hub of it, but it must get its act together quickly or socialism may come into it.

11.37 am Dr. Richard Taylor (Wyre Forest) (Ind): It is very nice to be under your chairmanship, Mrs. Humble, and it is good to see in the hot seats two hon. Members with considerable experience of the NHS from their careers as nurses. I am pleased to see them. I welcome this debate and the introduction given by my friend from the Health Committee, the hon. Member for Bristol, North-West (Dr. Naysmith). It is crucial at this time.

So many different definitions of rare diseases are used, but I think that the easiest is that a rare disease is one that a busy GP would not see more than once a year. A lot of work has been done in Europe by the rare disease task force, which has chosen the most ironic day to be rare disease day in Europe: 29 February. As to the availability of treatment, I commend the Government for following up the Carter review and creating the regional specialised commissioning groups and national specialised commissioning groups, which will make a huge difference. A word about the national commissioning group: its website gives a list of the illnesses and groups of illnesses covered, but there are just 38. I do not think that that can be complete.

We have heard about paroxysmal nocturnal haemoglobinuria, and I commend the Government for allowing treatment for that condition. I looked in my Merck Manual, the bible for those who, like me, are out 14 Oct 2008 : Column 220WH of touch with medicine. My 2006 edition dismissed treatment for PNH as being only supportive. However, I received a letter from a constituent of mine with that very rare disease. He is 45-years-old with a wife and three children under 16. In 2000 he lost his job when the disease was diagnosed and for a long time was out of work and receiving disability living allowance and incapacity benefits. He also had to have blood transfusions every three months, despite which he was extremely ill. He heard of a team in Leeds working with Alexion—a drugs company in the United States—and went up there fortnightly. For four years he has been taking Eculizumab and has not required a single blood transfusion. Furthermore, the treatment has been free, because it is part of a phase 3 clinical trial. He is now off the disabled register and back in part-time work. He would have been devastated if he could not have had the treatment, which is to be introduced on 1 April. Will arrangements be made for those such as my constituent to receive the supply that they need up until that time?

That brings me on to NICE and other points raised by other hon. Members. Eculizumab seems to have bypassed NICE. It is absolutely right that it has been approved, and I suppose that it could not be examined by NICE because the condition is so rare that there is not enough evidence and are no comparative trials. That makes it very difficult. However, that means that, if things that are examined by NICE are turned down, they have a desperately unfair status. We have heard already from the hon. Members for Northavon (Steve Webb) and for Norwich, North (Dr. Gibson) about Sunitinib. I have seen three patients whom I thought were exceptional cases—the first two, in Worcestershire, were described as “not exceptional” just like in Gloucestershire, and it was suggested that there was no point in referring any more similar cases because they would not be exceptional either. Then I saw a patient whom I thought was definitely exceptional: a 36-year-old lady with young children to whom even an extra few months of life would make all the difference, but again she was not counted as an exceptional case.

Rare cancers are covered by specialist commissioning groups and will probably get funded, so why could they not take on people with common cancers who appear to have rare social conditions and the need for a rare drug. In those cases, some fairness could be introduced into the system, because Sunitinib, as we have heard, is funded in several parts of the country, but not in others. I would very much like there to be other ways of treating such non-exceptional cases of relatively common cancers, but where the patient is in truly exceptional circumstances.

Not very much has been said about research into rare diseases, which of course is desperately important. I shall always remember a John West cartoon of a very worried lady talking to her husband in a hospital bed saying: “The doctor says it’s so rare that they cannot be bothered to find a cure”. Sadly, that is rather near the truth. I remember a particular Health Committee report that found that drug companies at the time were investing £3.3 billion a year in drug-related research, which was many times the figure invested by the Department of Health, the Medical Research Council and medical charities combined. We are dependent on the pharmaceutical industry for research into drug treatment, but inevitably, owing to the costs of new drugs, the industry must consider drugs that will produce a return.

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What made Alexion look at paroxysmal nocturnal haemoglobinuria, which is so incredibly rare? I flashed Alexion up on Google a few moments ago, and as far as I could see it only produces that one drug and is desperately researching its use for asthma, and in transplantation and inflammatory disorders. Why did it start and come up with this remarkable drug that it describes on its website as the

“first and only medication approved specifically to treat PNH”?

In the 2005 Health Committee report into the pharmaceutical industry, we made it quite clear that we wanted the Government to direct, and have discussions with, the industry to include in its research rare diseases. With that report, we discovered that the Department of Health does not respond to a conclusion unless the word “recommendation” is in it. One of our conclusions read:

“Priorities for research into medicines inevitably reflect the interests of the pharmaceutical companies and are not necessarily well aligned with the medical needs of all patients. The industry will continue to undertake the bulk of research in this area, but there are improvements that could be made. We welcome Lord Warner’s recognition of this and look forward to his proposals to align more closely the drug companies’ research strategies with the public health aims”.

In fairness, there were some comments about that in the introduction to the Government’s response, although the Department did not pick out that particular conclusion. One comment read:

“To build on this progress, the Government is consulting on a new strategy for the NHS contribution to health research in England.”

A document entitled, “Best Research for Best Health: a New National Health Research Strategy”, was published around the same time. I am sure that the Minister is not quite prepared for this line of questioning, but what progress has been made on the NHS contribution to health research?

On the pharmaceutical industry, the response stated:

“One of the areas considered by the Committee was how the Government could inform the industry the disease areas where more research was needed.”

The response went on to say that the Government were forming the Ministerial Industry Strategy Group to continue the dialogue between the Government and the industry. I would love to know if any updates are available on that.

How do we find the money to begin to afford all these expensive treatments? To me, the answer is obvious, but no one will accept it because nobody likes the dread word “rationing”. In a briefing for this debate, the Specialist Healthcare Alliance suggested that we use the money saved from medicines coming off patent to re-invest in new treatments, which the Department has started to do. Ages ago, it produced the paper, “Better Care, Better Value Indicators”, which I have mentioned umpteen times before, and which showed that if everyone prescribed generic statins the way that the best 25 per cent. of primary care trusts do, we would save £80 million a year. So the answers are there.

In its submission, Myeloma UK said:

“We need a broad societal debate on what should be paid for by the NHS”.

14 Oct 2008 : Column 222WH

Finally, the British Journal of Healthcare Management, for which I have a great deal of time, popped across my desk this morning. I shall finish with a quote from Nick Bosanquet in an article about top-up fees, which I hope will be passed across the Minister’s desk as well. He said:

“Top-up payments should be regarded as an interim solution until we are prepared to reform the lop-sided rationing problems of the NHS. NICE is in effect applying an intensive form of rationing to one corner of health spending. NICE claims that it is making these decisions on the grounds of affordability, but there is no connection at all between the denial of these therapies and the financial state of the system. Nor are patients in neglected areas getting more because cancer patients are getting less. NICE is intensively rationing cancer drugs while large areas of inefficiency, waste and duplication have had no attention at all.”

That is an excellent summary of the position.

[John Cummings in the Chair]

11.50 am Mr. David Anderson (Blaydon) (Lab): It is a great privilege to work with you again, Mr. Cummings. A long time ago, we worked together in a very different place. I congratulate my hon. Friend the Member for Bristol, North-West (Dr. Naysmith) on securing the debate, and I assure those present, particularly Hansardstaff, that I shall do my best not to use words of more than three syllables.

I am not a health professional, as many colleagues present are. The hon. Member for Wyre Forest (Dr. Taylor) spoke about the Merck Manual; the only Merc I ever had was a 1990 230 estate, but that was an automatic, not a manual. My background is in coal mining, and I was once a care worker for elderly people, but I have spent a lifetime in a family that has been devastated by muscular dystrophy.

Within a month of coming to this place, I was asked whether I would be prepared to chair the all-party group for muscular dystrophy, and I was pleased to take up that opportunity. I want to put on record my thanks and the thanks of those involved with the parliamentary group, as well as campaigners on muscular dystrophy, for the great response that we have had so far from the Minister. She has shown real good will in trying to take forward the campaign with which we are involved. I thank her in particular for giving us access to the civil servants in the research department whom we met during the recess. They were very positive about their role in helping us to maximise opportunities to develop good-quality research.

I shall spoil the party a little bit now, though, by telling the Minister that I am going to write to her about an issue that has arisen as a result of those meetings. It is ludicrous that Government money that had been allocated to the development of drugs to help people with this disease has been classed as underspend because it has not been spent within a certain time scale, and will probably be clawed back. That money has been underspent not because people have not wanted to use it, but because the phasing of what they have been doing did not work as they thought it would. It is not rocket science, but it is research science. Surely, the essence of research is that things develop in a way that is uncertain. Things sometimes go much quicker than expected and sometimes much slower. That money is a relatively small amount in the Department’s global sum, and the 14 Oct 2008 : Column 223WH fact that it has not been spent within the expected time scale should not be a way of getting money back into the Department. It should be kept by the groups doing the research.

I have received information from the Muscular Dystrophy Campaign that I want to take hon. Members through to inform them of the current situation. There are more than 60 types of muscular dystrophy and related neuromuscular conditions—rare conditions for which there is no cure. That shows the importance of the research work being done. It is estimated that such conditions affect more than 1,000 children and adults for every 1 million of the UK’s population, and conditions can be genetic or acquired. Some types, such as Duchenne’s, are aggressive, causing muscular deterioration and wasting. They are responsible for respiratory and cardiac problems and, sadly, result in premature death, particularly in young boys. Other conditions can cause lifelong disability. My sister was 53 when she died and my brother was 48. They had a lifelong disabilities, but not very long lives.

The campaign invests about £3 million of its own money in research, care support services, muscular centres, development networks, and in sharing information and resources. It has pioneered research into treatments and cures for nearly 50 years, but it cannot do everything on its own. The House, the Department, the Government and the Minister all have a responsibility, and I know that the Minister takes her responsibility very seriously.

Last December, the campaign produced a report called “Building on the Foundations: Establishing a Specialist Neuromuscular Service across England”, which found classic disparities such as those that the hon. Member for Northavon (Steve Webb) mentioned. In the north of England, where we have a strong lead in muscular research, the average survival rate for patients with Duchenne’s muscular dystrophy is 30 years, whereas in the south-west it is, sadly, only 18 years. That is a huge difference in life expectancy. The report also found that two out of three primary care trusts do not support a muscle clinic for either adults or children, which means that many patients do not receive the special care that they need. It also found that the service is dependent on a handful of world-class specialists. What will we do when those people retire or move on to another area and there is no on left to come behind them? We must take control and embed what they are doing into a national structure.

Last month, the Muscular Dystrophy Campaign carried out the “State of the Nation” survey as part of its muscle week. The survey focused specifically on access to specialist services, quality of life and the impact of living with a rare disease. There were 1,000 respondents, of whom 50 per cent. said that their experience of the diagnosis process was either poor or very poor. The results showed that half of patients have not seen a physiotherapist and that half do not have access to a specialist neuromuscular consultant. The survey also found that 80 per cent. of patients do not visit a specialist centre or receive specialist care for their condition. The campaign believes that those problems can be put right, and we seek commitments from the Department on its recommendations. It would be great if the Minister said yes today, but I do not suppose that she has the authority to do so.

The campaign recommends that we should, as a matter of course, designate specialist muscular services within the Department of Health’s specialised services 14 Oct 2008 : Column 224WH definition set, so that specialised commissioning groups can be set up across England. Each such group, and responsible bodies in Scotland, Wales and Northern Ireland, should follow the lead of the South West SCG and carry out a comprehensive review of the provision of specialist services. Let us know what is going on out there. We should also ensure that every person who is affected by muscular dystrophy has access to a care co-ordinator or key worker who can take a lead on their behalf with the care team and provide them with support, information and a regular review of their care plan. We need more. Far be it from me to fall out with my hon. Friend the Member for Norwich, North (Dr. Gibson), but the truth is this: socialism might put this matter right, but whether there is socialism, capitalism, a laissez-faire approach or a middle-of-the-road system, those people are not being looked after properly, and we need a system that does look after them properly.

11.57 am Dr. John Pugh (Southport) (LD): I congratulate the hon. Member for Bristol, North-West (Dr. Naysmith) on his introduction to the debate. Indeed, all hon. Members have spoken in a well-informed and, at times, moving way. I apologise for the manner of my delivery, as I have a heavy cold, which, fortunately, is neither rare nor complex.

It is a principle of NHS care that care should depend on the severity of a condition rather than its rarity. No one should be discriminated against simply because their complaint is rare or complex. In reality, rare conditions have fewer lobbyists—there are many in this Chamber, but not so many in the outside world. Rare conditions are less well understood, are generally more expensive to treat and interest the world of pharmacy and commercial medicine less because they do not hold the prospect of such lucrative gain. Often, the therapies and treatments for such conditions are less certain and are harder to test.

In such a world of limited resources—the hon. Member for Wyre Forest (Dr. Taylor) talked about rationing, as he does in many debates—there is a utilitarian argument that would lead to the deprioritisation of such illnesses and complaints. However, I do not think that the NHS was ever meant to be run along utilitarian principles. To address the natural effects of resource pressure, the Government have wisely allocated the commissioning of services for rarer and complex conditions to special commissioning groups, using pools and top-sliced funds from PCTs. That follows the Carter review’s recommendations, which I think everyone in the Chamber broadly supports.

We also have a national commissioning body to deal with those things that cannot even be financed on a regional basis. That has a sound objective: to ensure an even pattern of commissioning, which we clearly do not seem to have at the moment, given hon. Members’ contributions. I support that strategy, but it does not quite get us out of the woods, for two reasons. First, there will be an understandable tension over budgets between the regional commissioning bodies and the individual PCTs, and I have certainly seen PCT minutes that express anxiety about what the specialist commissioning groups might do. Secondly, specialist commissioning groups and PCTs might have different expectations of each other, as patients often access services that are 14 Oct 2008 : Column 225WH commissioned by both—physiotherapy is a prime example, particularly for patients with muscular dystrophy. We must admit that, even with regional commissioning groups on a specialist basis, they will not all follow the same pattern of commissioning and are not bound by an absolutely fixed list, although there are definitions on what counts as specialist commissioning.

The postcode lottery will not be absolutely abolished by the Government’s proposals, but I support them and think that they will make significant progress. I am encouraged by the reports I hear from the north-west region, where the specialist commissioning organisation has a budget that is almost as big as that of the largest PCT and is making appreciable strides, not only in producing new facilities and arrangements, but in giving positive guidance with regard to therapies.

The issue of drugs is the most acute issue that has been raised today, particularly the orphan and ultra-orphan drugs. We ought not underestimate the fact that controlling the drug price is an important issue for PCTs in delivering value for money across the piece. I am familiar with the National Audit Office report on that, which pointed to wide disparities in the efficiency of PCTs in using their drugs budget. I would like to quote from Sophie Christie, the chief executive of Birmingham East and North PCT, whose views on that issue were included in the Library’s debate pack. She puts it rather nicely, and certainly better than I could:

“The delegation of the rare and the expensive to the service provides a real test of our ability to commission collaboratively with a focus on outcome. Alternatively, we could just be the meat in the sandwich between the pharma-induced public outrage—”

a rather good expression—

“and political assessments that a few million here and there is nothing between friends.”

Clearly, the procedure currently being followed is unsatisfactory. Hon. Members have mentioned the exceptional cases procedure, and the hon. Member for Bristol, North-West made absolutely clear that it was never intended to do the job. My hon. Friend the Member for Northavon (Steve Webb) made it absolutely clear that, as it is currently being conducted, it is a hopelessly confused process.

Even using guidance from the National Institute for Health and Clinical Excellence does not resolve the issue because it can always be argued that NICE has neither sufficient data on those rare conditions, nor the resources and time to test within a reasonable timescale. In any case, hon. Members have consistently been told by Ministers over the years that the absence of NICE approval is not a trump card for the PCT. It is a difficult and fraught area, and the specialist and exceptional nature of orphan drugs is probably the reason why there is special legislation from the EU and the USA on that subject. It is a profoundly difficult area for PCTs, which have to made a profoundly difficult judgment call. That is why the help of the specialist commissioning groups can be so important in producing the standardisation that hon. Members would like to see.

However, there is also a role for the charity and voluntary sector, which is often the prime advocate of better provision for people with all kinds of conditions, including rare ones. The sector needs to be forceful and fair: fair in its demands and expectation and forceful in 14 Oct 2008 : Column 226WH advocating what is reasonable. Its role is so crucial to the piece, both in fighting battles on behalf of patients and educating the wider NHS. That applies not only to the most critical and life-threatening conditions, which have largely been dealt with in the debate, but to less-threatening conditions. I was recently approached by someone in my constituency who suffered from a disease called Fibromyalgia, which had to be explained to me. That person found that there was wholesale ignorance of the disease in all parts of the NHS, and many parts had been accessed about the condition. There was a real need for the voluntary sector to fill the vacuum in educating the professionals.

12.6 pm Anne Milton (Guildford) (Con): It is a pleasure to serve under your chairmanship, Mr. Cummings, and I congratulate the hon. Member for Bristol, North-West (Dr. Naysmith) on securing the debate.

Although the hon. Member for Wyre Forest (Dr. Taylor) attempted to give a definition of a rare and complex disease by stating that a GP would see one example per year, there are a number of definitions. There is an official definition, but the prevalence criteria used in national commissioning is one per 50,000. Interestingly, that varies from the EU definition of fewer than five per 10,000. Many diseases with a prevalence of fewer than five per 10,000 do not require special arrangements for health services to be commissioned.

None the less, there are many thousands of different diseases, many of which are suffered by only a few hundred people in the UK, and even fewer than that in some instances. Collectively, however, the numbers can be much higher. For example, recent research shows that between 30 and 50 per cent. of all cancer cases could be classified as rare as they fall outside the more common and highly publicised cancers such as colon, breast, lung, prostrate and bowel cancer, which we hear about frequently in the press.

One prominent feature that I do not think has been highlighted strongly enough in the debate is that those suffering from rare and complex diseases often feel a tremendous sense of isolation—more so than if they were suffering from a more common disease. There might be few survivors and no available support networks, the GP might know little about the condition and it is often difficult to get accurate information about the prognosis or effective treatment. Of course, availability to much wider networks on the internet has made a significant impact on that problem, but many of those people do not necessarily have access to the internet and might not be comfortable joining support networks in that way. The isolation, the feeling of fear and the lack of information are significant factors.

14 Oct 2008 : Column 226WH—continued

I understand that there are currently around 8,000 identifiable rare diseases. As we have heard, it is clearly not practical to plan and purchase separately for each of those, and as a result, the UK’s approach has been to provide those specialist services around groupings of expertise, and increasingly that is becoming the case. In fact, the provision of specialist services in specialist centres is certainly not an innovation. The hon. Member for Wyre Forest commented on the fact that the Minister and I, who are both in the hot seats today, both trained as nurses. I am sure that she will join me in noting that, 14 Oct 2008 : Column 227WH even 30 years ago when I was training, the newest surgical services were provided on a regional basis and in specialist centres. None the less, the aim of the arrangements is to purchase specialist services, ensure fair access to clinically effective services where patient numbers are small and a critical mass of patients is needed to achieve the best outcomes, maintain clinical confidence, sustain the training of specialist staff, ensure cost effectiveness in provision and made the best use of scarce resources.

The hon. Member for Bristol, North-West rightly commented that local decision making should not prejudice the situation of people with rare or complex conditions and raised the fact that there is considerable variation in the applications to PCTs for exceptional cases. There are wide variations in the review of those and in the clinical input of those review panels and the decisions made.

What is causing the increasing concern that we are seeing among the public and in the press are these huge variations and indeed the lack of fairness and transparency associated with them. We must have right of access extended to specialist services. It is very important that people have confidence and trust in a system that is making what could be life or death decisions about them.

The hon. Member for Bristol, North-West also said that the Department of Health and NICE should work together better. I find it extraordinarily frustrating, and I think that my frustration will be shared by many people, that NICE and the Department of Health do not work more effectively together. It staggers me that everybody wants this process speeded up, to be more efficient and to be more transparent, but the continuing frustration is that that improvement never seems to happen. I am sure that the Minister will address the issue of why it takes so long to get what feel like quite simple decisions or simple actions taken to make this process work more quickly and more effectively for the patients involved; the delay makes me very impatient.

The hon. Member for Northavon (Steve Webb) highlighted the issue affecting one of his constituents and, as ever, personal experiences and personal stories are particularly poignant. He also mentioned another source of frustration, that Pfizer was prepared to share the cost of the drug that his constituent required, but that offer was not taken into account by NICE. I and many other people would like to see a much more common-sense approach taken by NICE. The fact that Pfizer would share the cost of the drug is relevant and should have some impact on NICE’s decision making.

I would like to congratulate the hon. Member for Norwich, North (Dr. Gibson) for his excellent work on the Rarer Cancers Forum. However, although he has clearly felt a wave of socialism around the place recently, I would suggest that nationalising the drug companies might see a halt in any progress that has been made in the innovation and research carried out by them, particularly in relation to PNH—I leave the full pronunciation of that condition to the hon. Member for Wyre Forest (Dr. Taylor).

Dr. Ian Gibson (Norwich, North) (Lab): Try it.

Anne Milton: I could try it, but I do not want to take up any more of Members’ time, so I will not.

14 Oct 2008 : Column 228WH

The hon. Member for Wyre Forest rightly raised the issue of research, which had not been mentioned until that point. The hon. Member for Norwich, North talked about people with rare and complex conditions punching above their weight; I think that he is absolutely right that they do punch above their weight. Nevertheless, there are concerns about the lack of incentives within the system, not only for research but for diagnosis and treatment innovation.

The hon. Member for Norwich, North also talked about some obvious ways of saving money to pay for new and expensive treatments. I could feel a certain tension—an anticipation—as we heard from him that the way that he would finally solve the problem was through paying for some of these drugs, which I well appreciate is not easy.

I would also like to congratulate the hon. Member for Blaydon (Mr. Anderson) on his work on muscular dystrophy. It was very useful to have the example of one particular rare and complex condition. He also highlighted the fact that, even within the group of people who suffer from a rare disease such as muscular dystrophy, that rare disease can itself be further split up, into even rarer subsections of the same disease type. It is very sad that the experiences of people with muscular dystrophy have been poor, in terms of the diagnosis and treatment that they have received. He then widened the debate away from the issue of drugs, which was the focus at the start of the debate this morning, into the wider and important societal and care issues surrounding rare diseases.

I would like to finish by asking the Minister to address a few a few points, in particular the view that was expressed that PCTs are out of their depth; the issue about their decision making on exceptional panels, and the significant issues that surround some of the ignorance among those in general practice, even if that ignorance is not surprising given that these conditions so rarely emerge. Nevertheless, the issues of training, education and, just as importantly, continual professional development are important and it would be encouraging to hear from the Minister what she is doing to ensure that those issues are addressed.

It is also of note that since 1997 there has been an increase in mortality for those people with rarer cancers. Although that increase can be partially attributed to the lack of knowledge among physicians of the symptoms of rarer cancers and also the late presentation of such symptoms, it would be interesting to know what the Minister is doing about this issue and whether she has any ideas in the pipeline about how to reduce the mortality for those people with rarer cancers.

The next point that I would like to make is that there is a European directive to incentivise the investment in research and development in orphan medicines for rare and life-threatening diseases, which I understand has had some success. Since its adoption, 22 products have received a marketing authorisation. Overall, that is still a comparatively low number, but given the disproportionately low survival rates for rarer cancers, does the Minister agree that more needs to be done to incentivise drug research?

Rarer cancers often require treatment by drugs that have not yet been approved by NICE or rejected on cost, requiring patients to plead the exceptionality of their case, as we have heard on numerous occasions. I know that we have heard a few figures, but perhaps we 14 Oct 2008 : Column 229WH have not heard so many this morning. I would like to give one other figure; 5,000 patients have been forced to demonstrate their exceptionality in the last 20 months, in order to receive cancer treatments that are not recommended by NICE. Of those 5,000 patients, 1,300 had their request rejected.

I think that it was the hon. Member for Northavon who said that what finally gets to people is this battling away against the system. Not only do they have to live with a rare disease and with the isolation that surrounds the fact that they have a rare illness—there is fear and lack of information—but they also have to do battle against a system that they do not entirely understand. In fairness to the Minister, I think that she would agree with me that that system is indeed not understood by herself of the Department of Health. The lack of fairness and transparency makes the situation even worse.

In the past, NICE has proposed an ultra-orphan drugs evaluation committee, to undertake an appraisal of medicine for very rare diseases. I understand that Ministers have received NICE’s report on appraising ultra-orphan drugs and have concluded that it is not appropriate at this time to establish a separate appraisal system for such drugs. Perhaps the Minister could bring me up to date on that issue.

We have had a debate today on exceptional and rare conditions. Special cases require special treatment; exceptional medical conditions need exceptional treatment. I know that the Minister agrees with that view and has much sympathy with it. However, what we want to hear from her now is what action she will be taking.

12.18 pm The Parliamentary Under-Secretary of State for Health (Ann Keen): Thank you, Mr. Cummings; it is a pleasure to be in attendance with you today.

I thank my hon. Friend the Member for Bristol, North-West (Dr. Naysmith) for securing this debate. He has particular knowledge and expertise in all House matters, but he has been consistent in holding a strong interest in the treatment and care of the wide range of patients who are unfortunate enough to suffer from a rare or complex medical condition.

My hon. Friend last raised this issue in the House in 2005, and he was kind enough to say that we have made strong progress in improving the overarching commissioning arrangements for specialised services, which I will mention in more detail shortly, and that patients are starting to see the benefits of those improvements. In fact, all hon. Members here today have congratulated us on that progress.

My hon. Friend made some important points in his speech and I will respond to his concerns as far as I am able to, given the time constraints that I now face. I commend the efforts of the Specialised Healthcare Alliance and its chairman, Baroness Pitkeathley, which has supported my hon. Friend in raising this debate The SHCA has actively engaged many of my predecessors and colleagues to advance the case for improvements in the treatment and care of those people with rare conditions, and it 14 Oct 2008 : Column 230WH continues to promote these causes vigorously and determinedly, with the help of stakeholders and sponsors. It is right to do so.

I thank my hon. Friend for his kind words about the Carter review of arrangements for the commissioning of specialised services, which was introduced in April 2007. The arrangements, which have been in place for 18 months, are making significant progress in improving the quality of specialised commissioning at regional and supra-regional levels and, as a consequence, are improving access to specialised services for local people. Parts of the country, including the area in which my hon. Friend serves, which had hitherto been notably weak in their approach to commissioning specialised services, have improved rapidly as a result of the Carter reforms. From next year, we expect that more services than ever before will be commissioned by specialised commissioning groups through primary care trusts’ pooled budgets. Additionally, the new arrangements allow the national health service to take collective and consistent action across the country to pursue areas of agreed priority. A good example is work now commencing in SCGs to plan for improved levels of renal transplantation, in response to the recently published report of the Organ Donation Taskforce.

Another example of the strengthened national approach that the national specialised commissioning group has delivered is provided in the agreement of all SCGs to adopt the unified commissioning approach in “Target Therapies for the Treatment of Pulmonary Arterial Hypertension in Adults”. Adoption of a national policy by all SCGs will mean substantial increases in investment by some of them to raise standards to those of the best and to provide a level playing field for patients across England.

Our world-class commissioning programme is designed to raise ambitions for a new form of commissioning that has not yet been developed or implemented in a comprehensive way anywhere in the world. World-class commissioning is about delivering better health and well-being for the population, improving health outcomes and, of course, meeting the huge challenge of reducing health inequalities. As part of the programme, a commissioning assurance system has been launched this year. It is a national system to hold commissioners to account, to reward performance, and to ensure that health outcomes improve. As the hon. Member for Southport (Dr. Pugh) said, we are running a pilot with the north-west SCG to design a national scheme for holding commissioners of specialised services to account, and for encouraging better co-operation and co-ordination between PCTs and SCGs.

Hon. Members may be aware that the Government have actively supported the provision of high-quality treatment services for many rare conditions and complex procedures through the arrangements. Some 40 highly specialised services are currently commissioned nationally through the national commissioning group. I approved the national commissioning from April this year of a proton-beam therapy service for complex and difficult to treat patients with rare cancers, and of an islet cell transplantation service for diabetic patients who suffer recurrent episodes of hypoglycaemia.

The Minister of State, Department of Health, my right hon. Friend the Member for Bristol, South (Dawn Primarolo), who has responsibility for public health 14 Oct 2008 : Column 231WH matters, released a statement last week that confirmed approval for the national commissioning of a service for paroxysmal nocturnal haemoglobinuria—perhaps I should have said “PNH”, as I obviously did not see those words coming. It will ensure a high-quality service for patients who would benefit most from high-cost drugs, which are estimated to cost some £25 million a year. The hon. Member for Wyre Forest (Dr. Taylor) raised that matter. I congratulate Dr. Peter Hillman, the professor who is leading the group in Leeds, and can say to the hon. Gentleman that, yes, the drug will be funded before the service commences in April. Dr. Hillman has been important in our making that decision.

Lord Darzi’s final report, “High Quality Care for All”, sets an important context that is as applicable to patients with rare or complex medical conditions as it is to patients with more common conditions. The report describes a health service that delivers fair, personalised, effective and safe care. Lord Darzi calls his final report an enabling document because it sets out more than 90 commitments from the Department of Health that will help the NHS to deliver high-quality health care that puts the patient at the centre of the organisation and meets the challenges of the 21st century. Its time is overdue. The time is right to bring quality into the NHS.

I am aware of colleagues inside and outside this Chamber who have discussed quality over the years. Since entering the House in 1997, my hon. Friend the Member for Norwich, North (Dr. Gibson) has chaired groups, in particular on cancer, and has described the way forward for the Rarer Cancers Forum. I have had the pleasure to be involved with him on that forum.

I was probably at the conference at which discussion of nationalising our pharmaceutical companies was doing the rounds, but the style of delivery of a speech at that time—things were put in a particular way—did not necessarily demonstrate the need for it. Of course, we are getting the huge co-operation from scientists and researchers that hon. Members have asked for today. I am sure that we all look forward to the return of the Human Fertilisation and Embryology Bill, when the House will be challenged by even more advancement of science. Nevertheless, it is necessary for us to deal with such matters.

The hon. Member for Northavon (Steve Webb) spoke about his constituent Mr. Derrick and the moving way in which Mr. Derrick’s daughter put the case for a particular drug that the National Institute for Health and Clinical Excellence is reviewing. I hope the hon. Gentleman will accept that it is not possible for me to 14 Oct 2008 : Column 232WH comment while the appraisal is taking place; however, I hope that this debate will be read in Northavon and that it will be helpful.

Steve Webb: Will the Minister give way?

Ann Keen: I have very limited time, but of course I will.

Steve Webb: I am grateful. Could the Minister discuss a matter for which she is responsible, and which the hon. Member for Bristol, North-West raised, which is the threshold that NICE uses for all of its appraisals? That is not an issue for my constituents specifically but for all our constituents. Could the Department look at raising the threshold to reflect increases in inflation since it was introduced?

Ann Keen: The consultation on the constitution is out. It includes some of the discussions that we have had today about NICE. I am sure that all Members are aware of the consultation and the effect that it will have. It is important that we as a House consider it.

My hon. Friend the Member for Blaydon (Mr. Anderson) mentioned a meeting in the Department with colleagues who brought constituents with muscular dystrophy. It was important that that meeting with officials was held at that time. My hon. Friend said that he has written to me. I can say to him before seeing the letter that I will meet with him, but also that I believe a review is necessary. Let me consider that in preparation for our meeting. The director of national specialised commissioning has been in discussion with the Muscular Dystrophy Campaign about its concerns, so some progress has already been made, but there is obviously more to do.

Specific points were raised by my hon. Friend the Member for Bristol, North-West about commissioning and the openness and transparency of PCTs. I believe that the constitution and the consultation on it will improve transparency. The differences that have been described today by hon. Members are not acceptable in a modern, national health service. We must address the points that were raised so powerfully in my hon. Friend’s contribution. We must work with NICE, which is independent—its whole point is its independence—on the speed of delivery of what are obviously complex issues that are challenging to health clinicians, politicians and economists in the health field. I believe that every patient in the United Kingdom recognises that they have a national health service that is there to be a safeguard and to give treatment but also to do research. Bringing together the work of the NHS and the Medical Research Council will be only to the betterment of patients in the future, and future research and knowledge will be used effectively.

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