Skip to main content

Primary Care Trusts (Exceptional Cases)

Volume 475: debated on Tuesday 29 April 2008

I am delighted to serve under your jurisdiction for the next hour and a half, Mrs. Humble. The debate has caused many different organisations to pick up this issue and put forward points of view on which I should like to expand today. I thank the bowel cancer groups that have been in touch with me. There might be over-emphasis on cancer in the debate, which also relates to drugs used to treat macular degeneration, for example, but cancer has received most publicity, and reports have appeared in every major newspaper. Almost daily, the issue of the availability of drugs in exceptional circumstances arises, so I shall concentrate on the meaning of “exceptional”.

I thank the NHS Confederation, Macmillan Cancer Relief and the various lawyers who have been in touch with me. The latter seem to do rather nicely out of taking up cases around the country—some 110 such cases have been taken up to protest against decisions made by primary care trusts on exceptional cases. I also thank the specialised healthcare alliance and the Pamela Northcott Fund for the information that they have given to me on their experiences. All that makes me confident that this is a major issue. If I were Prime Minister for a day—God forbid, but it could happen given the way things are going these days—I would recognise that inequality in the health service and the unavailability of drugs is a major problem in this country. It should be a priority to get rid of something we often call the postcode lottery, but which I shall call “exceptionality” in our debate. Finally, I thank Myeloma UK. Myeloma is a rare cancer, but the debate involves rare cancers as well as bowel, breast and lung cancer, which are more common. The chances of obtaining a drug for the rare cancers are pretty poor in this country because of the financial considerations that I shall discuss.

PCTs commission health care services for their local populations. The majority of services are commissioned through a process that involves contracting arrangements with health care providers, but there are occasions when patients and clinicians may request a treatment that is not ordinarily provided. I shall concentrate on those situations, rather going through the usual arguments about drugs approved by the National Institute for Health and Clinical Excellence. Such cases usually arise because of the rarity of the treatment or condition, as I have pointed out, and the use of high-cost drugs.

The NHS has a finite budget, and tough decisions must be—and are—made to determine which treatments should be routinely available. NICE—a fine organisation—must consider the clinical cost-effectiveness of treatments and issue guidance as to why a PCT should fund them. If NICE issues positive guidance on a particular treatment, PCTs in England have three months, I believe, to make arrangements for funding; if NICE turns down a treatment, having judged that the NHS should not fund it, or if does not provide guidance, it can be difficult for clinicians and patients to gain access to those particular treatments, as we know. That is illustrated effectively by the Health Committee report that we shall debate later this month—I am sure that everybody will be present for that debate.

On the exceptional case and exceptional funding process, some PCTs have a system that allows individual patients to apply for a treatment that is not usually funded by the PCT concerned. I have lots of anecdotal evidence from organisations and individuals who have tried to use such systems, as I am sure every MP does. Not every PCT has a system in operation, and there are no countrywide standard processes or criteria for making decisions on whether patients can access treatment in exceptional cases. I shall give one or two examples later, but the measures used are commonly referred to as “exceptional case processes”, although their titles vary according to PCT.

The issue was brought to public attention as a result of Ann Marie Rogers’s fight to access Herceptin for early breast cancer. The Court of Appeal ruled that Swindon PCT’s policy of prescribing Herceptin in exceptional cases was irrational and unlawful. The court did not rule that Mrs. Rogers should be able to receive Herceptin, but rather that the PCT needed to formulate a lawful policy on which to base such decisions, which I believe was a fair comment. Lots of different names for the practice are used by different PCTs, but we all know that going to court is stressful and extremely costly, and people are inhibited by such a system. The inequalities that are created by the exceptional case process have become apparent. Every PCT has its own system, and they are given different names—some are called “special funding”, some “special circumstances”, but there is no uniformity to define that arena of activity.

I apologise for arriving late and also for the fact that I must leave early.

Having spoken to the hon. Gentleman before the debate, I know that he is aware of the case of a constituent of mine, Mr. Barry Humphrey—the hon. Gentleman has a local newspaper article on the case in front of him. Mr. Humphrey has been refused cancer drugs by Norfolk PCT. As the hon. Gentleman said, the PCT must decide whether the circumstances are exceptional, but no one seems to be able to clarify what that means. Does he agree that there is no transparency or guidelines on what test must be applied? In that particular case, everything, including the clinicians’ view, points to the fact that Mr. Humphrey should receive the treatment that he needs and which would give therapeutic value.

I agree with the hon. Gentleman—sorafenib, which would slow the growth of the cancer in that case, is available, but it is has not been made available by the PCT under its exceptional circumstances rules. People in other counties would be able to get the drug from their PCTs, but that is not the case in Norfolk. Lawyers around the country have been in touch with me about the matter. The availability of the drug is unequal and unfair. I have promised not to say anything about Scotland, because I no longer know what is true there and what is not. I am rather fed up being told, “If such and such happens in Scotland, why don’t you go back there”—that is a familiar argument in politics—but it is possible to say that the situation in Scotland is different.

Yes, but depending what type of operation we are talking about, I might live longer if I had it. I might live to see my local team in the Scottish cup final while I waited.

The point made by the hon. Gentleman’s Norfolk compatriot, the hon. Member for North Norfolk (Norman Lamb), applies to my constituents in Dorset. Does the hon. Gentleman agree that part of the problem, apart from the inequities, is that the process is highly non-transparent? In fact, it is almost impossible to obtain clarity on what South West Dorset PCT means by “exceptional circumstances”, so apart from questioning whether it means the same as it does for other PCTs, one cannot find out for one’s constituent what rule is applied.

I agree. It is also true that the systems that have been set up to examine whether exceptionality, special needs or whatever they are called in a particular county are different, and are not transparent. It is not even clear whether people can appeal against decisions—some PCTs say that people can appeal and some say that they cannot. I might well come to the obvious conclusion that we need uniformity throughout the country, and a discussion on that subject so that we do not have a postcode lottery.

Although such systems exist, patients who, together with their clinicians or oncologist, believe that they face a unique set of circumstances, and that the NHS should make the treatment or drug available to them and fund it because of the clinical benefit, can apply for it to be made available as an exception to the usual rules. A panel will typically consider such cases on their individual merits, and the factors that may be considered include the patient’s medical history; the medical need that the exceptional funding is requested to meet; the expected benefits of the drug or treatment; details of any relevant research or trial supporting its use; and the patient’s personal circumstances. Although a patient in one PCT may be considered an exceptional case and receive the treatment requested by their clinicians, they may not qualify under the criteria used by a different PCT.

That creates a decision-making lottery. The Department of Health does not give PCTs guidance on how, or whether, they should consider individual applications for treatments that are not routinely funded. In 2007, I asked the Minister about the committees established by PCTs to consider such cases, and he told me:

“Primary care trusts are able to appoint committees of the trust, but there is no requirement for a special exception committee, an exceptional circumstance committee or other committee to approve treatments. There is no national guidance on the functions and operation of any such committee.”—[Official Report, 11 July 2007; Vol. 462, c. 1566W.]

So, no messing there. As has been said, little is known about the operation of exceptional case processes. Committees do not publish details of their process, their membership and the outcomes of their meetings. However, data about the usage of the rarer, often higher-cost treatments would be invaluable to NHS planners and could be useful to NICE when such treatments eventually become part of its appraisal and review process.

I have been the chair of the all-party group on cancer for 10 years—indeed, we will celebrate our 10 year anniversary in a few weeks’ time on the Terrace. We are very proud of the process that the Government have carried through under cancer plan one, the reform strategy and so on. We have seen real movement on the treatment of cancer right across the country: money has been put in, structures have been set up and people are living longer, which is a great tribute to the Government and to what they have done since 1997.

The all-party group is, however, concerned that applications from patients and clinicians are not always fully assessed case by case. In some cases, people are discouraged from proceeding, while some PCTs predetermine the outcome of cases. According to anecdotal evidence from Bayer Schering Pharma, clinicians have told members of its sales force that their PCTs tell them not to bother applying for certain drugs under exceptional case processes.

I am listening carefully to the hon. Gentleman. He mentioned resolving such issues case by case, but he also said that he wanted more uniformity. Is there not a paradox here? I understand that people want uniformity of procedure, but is there not a real difficulty about trying to deal with exceptional cases in a wholly uniform way?

Yes, there will always be difficulties—not least the availability of funding. Provision will differ in different parts of the country, and a certain tumour might, for example, be more prevalent in one part of the country than another. Although there is a process for assessing cases, we must bear in mind how helpful the treatment would be for the individual concerned. To take another example, Herceptin was not the best thing for everybody with early-stage breast cancer. People had to have a particular genetic factor—HER2—before the drug became active, although it was hard in the climate that evolved at the time to stand opposite a patient and say, “This is not going to affect you.” However, the day is coming when personalised medicine will allow us to say that a certain drug will work with A, but not with B, although it might work with C. That is happening more and more, and we should encourage it to bring a certain rationality to the use of drugs. However, such knowledge must be plugged into the system before we can make decisions in Dorset, Norfolk or wherever.

Many people use Macmillan Cancer Support’s helplines to seek information about the exceptional funding processes operated by PCTs. Such processes can be lengthy, arduous and difficult for patients, and the problem is often perpetuated by the lack of information and support. An attempt has been made in the reform strategy to keep the process to 31 days, although that is still a long time. My instinct is that information and treatment should be made available much more quickly, and that should happen right across the country. That would be a real advance, and it would be extremely popular with the public.

I know that fellow MPs receive correspondence from constituents on this issue, because they often give it to me. In conjunction with groups such as Macmillan and Cancerbackup, which have now merged, of course, I use that information for other individuals. Exceptional case studies and processing are an important part of the PCT process, as PCTs’ resources are finite, and treatment decisions must be made. The system could, however, be more equitable and transparent, and patients and clinicians should expect to receive the same decision wherever they live.

I do not want to go into lots of different cases, and I will mention just a couple. One woman, whom I will not name, was being treated for bowel cancer by Enfield PCT, and details of her case were sent to me for a view. She had had six years of treatment, involving chemotherapy and radiotherapy, but her condition was advancing. Her oncologist advised her that the next line of treatment would be a substance called Erbitux. The PCT does not routinely fund the drug, but the oncologist was allowed to appeal to the trust. That would have taken four to six weeks, so the woman, who was concerned that it would take such a long time, contacted the trust. She was told that funding decisions were taken at a monthly meeting on the seventh of the month. Eventually, her appeal was turned down. She was told that the extra life that the treatment might provide was not worth the money. She will apply again. As hon. Members can see, that takes us into the private sector, where there is the money and all the resources. The Library has sent me details of many such cases, which have featured in the newspapers over the years.

In another case, from a constituency next to mine in Norfolk, a patient sought Sutent from the PCT to treat kidney cancer. The drug is going through the NICE process, and there is no final guidance yet. Reissued health service circular 1999/176 states:

“It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment”,

which is fine. According to the press coverage of the case, Norfolk PCT said that the treatment is not cost-effective and that it cannot prescribe it. However, PCTs have a duty in such cases to consider not only cost-effectiveness, but clinical effectiveness. The individual concerned is using £3,000 a month from a nest egg to pay for his treatment—that is the level of commitment that individuals need to make.

The hon. Gentleman is making a powerful and important speech. Has he come across cases in which somebody has said, “Okay, you won’t provide this on the NHS. I’ll pay cash for the drug,” but where the NHS has said, “If you do that, we won’t carry on with NHS cancer treatment”? That seems wholly unfair.

Yes, there are such cases. Somebody will offer to use the co-payments systems, under which the individual will pay something and the NHS will pay something. That is not allowed under the current system, and the NHS cannot work on that basis—it must operate at the level that the PCT has decided.

I mentioned Erbitux and I want to say a little more about it. In Kent, co-payments are refused, and it is not possible to give Erbitux for bowel cancer. At Maidstone hospital, however, the PCT allows co-payments and Erbitux, so there are differences within counties, and the position is not always clear. The patient in Kent has been happy to talk to me about his case, but I have said enough to illustrate what happens.

I have a whole list of places to illustrate the differences that I have described. Surrey, Sussex and Bromley are not good for allowing exceptionality. In North Yorkshire and Dagenham, there is a 50:50 success rate, but only if people threaten, or actually undertake, a judicial review. In Cumbria and north Lancashire, there is some mixed funding, and treatment is carried out on a case-by-case basis. In the Birmingham area, there is little exceptionality. In Manchester, however, there is nearly 100 per cent. success. That is the extent of the variability. That information comes from lawyers who have taken up the cases.

So what is the solution? We must make sure that we provide the best treatment available under the NHS. In relation to drugs, there is—never mind about NICE approval—the exceptionality process. For the system to continue to operate in the national health service, there must be national guidance outlining the obligations of PCTs. A framework should be set up to help committee members decide what should be considered an exception. For the patients with whom I have been in contact, one of the hardest things is that there is no way of knowing whether their case will be heard, let alone whether they will finally get the treatment they require. The additional stress and uncertainty is detrimental to the health and quality of life of patients with cancer.

A recent report on NICE by the Select Committee on Health—I am pleased to see a member of the Committee, the hon. Member for Wellingborough (Mr. Bone), present for the debate—made several recommendations on tackling postcode lotteries, including the need to assess all medicines at launch and to involve PCTs in developing guidance. However, in my opinion the recommendations fall somewhat short of what is required, as they would still leave a discrepancy between PCTs in the matter of exceptional cases. That was not clear in the report.

Patients should have all the information that they want, at the appropriate time, to make informed decisions about their treatment. The lack of transparency and the postcode lottery affecting exceptional funding are not acceptable. PCTs are autonomous in the way they spend their limited resources, and must provide the best health care for the community they serve. Patients should be informed about how resources are distributed within the local PCT, and arrangements for exceptional funding should no longer be “shrouded in mystery”—to use a phrase from a judge’s deliberations—from the general public.

Macmillan is in the process of surveying all PCTs in England by way of a freedom of information request, to discover how many have a formal exceptional funding process, what the processes are, details about the decision-making panel, how much it is used, patient criteria, whether information on the process is published, and so on. That information will be used to inform PCTs of how their processes compare with those of other PCTs.

Other organisations in the cancer community are doing the same thing—finding out how different PCTs operate. Some hon. Members will have been involved with the screening procedures that Cancer Research UK is examining to see whether different PCTs have different ways of carrying out screening for particular cancers. The current mood is that in addition to what was outlined by the Select Committee, an attempt should be made to do something about the differences between PCTs in certain fields. Those concerned will of course share their findings with MPs when the information is obtained.

I call on the Government to provide direction to PCTs and to support them in operating equitable and accessible exceptional case processes. That should include guidance on how exceptional cases should be dealt with, what criteria exceptional case committees should use to decide whether a case should be approved, who should sit on the committees and what patients should be able to expect, regardless of where they live. I want all PCTs to publish their exceptional case processes on their websites and through the local office of the patient advice and liaison service set up by the Government. The information should be freely available. PCTs should ensure that patient information about the exceptional case process is made widely available, in different formats and languages. I am continually astonished that in Norfolk 108 different languages are used, and I found that the PCT used only one—English. Suddenly Portuguese, Lithuanian and other tongues must be fed into the process, so that everyone gets the appropriate treatment, even within a county. It is a more complex matter than just trying to equalise what happens county by county. PCTs should provide all members of exceptional case committees with training in considering the relevant situation. They should collect data on how many cases are heard, the numbers approved or refused, and the therapy to which the decisions relate. That data should be considered by NICE when it gets round to appraising or reviewing its guidance.

The issue is an extremely important one in dealing with a facet of the work in question. Drugs are a major part of the treatment of patients in the national health service, and there will be more cancer drugs coming on to the market. It is estimated that in the next two years there will be 12 new drugs for different cancers. We should be proud that our scientists and medics are coming forward with new treatments—new cures, even—prolonging life and the quality of life. Politicians should ensure that if those treatments are available, they are available to everyone, wherever they live in this country.

It is a privilege to follow my hon. Friend the Member for Norwich, North (Dr. Gibson)—I can call him my hon. Friend because sitting in the middle I can have Friends on both sides. I pay tribute to him for his work as chairman of the all-party group on cancer. For 10 years he has been indefatigable in working for cancer patients.

I shall try to illustrate my remarks from my local experience in Worcestershire, where we have what is called a complex case panel. I have had several battles with it over the years. The first related to anti-tumour necrosis factor drugs for rheumatoid arthritis, several years ago when Worcestershire had three PCTs and postcode rationing was even more ridiculous, in that one of those small PCTs would not fund anti-TNFs and the other two would. A huge advantage resulted from the merging of PCTs into larger areas, from that point of view. Since the merger I have had battles over biventricular pacemakers, cochlear implants and drugs for wet macular degeneration—all before NICE has made a ruling.

There is a tremendous difficulty, even with technology appraisals, which are mandatory, because they may override local clinical priorities. I remember that during the first inquiry into NICE by the Health Committee, several years ago, we received objections from St. Thomas’s, over the water; the hospital representatives could not equate the demands from the technology appraisal for implantable defibrillators with their much greater desire for more nurses in accident and emergency. There is a tremendous conundrum: local priorities against national uniformity. I do not pretend to have an answer to that, but we must think about it.

My most recent, continuing, failing battle with the complex case panel is over the drug called sunitinib, which the hon. Member for Norwich, North mentioned under its proprietary name, Sutent. Sunitinib is for renal cell cancer, and amazingly has been approved as a first-line treatment for renal cell carcinoma in the north of England. On 23 July 2007, the north of England cancer drug approval unit, taking the cost into account, approved the drug not for second-line but for first-line treatment of patients with renal cell carcinoma, and listed such evidence as improved progression-free survival and improved survival in patients who had failed on, or could not tolerate, current therapy. That was enough for the north of England patients, and for medical oncologists in Birmingham. One with whom I have had dealings in connection with two patients in my area wrote, in reply to an inquiry from me about the current position in the west midlands:

“I have worked with most PCTs in the West Midlands and Worcestershire regions and in many cases the PCTs have funded treatment with this drug. I am aware that Worcestershire PCT is funding treatment with Sunitinib in at least two cases.”

That seemed to me rather more hopeful.

I tried to find out more about the prescribing of sunitinib across the country, and tabled a parliamentary question:

“To ask the Secretary of State for Health which primary care trusts in England provide funding for Sunitinib for patients with renal cancer who have failed to respond to all other treatments.”

I do not really blame the Department of Health, but this is one of the many matters on which it does not hold information. However, the Minister who responded said, because we all know that NICE is appraising the drug:

“In the meantime, it is for local PCTs to decide whether to make Sunitinib available to patients. In doing so, they need to take into account the available evidence. It is not acceptable for national health service organisations to refuse to fund a treatment simply because it has not been appraised by NICE.”—[Official Report, 19 November 2007; Vol. 467, c. 599W.]

On 22 November, Mr. Nicholson, the chief executive of the NHS, came before the Health Committee. That was just when we had heard the revelations that the NHS had gone out of deficit and into the most magnificent surplus. When we asked him about the surplus, he said quite clearly that the Department of Health was not telling PCTs not to spend their money on measures to undo postcode rationing. He said:

“What I can say is that the kind of decisions that you have described can now be taken wholly on clinical grounds, not on the basis of whether we have the resource.”

I went back to the PCT, because in the meantime my two constituents who need the drug had failed in their appearances before the complex case panel and their appeals. Worcestershire PCT’s reply quoted the PCT’s area prescribing committee. In his letter to me, the chief executive said:

“Sunitinib is not routinely used or funded for patients in Worcestershire with metastatic renal cell carcinoma.”

He went on to list the guidelines issued by the area prescribing committee:

“1. There should be no funding of these agents until further evidence is available to support use. It is expected that this should be in the form of mortality data.”

My two constituents are literally waiting to die.

The second guideline is a very good way of getting rid of exceptionality:

“2. No cases are likely to be exceptional in nature, and in view of the current available treatment it would not be equitable to consider any case as exceptional in the future. All cases considered as such to date merely represent the natural progression of the disease and response to existing treatment options. It is not appropriate to consider any further requests in line with previous requests considered.”

So exceptionality can just be got rid of. I looked up “exceptional” in my huge “Webster’s” dictionary. It just means “uncommon or rare”, nothing more. The chief executive went on:

“I trust that this reassures you that the prime decision for not funding this treatment is the lack of sufficient clinical evidence with which to support use; and that the way in which this drug was considered for use is consistent with the mechanism by which all new drugs are introduced into clinical practice in Worcestershire, i.e. through the Area Prescribing Committee.”

I was further confused by a letter from the chief executive of the West Midlands strategic health authority; I was trying to apply a little pressure higher up. I cannot resist reading this paragraph, which she herself admitted she did not understand:

“I understand from the Cancer Network that an improvement in progression free survival alone is not accepted as reason for approval of a drug and, in this situation, if a drug is on the NICE agenda then the Network would await a decision from NICE, as the survival of patients is not compromised. They add that an improvement in progression free survival is not evidence that a drug changes the natural history of the disease; progression may be delayed but there may be accelerated repopulation of the tumour after the drug stops being effective. As a clinician, I assume this statement is more readily understandable to you than to the lay person.”

It was completely un-understandable to me, even as a clinician of some years’ retirement. I found it very difficult.

Is there an answer? Ideally, NICE should make its appraisals, which are mandatory, much quicker. We shall debate that here in about a week’s time. That would be the ideal, as we all know that NICE goes into incredible detail to find out the facts. Another answer would be—please do not think that I am asking for more money for the health service—for more of the money in the health service to be made available so that more of the new, expensive drugs can be afforded and NICE can use its quality-adjusted life years to let a few more drugs through. I am seeking not more money but more efficient use.

The Department has made a start with its NHS better care, better value indicators. We must stop waste and the inappropriate use of drugs and reduce medical mishaps, which so often arise as a result of drug errors. As I have said many times, I believe that we must have a public debate on health care rationing, because I do not think that the NHS will ever be able to afford everything. That debate must be both national and local. Many people have mentioned co-payments, and there must be a national debate on that too. The very idea of co-payments underlines the fact that the NHS is free to everybody, because only those who can afford it could make co-payments, but there should be some way to tap into that. I do not know what that is. I hope that hon. Members might have some ideas. We also need better input from the public and patients into the commissioning system at PCT level. I am grateful to have taken part in this debate, and I hope that some answers will come out of it.

It is a great pleasure to follow—I am not sure whether I can say “my hon. Friend”—the hon. Member for Wyre Forest (Dr. Taylor), my colleague on the Select Committee on Health, and to participate in the debate so ably introduced by the hon. Member for Norwich, North (Dr. Gibson). I listened to his opening speech, which seemed to go by in five minutes. He raised so many important issues that I could have sat here and listened to another hour of it.

To return to the point made by the hon. Member for Wyre Forest about co-payments, rationing and the NHS—we must have a grown-up debate about those issues on another occasion—my blood boils to think of it. Imagine that your mother was seriously ill with cancer, Mrs. Humble—unfortunately, my mother died of it—and that there was an opportunity for a drug that might help. Imagine being told, “We won’t provide it on the NHS.” You might ask, “What if I use my life savings to buy it? That’s okay,” but you would be told, “No: if you do that, you’ll have to fund all your treatment privately.” Most people cannot possibly afford that. What we are saying is that we will allow only very rich people to be treated with the new drugs. That is where the whole system falls down.

I believe that the unique NHS system into which we have got ourselves may have many advantages—terrific doctors and nurses work within it—but it has a flaw: it is actually a rationing system. Of course, in an insurance-based marketplace system, people would get the new drugs. One problem is that this country has one of the worst take-ups of new treatments.

I shall touch on two personal matters to illustrate the problem with exceptional treatment. First, many years ago, my father was diagnosed with the first signs of Alzheimer’s, at which time he lived in Southend. The doctors said, “We have a new drug that we think might help your father. Would you like to try it?” We tried it, and not only did it stop the onset of Alzheimer’s, but it actually improved his quality of life, and for the rest of the eight or nine years that he lived there was no deterioration. However, that very drug can no longer be prescribed in the early stages of Alzheimer’s, which is nonsense.

For me, the second, and classic, case involved my wife: five years ago, local general practitioners spotted a lump in her chest and quickly referred her. It turned out that she had both liver and bowel cancer, and she was given a 30 per cent. chance of survival. She had an immediate bowel cancer operation, after which she received chemotherapy with a new drug. Luckily, we had private insurance, which it seemed right to use to save the NHS money—over the whole period, I suppose that the private insurance company paid up £40,000 or £50,000. After the chemotherapy, she underwent a major NHS liver operation—it was at the top of the scale for liver operations—performed by Mr. Ashley Dennison, a marvellous consultant in Leicestershire. After the operation, she again received chemotherapy, and tomorrow—thankfully—she goes for her five-year check-up, after which we hope she will be released from check-ups.

Listening to this debate, it struck me that if we had not had that private insurance, we would probably have been denied that drug, without which I do not think my wife would have survived. At the moment, only the rich, or those with private insurance, which tends to mean that they had the money in the first place, will get the treatment. That goes completely against the principle of the NHS being free to everyone based on clinical need. That is where the system is falling down. I am sure that that is not what the Minister, who is very able and caring, and the Government want. Sometimes these things happen without anyone realising it.

I agree entirely about the standardisation of exceptional circumstances. There is no clear guidance across the country. My only worry is that if the Government introduced that, it could bring in the lowest common denominator, so that fewer people might end up being treated, which I do not want to happen. My personal view is that if a consultant says, “This person should benefit from this drug,” they should get that drug. I know that that is frowned on within the NHS’s rational system, but it happens in other countries.

Does the hon. Gentleman agree that behind-the-scenes consultants sometimes campaign through patients and using militancy or The Sun newspaper in order to get their way? Others adopt approaches different from the straightforward methods being suggested today.

That is entirely true.

Leaving that aside, however, I want to spend most of my time talking about wet age-related macular degeneration, and the campaign in which I was involved, which provides a clear case of something going fundamentally wrong. As the Minister will know, last year, NICE considered this issue, because of three new drugs that can cure the disease. For those who do not know, wet age-related macular degeneration applies to the elderly—obviously—and those suffering from it go blind unless they get treatment. Until last year, there was no real treatment, and the disease would simply progress towards blindness. Three drugs then came along: Lucentis and Macugen, which were developed purely for this disease, and Avastin, which is a bowel cancer drug but was found to do the same job.

The problem was that NICE made a pig’s ear—unusually—when it published its draft recommendations. A massive row followed, and NICE withdrew its representations and reconsidered. Each year, 30 to 40 people per constituency contract this disease, and they were left with no NICE guidelines. In many parts of the country—in Liverpool, Somerset and Scotland, for example—patients received that treatment automatically. However, the thing that annoyed me the most was that it does not cost hundreds of thousands of pounds, but a few hundred pounds per injection, of which anything from three to 12 are needed to cure and reverse the disease.

I disagree with the term “postcode lottery”—it is no lottery, because my constituents will never win. Ours is the worst-funded PCT in the country, according to Government figures, so we will never provide something that someone else does not.

That brings us back to exceptional treatment—I think that my PCT called it low-priority funding. Bear in mind the rapidity of the disease—within three months the patient will go blind: there will be a delay before the patient can visit a consultant; the patient is diagnosed with the disease, and the doctors say, “You will go blind unless you receive the treatment. The good news is that there is treatment that will cure you, but the bad news is that we do not provide it on the NHS,” which is what a consultant at Kettering hospital rightly told my constituents. He then added, “For £1,500 you can come down the road and I will give you the injections,” which seemed rather a lot for an injection. However, someone with a relative who will go blind unless they pay for the treatment, will pay for the treatment somehow.

When I first challenged Kettering hospital, it was very good, admitted that it was wrong, and paid for somebody’s treatment privately. That was one case solved, but then of course I received many more cases, and I realised that the denial of treatment was commonplace. The PCT said, “It is not that we are denying treatment. Either they are exceptional cases, or low priority.” This is what happens: the consultant makes a decision, which goes to a meeting a few weeks later, after which the patient is referred to Leicester for a second opinion, even though the first consultant has already said that they need treatment. Of course, by the time the final decision is taken, the patient will be blind. It is a Catch-22 situation: patients cannot win.

I am very pleased to say that after campaigning in Parliament, and with the help of local media and even the Prime Minister who got involved and said that it was unfair, NICE produced provisional guidelines in the middle of December saying that people should get treated on the NHS, which made complete sense. Not only was it right morally to stop people going blind—there could be no argument about that—but it was financially sensible. When people go blind, the cost of social services is enormous. So it did not even make sense monetarily.

My hon. Friend has reached the point on which I wanted to speak—this should spare hon. Members the need for a full speech from me. His example affected a run of my constituents. As we investigated, it became clear that the regime under which NICE operates does not allow it to consider the knock-on consequences for social security, benefits, tax credits and other forms of personal and social care and support, which might—this is the case here—on any analysis, and regardless of the discount rate applied, hugely outweigh the up-front cost. Does he agree that one of the most urgent necessities, as well as trying to find means of speeding up NICE’s consideration, is to find some means of injecting into the regime a consideration of the genuine economics, so that NICE can operate on a rational basis, rather than being forced to operate on an irrational one?

It must be clear to everyone that that is what should happen. There was a prime example of wet age-related macular degeneration in my constituency. Two people were living independently. I think that the lovely lady was 84 and her husband might have been slightly older. He had a mild disability and she was looking after him. She then got wet eye in both eyes and the PCT was going to allow her to go blind, which would have meant that the couple could not have lived independently and would have had to be looked after. The cost would have been enormous. Luckily, a private company stepped in and paid for their treatment, but we should not be operating at a level in which a local company steps in because of a media campaign. To its credit, the PCT changed its mind in February and decided to implement the provisional guidelines. However, that is not always the case across the country. This nonsense of exceptional decisions taking weeks and weeks to make does not help our constituents who are suffering from wet eye or cancer. If a cancer patient is fearing for their life and their whole world has been turned upside down—as happened in my family—they do not want to go through a bureaucratic process to see whether they can get treatment. That is fundamentally wrong and totally against what the NHS was set up to do, and I hope that the Minister might have some answers for us.

I congratulate the hon. Member for Norwich, North (Dr. Gibson) on introducing the debate and on having said so many wise things, as he often does, on subjects as diverse as health and taxation. Health care has been rationed from time immemorial, and that is because time and resources are limited. A lot of prioritisation, or rationalisation—whatever one wants to call it—is uncontentious. It is hidden behind the labels that we give to complaints, such as acute, chronic and minor. We are all familiar with prioritising when it comes to the very young, the accident victim, the heart attack patient or the victim of a life-threatening disease. Some prioritisation, however, can be contentious. The treatment of a drug user, a reckless individual, those with a smoking-related disease, victims of irreversible, incurable conditions that nobody knows what to do with, and those in need of cosmetic surgery can be set against therapies for common and widespread and more frequently met complaints. There will always be a public debate about the choice to prioritise, favour or rationalise—to favour treatment of group A at a partial cost to the treatment of group B, or to fund one kind of therapy as opposed to another. Ultimately and inescapably, how we resolve those issues boils down to the issue of society’s values. However, the issue may be how those choices are made. Clearly, there are a number of different ideas about how they should be made. For example, such choices can be made by open democratic debate, by the popular press or by medical experts. Whichever choice is made will be contestable, because either the public—if they make the choice—may not know enough, or the medics may not share our values or be attuned to the values that the public hold. Whatever we do, different and hard-to-explain variations will exist in different areas and hospitals.

Here NICE enters as a kind of solution. It is a very professional outfit, but it does not get us off the hook. We cannot criticise NICE for not getting us off the hook or for attempting and failing. What NICE does is inform choice: it does not make the choice for us. It provides benchmarking of therapies and guidance. If it fails to make an appropriate mark or benchmark, it makes a recommendation to the people who have to make the choice—the PCTs—to fund or not fund. The debate primarily is about those PCTs that ignore, bypass or overcome those recommendations, either in general or in selected cases, funding things that NICE thinks they should not.

What the hon. Member for Norwich, North has shown very capably is that PCTs vary, and that they vary for a variety of reasons. They vary across the board and there may also be a lack of internal consistency within PCTs. Certainly, and most culpably, PCTs vary in procedure as to how they address very difficult issues.

[Mr. Greg Pope in the Chair]

I take a slightly different tack from the hon. Member for Norwich, North. I reckon that NICE is always going to leave room for judgments: it is not an oracle. It endeavours to do three very obvious things: first, to assess the cost of drug therapy; secondly, to evaluate the evidence of its benefits; and thirdly, to link those costs to the benefits using a strange unit of measure called the QALY—a quality-adjusted life year. In every stage in that process, controversy almost inevitably lurks. The cost, for example, is normally the UK market cost and not the cost of production plus a reasonable profit. We must be very wary in all such debates—it has been mentioned in other debates in the House—of drugs companies persuading patients and patient groups that the real problem is NHS parsimony and not drug company greed, because sometimes it is the latter.

In exceptional cases in particular, the assessment of the benefit by NICE is also a matter of debate. It considers the statistically average benefit, which ignores the fact that some drugs, for reasons unknown, benefit considerably some, but not all, targeted patients. That was almost certainly true of the Alzheimer’s drugs that seemed to work partially, but not across the board. Doctors can often, and quite legitimately prescribe—the hon. Member for Norwich, North is a doctor so he can correct me if I am wrong—therapies that may work, but cannot be guaranteed in all probability to work. When needs must, they will try something that is possibly, but not necessarily, the likely solution of the patient’s problems.

To make matters worse, the problem of linking the cost to the benefits by calculating the QALY is also methodologically questionable. The QALY is a bit like a unit invented in the 19th century by the utilitarian philosopher Jeremy Bentham called the hedon, which was a unit of happiness. He thought that one could solve all moral and political debates very quickly by totting up the number of pleasure units caused by adopting one policy or another. He recommended the unit to Government. It was a kind of hedonic calculus: one did one’s sums and got the right answer. We could add up on one side the pleasure caused by compensating the millions of losers from the change in the 10p tax band and set against it the embarrassment and discomfiture caused to the Prime Minister and the Chancellor and then we could work out on a scientific basis what we ought to do.

The QALY enjoys the same fate as the hedon, because we can question whether we should or can rate a drug that, for the same money, delivers a 5 per cent. benefit to thousands against a drug that for the same money, not the same price, delivers a 50 per cent. benefit to a handful of severely affected individuals, or exceptional cases. How can we, or should we, distinguish a drug that may add a year to the life of a child as opposed to a drug that adds three years to the life of a middle-aged man or five years to the life of a person with a history of voluntary substance abuse?

The most touching case I came across in preparation for today’s debate was in the Library notes. It was the case of a young lad who had to go to Germany to get a drug to sustain him so that he could live on for a few extra years. He was not likely to live for long, but without the drug he would die very quickly. That very vividly made the case that a young life is worth far more than the life of any of us here today. As the right hon. Member for West Dorset (Mr. Letwin) pointed out, NICE benchmarking does not tell us about social effects or the effects on others, which are particularly poignant in the case of children.

NICE offers guidance, identifies downright useless therapies and aids comparison, but it does not and cannot eliminate the need for judgment calls, by the PCTs or by whomever we think ought to make them. The question, which the hon. Member for Norwich, North put well, is whether that judgment should be unfettered and ad hoc, as it currently appears to be. I suggest that, however the PCTs exercise their discretion, or clinicians exercise their discretion in advising the PCTs, they should do so in a reasoned fashion, and not because they are stampeded into it by, for example, a press campaign. The process should be transparent, so that people know what has been done and why. It should be open to both expert and public scrutiny, and it should certainly be accountable, however we want that accountability to work.

Is the hon. Gentleman saying that it would be tolerable to have different results from different PCTs across the country for the same exceptionally used drug?

I suppose that one must ask whether we would be more comfortable with a judgment call being made by whichever national body was to prescribe to PCTs how to do things, or on a more locally accountable basis.

I was talking about non-NICE-approved drugs as well. There are situations in which there is evidence, but NICE has not got around to assessing it. What is the hon. Gentleman’s position on non-NICE-approved drugs across the country?

I am just illustrating a case, not trying to solve the problem for the hon. Gentleman. We want a variety of opinions to come into an assessment, but we do not want the whole issue to be entirely predetermined by a national body.

I join colleagues in congratulating the hon. Member for Norwich, North (Dr. Gibson) on the excellent way in which he opened the debate. He is a diligent campaigner, particularly on behalf of the cancer community and cancer groups. I congratulate him in advance on his 10 years of work with the all-party group.

I wish to touch on the points that very learned hon. Members have made, and also on NICE. I know that there is going to be a debate about NICE in the near future, but we cannot do justice to this debate without considering it, or without considering how the funding formula in the NHS works, particularly in England.

I have looked at a Library paper setting out figures for exceptional circumstances appeals in the hon. Gentleman’s constituency. Some 57 per cent. won their appeal, and 31 per cent. lost. I do not know what happened to the other 22 per cent.—I have not had the opportunity to ask the Library whether they are just sitting out there in limbo—but there is obviously a problem. Those figures relate to people’s lives. I do not think that the Minister and I will disagree about much in the debate, because we care passionately about getting things right.

In the constituency of the hon. Member for Norwich, North, 31 per cent. of those who were told that they needed a drug or treatment and appealed under the exceptional circumstances rule were declined. Many of those patients and their families will have known that, in another part of the country, they may well have had their treatment funded. That is right at the heart of the problem. The hon. Member for Southport (Dr. Pugh) was right that it is impossible to fund every treatment that experts come up with, and that the NHS has rationed treatment for the past 60 years since its inception. However, patients and their loved ones deserve as much open and honest information as possible about why they are likely to need treatment, why they will not get it and, as was said earlier, whether the treatment will work.

That is why I was worried by what the hon. Member for Wyre Forest (Dr. Taylor) said. He has generations of experience in the medical profession—probably longer than I have been alive. Having sat with him on the Select Committee on Health for two and a half years, I know that his knowledge is invaluable to the Committee. He said that the document that he had got from an SHA was—I shall use my language rather than his, which was much more generous—complete gobbledegook. He said that not only did he not understand the letter, but that nor would the patient, and probably none of the consultants who have seen it.

We are moving towards having drugs specially prescribed for a patient with a particular genetic footprint. How will a patient have faith in a consultant telling them, “This drug is no good for you, because you do not have the genetic footprint for it”, if we cannot even get the basics of an appeals procedure into language that is common to us all. The hon. Member for Norwich, North, mentioned the diversity of his community and the number of different languages that are spoken, but here we are dealing with only one language, English, and even a retired senior consultant with years of experience could not communicate to his constituents what the SHA meant.

I was also concerned by what my hon. Friend the Member for Wellingborough (Mr. Bone) said. He is a doughty fighter for his constituents, and I congratulate him. How can we explain to anybody that they or their loved one will not get a drug that may well help them, because they are on the wrong side of an arbitrary border? I know that the Government are examining the funding formula as a result of the Health Committee’s excellent report on the funding and deficits of the NHS. As the Minister knows, I am sceptical about how we have suddenly leaped into a wonderful period of surplus in the NHS.

My hon. Friend is laying out the arguments clearly. Before he moves away from formulae, I wish to say that the national capitation formula is worked out at great expense and is used to decide how much each PCT should get. Every year since that formula was introduced, my PCT has received less than 100 per cent. How can that possibly be fair? The Government cannot even fund their own formula.

My hon. Friend has raised the core issue that the Select Committee, a Labour-dominated Committee, examined. We had grave concerns about how a formula that has cost huge amounts of money to decide could be so fundamentally flawed. My constituency is not a long way from his, and during the Committee’s proceedings I asked the then Secretary of State why her constituents would get some £400 a head more than mine each year, which was causing extensive rationing, cuts and closures in my constituency. She simply said, “Your constituents are more healthy than mine, which is why you get less money”. I think that the hon. Member for Wyre Forest was present at that evidence session.

I cannot say strongly enough that there is a dire need to address the anomalies in the funding formula. In my opinion and that of my party, many of the anomalies exist because there is not enough attention allocated to the age profiling of the particular area. Naturally enough, where there is social deprivation and there are early deaths because of that deprivation, we need to work on the public health side of matters. At the same time, however, if there is an ageing population in a constituency—the particular disease that my hon. Friend the Member for Wellingborough referred to is age-related—that constituency is penalised, because people are living longer, which is when that disease affects them; that is the situation in his constituency.

My right hon. Friend the Member for West Dorset (Mr. Letwin), who I am sure has gone to carry out very important duties elsewhere, talked about joined-up government and we would all like to see more of that. It is very difficult for NICE to make decisions without the knowledge of how those decisions will affect the community as a whole.

I would now like to look carefully at some ideas for NICE, and my party would be very happy if the Government took them up before the election, whenever that comes; I say all this completely in good faith. Often the problem with NICE is that, by the time it starts to look at a drug, that drug is a long way down the line. Perhaps lots of articles have already appeared in the press or consultants have talked about it, but NICE’s assessment has not taken place early enough. It is very important that NICE starts to assess new drugs and treatments during the drug licensing process, so that it communicates much earlier with the drug companies and it knows what drugs are coming down the line. Therefore, it can start its assessment while the licensing process takes place. At the present time, the assessment takes place after the licensing process. Obviously, that situation applies not just to drugs but to treatments.

It is important that NICE is an independent body and that it is autonomous. However, it must also be set out as an autonomous body, and as one that is accountable. Perhaps we need a Bill before Parliament to give it that statutory role. At the moment, it has a special health authority role rather than a statutory role.

Earlier on, several colleagues alluded to the issue of the QALY, the quality adjusted life year. Colleagues, we must think of another title for this measurement; we are talking about people’s lives here. It is imperative that we not only look at the term “quality adjusted life”, but that we look at what it actually means and whether it will give quality of life. On the Health Committee, we always looked at the top figure; how much is a life worth? It is much more detailed than a QALY would suggest.

NICE must also look much more at producing evidence-based commissioning guidelines. It must be much more involved with the whole process whereby evidence is given to different PCTs around the country.

Finally, I return to where I started, which is that we must not get away from the fact that this issue is about people, lives, futures and relationships with loved ones. The system is struggling to cope. I think that we would all agree with that; it is why we are debating this issue today. All too often my constituents come to me and say, “I have been denied this”, or “My loved one has been denied that”. People expect an openness and a frankness about decisions that are made which sadly, in many PCTs around the country, are not there.

I say to the Minister that, if the Government want to pick up on anything that I have said today, particularly on NICE, we would support them on that. We would also very much support the Government on establishing a much better practice within the PCTs around the country as to how they deal with these exceptional circumstances. I do not think that it is acceptable for a PCT not to have an appeals procedure, but some PCTs still do not have one. I do not think that that is acceptable in society today and certainly people should be able to appeal after they have applied.

I start by congratulating my hon. Friend the Member for Norwich, North (Dr. Gibson) on securing this debate; Norwich is my home city. I also apologise that the Under-Secretary of State for Health, my hon. Friend the Member for Brentford and Isleworth (Ann Keen), who is the Minister responsible for this policy area, cannot be here to respond. She is away on departmental business.

My hon. Friend the Member for Norwich, North and other hon. Members have raised a number of specific points about how the local health service across England manages and considers exceptional cases for cancer drugs. I hope to respond to as many of those issues as possible today.

Let me start by trying to define “exceptional cases”. They are cases where a primary care trust considers whether or not to fund a treatment where NICE has either not issued an appraisal or not recommended the treatment in its appraisal. It is worth remembering that, before the establishment of the National Institute for Health and Clinical Excellence, guidance on new drugs and treatments was being issued by numerous bodies at national, regional and local levels. Those bodies had very different ways of appraising evidence and developing recommendations. The status and implications of the guidance produced were not clear. That was confusing for doctors, who wanted to know what care they should be expected to give, and for patients, who wanted to know what care to expect.

That lack of coherent guidance led to big variations in prescribing practices across the country. It is precisely because of the complexities of modern treatment opportunities and also the need to ensure equity, clinical effectiveness and value for money for NHS patients that this Government established NICE as an independent body in 1999.

NICE is responsible for producing guidance for the NHS on the clinical effectiveness and cost-effectiveness of new and existing treatments, and it has become widely recognised as a world leader in its field. As I think my hon. Friend the Member for Norwich, North acknowledged in his speech, any taxation-based health care system will sometimes need to take difficult decisions on what to fund.

NICE’s guidance is based on a thorough assessment of the best available evidence and is developed through wide consultation with interested parties, including the drug manufacturers, patient groups and the NHS itself. Its appraisal and clinical guideline programmes have been both assessed and commended by the World Health Organisation.

As part of its technology appraisal process, NICE calculates the cost per quality-adjusted life year—if the hon. Member for Hemel Hempstead (Mike Penning) has any suggestions for a better name for that measurement, or a better means of assessing appraisals, I am sure that NICE would be very pleased to hear from him—to assess both the health gain arising from a particular treatment and the cost of that treatment.

I was not talking about how NICE comes to its conclusions; I was talking instead about the need to perhaps have more sensitive language, rather than language such as “QALY”.

Again, I am sure that NICE would be grateful for any constructive suggestions in that regard.

NICE does not operate a fixed threshold for the approval of a treatment but uses a broad range, to enable it to consider a broad range of evidence. The chair of NICE often refers to NICE’s use of the quality-adjusted life year as a “tool not a rule”.

NICE is currently carrying out a scheduled review of two of its key documents that provide a framework for its technology appraisals. These are the “Guide to the Methods of Technology Appraisal” and “Social Value Judgements: principles for the development of NICE guidance”. These documents cover a range of important issues, such as NICE’s use of QALYs and its consideration of orphan drugs, which I will come on to in a moment and which my hon. Friend mainly concentrated on in his speech. Draft documents have recently been subject to a full public consultation and NICE is considering all the comments that it has received.

Clearly, as hon. Members have said, it is vital that when NICE issues guidance, it is implemented consistently across the country and the Government have a role in facilitating that implementation. Provision for NICE guidance is made in funding allocations to PCTs, and NICE’s technology appraisal guidance is supported by a funding direction that requires NHS commissioners to make funding available for NICE-recommended drugs within three months of guidance being issued. These measures ensure that NHS clinicians across the country should be able to prescribe any treatment recommended by NICE. NICE guidance does not override the clinician’s responsibility for individual patients, but we expect NHS doctors to take NICE guidance fully into account in their decision making.

Compliance with NICE’s technology appraisals is now a core standard against which NHS organisations are judged. NHS organisations are required to demonstrate for the annual health checks that they are providing funding for NICE-recommended treatments within three months of guidance being issued.

There is an important point to be made here. I think that the Minister is saying that, once NICE has reached a decision, it is three months until implementation of that decision. However, there is of course the whole procedure where NICE gathers evidence, then the matter goes out to consultation and there is a three-month period. What does he think that PCTs should be doing in that period?

I will come on to that subject in a moment, if I may.

Where an NHS organisation fails to comply with NICE’s technology appraisal guidance, it is the responsibility of the strategic health authority in the first instance to support any of its organisations to achieve the necessary improvement. My Department has made it absolutely clear that if evidence comes to light that a particular body is failing to comply with the statutory funding direction to put in place funding for NICE technology appraisals within three months, it would expect the relevant strategic health authority to ensure that action is taken. If any hon. Member in this Chamber or elsewhere in the House has examples of where that is happening, I would be happy to draw them to the attention of the relevant SHA.

No, I must make progress. I have to get through many responses.

Trusts are monitored against the core standards by the independent Healthcare Commission in its annual health checks, and each NHS organisation’s rating is published. In 2006-07, 89 per cent. of NHS organisations were compliant with the standard relating to the implementation of NICE’S technology appraisals. That was a 5 per cent. improvement over the previous year.

A report issued in 2006 by the national cancer director, Mike Richards, showed a continued increase in the uptake of new cancer drugs by the NHS following positive NICE appraisal. It also confirmed a reduction in the variation around the country of the use of such drugs. That was partly due to the big increase in spending on cancer drugs—£729 million in 2006—which is expected to grow by between £60 million and £80 million a year for the next few years.

The improvement in implementation shown by Mike Richards’s reports can be attributed to several factors. In addition to the comparative data presented in the reports themselves, the period also saw the establishment of NICE’s implementation directorate and the introduction of the Healthcare Commission’s independent assessment. Professor Richards will repeat his evaluation of NICE-approved cancer drugs during 2008 to ensure that patients across the country continue to have access to such treatments. The evaluation will assess the period July to December 2007 and is expected to be published by the end of the year.

Where NICE guidance does not exist, either because it has not yet been developed, as in the case of the renal cancer drug referred to by the hon. Member for Wyre Forest (Dr. Taylor)—incidentally, the letter that he read out is a good example of why a plain English campaign is needed in the health service—or because it is not part of NICE’s work programme, it is for PCTs to make decisions based on the evidence that is available on whether to fund the drugs locally.

Such decisions are not new to PCTs. The principle of some local autonomy in decision making is supported by all parties in the House. It is important, as the PCTs are usually best placed to determine and meet the health needs of their population and to know more about the exceptional needs of individual patients.

Concerns have been raised about the speed between drugs being licensed and NICE appraisals being finalised, and the different decisions that might be made by PCTs around the country during that time. Four actions have been taken to try to address that. First, NICE introduced a new fast-track process so that for certain treatments it can provide guidance within weeks of a drug’s being licensed. That process was used for the appraisal of Herceptin.

Secondly, we issued management guidance to NHS organisations in December 2006 reiterating the message that decisions on funding for individual treatments should be made on the basis of the available evidence. The guidance makes it clear that it is not acceptable to refuse to fund a treatment solely because NICE guidance does not exist. It also pointed PCTs to useful sources of information to help them in reaching their decisions.

Thirdly, the cancer reform strategy, which was published in December 2007, set out several sources of information that PCTs should consider as a minimum when making decisions on treatments not yet appraised by NICE. Finally, the strategy also proposed a default position that all new cancer drugs will be referred to NICE for appraisal if there is sufficient evidence and a large enough patient population to justify doing so.

My hon. Friend the Member for Norwich, North raised a couple of specific issues. He discussed the problem that he had encountered in respect of transparency and the democratic deficit in decision making by PCTs. He has a point. It is general good practice for PCTs to be open and transparent about their processes. Indeed, my noble Friend Lord Darzi will address the whole issue of democratic accountability of PCTs when he publishes the final report on his review of the health service later this summer.

The hon. Member for Wyre Forest also stressed the importance of commissioning. He is absolutely right. Again, we need better commissioning and better accountability in commissioning decisions, which I think will be helped by the recommendations that we expect will be published this summer.

The hon. Member for Wellingborough (Mr. Bone) repeated his affection for a social or private insurance system of co-payments. That is not a position that we hold or, indeed, that his Front-Bench spokesmen support. We do not think that the solution to the problem involves any kind of subsidy for the private sector.

The hon. Member for Hemel Hempstead discussed the funding formula. He will be aware that we are awaiting the final recommendations of the independent body that gives the Government advice on such matters, and we will be making announcements in due course.

Let me turn to orphan drugs, on which my hon. Friend the Member for Norwich, North concentrated. Orphan drugs treat a condition that affects fewer than one in 2,000 people within the population, and it is true that they can often be expensive. However, it is not the case that they are less likely to receive a positive NICE appraisal. Over the past seven years, for example, NICE has completed 46 appraisals of cancer drugs, representing about one third of all its technology appraisals, and 41 of them have partly or fully recommended the treatment.

Up to 2007, NICE had appraised 26 orphan drugs. Three had negative appraisals and the other 23—including, for example, riluzole for motor neurone disease—received either a complete or partial approval. Indeed, information from NICE suggests that the proportion of orphan drugs that are considered cost-ineffective is not out of line with the technologies that it appraises for more common conditions.

Because cancer drugs are usually given for a relatively short period of time, even quite expensive ones can secure a positive NICE appraisal if they are effective. I know that the communities involved with less common cancers have expressed concerns about the use of cost per quality-adjusted life year in the NICE technology appraisal process for orphan cancer drugs, but, as I said, that specific concern is being considered as part of NICE’s review of its framework for technology appraisals.

The drugs that NICE cannot really deal with are those that are both very expensive and require long-term, sometimes lifetime, treatment; for example, treatments for rare genetic conditions. Such drugs are sometimes referred to as ultra-orphan drugs, and some are considered outside NICE by the national specialised services commissioning group.

If a disease is rare, PCTs can collectively arrange a risk-share through their specialised commissioning group so that the planning and delivery of interventions that cannot be made available everywhere can be made available in enough hospitals to serve their population. Alternatively, if it is important to concentrate expertise, services can be commissioned through the SCG or the national commissioning function. I can tell my hon. Friend that the treatment for some 40 diseases, including primary malignant bone tumours, retinoblastoma, or cancer of the eye, and coriocarcinoma, or cancer of the placenta, is commissioned by the national commissioning group.

I know that my hon. Friend has had an opportunity to discuss some of his concerns with my colleague the Under-Secretary of State for Health as well as officials in my Department, and I understand that those officials are in correspondence about his concerns with representatives of the Rarer Cancers Forum.

I hope that I have managed to go some way to reassuring hon. Members that the Government take this issue extremely seriously. Both the Department and NICE take the issue of access to new drugs very seriously indeed. As I mentioned, NICE is assessing its policy on approval of orphan and ultra-orphan drugs. We recognise that local NHS trusts are in the best position to make decisions for their local populations, particularly for the exceptional cases of individuals, because they know their needs best. However, it is important to remember that mechanisms are in place through the national specialised services commissioning group to resolve some of the issues that have been raised today.