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Westminster Hall

Tuesday 1 November 2005

[John Bercow in the Chair]


Motion made, and Question proposed, That the sitting be now adjourned.—[Tony Cunningham.]

9.30 am

Mark Fisher (Stoke-on-Trent, Central) (Lab): I am conscious of, and grateful for, the good fortune that allows me to raise this issue. For those women in Britain who have breast cancer and who are HER2 positive, it is literally a matter of life and death. If treated with the   drug Herceptin, it is likely—indeed, it is almost certain—that, in the first year after they are diagnosed, 50 per cent. of those women will survive and lead a full and normal life. If the drug is not available to them, they will suffer and die.

Other cancer drugs, wonderful though they are, tend to have a success rate of 3, 4, 5 and 6 per cent. That is a good success rate for cancer drugs. However, the success rate for Herceptin is without precedent. It is 50 per cent. It has led the eminent oncologist, Professor Ian Smith, to describe the trials on Herceptin as the "most stunning" data that he has ever known throughout his career.

The brilliant scientists who developed the drug won the Nobel prize in the 1980s. It has been developed by the pharmaceutical company Roche at a cost of about £900 million. In the past two weeks, The New England Journal of Medicine has given the drug a peer review. I am no expert on such matters but, by all accounts, the journal is the most rigorous and highly respected medical journal in the world. It stated that the drug really is as good as everyone hoped that it was. It is a potential savour. Yet, it is not generally available in this country.

David Taylor (North-West Leicestershire) (Lab/Co-op): No one in the Chamber would speak against prescribing Herceptin to those who will benefit from it. Does my hon. Friend agree that describing it as a magic bullet masks the reality that it can have serious side effects and that its benefits may be less than the breathless press coverage suggests? Does he accept that such matters can skew finite research resources away from, say, hepatitis, dementia or prostrate cancer where clinical needs and patient benefits are every bit as great?

Mark Fisher : My hon. Friend makes an interesting point. When referring to new developments, it is, of course, always right not to overstate them and raise people's expectations. There is nothing more cruel for people with breast cancer than to believe that the drug will solve all problems. It will not; only 23 per cent. of women with breast cancer are HER2 positive and it can help only them.

I thoroughly disagreed with my hon. Friend when he said that there are substantial problems. I cannot claim to have read the whole of the report on the drug in
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The New England Journal of Medicine. I would not have understood it even if I had, but eminent clinicians say that the drug really is as good as everyone said. As for his further point that it would divert resources, it should not do that. If it is as good and will save the lives of women with breast cancer, we need resources directed at the drug. On the whole, I do not share my hon. Friend's reservations.

Given that the drug is so extraordinary, why is it not available in Britain? It is now available for late-stage breast cancer, but oncologists will prescribe it for women who can afford to pay for it and that is not a satisfactory solution. We are talking about a matter of life and death. It should not be about where a person lives and whether she can afford the drug. There should not be a market in the drug. It is saving lives. It should be used to save the lives of all the women who can be treated by it successfully.

Mr. Nick Gibb (Bognor Regis and Littlehampton) (Con): On the point about paying for drug, a huge number of people went on a sponsored walk in Rose Green in my constituency to raise £20,000 to enable Mrs. Chris McKrill, a district nurse, to pay for the dosage of the Herceptin that she needs to secure recovery. Does that not show that there is public support for prescribing the drug on the NHS? Does the hon. Gentleman agree that anyone diagnosed with breast cancer should automatically have the test for the presence of HER2?

Mark Fisher : I entirely agree, and I will come to the general availability of testing—or lack of it—in a minute. At the moment, the only cases that we know about are in those areas where there have been trial tests. That is how I came to be involved in the subject in a slight way, because Stoke-on-Trent was one of the areas chosen for testing. For that reason, women with breast cancer in my constituency—and in other areas, including Somerset, along the south coast, Devon and Cornwall—have been made aware that they are HER2 positive and so might be susceptible to the benefits of the drug.

Paul Farrelly (Newcastle-under-Lyme) (Lab): I thank my hon. Friend for giving way, because I have a Select Committee to go to; I am afraid that I will not be here at the close of the debate.

On testing, does my hon. Friend welcome the Secretary of State's statement over the summer and her generally sympathetic response on the issue, not least in making testing available to sufferers, so that they can see whether they might benefit from Herceptin and whether they are, in the jargon, HER2 positive? Also, does he agree that there seems to be an anomaly, in that the statement seems to suggest that testing will be given to those newly diagnosed with breast cancer, but not to existing sufferers? Does he agree that that position is not defensible, and that the Minister should address that when she responds?

Mark Fisher : My hon. Friend makes an excellent point. Anybody who cares about the subject must want testing to be universally available. Everybody should be tested; only then will we know who can be helped by the testing, and only then will the Government, and primary
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care trusts, know definitively the scale of the problem and so will be able to work out the cost and a way of getting treatment to the people who need it. So, yes, my hon. Friend makes an essential point.

The Secretary of State's involvement and interest is   terrifically encouraging, but testing has got to be widespread and general. At the moment, it is partial. That probably accounts for the fact that the matter is not a major national issue yet. Only in those areas where there has been testing have women, and therefore their parliamentary representatives, really been made aware of it.

As I say, I came across the issue in Stoke-on-Trent because women are being tested there. The circumstances of many women are extremely upsetting. Like the hon.   Member for Bognor Regis and Littlehampton (Mr.   Gibb), I have a constituent—Dorothy Griffiths—who has raised money for her treatment, but she is determined that it should be generally available, and not just to those lucky enough to be able to afford it, or to find   means of affording it. There are women such as Joanne Leese, 31, who is from my constituency. She was diagnosed with breast cancer while she was pregnant, and therefore had to wait until she had given birth to begin treatment. She now has a son aged 11, and she started treatment for breast cancer the day after she gave birth, her son having been prematurely induced. She wants her son to grow up knowing her; at the moment, if she cannot get Herceptin, she will not see her son get older.

Annette Brooke (Mid-Dorset and North Poole) (LD): Is the hon. Gentleman aware that the Secretary of State for Health said, at a Breakthrough Breast Cancer meeting last week in Methodist Central hall, that Herceptin should not be refused by any primary care trust solely on the grounds of cost? Does he agree that it would be very helpful if the Minister could say how that will be communicated to PCTs, so that we get rid of the postcode lottery?

Mark Fisher : I had noted that remark and, indeed, the Secretary of State's evidence to the Select Committee on 27 October, in which she said that the matter was one for PCTs, and that they should proceed with the issue. She then gave her support to the drug. However what she said rather clouds the issue. It is no good saying that prescription for the drug is a matter for PCTs if they cannot afford it, and we cannot leave the issue of whether women die from the disease to the financial skills of PCT managers around the country. This is not really a local matter; it needs to be decided nationally and we need guidance and a lead from the Minister. She cannot hide behind the PCTs and say, "It's over to you. You make the decisions and find the money." Most PCTs—or very many of them—are heavily in debt, and the women in those PCTs could be denied this drug simply because of those financial problems. This national problem should be dealt with nationally, and that applies as much to diagnosis as to prescription.

Some very small PCTs do not have oncologists on the panels that make such decisions. A PCT in the constituency of my hon. Friend the Member for Staffordshire, Moorlands (Charlotte Atkins) had to decide a case last week, but felt that its panel did not
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have the necessary professional expertise. It had to defer its decision and look outside the panel for that expertise. That is not a problem for a PCT in a big city such as Leeds or Manchester, but it is a genuine problem across the country. We cannot leave this issue to the vagaries of, and disparities between, PCTs.

This problem affects women all over the country, and   regardless of where they live or of the financial circumstances of their PCTs, this issue should be decided on the basis of clinical need. PCTs in deficit are unlikely to feel that they can afford to prescribe the drug. They need not only guidance and a lead from the Secretary of State, but some help.

I have mentioned two cases in my constituency, and there are others: a staff nurse is using her life savings because, as she said, she wants to live to see her daughter walk down the aisle. The husband of another sufferer has just lost his job, and she now wonders whether she will be able to remortgage her house to pay for the Herceptin that may keep her alive. She does not know whether she will get a remortgage, given that her husband is now out of work.

I am very conscious that we should not decide these things on the emotional context. Nevertheless, we ought all to be aware of that context, and I am sure that we are. These matters are not simple but they concern people's lives and hopes, and we should therefore at least be aware of the emotional context, even if that is not the sole factor.

What are the problems? Why is Herceptin not being prescribed? It is licensed for late-stage treatment, but giving it for late-stage breast cancer means that the patient has to be on the drug for the rest of her life,   however long that is, and that is very expensive. Moreover, the drug will never cure them. Herceptin is not licensed for early-stage breast cancer, when 12 months' treatment is enough to decide whether the patient can be cured. As the hon. Member for Mid-Dorset and North Poole (Annette Brooke) suggested, not everybody is tested, so there are no national statistics. That inhibits the debate.

Herceptin is not yet approved by the European Medicines Evaluation Agency and is not licensed by the National Institute for Health and Clinical Excellence, which is the Minister's particular responsibility. We shall be very interested to hear what she has to say about that.

Until recently, few primary care trusts would prescribe Herceptin; they were waiting for formal approval, as is understandable and correct. However, the drug is now prescribed widely, off-licence, in other countries such as France. Waiting for a drug as well proved and mature as Herceptin to be licensed is not as essential, I understand, as it might appear to the layperson.

Dr. Ian Gibson (Norwich, North) (Lab): As my hon. Friend will know, in the early stages, the drug is directed against a certain characteristic of the cells that express the HER2 receptor. That receptor is present in both late and early stages, so there is no scientific or medical reason why the drug should not be used at both stages. What is the point of NICE in all this? If NICE is
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examining the issue and giving out a message, what is happening between it and the PCTs? What is the point of NICE?

Mark Fisher : It is not for me to say; I suspect that the Minister will have a clear view on that. However, my hon. Friend makes a good point; given his medical and scientific expertise, I think that he will be listened to carefully.

The drug is not yet approved by NICE. As a result, until quite recently, few PCTs were anxious to prescribe it; they wanted to wait and see. Roche has not yet applied for a licence. I spoke to people from Roche yesterday and I asked what the delay was. They said, "Licence applications are very difficult. This one will probably have 3,000 pages of text and analysis. We have not finished it, but we hope to do so and apply for a licence in February. It should not take very long then." Nevertheless, Roche emphasised that we do not have to wait for the licence. Oncologists want to prescribe the drug and they feel safe about doing so. It is being prescribed in other countries, such as France and Canada. I do not think that that necessarily is a full explanation about why it is not being prescribed in this country.

The drug is undoubtedly expensive; it costs £21,000 for a year's treatment. However, the Secretary of State told the Select Committee on 27 October that cost is not an issue. Perhaps it is not an issue for her—it is rather encouraging to hear that she believes that this should be paid for—but it is one for many PCTs that are millions of pounds in debt. It is not a satisfactory solution for the Secretary of State simply to say to PCTs that are £10 million or £15 million in debt, "Cost is no problem, go on and do it." It is not satisfactory that women in those PCTs should be penalised for whatever the financial problems of those PCTs are.

The drug has terrific cost benefits. If a diagnosis is made in the early stages of breast cancer, it can be cured and the direct saving of cost to the NHS is enormous. If, as now, it is prescribed only at a late stage, the cost of the treatment through Herceptin and the chemotherapy associated with it will be considerable for a number of   years. It is in everybody's interest—the patient's, the   PCT's, the Government's and the national health service's—that it is prescribed at an early stage, when it can save lives rather than simply prolong them.

Those cost benefits do not take into account the indirect cost benefits to the state. If these women die, the costs of the people who are dependent on them—young children and dependent parents—will fall considerably on the state. The knock-on costs of not prescribing the drug at an early stage are considerable. As we do not know how many people in the country are suitable to have the drug, we cannot calculate those costs. That is yet another reason for getting on with the testing.

Where are we with this issue? Women with money and access to the finances receive the drug. Women in Cornwall, Devon, Dorset and now Leeds are receiving it; I gather there was also a case in the Wyre valley last week. It is more widely available in the south of England than in the north. In the midlands, it is hardly available at all. Why is there yet another postcode lottery, when postcode lotteries in health have been so discredited and reviled? I cannot understand it, and it is not acceptable.
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I understand the difficult position that the Minister is in and the fact that she, as all Members of this House do, cares very much about the fate of these women. However, there are things that it is right that we ask her and the Government to do. First, we must make testing generally available now, so that we know how many people can be helped by this drug. Secondly, we must give clear guidance to the PCTs now. It is not enough simply to give encouragement to them. They need to know that the Government are behind them and will back them up financially. This is not a local decision and should not be left as such.

Will the Minister take the issue back to the Secretary of State, so that she can reconsider her decision that this is a local decision? It is not a local decision. Discussions should be entered into with Roche. That £21,000 might, in some ways, be a negotiable figure, particularly if the drug is widely prescribed and therefore the unit costs ought, logically, to come down—although once £900 million has been invested, that will take some time. Also, amazingly, Roche's patent expires in 2011, so it does not have much time to recoup its costs. Nevertheless, with the Secretary of State's influence and strong position, it would be helpful if she entered into discussions with Roche.

Finally, the Secretary of State really must enter into discussions with the Chancellor of the Exchequer and the Treasury now. More money is going to be needed for this. In Government terms, it is not a huge sum of money, but it is more money than the primary care trusts can find. There has to be some additional funding from the Treasury to recognise the potential of this drug. Those are not unreasonable requests and they make good sense.

Dr. Gibson : Does my hon. Friend realise that there may be another 100 cancer drugs in the pipeline over the next five years, so we had better get this one right before we address the others?

Mark Fisher : Yes, but I suspect that my hon. Friend understands more than me how particularly effective this drug is and how startling, compared with other drugs, the percentage of cure is. Of course, he is right. This is not the only drug now; it is not the only drug in the future. But it is one that we believe, and The New England Medical Journal believes, can save a great many lives. It is a matter of life and death.

Where women live should not determine whether they get this drug. On behalf of those women, I say to the Secretary of State, let them live. Let them have this drug. Let them be tested. Let its availability not be dependent on where they live or how much money they have, but on the national health service, which has served this country well. I beg the Secretary of State not to turn her back on these women. The Government must act on testing, on guidance and on finance. If these women are to be saved, they must act now.

9.52 am

Mr. James Gray (North Wiltshire) (Con): May I first congratulate you, Mr. Bercow, on your elevation to the Speaker's Panel? However, seeing a member of one's own intake in your elevated position does age one a little. My congratulations are therefore a bit half-hearted in that
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sense. May I also congratulate the hon. Member for Stoke-on-Trent, Central (Mark Fisher) on initiating this extremely important debate?

I have a small personal interest to declare, albeit not a financial interest as far as I am aware at this stage. Right in the middle of the general election campaign, horrifyingly enough, my wife was diagnosed with breast cancer. I remember going to see the surgeon who said, "Oh yes, I've arranged a date for surgery. It will be 5 May." Sarah and I had to explain why that would not be appropriate. She is now in the middle of her chemotherapy.

I understand that Herceptin is not suitable for women who are in the middle of chemotherapy. Therefore, I presume that it would not be suitable for Sarah. But the interesting point is that as far as I am aware—I have not checked her notes—she was not tested for HER2 and she certainly was not offered the opportunity of having Herceptin. Although it would not now be appropriate for her to have it, I would be interested to know whether it would have changed the course of her treatment, which is a tough business by any standards, as many here will know.

I was very impressed when I attended the Breakthrough Breast Cancer lobby last Tuesday. What a well organised lobby it was. We are all subjected to all kinds of lobbies from all kinds of different interest groups. Breakthrough Breast Cancer organised a superb lobby and told us all precisely what to do. One thing it told us to do was to get in touch with our local primary care trust and discover whether Herceptin would be prescribed automatically and whether testing was done. Being an efficient bunny I did exactly that. I   wrote to my PCT and I got the reply this morning. I   wrote simply asking whether North Wiltshire and Kennet primary care trust would prescribe Herceptin.

I spent six years at university so I pride myself in not being too dim, but I shall read out the reply carefully. It states:

whatever that might be—

I have read that about six times and the meaning is just dimly beginning to come through to me. At the moment, the Government say that hospitals can make up their own minds on the subject—the PCT does not have to   decide—but that they will none the less take full account of emerging national guidance over the next few months. Frankly, if I sent that letter to a constituent, particularly one who had recently been diagnosed with breast cancer, and said, "Here is what the local NHS has to say on Herceptin", it would make the situation a great deal worse than it is at the moment.

One thing that we must do—perhaps it will be an outcome of the debate—is to clarify to the many thousands of women being diagnosed year by year with breast cancer what Herceptin is for and whether they
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will be automatically tested for it. The question of testing is extremely important. I think that only 35 per cent. of PCTs test for HER2. Such testing should be universal. Will women be tested for it; will they be suitable for Herceptin? If they are suitable, will their local PCT or the local hospital deal with the issue?

Frankly, the architecture of the health service is an academic matter. It may interest the Minister and others in this Room, but my constituents who have been diagnosed today with breast cancer do not care whether it is the PCT, the Avon, Gloucestershire and Wiltshire strategic health authority, the national health service in London or the Bath Royal United hospital that deals with the issue. My constituents want to know whether Herceptin will work for them and whether Her Majesty's Government, or the national health service, will pay for it. Those are the important things. Sending out confusing letters is not helpful. Some of the language that we have heard is exactly what the national health service should not be using. It is national; it is the health service. Her Majesty's Government are responsible for it because it uses taxpayers' money. We want to know from the Government whether they will make automatic testing for Herceptin available and whether the drug will be available more generally than it is at the moment.

Incidentally, I accept the point made by the hon. Member for Norwich, North (Dr. Gibson). He is absolutely right to say that many more breakthrough drugs for all kinds of cancer will come along in the next few years as science develops rapidly, so getting the protocol right for this breakthrough drug now is desperately important for the future.

Many other hon. Members want to take part in this very important debate, so I shall conclude with a relevant issue that is a particular hobby-horse of mine.   We welcome the establishment of NICE. It is perfectly reasonable and sensible that there should be a Government organisation set up to examine the efficaciousness of drugs. Some drugs work for some people and some drugs do not. It is absolutely right that the Government should examine which are which. However, the word that we do not like in the task given to NICE is "cost-effective". NICE should determine whether drugs are effective—whether they work. NICE should determine whether Herceptin would have been appropriate in my wife's case. That should be a clear and straightforward matter. It should then say to the Government and to the national health service whether the drug is good, bad or indifferent.

Of course, the situation may be much more complicated than that. NICE might say that the drug is good in some cases, but not in others. However, it should not have to say, "This is a good drug. It works, but we are not certain that the Government can afford it." The affordability of drugs should be a matter for the Government—for politicians. It should be up to the Minister of State, Department of Health, the right hon. Member for Liverpool, Wavertree (Jane Kennedy), to stand up this morning and say—this may well not be the case—"NICE has said that this is a brilliant drug. It works. However, I am awfully sorry but my right hon. Friend the Chancellor of the Exchequer has said that he is spending the money this year on schools, so the money will not be available for Herceptin." That would be a perfectly legitimate political decision to take—a tough
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decision, but perfectly legitimate. To shuffle off the decision about whether the drug is cost-effective to an   anonymous organisation called NICE, which few people know, seems to me to be less acceptable. The Government should come to a conclusion as to whether the drug is cost-effective as well as effective; that should not be left to NICE.

We need greater clarity. My local PCT, like many others, is massively in debt—to the tune of millions of pounds. Is the decision up to the PCT? In that case, I fear that the nice people who run my local PCT will have to say, "Well, I'm awfully sorry, but I'm going to be faced with a choice between closing two or three community hospitals"—there is a debate in this Chamber tomorrow on community hospitals—"and making Herceptin available." That should not be a decision that it takes. It should not be a decision that the Bath Royal United hospital takes, because it is deeply in debt. That decision should be taken by the NHS; it is a national health service, and if this drug works, it must be available to all.

I hope that the Minister echoes some of the remarks that the Secretary of State made at the Breakthrough Breast Cancer lobby meeting last Tuesday. She made encouraging comments on this matter at that meeting. The Government agree with me about what is the right direction, so I do not want to press them unduly. However, I hope that the Minister will acknowledge that the drug works, that testing is essential and should be universal rather than done on a postcode basis, and that it should be the Government who decide whether it is affordable. If it is, I would also like her to explain the mechanism by which it will be paid for.

I congratulate the hon. Member for Stoke-on-Trent, Central on asking the right questions so well. He is right: we need to know from the Government today—as do the tens of millions of women throughout Britain who have a keen personal interest in this subject—whether the drug will be made available, on what basis it will be made available and who will pay for it.

10.1 am

Joan Walley (Stoke-on-Trent, North) (Lab): May I start by saying what a pleasure it is to debate this subject under your chairmanship, Mr. Bercow? If, as a result of this debate secured by my hon. Friend the Member for Stoke-on-Trent, Central (Mark Fisher), we end up with a Government position that allows us to deal with Herceptin within the NICE bureaucracy so that we have a way forward on this issue, we will have performed a good service.

I congratulate my hon. Friend. We and other Members of Parliament from north Staffordshire met our constituents in the summer, and it is clear that we are totally behind them in their campaign, from north Staffordshire, to make Herceptin available throughout the country. I hope that this debate will lead to a better engagement with the Secretary of State and Ministers. There are still many unanswered questions and issues that urgently need to be resolved.

Over the weekend, there was much press speculation and discussion about a conference in Birmingham that was attended by more than 1,000 people. As I tuned into   various media shows, I heard how much the Government wanted to listen to people—wanted to
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listen to those 1,000 people about the way forward for the health service. I say to my right hon. Friend the Minister that 37,000 people in north Staffordshire have signed a petition; they simply want the Government and the Secretary of State to listen to what they are saying about Herceptin.

It is important to set out, as the contribution of my hon. Friend the Member for Stoke-on-Trent, Central did, the real issues that we are dealing with. We are dealing with the long term and the short term in respect of the way in which the NHS is able to provide care across the country.

I have followed this matter carefully since we first had meetings with our constituents in the early summer months, and I think that the Government have made a lot of progress, and I commend them on that. In particular, it is good that the Government have now said that there will be testing throughout the country. I assume that that means that they have conceded that it is almost certain that NICE will approve the licensing once the drug has gone through its submission from Roche to the European licensing structure and then on to NICE. As we are to have national testing, I also assume that the necessary machinery will be put in place, and that finance will subsequently be put in place, and that guidance will follow in order to ensure that anyone diagnosed now will have that testing.

Those bureaucratic hurdles must be overcome, and other hurdles that are not bureaucratic must also be overcome. I genuinely believe that we need to have a proper licensing structure. I assume that when they have been overcome and everything is in place, there will not be any problem in the long term with people being able to access Herceptin as a NICE treatment, as the Government are starting to put those particular bits of the machinery in place. I welcome the decision about testing.

I also welcome the statement that the Health Minister in the other place made on 19 October. He said that a review of how the NHS pays for expensive treatments and expensive drugs would be undertaken. I gather that that review will be completed in December. I hope that the debate on the non-availability of Herceptin will be able to contribute to that review.

When I raised the issue at Prime Minister's questions almost a fortnight ago, I felt that I received a sympathetic response from the Prime Minister. He acknowledged that NICE's drug-approval system is not   working quickly enough, not only in approving Herceptin but, as my hon. Friend the Member for Norwich, North (Dr. Gibson) pointed out, the other new cancer treatments that are about to be introduced as a result of technological advances. The Prime Minister's response suggested that we must do more, more speedily; however, we must to do it effectively, too.

In response to the intervention from my hon. Friend the Member for North-West Leicestershire (David Taylor), there is no way that we want to be in a situation in which we say that drugs that will cause other serious medical illnesses should be prescribed. I accept that the Government are looking to do more, which I welcome and on which I congratulate them.

When it comes to the short-time issue, however, I feel   angry. The Government are almost hiding behind bureaucracy and the machinery that is in place. As my
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hon. Friend the Member for Stoke-on-Trent, Central pointed out, we have a system whereby tests have been ongoing for five years with the manufacturers Roche. We now know that 50 per cent. of the women who have tested for HER2 positive status could benefit, and they are now having that treatment. A huge sense of injustice and unfairness is building because treatment is being considered on a case-by-case basis. I could understand that if case by case meant that the consultant clinician said, "You have tested positive for HER2; therefore Herceptin can make a real difference to your treatment. The primary care trusts will decide whether to agree that treatment in exceptional cases." However, each primary care trust has to reinvent the wheel while NICE assesses whether to approve the treatment. That cannot be right. Why, for example, should the North Stoke primary care trust have to fund research into whether the outcome of the New England review will be as cost-effective as we have been led to believe in order for it to be able to prescribe Herceptin subject to conditions?

We have NICE, yet every primary care trust in the country is seeking to establish that it will prescribe the drug cost-effectively for the small group of women who are now known to be HER2 positive and who need the treatment now. Those women cannot wait to be treated, yet the NHS is denying them the treatment because the Government are hiding behind NICE.

Following meetings that I—along with colleagues in north Staffordshire—have had with the women who are waiting to be treated, I have asked for a meeting with the Secretary of State, although I have not yet been given one. I hope that when the Minister responds, she will look carefully at agreeing to a meeting with the north Staffordshire MPs to see how we can deal with the situation in the interim.

It is too late for some women in north Staffordshire to be tested. Had they been involved in the tests, they would have had Herceptin. Had they been in the control group, they would still have had access to Herceptin. However, their cancer is at too early a stage for NICE. About 1,000 women are affected by that. That is where the nub of the debate lies: what do we do about those 1,000 women around the country, of whom there are about 14 affected in north Staffordshire? Budgets have been set for this year that have been unable to account for unanticipated expenditure should treatment be agreed on a case-by-case basis. The money is not there because the primary care trusts are so much in deficit. The Government must deal with that issue, but they have not done so. They have put all the long-term measures in place, but they have not faced the reality that about 1,000 women known to be HER2 positive will simply not get the treatment because the primary care trusts cannot agree it. That is a question of money. It is important in the long term that this discussion should open a wider debate on NHS funding. We talk about taxes, but I do not think that we should be in the position where we say that we will pay less tax. Everyone whom I meet says, "Joan, we want these women to get this treatment if they need it, and if it has been recommended."

We must hold the debate on how we fund the NHS and ensure the availability of stunning treatments such as Herceptin, which is 50 per cent. effective in cases for
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which it is available. For that reason, I support my hon. Friend the Member for Stoke-on-Trent, Central. I    ask the Minister to hold a meeting with north Staffordshire MPs. Our primary care trust is asking whether the Government will give them a bridging loan, as this is a matter of short-term finance between now and the next financial year.

10.11 am

Dr. Richard Taylor (Wyre Forest) (Ind): I join in congratulating the hon. Member for Stoke-on-Trent, Central (Mark Fisher) on securing the debate. I hope that we will make the Minister aware that we must have a more satisfactory plan. I welcome the prospective affordability and availability of Herceptin, but I wish to explore the other side of the question so that we can find a way forward.

This week's Health Service Journal editorial states:

The Secretary of State's knee-jerk reaction to an emotive appeal in the press does not take account of many of the problems that are associated with Herceptin. One cannot simply take a pill. An injection has to be given. Full back-up and resuscitation facilities are required because there can be acute reactions to it. There must be tests for safety because cardiac side-effects must be taken into account. Therefore, it is not just a matter of money; there are other matters to consider. Within my PCT area, about 10 ladies could benefit from the treatment. One has been approved, but I spoke to the director of public health yesterday, and the facilities for giving the treatment are not in place, even if the money is there to fund it. That is a major problem.

How should it have been done? First, we should not have waited for a patient to raise the matter. In a way, I blame my profession. It was well known from The New England Journal of Medicine and from the conference that the treatment was a major breakthrough. Ideally—I do not know that this did not happen—oncologists should have gone to the cancer tsar. The cancer tsar should have gone to the Secretary of State, who should have gone to NICE. A committee of oncologists should have been urgently convened to make an interim appraisal. If one looks back to the Health Committee report on NICE, which was published as long ago as 2002, we stated:

Surely, therefore, a rapid assessment by a committee of oncologists to give an interim appraisal would not be beyond possibility.

Dr. Gibson : Is not the licensing of the drug another aspect of the process? The pharmaceutical company raises in its defence the fact that it did not get the licence. How does that relate to what the hon. Gentleman mentioned about NICE? Without the licence, can one proceed?
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Dr. Taylor : I thank the hon. Member. We are getting confused between licensing and NICE guidance, which are entirely separate matters. However, my understanding is that a doctor can use an unlicensed drug under his responsibility, but he may not be covered if something goes desperately wrong. I can understand the company's dragging its heels. Think of the trouble the makers of Vioxx and of Celebrex have got into. There could be tremendous troubles ahead for this drug. It is entirely different when one is talking about a drug for cancer, for stomach ulcers or for arthritis, but there is a huge problem.

The Minister of State, Department of Health (Jane Kennedy) : On the rapidity of the response, does the hon. Gentleman accept that the article in The New England Journal of Medicine was only published on 20 October 2005? Does he accept that discussions had been taking place with the cancer tsar, with my colleagues in Government and with oncologists about the speed with which we were getting new cancer drugs to patients who were identified as being able to benefit from them? I hope that the hon. Gentleman will accept that response to his point.

Dr. Taylor : I said that I did not know if that had happened. I am delighted to hear that it has, as it appeared that it was all due to the lady who went to the press. As to the future, ideally, NICE must be set up to respond very quickly in every such case if it is possible.

Recommendation 26 of the Health Committee inquiry this year on the pharmaceutical industry stated:

The Government stated in response:

That is rather kicking the whole thing into touch.

What is NICE's work load? I tabled a parliamentary question to try to find out the number of cancer and non-cancer drugs waiting for appraisal. Cancer Research UK says that it is waiting for 13 appraisals on cancer drugs, of which 11 are being delayed, nine as a direct result of NICE having been given extra jobs to undertake without being given money. It has made proposals to the Department of Health about how to speed up the appraisal process and I hope that the Minister may tell us something about the Government's response to those proposals.

Other hon. Members mentioned the possibility of other drugs becoming available. There is an exact parallel. A drug called Eloxatin has NICE guidelines for use in a specific group of patients with bowel cancer, rather as Herceptin has guidelines for use in a specific group. Now there is evidence to suggest that it is the most effective treatment advance for early colon cancer after surgery for 15 years. Up to 8,000 patients a year could need it. We must get the mechanism right now, so that when that and other drugs that are in the pipeline come along we do not have to wait for people to go to the press to get their drugs.
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I want to mention another difficult problem of rationing. Orphan drugs, which are for very rare illnesses, are protected. They have a specific pot of money for their prescription. Is that right? Two articles in the British Medical Journal this week question whether it is. It brings one back to the question of health care rationing which has absolutely got to take place. I shall quote briefly from an article by McCabe, Claxton and Tsuchiya in the British Medical Journal this week:

Funding and priorities are the huge issue. In the Health Committee report on NICE in 2002, when we   suggested that the Government were not giving sufficient funding for NICE guidelines, the Government response was:

Many primary care trusts are in deficit. I would like the Minister to talk about affordability, as other hon. Members have requested. However, if one other thing can come out of the debate, there is a need for a rational open debate on health care rationing across the NHS.

Several hon. Members rose—

John Bercow (in the Chair): Order. I intend to call the first Member to make a winding-up speech at 10.30 am. Two Members are still seeking to catch my eye. I hope that the next Member who has the Floor will tailor his or her contribution accordingly.

10.21 am

Charlotte Atkins (Staffordshire, Moorlands) (Lab): I congratulate my hon. Friend the Member for Stoke-on-Trent, Central (Mark Fisher) on securing this vital debate, which is particularly vital for those of us in North Staffordshire. Herceptin has become the cope for countless women with breast cancer. It seems to be a remarkable drug. I was delighted to hear that the Secretary of State for Health has cleared the way for its use by women who have early onset of aggressive breast cancer long before the drug is likely to be licensed.

The Secretary of State rightly said that local health trusts must not refuse to fund the drug solely on the ground of costs. In North Staffordshire, the PCTs have large deficits—in my constituency, there is a cumulative deficit of £5 million—so it is easier said than done for the financial aspect to be taken on board. Such heart-rending cases will go to the PCT complex case panels and the decisions will have to be made largely by non-specialists—lay people, supported or not supported by experts.

Effectively, on Herceptin, the primary care trusts are going to be taking over the role of NICE, but they will be doing it in a highly-charged emotive atmosphere, because they will be dealing not only with theories and medical views but with real women whose lives literally are in the balance. It does not seem the right way forward in the present situation to put such pressure on
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PCTs and on lay non-executive directors, who will have to balance their decisions against the services that they know they will have to withdraw from other deserving patients just to fund this drug.

Time is on no one's side. One constituent, a young woman whose name I cannot reveal because she works for the NHS and does not want any publicity, needs the drug as soon as possible if she is to survive. I have referred her case to my local PCT, which will decide on her individual circumstances, but even at an overall cost of £40,000 for a year's treatment, which includes the cost of administering the drug, Herceptin could be in the long term a saviour for PCTs in terms of finance. The chances are that, if a patient has Herceptin early enough, the breast cancer from which the patient is suffering will be eradicated after a year.

The trouble is that PCT budgets do not work in that way. The trusts cannot say, "Well, we will invest this money now to save it over the next five or six years". Each PCT has to stay within its budget year on year. The cost of an expensive drug such as Herceptin cannot be spread over those years, although, clearly, it could reduce the risk of that disease coming back in women with early stage HER2 positive cancer by nearly 50 per cent. That will provide a huge saving not just to the PCT but in social security benefits if families are not deprived of women's help and care.

I suggested to the Secretary of State last Thursday when she appeared in front of the Health Committee that such cases should be funded in the short term not by the PCTs but by the NHS bank. This is an immediate problem that we must overcome. Clearly, we do not want to go back to the bad old days of postcode lotteries. These women are fighting for their lives and for the future lives and happiness of their families. Money should not be part of that equation, yet Herceptin's heavy price tag has an impact, particularly as Roche needs to recoup its £900 million expenses over just six years. Private companies need to make those profits, but they are incredibly high. I want the NHS to take a longer-term view over the next 20 to 25 years, by when the cost of Herceptin will have come down. The NHS should fund the drug over 25 years and reimburse PCTs accordingly.

10.26 am

Mr. Owen Paterson (North Shropshire) (Con): I congratulate you on your chairmanship, Mr. Bercow. You make me feel old, but it is as great a pleasure to see you as trick or treat follows on from Halloween.

I congratulate the hon. Member for Stoke-on-Trent, Central (Mark Fisher) on securing this debate. I am acutely aware that I do not have the personal experience so eloquently demonstrated by my hon. Friend the Member for North Wiltshire (Mr. Gray) or the hon. Ladies who have spoken.

I am here because of a very moving letter, which I received two weeks ago from a well liked, respectable family. It says:

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On that basis, I tabled about 30 questions and I would be grateful if the Minister sped up the replies. The drift   of the letter was that some drugs were already licensed in Scotland. Taxotere, for example, has already been licensed by the Scottish Medicines Consortium. Apparently, a drug called Arimidex will get its licence a year ahead of the rest of the UK.

When I got into it, I discovered that the regulatory system is even more complicated. It is not just a question of an agency in Scotland giving a yes while a slow agency in England gives a no. There appear to be four agencies, and I would be grateful if the Minister explained exactly what the process is if a company with a world-wide reputation such as Roche produces a drug that it believes works. First, we have the European Agency for the Evaluation of Medicinal Products and, apparently, a consultation process to speed that up is going on. Can the Minister clarify that?

Secondly, we have the EU Committee for Medicinal Products for Human Use, which, as I understand it, has to give formal marketing approval before a drug can be considered in this country. We then have the National Institute for Health and Clinical Excellence. In an incredible answer to my parliamentary question, the Minister said:

In that case, what is it for? Finally, we have the drugs tsar, about whom I knew nothing until this morning.

The Secretary of State has told us that cost is not an issue. I went to my PCT 10 days ago and it said that if Herceptin were prescribed across Shropshire it would cost £1 million a year. My hon. Friend for North Wiltshire put the point well. We need clarity. It is a matter of life or death, as the hon. Member for Stoke-on-Trent, Central said. Should the priority be primary care centres, community hospitals or Herceptin? It is extremely difficult for the PCTs. As the hon. Member for Stoke-on-Trent, North (Joan Walley) said, the procedure is not clear.

In my remaining minute, I ask the Minister to clarify the procedure if a drug appears to work. Hundreds of thousands of women are watching this debate. They want to know what the process is and what the Government are doing to speed it up. What is the form on money should such drugs come through? As the hon. Member for Norwich, North (Dr. Gibson), who has left his seat, said, Herceptin is not the only one. We will have a raft of new drugs coming through that will probably be extremely effective, but might also be extremely expensive.

10.30 am

Sandra Gidley (Romsey) (LD): I, too, congratulate you on your new role, Mr. Bercow. I also congratulate the hon. Member for Stoke-on-Trent, Central (Mark Fisher) on having initiated the debate. It is very timely, and somewhat emotive. Everybody who has spoken is keen to see women quickly identified and treated. The question of the prescribing of Herceptin raises wider issues on the health economy, and I want to pursue those.
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I do not want anybody to think that I have anything against Herceptin, but I would like to paint a context for it. Herceptin was the first monoclonal antibody drug licensed in the United Kingdom, initially to treat women with secondary breast cancer. It was approved for that by the National Institute for Health and Clinical Excellence in 2002 because trials had shown that it increased the survival rate of women with secondary cancer from 22 per cent. to 33 per cent. Not all breast cancers are helped by Herceptin. Only those that test positive for HER2 benefit, and they are often the most aggressive cancers. I shall return to that point later, because it is important in the context of testing and when women will be allowed access to the drugs.

Every year, in Britain breast cancer is diagnosed in 35,000 women, of whom 20,000 are suitable for HER2 testing and 5,000 may benefit from Herceptin. There has long been speculation about whether we should give the drug earlier, because it might have long-term benefits. That is no longer speculation, because The   New England Journal of Medicine very recently published a remarkable paper showing that the risk of the recurrence of breast cancer could be cut by almost half. Having worked as a pharmacist in a previous life, I know about being bombarded by drug companies claiming all sorts of benefits. However, the cure rate of Herceptin is exceptional. That is probably why there has been so much excitement about the potential of the treatment—in many ways, it is justified.

I share the feeling that it is a shame that it took an individual, Barbara Clark, to highlight the issue by threatening to take Somerset primary care trust to the European Court of Human Rights. Although I am delighted that Barbara will receive the treatment, we are talking about real lives, and thousands of women still have their own battles to face. I hope that recent announcements have not raised their hopes too much.

Let me make a few more points. First, the drug is not yet licensed for use. The licensing process usually balances the efficiency of a drug against its side effects. Roche must be kicking itself for not being further ahead   in the process. However, as has been said, that process is cumbersome, requiring a huge amount of documentation. When we consider the people who have suffered the side effects of drugs that have not been identified properly, we realise that that balance must be struck. Secondly, the drug has not been to NICE. Neither of those things would in itself preclude the prescription of the drug by a consultant. However, in this litigious society, many are rightly wary of prescribing a drug for an indication for which it has not received a licence.

It was all too easy in the past, as the Select Committee report highlighted, for primary care trusts to hide behind the fact that NICE was still appraising the technology and to say that they would not provide funding until the results were known. That was a process commonly known as "NICE blight". Yet that was also rubbish, for if the primary care trusts had wanted to, they could have funded those drugs. Indeed, on occasions, some decided to do so.

The odd thing in this was when the Secretary of State made a superficial and bizarre announcement that was still wholly welcome. The wholly welcome bit was the fast-tracking of Herceptin. We should have a determination on that by July 2006. However, the
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current record of NICE does not bear close scrutiny, since many appraisals have overrun. The bit that I found rather strange was to say that women should be able to have HER2 testing straight away. I return to my point about these often being the most vigorous and aggressive cancers. If the drug is not to be licensed until next year and NICE is not determining next year, what is the point of testing a woman only to make her then jump through endless hoops—her cancer growing all the time—while the primary care trust makes a decision? I find it morally almost indefensible that we are saying 'Yes, we will test you, but you will then have to fight a battle for the drug'.

Mr. Gray : Is the hon. Lady seriously suggesting that there could be a scientific method of knowing whether a particular woman is suitable for Herceptin but, because of the bureaucratic problems that she has described, that testing should not in itself take place?

Sandra Gidley : I am saying the bizarre bit is that we are testing women, but are then unable to treat them. We would be making women jump through all these hoops.

Despite the assurances of the Secretary of State that primary care trusts should fund this drug, the point already brought out here by hon. Members is that most are cash-strapped, and will have to make many difficult decisions about where priorities lie. That could be raising false hopes, rather than being an absolute solution.

The fact is that only around one-third of women are now tested, which is completely wrong. If we are not robust in saying that we shall give the treatment, we must question the point in letting somebody know what is wrong and just raising uncertainty. Women may be able to fund the treatment themselves, but the battles will be there. The bottom line is that some women who would be tested may not receive the drug, and will actually die. That is the point I was hoping to stress. Anything that can be done to secure funding will be wholly welcome.

I have mentioned the capacity of testing, but I also want to ask the Minister what estimate there has been of the cost, the infrastructure and the manpower needed to ensure that the system is up and running fully—and as soon as possible. Will she look into why, in some areas, the PCTs that have the lowest funding per capita—because they are regarded as being in healthier parts of the country—actually have high rates of breast cancer? Will she commit to looking into whether there is some reverse inequality happening in areas with generally high health levels yet a high incidence of breast cancer?

The total cost of funding Herceptin has been identified as £60 million. An important point is that, in 1998, the total chemotherapy budget was £60 million. Clearly, as a Parliament and a country, we need a robust debate about funding these drugs. I am in no doubt that the long-term benefits make that investment worth while. Yet the short-term problems facing PCTs that have already been pointed out mean that perverse decisions are sometimes made.

There are wider issues around NICE. It should, perhaps, be allowed to give interim approval in such cases, as in Scotland, to help to avoid the delays in the
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system that have just been challenged. If we could go down that route, women might not have to wait if they tested positive. On behalf of the women who will benefit, I am delighted that the Secretary of State has created this somewhat uncomfortable precedent. However, by stating that she wanted to see widespread use and the licence granted as quickly as possible, she has called into question the role of the licensing authority and the role of NICE. Those bodies were initially—

John Bercow (in the Chair): Order. I am sure that the hon. Lady is bringing her remarks to a close.

Sandra Gidley : Yes. Those bodies were initially set up to make the professional decisions—to take them out of the political arena.

There are 23 drugs in the system for cancer: some are still in a queue for consideration at the Department of Health, and the process needs speeding up. Licensing and NICE need to be streamlined without compromising patient safety. Most importantly, we need to have an answer to the question of where the funding will come from.

10.40 am

Mr. John Baron (Billericay) (Con): May I add my congratulations to you, Mr. Bercow, on your elevation to the Speaker's Panel?

I shall start by congratulating the hon. Member for Stoke-on-Trent, Central (Mark Fisher) on securing this timely debate, and other hon. Members on their heartfelt contributions. We all have families in our constituencies to whom this issue matters a great deal. The debate has raised a number of serious questions that the Government need to answer.

It has long been apparent that the postcode lottery in cancer health care is not a scare story put about by the media, but a reality that must be addressed. Last year, the cancer tsar, Mike Richards, confirmed that fact by denouncing the unacceptably high variations in cancer treatments. A survey by CancerBACUP published in 2003 measured the extent to which a postcode lottery existed for the drug Herceptin, despite the drug's undoubted merits and efficacy. Some 61 per cent. of women in the south-west had access to the drug, compared to a shameful 14 per cent. in the midlands. Those figures were updated recently by a study cited in Clinical Oncology, which last year confirmed the extent of the postcode lottery when it came to Herceptin. It showed that 16 per cent. of eligible women in Essex were prescribed the drug, compared with some 90 per cent. in Dorset.

Why does that postcode lottery exist? Part of the reason is that although primary care trusts no doubt want to prescribe Herceptin and many other drugs, they are unable to do so because of the financial deficits that many of them now face. That issue has been raised time and time again by hon. Members in debates such as this. The situation seems to be getting worse rather than   better. We in the Opposition contend that the Government's 300-plus targets have spawned a massive bureaucracy, which has soaked up a lot of the new
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money that has undoubtedly been put into the NHS. That bureaucracy has prevented a lot of that new money reaching front-line services, including drug delivery.

International comparisons are revealing. In the cancer plan 2000, it was claimed that, by 2010, the UK's survival rates in relation to cancer mortality would be comparable with the best in Europe. However, the truth is that the UK remains in the bottom third of the European cancer mortality league table. If the UK matched the European leaders in respect of cancer mortality, as many as 23,000 to 25,000 lives could be saved.

A key reason for our poor survival rates is that Britain lags considerably behind many of our European neighbours when it comes to the uptake of new medicines for the benefit of cancer patients. A very interesting and recent report by the Karolinska institute and the Stockholm school of economics found that, despite the proven benefits of new treatment options, patients across Europe did not have equal access to new drugs. Of the 19 countries surveyed representing something like three quarters of the population of Europe, the UK lagged well behind, in good part because of financial considerations and pressures.

The postcode lottery in Herceptin also exists because of the Government's ambivalence to NICE. NICE should have a crucial role to play in appraising drugs for the benefit of patients, with the minimum of delay. It should be at centre stage in the Government's efforts to allow patients to benefit from the latest technology, treatment and drugs. However, the Government have recently cut NICE funding by £3 million, forcing it to scrap one of its appraisal committees. Does the Minister not agree with me—and with CancerBACUP—that it is unacceptable, with all the extra billions being put into the NHS at the moment, that 23 vital cancer treatments have been subject to long delays before being made available to the NHS? In September, NICE submitted its recommendations for reform of its procedures. Will the Minister publish those recommendations and set a timetable for the Government's response in order to try to eradicate the postcode lottery?

It is equally unacceptable that NICE, which was set up to stamp out postcode lottery inequalities and to ensure that patients have rapid access to the best available treatments, is having its guidance ignored by NHS bodies because of financial pressures. How are the Government going to address that issue?

The Opposition have consistently called for NICE to be given the support that it needs to achieve, primarily, two objectives. The first is that appraisals for new drugs are, where possible, considered with their original licence applications, so that the unacceptable delay between drugs being licensed and being approved by NICE are removed from the system. I welcome the Government's consideration of that. The second objective is that resource implementation assessments—the issue of NICE's funding has been raised by several hon. Members—are conducted alongside NICE appraisals to ensure that NHS bodies implement NICE guidance with the necessary resources.

A third strand of our thinking is that it is wrong that although appraisals have statutory backing, NICE guidelines do not. NICE would be at centre stage in our proposals for the NHS, and guidelines would be given
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statutory force. The targets now set by politicians would be replaced with standards set by medical professionals through NICE. That would ensure that money soaked up by bureaucracy because targets need measuring would be released for the benefit of cancer patients and of drug delivery.

The question of the availability of Herceptin for early-stage breast cancer crystallises a number of issues. The Secretary of State's announcement in the summer about the decision to fast-track NICE's appraisal of Herceptin is to be welcomed, but it is still likely to be many months before Herceptin is widely available for women with early-stage breast cancer. Many women who have already been diagnosed with breast cancer simply do not have time to wait until the licence and approval processes are completed next year. They need Herceptin now. According to Breakthrough Breast Cancer, experts estimate that about 1,000 lives could be saved every year if Herceptin were available to treat early-stage breast cancer. It is possible for women to be prescribed Herceptin prior to its licensing if their PCT agrees to fund it and the patient's doctor retains clinical responsibility.

As we have heard, on 25 October the Secretary of State stated—perhaps because of the Barbara Clark case—that PCTs should not refuse Herceptin solely on the ground of its cost. Two days later, she seemed to go further by suggesting that all PCTs will be directly informed that they are now required to fund and prescribe Herceptin to treat early-stage breast cancer when there is a clinical need to do so. The Secretary of State's intervention is all-important, yet, as we have heard from many hon. Members, it is causing confusion. Will the Minister clarify the situation? Is the Secretary of State obliging PCTs to fund Herceptin when it is prescribed even if that means diverting resources that are already intended for other services? If so, what assessment has been made of the services that will suffer as a result of finances being redirected to achieve that directive?

Will the Minister tell us how many trusts are in a financial position to take up the Secretary of State's instructions? She must be aware that many PCTs have financial deficits. A British Medical Association survey suggests that three out of four PCTs face deficits. As the hon. Member for Stoke-on-Trent, Central said, the Secretary of State cannot hide behind PCTs on this issue. She seems to be placing obligations on PCTs without providing the resources to enable them to meet them. Does the Minister agree that the Secretary of State's comments are an admission that the licensing and appraisal processes are taking far too long? What is the point of NICE if the Secretary of State is just going to bypass it?

Those questions need to be answered because the Secretary of State's intervention has caused confusion. If it is a directive, many PCTs cannot afford it, while the treatment may not be prescribed because it is unlicensed and NICE seems to be left on the sidelines. If, on the other hand, the comments did not amount to an instruction, what were they meant to achieve? The uncharitable view might be that the Secretary of State was simply responding to media pressure, as PCTs already know they are free to fund the drug.
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There has been no shortage of evidence from respected charities in the country, well known bodies and think tanks internationally, and from hon. Members in this debate, that a postcode lottery in cancer drugs exists. The Government are to blame because they have failed to reform the way in which NICE operates and have created a situation in which PCTs are unable to implement its guidance in many areas because of financial pressures. I hope for the sake of the many women who are anxiously waiting for Herceptin to be made available to them that the Minister directly responds to the questions other hon. Members and I have asked today.

10.51 am

The Minister of State, Department of Health (Jane Kennedy) : May I add my voice of congratulation to you, Mr. Bercow? I think that you should have made, and deserved to make, a longer contribution from the Front Benches—albeit the Opposition ones. I will miss you from that point of view, but I look forward to serving under you in debates of this nature. May I also congratulate my hon. Friend the Member for Stoke-on-Trent, Central (Mark Fisher) on giving us the opportunity to debate this issue today?

The hon. Member for North Shropshire (Mr. Paterson) asked me to clarify the procedure. That would take longer than the nine or 10 minutes I have available. So, if he will permit me, I will write to him, not only about the procedure as it stands, but about the thinking that I   am engaged in about how we can streamline the process, not only for drugs but for future treatments. I   will copy that to all hon. Members who have participated in this morning's debate.

Herceptin has received an enormous amount of publicity and I am therefore grateful to be able to clarify the action that we are taking and to respond to some of the issues that have been raised. I intend to address the points about funding and the NICE procedures if I am given the opportunity.

We are committed to ensuring that all breast cancer patients are given the best possible chance of a successful outcome. To achieve that, we streamlined the diagnosis and treatment of breast cancer, so that more than 97 per cent. of women with breast cancer receive their first treatment within one month of it being diagnosed. None   the less, when the hon. Member for Billericay (Mr. Baron) draws attention to the UK's position in the league tables, he is right to point out that there is still more to do. I would not necessarily agree with much else of what he said, but I take on board his questions and I will seek to answer them.

I am grateful for the acknowledgement from my hon. Friends of the steps that we have taken to address this problem. We are committed to ensuring that all breast cancer patients get the best possible treatment and care. Of the estimated 20,000 women who receive adjuvant chemotherapy, 5,000 will be HER2 positive and could therefore benefit from treatment with Herceptin.

Mark Fisher : Will the Minister address the point that not everybody has been tested to see whether they are HER2 positive? That is one of the central issues of this debate.

Jane Kennedy : I absolutely accept the point that my hon. Friend makes and I will come to that, if he will allow me.
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My hon. Friend the Member for Stoke-on-Trent, North (Joan Walley) said that she felt that some people may have missed the opportunity to be tested. I reassure her that people can have the test at any time. The tumour sample is kept and can be tested. However, I acknowledge that the problem is the point at which the treatment begins after the testing.

It is important that we take care not to give the impression that the drug is suitable for all or even most   women with breast cancer. It is also linked to serious cardiac problems, and I know that that was acknowledged by other contributors to the debate. Nevertheless, as has been repeatedly said, the early evidence of effectiveness in women who do fit the category is very strong. That is why we acted in response to that evidence.

To ensure that we can identify all the women who can   benefit from treatment, we have asked professor Professor Mike Richards, the national clinical director for cancer, to ensure that HER2 testing is available across the NHS as soon as possible. He has already met with the directors of the 34 cancer networks and that move has been enthusiastically welcomed by them. The manufacturers of Herceptin have not yet applied for a licence—that point, too, was made. The Government play no part in the licensing process—we cannot intervene—but we have urged the manufacturer to apply for a licence as quickly as possible. However, I   appreciate that the company is taking time to ensure that it gets the details of the licence application right.

A number of hon. Members, including my hon. Friend the Member for Norwich, North (Dr. Gibson), who has left the Chamber, asked why we are bothering with licensing or the NICE process. I urge hon. Members to bear in mind that the number of people with early breast cancer is much larger than those with late-stage cancer, and that the side effects are potentially much more serious when compared to the likely outcome.

That question will be addressed by the licensing process, not the NICE process. However, NICE will consider a complex range of factors, including cost-effectiveness, which is an important consideration when introducing an expensive new treatment. I strongly support the NICE process. I hope within a few days to be able to go into detail about the work that we are doing with NICE. I am considering proposals for a faster technology appraisal process for important new drugs, not only for Herceptin, so that NICE can offer the NHS guidance on their clinical worth and their cost-effectiveness closer to the time of licensing. I am grateful to NICE for that important work.
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The Secretary of State has asked NICE to begin its appraisal of the use of Herceptin for early-stage breast cancer as soon as possible; indeed, that process has begun. As a result, the appraisal of the treatment will run concurrently with the licensing process. If the licence is granted, NICE guidelines can be issued shortly afterwards.

We now come to the nub of the matter. A number of women being treated for early breast cancer could benefit from Herceptin. I accept that. The Minister of State, Department of Health, my hon. Friend the Member for Doncaster, Central (Ms Winterton), met representatives of the women fighting for Herceptin on 22 September. My hon. Friend and I are in close touch, and we will be communicating by way of a NHS circular exactly how we expect PCTs to respond to patients whose clinicians believe that they would benefit from Herceptin.

It has been said many times that the Secretary of State has announced that PCTs should not refuse to fund Herceptin on cost grounds alone. What does that mean? It means that there has to be a medical reason for the medicine not being prescribed. That reason ought to be communicated to the patient and her clinician.

Joan Walley : Is the Minister saying that if there is a medical reason for prescribing it, she would wish PCTs to fund it? If so, she must pay attention to the need for additional funding—or even emergency funding—in this financial year.

Jane Kennedy : My hon. Friend has raised that question before. Indeed, as a result, I began to look at the circumstances that have given rise to genuine anxiety among our friends in Stoke and elsewhere. I want my constituents, too, to be able to gain from the potential benefits of Herceptin. We are continuing to look at the situation.

As for funding, my hon. Friend knows that we have passed to the primary care trusts the resources that used to be held centrally. We have seen big increases going to the primary care trusts as a result. However, if PCTs are having specific cost problems, they need to talk to their strategic health authority. I want to know if primary care trusts are making blanket decisions to refuse funding for Herceptin on the ground of cost alone. I will need to examine the circumstances surrounding such cases.

Mr. Baron : Time is short, but will the Minister assure the House that she will respond to our questions in writing?

Jane Kennedy : Of course, I intend to do that, but only the pressure of time has forced me to reduce my comments to the minimum. I hope to have reassured all those who have participated in the debate—
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