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8 May 2008 : Column 316WH—continued
Last but not least, I want to revisit our old friend, the PPRS, and consider what is happening at the moment. As I have said twice, we did not look at the matter in any great depth. We had one evidence session on the likely outcome of the Government’s reaction to the OFT report. If we had thought that they were going to implement the OFT report, we would probably still be taking evidence now.
As a distraction from the other things that were going on last Thursday, I read this headline in The Daily Telegraph, “Drug makers hit out at new pricing deal”. It has since come to my notice that in March, a letter was sent out to 180 companies, which had participated in the PPRS, officially terminating the present scheme from September 2008. That was not my understanding of the situation when we were taking evidence. I did not know that the PPRS was to be terminated, and I would have accepted its renegotiation. I do not have the Government’s press statement on the issue, but I was very surprised to read that headline. I must say to my right hon. Friend that I recently met the new president of the Association of British Pharmaceutical Industries. I was not prompted by him to bring up the matter; I was prompted by what the retiring president said in the press. We are ripping up the pharmaceutical price regulation scheme, which has stood the test of time—some 50 years now. The scheme has loosely held together the pharmaceutical industry, which is a credit to this country and a great arm of ours when it comes to manufacturing and selling abroad. The Minister will have seen some of the first-class research and development that is done in this small nation of ours—in many areas, it is world class. I was surprised to see that, effectively, the PPRS had ended, and I assume that some sort of voluntary agreement will replace it.
The Minister of State, Department of Health (Dawn Primarolo): I am sorry to interrupt my hon. Friend in mid flow, but I think that it would be helpful if I tell him now that part of the renegotiation of the PPRS also requires a formal notice to be issued that the current one will terminate within a certain period. It is all part and parcel of the renegotiations and how the PPRS works. It is not a separate process.
Mr. Barron: I am grateful to the Minister for that. I know that if someone is given a strong letter that says that their contract ends in six months’ time, one is likely to get them to the table in a more positive manner. I understand what negotiations are like, but the system has survived in this country for half a century now. I do not say that I endorsed everything that the OFT recommended in its report. None the less, the Minister’s words are reassuring. Under those circumstances, six months is not a very long period of time to replace, review or amend an organisation, although I accept that that may be different now. I thank my right hon. Friend for that. I would like to sit down now, but before I do I want to thank the members of the Health Committee who were involved in the evidence sessions and drawing up the report. I suspect that quite a number of them will want to catch your eye this afternoon, Mr. Gale.
2.58 pm
Dr. Richard Taylor (Wyre Forest) (Ind): It is a great privilege to follow our Chairman, who is allowing us to get out some quite strong condemnatory reports—not that this is one of the most condemnatory. It is also a huge privilege to speak second, because the Chairman has left us with a little more to say, and I can get in before all my hon. Friends—and I do call them friends—on the Committee.
The first matter that I want to raise is the use of experts, which the Chairman has already mentioned. We heard criticisms about that from several witnesses from various walks of medical life. The Government’s response was that that should be left to NICE, while NICE’s response was that there should be extensive engagement. Its response to recommendation 11 stated:
“The Committee’s suggestion reflects our current arrangements. We will re-examine our arrangements for providing our advisory bodies with access to appropriate expert advice from individuals unencumbered with actual or potential conflicts of interest.”
I suspect that the difficulty is finding people who are unencumbered in that way.
I shall give two examples that are related to criticisms made by the Committee. There was a rather unkind article in the Journal of the Royal Society of Medicine last October headed “A NICE mess”. It did not actually prove that it was a horrendous mess, but in discussing anti-dementia drugs, it pointed out the fairly limited contribution that expert geriatric psychiatrists were able to make. One of our strongest recommendations was that if NICE could find suitable, unencumbered expert advisers—we as the Health Committee prize and value our expert advisers tremendously—that would be well worth doing.
Secondly, NICE’s guidelines rightly point out that there is no hard evidence that antibiotic prophylaxis is necessary for bacterial endocarditis, but then go a step further and imply that it is no longer worth using antibiotic prophylaxis, the use of which is time-honoured. In a letter in the British Medical Journal this week, some cardiologists have questioned whether NICE has gone a little too far.
Dr. Howard Stoate (Dartford) (Lab): The hon. Gentleman will appreciate that there is a great difference between time-honoured and evidence-based. Just because we doctors have done something for a long time, it does not necessarily make it worth doing.
Dr. Taylor: I thank my friend and medical colleague for that. I absolutely accept that, but things should not be discarded lightly.
The Chairman of the Committee mentioned the speed of decisions. In our recommendations 15 and 16, we toyed with the idea of shorter inquiries or evaluation at launch. The Government’s response was fairly defensive, but NICE’s was rather better. It stated that it was not asked early enough and that it did not have enough capacity. That needs to be looked at. It also stated that the appeals process slowed down decisions.
Dr. Ian Gibson (Norwich, North) (Lab):
The hon. Gentleman talks about the need to get evidence earlier. Is that because it comes from the later stages of treatment?
For example, evidence about cancer drugs comes from metastatic stages, rather than from the earlier stages of detection and prognosis.
Dr. Taylor: That is one of the huge difficulties with drugs. Some of their effects—good and bad—are not discovered until a long time after they have been used by hundreds, if not thousands, of people.
NICE concluded its response to recommendations 15 and 16 by stating its aim to start assessment when a manufacturer requests marketing authorisation. It said that it might then be able to create at least draft proposals within three months of licensing. That is something excellent to aim for.
The Chairman of the Committee mentioned the confusion about the differences between guidance on technology appraisals, which is mandatory, and clinical guidelines and public health guidance, which are advisory. That is a real problem, and it is demonstrated in the Government’s response. Within about four paragraphs, they use the term “clinical guidelines” once and “guidance” eight times. I am still not convinced that they know the difference between technology appraisals and general guidance.
In their response, the Government objected to the word “directive”, stating:
“we believe that re-branding appraisal decisions as ‘directives’ might be taken to imply that they are intended to override clinical decision-making.”
If it is cut and dried that something is far better than anything else, who wants clinical freedom? Doctors do not need it. They do what they are—[Interruption.] Well, I am speaking as a retired doctor, and I am prepared to stand up for that. If something is right, and if it is far better than anything else, it should be used. I would have no objection to the use of the word “directive”, or a slightly softer, kinder word if one could be thought of. Tremendous confusion is caused by calling three things “guidance” when one of them is mandatory.
Sandra Gidley (Romsey) (LD): I am slightly confused by the hon. Gentleman saying that we do not want clinical freedom. I am sure that he agrees that patients come in all shapes and sizes. There is no such thing as the average patient, and there are occasions when a patient is not textbook and there needs to be flexibility. I agree with his general point, but there is a danger that his comment about clinical freedom might be misconstrued. I am trying to help him out.
Dr. Taylor: I am grateful for that helpful comment. I do not want to be misconstrued. I am talking about when it is absolutely cut and dried that one thing is right and others are not. That is when the word “directive” should be used, or another word, if we can think of one.
I echo the Chairman of the Committee’s comment that there could be one mandatory element in some clinical guidelines. He mentioned NICE’s current work on venous thromboembolism. Of the recommendations that have been made on that, the risk assessment should be mandatory for everybody going into hospital.
Disinvestment is an incredibly important part of NICE’s work. We are not going to get any more money coming into the health service, so we want to make absolutely sure that what we have is being used as best it can be. I
was pleased to read about NICE’s recommendation reminders in its optimal practice review, and the fact that it recommends savings in its technology appraisals. That is a hugely important part of its work.
If we cut out inappropriate prescribing, we will make huge savings. The Department of Health made a start on that with its “Better Care, Better Value” indicators, which showed some time ago that just by prescribing generic statins at the right time, the NHS could save £80 million a year, which is amazing. If we can make such savings through appropriate, correct prescribing, we will do the health service a power of good.
On implementation, I was pleased to read about implementation consultants, but slightly disappointed that there are only six of them for the whole of England. The Chairman of the Committee mentioned our trip to Canada, on which we found that NICE’s equivalent there had such people in every part of the country. They were making a huge difference.
Dr. Gibson: Why are there so few in Britain? Is it just not an appetising job?
Dr. Taylor: An advertising job?
Dr. Gibson: Appetising. Well paid.
Dr. Taylor: Oh! I have no information about how much those people get paid. No doubt some of guests in the Public Gallery might tell us afterwards.
I understand that NICE has an implementation directorate and an interactive costing tool. I do not know—perhaps the Minister does—whether that applies just to mandatory technology appraisals, to voluntary guidelines, or both.
Recommendation 27 deals with the better measurement of guidance implementation. At the moment, the Healthcare Commission relies on those involved declaring that they have implemented NICE guidance, and I wonder how the Care Quality Commission will deal with that issue.
I was delighted that our Chairman took the bull by the horns and used the word “rationing”. Some people might remember that I tried some time ago to secure an Adjournment debate about rationing in the NHS, but somebody—I still do not know who—changed the title to prioritisation, so my debate was about that, rather than rationing. We must face up to the issue of rationing. In one of its responses, NICE stressed the importance of disinvestment and of looking at investment and disinvestment opportunities, which really comes down to rationing.
To finish, my one regret about the report is that we shied away from QALYs and incremental cost-effectiveness ratios—we were probably scared of delving into the unfathomable mathematics of calculating them. After we completed our inquiry, I received a piece of paper that had fallen off the back of a lorry, but it confused me even more. It gave figures from the Southampton university health technology assessment for the cost per QALY of three anti-dementia or Alzheimer’s drugs. I can understand why the cost of all three was pretty high—when people are not convinced that a drug works or that it has much benefit, the cost per QALY will be high—but I could not understand why it was so
extraordinarily different for all three. As we have recently learned, the Appeal Court has ruled in favour of the makers of the one of the drugs for Alzheimer’s. I hope that that will bring into the open a little more about how the cost per QALY is worked out, because unless we know that, a little of the transparency that we want, and which NICE is aiming for, will be missing.
3.12 pm
Dr. Howard Stoate (Dartford) (Lab): I shall start by paraphrasing Kryten from the TV series “Red Dwarf”. There are two problems facing every health care system in the world: first, it is impossible to meet every need and, secondly, it is impossible to meet every need. I realise that, technically, that is only one point, but it is such a good one that it is worth making twice. The fact is that no system in the world can ever meet every competing need; indeed, if it did, that would prove that it was failing. One of the drivers of change in the health service is the constant striving for improvement, for better value for money and for better patient care. That automatically implies that one must keep pressing for change and improvement. Always having to look over one’s shoulder to see what one can afford is one of the major drivers in that respect. That sounds a bit harsh, but it is important.
The hon. Member for Wyre Forest (Dr. Taylor) talked about rationing. One reason why I am not happy with the word “rationing” is that rationing is actually very easy, whereas health care apportionment is very difficult. Those in the room who are old enough to remember rationing—that does not include me, of course—will know that it is relatively easy to tell somebody that they can have one egg or one ounce of butter a week or that they can have a British standard loaf every two days—that makes sense. It is easy to do that because the one thing that everybody in the world does that has a cost to society is eat. What makes rationing even simpler is that everyone has broadly the same nutritional needs, so the parameters are quite narrow. It is easy to say, “I have 1,000 kg of rice and 1,000 people, so they can have a kilo each.”
Unfortunately, it does not work that way with health care. Let us imagine that I have 1,000 people in the room and I have six replacement hips, 20 doses of penicillin and 30 doses of Aricept. First, those replacement hips might be completely inappropriate for those 1,000 people because none of them might need a hip replacement; alternatively, by luck, 100 of them might need one. In other words, it is far more difficult to work out who should get what. Furthermore, how do we compare a hip replacement and Aricept to decide which does the greater good? That is an extremely complex and delicate decision.
I agree with those who have said that we need a much wider public debate about how we make such decisions. Such things are not news to society; the concept of distributive justice has been with us for thousands of years, although we have not always called it that. If we talk about distributive justice or competing claims for resources, rather than simply about rationing, that will make it easier for the public to join the debate. They will begin to understand the complexities of how people make some of these extraordinarily difficult decisions about distributing resources.
Mr. David Drew (Stroud) (Lab/Co-op): The Committee’s Chairman referred to this earlier, but I have taken part in two events organised by NICE in the past couple of months to look at public policy and access to health, particularly for disadvantaged groups—in that respect, I owe a lot to my friend Bren McInerney, who is on the participation panel at NICE. NICE is moving in the right direction, and such events change the perception that NICE deals only with decisions about which medicines will get over which hurdles.
Dr. Stoate: My hon. Friend makes the important point that we are moving in the right direction, but we have a long way to go in helping members of the public understand for themselves the difficult decisions that somebody ultimately has to make.
Some health care systems ration by price, and if people cannot afford a health policy, they get pretty awful insurance; other systems ration by exclusion, and still others ration by availability. If people want to use the word “ration”, then I would say that we in this country have always tended to ration by queuing. The health service has traditionally said, “There are this many surgeons and this many beds. Form an orderly queue, and when you get to the top, it’s your turn.” That is certainly a coherent way of doing things; it is just not a very good one. I am pleased that we have now moved away from that and that we have much shorter queues and shorter waiting times.
Dr. Gibson: Would my hon. Friend include orphan drugs and ultra-orphan drugs in the mystique that he mentions, which makes it difficult for the public to understand these things? Most MPs find it difficult to understand the definitions of ultra-orphan and orphan drugs, compared with the classic cancer drugs.
Dr. Stoate: I pay tribute to my hon. Friend, who does a huge amount of work for cancer patients and who has quite an international reputation for standing firm, helping cancer patients through difficult times and helping to make rational decisions. It is difficult for the public to understand what an ultra-orphan drug is. It is also difficult for the Government to deal with them, because they sometimes have such a skewing effect on overall health budgets, particularly in a relatively small health economy. The problem therefore needs special attention, and I pay tribute to my hon. Friend for raising it.
In this country, we have settled on the idea of measuring health benefits and deciding how to distribute resources using the QALY. As everyone knows, the QALY is a cost-utility index that combines the duration and quality of life. In some ways, it can be used as a comparative index. Perfect health is the equivalent to a QALY of 1, death is a QALY of zero and the various health states in the middle can be worked out on a fractional basis. In many cases, therefore, estimates of cost per QALY can be used to devise an indication of the relative value of different treatments and interventions.
That method certainly has the merit of being extensively researched in Europe, north America and Asia, but a number of people have expressed quite a few reservations about the manner in which NICE has used QALYs. For instance, John Harris, the joint editor-in-chief of the Journal of Medical Ethics, argues:
“There are two ways in which QALYS can be used...to determine which of rival therapies to give to a particular patient or which procedure to use to treat a particular condition, in short which of two different treatments is the more cost-effective, better for patients, better for society.... QALYS are also used, however, to determine not which of rival treatments to give to a particular patient or group of patients, but whether or not to offer any treatment at all to some patients, or whether to offer a particular treatment to some patients even when no alternatives are preferred.”
It is that latter approach which Professor Harris understandably objects to on moral grounds, and he exemplifies that by reference to the treatment of patients with Alzheimer’s disease. He claims that
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