Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 880 - 899)

THURSDAY 20 JANUARY 2005

PROFESSOR SIR MICHAEL RAWLINS AND MR ANDREW DILLON CBE

  Q880  Chairman: We have actually had that point made by patients.

  Professor Sir Michael Rawlins: I think they are absolutely right.

  Q881  Chairman: Do you have anything to add to that, Mr Dillon?

  Mr Dillon: Just a thought that those who produce and those who use our technologies have some strong common interests, that ultimately the benefits of what is produced have to go through to patients, but they also have some different interests too. They help to produce health technologies and have a need to make a return on their investment and to keep the businesses that they are responsible for viable in order that they can produce good things in the future for example, and those who, like NICE to some extent, value those products have a different set of responsibilities. Because of that, I think it is really important that when those different interests engage, there is actually a structured and open and transparent process that recognises the reality of those different drivers and makes sure that they can be reconciled in a way that enables those who look at how decisions are taken to understand how they are taken and to be satisfied that they are taken objectively.

  Q882  John Austin: In your submission, you acknowledge that there is a potential conflict of interest with the pharmaceutical industry's involvement in NICE's processes given their key responsibility to their shareholders to secure markets for their products and you have given a detailed description of the processes you follow to minimise this risk. The industry is also involved in selecting the topics that NICE addresses in its advisory programme.

  Professor Sir Michael Rawlins: It is ministers who fall responsible. The industry can comment on it. No companies have refused to take part in an appraisal or a guideline but it is not them who decide whether their product will go forward, it is actually ultimately ministers.

  Q883  John Austin: So, they do not have an independent involvement in determining—?

  Professor Sir Michael Rawlins: They are present in ACTS, the Advisory Committee on Technology Selection.

  Mr Dillon: There is an advisory committee within the Department of Health and the industry has seats on that quite large committee, but ultimately decisions are taken by ministers.

  Q884  John Austin: Do you see any benefits or disbenefits of the industry being involved at that stage?

  Mr Dillon: For us, the really important thing is that we pick up emerging technologies as early as possible in order that we can start work on evaluating them so that we can provide advice to the NHS as quickly as possible after they introduce them to the UK market. The people who know earliest and most about those emerging technologies are those who manufacture them. So, an understanding of how products are developed and the ways in which information can be obtained about developing products properly through publicly available data is quite important and I think one of the benefits of industry participation in that selection process is to provide that sort of perspective.

  Q885  John Austin: You will be aware from our previous inquiry that we know your position and how you share our view on the importance of involving patients with patient organisations. It has been suggested now that some patient organisations might be very closely in bed with the pharmaceutical companies and many of them are funded by them. Do you think there are risks there and what is your view towards patient involvement where there is a clear link with the pharmaceutical industry?

  Professor Sir Michael Rawlins: We do not exclude patient organisations or professional organisations because they have some relationship with a pharmaceutical company but we do formally ask them when they come to give evidence at the present committee meetings if they know what those interests are and we record them and they are placed in our minutes and the minutes of the meetings are placed on the website and I have a copy here of the guide which indicates the approach that is taken. We do not exclude them because they have an interest, I think that would be wrong, but we make sure that we know about the interest and we make sure that the members of the committee know about the interest and take that into account as part of the judgment.

  Q886  John Austin: Can I ask an unrelated question arising out of the exchange between myself and Sir Alasdair in the earlier session when we were talking about SSRIs. I put a question to Sir Alasdair following the report of the Expert Working Group when the MHRA put out a statement following the report saying that SSRIs are effective medicines in the treatment of depression and anxiety conditions and I asked Sir Alasdair if that should have had some qualification to it. Could I ascertain the position of NICE because I asked specifically about the use of antidepressants in the treatment of mild depression. Could you confirm that NICE does not recommend the use of drug treatment in mild depression.

  Professor Sir Michael Rawlins: I think it depends on the circumstances. We have recently produced a guideline on the management of depressive illness and that guideline indicates that, in mild depression, it may not be appropriate to go for pharmacological treatments but other sorts of therapy too. It is a very difficult decision if you are a general practitioner or psychiatrist as to the circumstances when you think that drug therapy is appropriate and circumstances when it is not. It is not all that easy to tell in the real world. We did want to shift a little bit away from automatically prescribing and availability of other forms of treatment. We were also very conscious that clinical psychologists are in short supply in the Health Service and those sorts of techniques, what someone would pejoratively call talking therapies, are important and that is one of the reasons why we have actually done an appraisal of computer behavioural therapy and they are at an early stage but they are another alternative route to that sort of form of treatment. Andrew, do you want to come in there?

  Mr Dillon: No, that is a good summary.

  Q887  John Austin: Would you acknowledge that there appears to be a difference of view between NICE and what the MHRA were saying?

  Professor Sir Michael Rawlins: I do not think so really. Having been Chairman of the Committee on Safety of Medicines for six years and Vice-Chairman for six years, I am well versed in the archaic rites of it all although it is six years since I was involved but it is slightly different. The regulatory authority is primarily there to regulate the industry, that is what the Medicines Act is set up to do, and previous chairmen used to shout at me when I was a raw young youth on the committee with Alasdair, they used to shout at both of us, that we were the Committee on Safety of Medicines and not Medicine and our role was regulating the industry and not regulating the profession. It is a difficult thing to balance and do; it was difficult when I was chairing the CSM and I am not sure it is not easier now. I think there has been a shift over the years to being more engaged with the professions, more helping them to prescribe appropriately and so on, which was not the original intention but I think that is the right direction to go in.

  Q888  Dr Taylor: Could you remind the Committee about the selection of drugs for evaluation, how you do it or who does it.

  Professor Sir Michael Rawlins: The topic selection is formally made by ministers. There is a somewhat complicated process which Andrew is much more well versed in because he goes to the committee meetings.

  Q889  Dr Taylor: So, you do have some influence in guiding the minister on what to select?

  Professor Sir Michael Rawlins: Yes.

  Mr Dillon: Very briefly, there is a whole series of sources of information about the kind of pharmaceuticals that NICE might look at and bear in mind that we only ever look at a small proportion of the total of new drugs introduced into the UK market at any one period of time. All that is looked at by a group called the Advisory Committee on Topic Selection, which is a Department of Health Committee with a whole range of membership from inside and outside the NHS. That creates a shortlist which is reviewed by a joint planning group that has NICE and Department of Health membership on it and that group makes final recommendations through civil servants to the minister.

  Q890  Dr Taylor: Would you tend to try and concentrate on drugs that offer a real advantage but fill a real gap?

  Mr Dillon: Yes. There are actually published criteria for selecting pharmaceuticals, those where there is the potential for real therapeutic gain, and another criteria might be where there is potential for very substantial resource impact on the NHS, and another would be where there is already considerable uncertainty in the Health Service about the therapeutic value of the drug and therefore NICE can add value by perhaps reducing some of that uncertainty.

  Q891  Dr Taylor: How are you getting on weeding out some of the things that do not provide particular advantages or particularly good value?

  Mr Dillon: Not well enough because we have not done enough on that, we have not had enough topics fed through to us and it is something that we, the ministers and the NHS think should change. In fact, the Department of Health is about to launch a series of workshops or seminars with the NHS to identify those topics in order that they can be fed through to the Institute.

  Q892  Dr Taylor: Can you not feed them in yourselves and say, "This needs looking at. We want to get rid of it"?

  Professor Sir Michael Rawlins: We could do but actually the Formulary does not have many totally inactive things in, I would be ashamed if it did since I was on the CSM for so long, and some of the very old things that you and I used to have to learn about in our youth are in the Formulary but are hardly ever used and to go through the whole . . .

  Q893  Dr Taylor: So, it is not much of a problem?

  Professor Sir Michael Rawlins: I think it is but I think it is more subtle. I think it is much more in areas like diagnostics. The pathologists have made proposals about the sorts of things which should not be done any more. The radiologists displaying films of the skull say this should not be done any more. I think it is those sorts of areas that offer opportunities that we really need to explore to a greater extent, even complementary and alternative therapy.

  Q894  Dr Naysmith: I want to explore this concept of substantial therapeutic advance just a little further and ask if there are any other implications for NICE in this. Some of the witnesses have suggested that it would be good if NICE could set criteria about what does and what does not constitute a therapeutic advance. Would that be something you would be interested in doing or is it so bound about by circumstances and depends on this, that and the other that it is not worth trying?

  Professor Sir Michael Rawlins: There have been discussions across the world about, what is innovation? I think the first group is where there is a substantial health gain in areas that have been previously untreated and those, I think, are the ones that we, as a society, would like to encourage. There is a very interesting report from the WHO commissioned by the Dutch Government on priority medicines making some really fundamental points about areas of great need, not just the sort of diseases of the third world like malaria but many other conditions which are common both in developing countries and in developed countries for which there is virtually no really effective form of treatment and for which there is great, great medical need. Somehow, we need to encourage those areas of researches and I think there are a number of moves in that direction. Professor Woods was just talking a few minutes ago about the regulatory part of that. One of the very interesting things and I think a very important thing is that there is much more pluralism in drug discovery nowadays. University departments and so on are much more actively involved. The National Institute of Health is setting up its own chemical library for academics in the United States—I do not know if others will have access to it—to be exploring drugs. I do not think that is regarded as a failure of the pharmaceutical industry, I think it is a good thing that others are involved in an area which for 50 years pharmacologists have not been in universities.

  Q895  Dr Naysmith: But it is not an area in which you see much role for NICE?

  Mr Dillon: In a way, NICE has done because all the decisions that we make together act as a kind of case law. Those who want to understand in a sense what it takes to obtain support for innovative interventions or want to identify what it takes in a sense to get NICE's support and endorsement for real therapeutic value, just take a look at the decisions and indeed how the decisions have been taken. You can look at the standard methodology that we have published on evaluating the clinical and cost effectiveness of interventions and look at how that methodology has been translated into specific decisions and there is a story really over the last five years or so which is, as I say, a kind of case law which could be used by those who want to understand how innovation is interpreted, at least in the UK.

  Professor Sir Michael Rawlins: Just to finally follow on from that, I have often used this example but Riluzole for Motor Neurone Disease which prolongs life by up to a year, we felt that was an important innovation for a disease that had previously never had anything at all specific. It was expensive at £38,000 per QALY. Relenza for influenza which you give to everybody also comes in at £38,000 per QALY and reduces your symptoms by a day and we said no to Relenza for everybody and yes to Riluzole. So, I think that demonstrates how we interpret it anyway.

  Q896  Dr Naysmith: Can we move on to something different. What, in your view, are the factors that contribute to the time lag between the launch for a new drug and the publication of NICE guidance on new technologies?

  Professor Sir Michael Rawlins: The processes—and Andrew will go into some of the detail—involve a very careful scrutiny of the relevant literature, full systematic review. That takes quite a considerable amount of time. Many hundreds, sometimes thousands, of references have to be looked at. We also have a very liberal, I believe liberal in the best sense of the word, approach to engaging our stakeholders and they have opportunity to comment and even to appeal against decisions. All that takes time. If we curtail it in any way we will do either a less robust job or we will end up disenfranchising some of our stakeholders. I believe the route we should be taking is to start with the appraisals around the same time as the licensing process and then complete the appraisal once we know the outcome of the licensing process. We have been doing this for the last couple of years. One of the difficulties, which happened, is that halfway through the licensing process and halfway through our appraisal the gentleman behind me finds there is a problem in the licensing, so it gets held up for a perfectly good reason I am sure, which means then we get held up in our appraisal process and have to stick that on hold.

  Q897  Dr Naysmith: You are trying to get to the stage where the appraisal will be published about the same time as the drug's launch?

  Mr Dillon: We have to wait about three months, I think, but we need to know the precise indications the MHRA are granting.

  Q898  Dr Naysmith: Are there any lessons to be learned from the drug licensing process for you in this in speeding things up? It used to take far longer 20 years ago than it does now for licensing.

  Professor Sir Michael Rawlins: I think we are fortunate, unlike the licensing process where they have to react to demand and the problems of surges and so on. I remember it from years back, it was always happening. For example, when they introduced a fee in 1988, there were huge surges the week before it came into force, which might have been predicted. We do not have that problem, we can control the rate at which things come in, which is an advantage to us.

  Q899  Dr Taylor: Are you working more closely with the MHRA than we got the impression you were when we did the short inquiry in 2002, I think?

  Professor Sir Michael Rawlins: I think we are and we have developed very good relationships. When we launched our depression guideline, we did it, as it were, as a joint enterprise with the MHRA because of the licensing issues which came up at the same time. I think that is a way we would wish to work, but nevertheless, we have separate functions.


 
previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2005
Prepared 26 April 2005