Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 740 - 759)

THURSDAY 13 JANUARY 2005

DR RICHARD BARKER, MR VINCENT LAWTON, DR DAVID CHISWELL AND MR SIMON CLARK

  Q740  Dr Naysmith: Do you have any comments on the points that were made previously about the spend on marketing compared to research? Presumably as a trade association you do not necessarily just look at research and the importance of research, but do you think enough is spent on research?

  Mr Lawton: The amount spent on research is approximately 24 or 25% of what we spend compared to something like 14% which is spent on marketing and promotional efforts. The balance between the promotional monies would be more or less stable over the last few years whereas the expenditure on research and development is increasing.

  Dr Barker: It is approximately £10 million per day across the industry and £3.5 billion a year. The other factor, which I think it would be worth the Committee knowing, is that the promotional efforts of the industry represent about 11 minutes a week of a GP's time, so the impression that some people would give you that GPs are overrun with promotional efforts is very misleading.

  Q741  Dr Naysmith: We heard in the previous session that there are something like between 4:1 and 5:1 personnel employed in marketing as compared with research. It is quite a lot of personnel.

  Dr Barker: I do not think that is representative at all of the UK.

  Q742  Dr Naysmith: I have a question for Simon Clark in the BGMA but first of all can I take up something you said way back in your initial remarks. You talked about you were different from the branded companies in that you promoted to pharmacists rather than to GPs?

  Mr Clark: Correct.

  Q743  Dr Naysmith: Have you given up persuading GPs to prescribe without naming a brand name or is that just a decision you have made?

  Mr Clark: One thing we are fortunate about within the UK market is that we have seen, as was alluded to earlier, about 78% of products being written generically by the INNA, and that is something that we would continue to encourage for the rest of those products that are appropriate to be written generically. As a result of that, doctors are putting through prescriptions to the pharmacists with a generic descriptor, therefore the role of the generic members and also competing against the brand is to offer the pharmacist various product prices, the lowest price being the one that the pharmacist will choose to meet the needs of that script.

  Mr Lawton: If I may add a point on that. One of my own company's drugs, simvastatin, when it went off patent was being prescribed 90% as generic simvastatin.

  Q744  Dr Naysmith: That is interesting because that brings us on to the question I was going to ask Simon. Your submission makes reference to evergreening. Maybe you could explain this term to us and describe the tactics used by the industry to limit profit loss when a medicine approaches patent expiry.

In the absence of the Chairman, John Austin was called to the Chair.

  Mr Clark: Evergreening is a term given where a company may use tactics to extend the commercial life of the original product at first patent expiry.

  Q745  Dr Naysmith: And you would be against that?

  Mr Clark: We would definitely be against that. What happens here is you will have a product that enjoys this market monopoly position for a period of in excess of 10 years and during that time there may be changes in the product or the product may evolve and that delivers real patient or clinical benefits to the NHS, and we would absolutely support that without a doubt. However, we have seen an increase over the last number of years in cases where one can be sceptical about some of the changes that are made, in some cases two or three months before the patent expires on the product. These changes could be a different form of the product being released, they could be different indications and a different type of product and, as you see, there are some examples there. The real issue is that the originating company would then promote strongly that product to move the position to start writing scripts in the new form of the product and not writing prescriptions in the old form, so when the generic comes to launch there are no generic prescriptions there to be met by the generic product, and the impact on the generic company is that it then has to do a new filing and go through a new licence with the MHRA so we could see a two-year delay before a generic comes out on the market-place to meet this new form. If you are dealing with a product that has worth of over £100 million (which a number of other products have) that are going off patent that is obviously a significant value to the originator company but it is also a loss of saving to the NHS. The examples we have put in the report are not specifically to pull out those or to dig into those in detail, they are just to illustrate the point. What we feel the focus should be on is looking forward to make sure that there is a healthy generic environment. To achieve that, a number of changes that have been made in the EU Pharmo Regulation that went through recently are helping us on that progress, but what the recommendation would be is that the Department has existing powers to make sure it puts in place a strong generic industry and has started using those, and we saw some pay-back 12 months ago with one particular product.

  Q746  Dr Naysmith: Is this a fairly widespread practice? Do all companies do it?

  Mr Clark: No, all companies do not do it. I would not say it is widespread on every single product but we are seeing a recurring instance of it and we are making sure that we are sharing that information where we see it with the various departments as well.

  Q747  Dr Naysmith: I am sure Dr Barker will have something to say about that.

  Dr Barker: The process by which companies bring new variants of products to the market is obviously one that is controlled by the same regulatory process that we have heard described in detail before. In other words, the product has to provide advantages and has to be approved by the regulator. The advantages could be efficacy advantages. For example, sustained release formulation could provide control of the use of that medicine over the day, it could be the ability to take therefore a medicine once a day rather than twice a day, and so there has to be a therapeutic benefit for this process to operate and therefore we do not think there is anything reprehensible about the fact that a company does that through the life of the patented product.

  Q748  Dr Naysmith: Yet in the process of giving market authorisation the regulatory authority is barred from considering whether the product holds any clinical advantage over other established products. Do you think this favours the industry to the detriment of prescribers and patients?

  Mr Clark: No, I do not believe it does. To set the context here, the UK has been pretty successful in stimulating a generic industry. As we have heard before, generic prescribing is widespread through the life of the branded product and the turnover to generics is really pretty rapid. If you look at it, as Professor Lawton said in the case of one of his own products, there was 90% generic writing by the end of the prescription period. So I think of the problems we have this may not be the greatest. There is a pretty significant creation of this headroom for innovation through the use of generics.

  Q749  Dr Naysmith: Does anyone else want to say anything?

  Mr Lawton: The product has to have a therapeutic benefit. If there is an attempt to change the form it is usually because there is a perceived need for that form.

  Q750  Dr Naysmith: Mr Clark is suggesting that sometimes this happens just because a drug is getting towards the end of its patent.

  Mr Lawton: I do not know if that is the case. He has more information than I do about it and certainly not widespread. The adjustment and development of molecules, whether it is single molecules or whole classes, is a gradually evolving thing. This is what we would call "incremental innovation". If you take the birth pill from 1961 when it first appeared up until current day, there have been about 18 different developments either in form, in strength, in tolerability and so on, as a result of which the medicine now is much more effective, it is much more tolerable and safer to take than it was when it originally came out, and there is now less active ingredient in a whole packet of these medicines than there was in one pill when they first came out in 1961, so I think these incremental changes do have a critical role, but I agree that they do need to have a role and they do need to have proven benefit. Doctors really need to be able to assess that.

  Q751  John Austin: One of the other issues that has been suggested in evergreening is cosy relationships between a manufacturer and a generic manufacturer prior to the expiry of the patent to extend the profitability. It has also been suggested that some manufacturers may buy up some generic companies in order to eliminate competition. Is this widespread and would you regard either of those practices as anti-competitive?

  Mr Lawton: Having had a number of products go off patent over the last five years—and very large products including simvastatin—I do not know that cosiness would be a word I would use in terms of the relationship. I think we respect very much the high-quality generics manufacturers. A number of pharmaceutical companies used to own their own generics manufacturers, some still do, but in fact fewer and fewer (rather than going the other way) own generics companies than was previously the case.

  Mr Clark: Just to build on your question and answer directly in terms of buying up companies whether there is a reduction in the number of generic companies in the UK—no, there is not and in fact the generic market now is more aggressive than it has been, and what you get with the generic market is a situation where each individual product is a commodity market in its own right. We see products such as pravastatin which went off patent during the summer and within 48 hours it was down 60-70% and amlodopine after three or four months was down to 98% off the original price of the product. So that is not the case; in fact, the converse is the case. To build on that, we are seeing an increase in the number of Indian companies that are entering the UK generic market because of the attractiveness of the generic market in itself.

  Mr Lawton: During the renegotiation of the PPRS before last we were looking very carefully at the competitiveness of various sectors and we observed that the UK generics market was seen as one of the most efficient in the world.

  Q752  Dr Taylor: Turning to the provision of information, I think it was Professor Lawton who talked about the inadequacy of clinical training of pharmacology students and now Dr Barker says 11 minutes a week is the GP's contact with the drug representatives. In the ABPI evidence you have given us the result of the Taylor-Nelson study showing that of the GPs surveyed they rated their contact with representatives among their top three sources of information. This is really getting rather alarming and certainly we will get advice from our expert advisers on the degree of training that medical students are having, but talking about the work that you do in promoting, is it right that the discoverer, the developer and the supplier of the product should be the most important adviser?

  Mr Lawton: I think that the people who know most about the medicine right from its inception are those who discover it and bring it to market. The information which we develop about it and how to use it and where not to use it, the benefits versus the risks, and so forth, is carefully studied and presented. They are subject to external scrutiny and we also have within our companies a medical legal control procedure so that all information—whether it is related to clinical papers or whether it is a smaller study—has to be approved by a medical doctor and legal expertise before it can go out.

  Q753  Dr Taylor: Is that an independent medical doctor?

  Mr Lawton: No, it is within the company, and externally there would be the Code of Practice of the ABPI which has to be adhered to as well and there are independent physicians on that and the complaints procedure is open to all medical practitioners if it is seen to be inappropriate.

  Q754  Dr Taylor: With their very limited training in pharmacology do you think the GPs have enough information to view your information critically or do you think they just take it at its face value?

  Mr Lawton: That is an extremely good question which I would hesitate to give a very simple answer to because it is a very complex issue. The GP is looking for clinical end points and benefits rather than the clinical pharmacology relating to how the medicine works, the molecule, the shape of the molecule, and the potential benefits of any chain in that molecule. I think they are less able to be critically evaluating the latter but on the former, in terms of the clinical benefits, they should be able to see whether or not those clinical benefits, as they are important to their patients, are properly represented in materials and also the quality of the discussions they are having with whether it is the company representative or external doctors.

  Q755  Dr Taylor: Do representatives concentrate more on GPs than on consultants because they think they can influence them more?

  Mr Lawton: There are 90,000 practitioners of one sort or another in the UK and general practitioners are the majority. A large amount of time is spent on general practitioners because they are the ones who are more likely to be in the prescribing area, but that is rarely done without consultation with the consultants who deal with those general practitioners, so that the consultants have to feel comfortable and they will ask very technical and difficult questions which we need to be able to answer and satisfy them on. They will be the advisers to the general practitioner within a primary care trust but we do visit general practice more.

  Q756  Dr Taylor: Information direct to the public is obviously limited to the non-prescription drugs.

  Mr Lawton: Yes.

  Q757  Dr Taylor: We gathered at a week or two ago's session that simvastatin was already being advertised pretty widely in the ordinary press. Does that come from the generics?

  Mr Lawton: Simvastatin went over the counter last year and that was the only time it has been advertised in the press. It has not been advertised in the press before that.

  Q758  Dr Taylor: No, but it has since then.

  Mr Lawton: Simvastatin over-the-counter version.

  Q759  Dr Taylor: Yes?

  Mr Lawton: Yes.


 
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