Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 120 - 139)



  120. It sounds okay. I am still very confused. How, for example, does a manufacturer then get a CE marking? Who do they go to get this CE approval?
  (Dr Ludgate) They go to a Notified Body.

  121. Any Notified Body?
  (Dr Ludgate) Any Notified Body.

  122. They can hawk themselves around Europe until they find some body that will give them a CE marking?
  (Dr Ludgate) In effect.

  123. That is literally it?
  (Dr Ludgate) Yes.

  124. The manufacturer will know who are the most easy ones to get it from. I will not name any countries in case I get picked up in the press. They can pop across to any country they felt was licensed and was a soft touch, get themselves a CE marking and there is nothing we can do about it. Then they can market that product in the UK and say "Seal of approval, CE marking obtained from goodness knows where" and that is acceptable?
  (Dr Ludgate) Yes, and I think that is where it is very important that there is very good post market surveillance on these products.

  125. Post market surveillance means that the product is in use and being watched?
  (Dr Ludgate) Yes, absolutely.

  126. Effectively we are doing clinical trials on people in a way that would not be acceptable if there was not an approval for such a product. Surely post market surveillance is nothing like as rigorous as a full study. I used to be the Chair of an Ethics Committee and we were extremely rigorous about the types of trials that were allowed to be carried out, far tougher than any post market surveillance report would have to achieve.
  (Ms Stuart) I think you are absolutely right at expressing your surprise at the fact that a manufacturer can go round and choose the Notifying Body. As it happens, of the three implants we have on the market all three Notifying Bodies are actually based in Germany. What has been lacking so far, and what we have been pushing for, and the UK has been leading here, is actually to have a body that co-ordinates those Notifying Bodies so we can make sure that all of them come up to the same kinds of standards. I think Britain has been very successful in that. We have also been pushing for exactly that post market surveillance. What should not be overlooked, if you take the case of the soya based implants, whilst they have the CE marking, once the real concerns were raised we got the agreement that they were withdrawn. There was much quick action. Whilst we are dissatisfied with some of the frameworks within the EC Directive, I think we are at the forefront of pushing that—I have seen some early successes—to have that much more standardised.

  127. I am very pleased, Minister, that the British Government is acting in this way, that is extremely responsible, but it still does not quite answer my concern. If a new drug was to come on to the market, the manufacturer would have to give very positive evidence to the drug control agency so that we were happy with that drug being allowed for use. Every other country in Europe is entitled to do the same thing, and rightly so, and so are the Americans and so on. That is based on there being solid evidence that drug is safe, effective, cost effective and all the rest of it. This is slightly different. This is saying if they get a licence from somewhere they can go on using it until we can prove that they should stop using it and then when we see significant safety worries in the newspapers and in the reports we will then stop it. Surely that is the wrong way round. Do we not need to take this same approach with devices that we do with drugs?
  (Ms Stuart) There is a clear separation.

  128. I know there is.
  (Ms Stuart) Again, we have pushed and succeeded in making it one of the high risk areas.

  129. That is not my point. I appreciate there is a clear distinction between the devices and medicine. What I am asking is should there be that clear distinction or on devices, such as cardiac pace makers and hip replacements, all the other things which count as devices, should there be the same approach to those devices as there is with any new drug going on to the market?
  (Ms Stuart) What I do think is we have to have much more co-ordination of what that threshold is when it comes on so that we make sure it is the same in the area. Also we do need more clinical data and I think that is an important thing, much more post marketing on that area.

John Austin

  130. Can I come back to follow the point that Dr Stoate was making. Can you tell us which Notified Body certified Hydrogel implants? What steps have you taken to tighten the procedures since?
  (Dr Ludgate) Right. There are two separate Hydrogel breast implants: the PIP Hydrogels where the notified body was a group called TUV Rhineland and for the NovaGold the other was ECM, another German Notified Body. You will forgive me if I do not give you the full name, it is very long and I cannot pronounce it. What have we done in terms of trying to improve the control on these? As I mentioned, the first thing we have done is to try and push them up into a higher categorisation because, just to go back to your point, to control a simple elastoplast dressing the same way as a pacemaker would not make sense. There has to be a risk classification. As I have said, this one is not in the highest risk, we think it should be and that would mean that it had to have much more clinical data before it came on to the market, so we are pushing for that. Not only are we pushing for it, we have actually got the support both from the Member States and from the Commission, so that has been taken forward. Additionally, as the Minister has said, we are pushing for this oversight group so that we get a level playing field across the Notified Bodies because we are aware that there are differences. This is a relatively new system and these have to be ironed out but it is important that they are ironed upwards and not downwards. This group has been started and it has been started under the Chairmanship of the UK. Thirdly, we are pushing to have much more surveillance on these products. As I have said, by the nature of devices a lot of the problems, because a lot have a very low incidents, only come to light over a prolonged period of time. It is very important that there is a good post market surveillance system in place, and we are pushing for that, that is much firmer on behalf of the manufacturers.


  131. How does that system work? Does it rely on the GP?
  (Dr Ludgate) It is the manufacturers under the regulations that have the responsibility for that. One of the problems under the regulations is that what that programme is is very nebulous, it just says "There must be a post market surveillance problem". That leaves it open to manufacturers to say "right, well we have got a complaints procedure, that is our post market surveillance". Some are excellent and actually go out to hospitals, gather data from their clinicians and have a proactive approach, and that is what we are pushing for.

  132. We picked up in the previous session that there is no ability for a patient to advise you of a problem. Is that correct?
  (Dr Ludgate) There is no regulatory requirement. I think I have to


  133. When you say there is no regulatory requirement, the picture I got from the patients, people who have had problems, was they were concerned that if they were to report problems with the product that they are using that there is no system in a sense for you recording that.
  (Dr Ludgate) We think it is very important that users report to us. A large percentage of our adverse incidents are reported mainly from clinicians and, in this case with breast implants, also from users.

  134. So what you are saying is that is incorrect, that you are happy for people to report?
  (Dr Ludgate) Absolutely.

  135. Just out of interest, and I am looking at the document the Government has issued which we have got copies of, is that point made in here?
  (Dr Ludgate) It is not made in here because—

  136. Why is it not then?
  (Dr Ludgate) The way we have in the past run the adverse incidents system has very much been to advise women first of all to go to their doctor and get their doctor to report to us.

  137. The GP or the surgeon?
  (Dr Ludgate) I am sorry?

  138. The GP or the surgeon?
  (Dr Ludgate) Whichever one they prefer to go to. Sometimes they have a clinical problem at the same time which we feel must have a medical input. We talk them through it and they go to whichever one they feel comfortable with. We have recognised, and I think this is something that we have been slow to learn, that we must take on board the patients phoning us directly, contacting us directly, and make this much more user friendly for them. We certainly do take this on board.

  139. This document has been revised, can that be looked at?
  (Dr Ludgate) In the new one our name and address and contact point is included.

previous page contents next page

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

© Parliamentary copyright 2001
Prepared 4 April 2001