Examination of Witnesses (Questions 120
THURSDAY 22 MARCH 2001
STUART MP, DR
CBE AND DR
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
(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we got the agreement that they were withdrawn.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
thatI have seen some early successesto 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
(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
(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.
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
(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.