Examination of Witnesses (Questions 774
- 779)
THURSDAY 20 JANUARY 2005
PROFESSOR SIR
ALASDAIR BRECKENRIDGE
CBE, PROFESSOR KENT
WOODS AND
DR JUNE
RAINE
Q774 Chairman: Colleagues, good morning.
Can I welcome you all to this session of the Committee and welcome
our witnesses. Can I thank you for your co-operation and for your
evidence to us; we are most grateful. Can I ask you briefly each
to introduce yourselves to the Committee.
Dr Raine: Good
morning. I am Dr June Raine. I am the Director of the Post-Licensing
Division at the Medicines and Healthcare products Regulatory Agency
and my responsibilities include all the issues that relate to
medicines once they are authorised for use on the market.
Professor Sir Alasdair Breckenridge:
I am Alasdair Breckenridge, I am the Chairman of the Board of
the MHRA.
Professor Woods: Good morning.
I am Kent Woods and I am the Chief Executive of the MHRA.
Q775 Chairman: Can I begin by asking
you this, Sir Alasdair: you have been around for quite a long
time in this whole area and obviously you have got some pretty
detailed knowledge of many of the issues that we have been addressing
during this inquiry. We are now towards the end of the inquiry
and I have no doubt you will have been following some of the sessions
and some of the evidence that we have had. What is our view, from
your background, of the key issues that perhaps have been picked
up in this inquiry in relation to the medicines regulatory system?
Professor Sir Alasdair Breckenridge:
I think one of the impressions that I have gained is that a lot
of the discussions which have taken place have referred to what
happened many years ago in the old Medicines Control Agency and
the one thing that I would like to stress is that since the MHRA
came into being in April 2003, there have been many, many changes
in the way in which the organisation works, partly because this
is the aim of the organisation itself and partly because the climate
in which medicines regulation takes place has changed totally.
Q776 Chairman: So what you are saying
is that some of the evidence that we have had is outdated? Could
you give examples in particular where you feel that the situation
is being inappropriately represented?
Professor Sir Alasdair Breckenridge:
Well, it is not misrepresented, but there was quite a lot of discussion
about how the Agency did not release information, for example,
on human albumen and on some of the other issues in the early
1990s. Well, we have changed that now and there are two big things
which we are actually changing. One is the transparency under
which we work and secondly is the communication skills which we
have put into being, and there are some very important examples
which I am sure we will be coming back to in terms of transparency.
For example, you are aware of the report which the Agency published
on the SSRIs at the end of last year and the other report which
we put into the press in May 2003. Well, as part of that, we published
all the evidence, published and hitherto unpublished, on which
the Agency made its decision. Now, people may look at that evidence
and disagree with it, but at least they have the evidence on which
we made our decision, so that is the kind of thing which we are
determined to do now and we are doing.
Q777 Chairman: I think that was a
good example which will probably be picked up by one of my colleagues
later on, but in terms of the future, do you see, from the evidence
that we have picked up, any particular key areas where you perhaps
would suggest there is a need for change?
Professor Sir Alasdair Breckenridge:
I think that the other area that I would pick up is that of the
education of the public in terms of risk and benefit. A lot of
the discussions which have taken place in the Select Committee
have been about the safety of medicines and relatively little
about this concept of risk and benefit. When we change a licence,
we do not do this purely based on a safety profile of a drug.
If we did this, there would be no anti-cancer drugs available
and there would be no anti-HIV drugs because the adverse reactions
to them are huge. They have got to be balanced against the benefits
which these drugs have and the one thing which I would like to
see you concentrating on, with all respect, is this concept of
risk and benefit. We are going to be communicating that very strongly
with our new communications set-up, but I would like to see that
as one important aspect coming through from this Committee.
Q778 Chairman: You had in 2003 a
report from the NAO which was somewhat critical about your external
profile. We have got a rough idea of the main findings. Now, in
terms of the way you suggest that the information we have received
perhaps is a little dated from some of the witnesses that we have
had and some of the representations we have received, in relation
to those findings what steps have been taken to address them and
perhaps what further steps might you take in the light of some
of the issues that we have picked up?
Professor Sir Alasdair Breckenridge:
The main thing which the Agency did when it received this report
is that we commissioned a report on our communications strategy
and this reported to us in June 2004 and there were many recommendations
from that report which we took up. The main two which we have
acted on are the two I have mentioned already, firstly, setting
up communications, and this is absolutely critical for an agency
like ours. In the past, the old Medicines Control Agency and Medical
Devices Agency, working in a different time, did not see this
as one of their main purposes. Now it is quite clear, and we are
determined, that this is one of ours. The second one is the issue
of increased transparency and I have already mentioned the example
of SSRIs. The other thing which we have done is that as of the
middle of this year, when we give a licence, we will be issuing
what we call a "United Kingdom public assessment report"
which will give data of all the clinical trials on which we made
our decision, so the public will be able to see again the evidence
on which a drug has been licensed. The third part of the transparency
move which we have made is that we have reviewed the yellow card
system. This was done independently and we might be coming back
to that later, but in fact as of this week we have published on
our website all the adverse reactions to every licensed drug and
this is accessible to everyone, suitably "anonymised".
Therefore, we have taken concrete steps with respect to transparency,
communication, and the other question which was raised by the
National Audit Office was the question of interests and we have
moved on that both with respect to the staff and with respect
to the committee structure, and we can deal with that. The final
one which I would mention is that we have increased greatly the
patient voice in medicines regulation. We have been conscious
for a long time that regulation was too inward-looking, not involving
the public enough, and we can discuss again in some detail how
we are actually increasing the patient voice in regulation.
Q779 Chairman: So taking account
of the views we have had expressed about your external profile
as an organisation, how would you describe it now?
Professor Sir Alasdair Breckenridge:
We are moving very quickly from the time when we started business
in April 2003 and if someone who worked in the Agency even in
the early part of the 2000s came back and looked at the work that
we are doing now, they would find huge changes.
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