Examination of Witnesses (Questions 860
- 877)
THURSDAY 20 JANUARY 2005
PROFESSOR SIR
ALASDAIR BRECKENRIDGE
CBE, PROFESSOR KENT
WOODS AND
DR JUNE
RAINE
Q860 Mr Bradley: Do you think the
public will have confidence in a voluntary system?
Professor Sir Alasdair Breckenridge:
I would hope so, combined with the European Clinical Trial directive.
Kent, you have had experience with the Clinical Trial directive
and I wonder if you would come in on that.
Professor Woods: There are of
course these two separate issues which have been referred to before.
One is the registration of the fact that a trial has been started
and the second is the availability of the results of that trial
when the study has been completed. From the point of view of the
regulator, the first part is important in terms of enabling us
to ensure, as we are still here, that we have everything. In terms
of the general public, it is the availability of clinical trial
results in an accessible place which is perhaps more fundamentally
important. The voluntary system which the global pharmaceutical
industry has come up with in the last week or two offers a promise
of how that might work but it is early days and, as we say, there
must be public confidence that it will be actually implemented.
Secondly, there are some technical questions to be sorted. Where
do you put the trials data in a site which can actually be accessed
by people? Thirdly, what should those records contain? Are they
intended to be totally comprehensive, in which case they will
be almost inaccessible to the general public, or are they in some
way summarised data? I think there are some very important practical
issues and issues of trust too which do need to be clarified.
I think the default position would have to be some form of legislative
requirement if that voluntary system does not work. We will know,
I think, quite soon.
Professor Sir Alasdair Breckenridge:
As I have said already, we hold out great hope for the European
Clinical Trial directive registering trials on that system and
this will teach us a lot which may well help to inform the other
systems which Kent was describing.
Q861 Mr Bradley: Do you think there
are any anomalies in the situation where clinical trials information
is voluntary given by the companies but you may feel that you
have to protect that same information because of commercial confidentiality?
Do you think there are potential conflicts within that?
Professor Woods: Of course, the
Freedom of Information Act which came into effect at the beginning
of this month does substantially shift the rules of the game in
effect in that the default position is disclosure whereas the
tradition, the legal position in UK medicines regulation going
back to the 1968 Medicines Act, was very much that the presumption
was that data submitted for licensing purposes were confidential
data and indeed, under section 118 of the 1968 Medicines Act,
it was an offence to release information unless, in the course
of one's duty, it was necessary to do so. The Freedom of Information
Act is shifting that towards the presumption of disclosure and
therefore it is no longer the case that information submitted
to us as a public body is protected from the Freedom of Information
Act and any exemptions from disclosure, that is relevant exemptions,
are conditional on a test of the public interest of disclosure
versus the public interest of non-disclosure. So, I think that
does quite fundamentally shift the accessibility of trials data
and we welcome this. We, as an agency, would sooner have information
out in the pubic domain provided, from the company's point of
view, there will be occasions when the exclusions built into the
act will be necessary, but the default has changed.
Q862 Mr Burns: Sir Alasdair, you
slightly dealt with my first question in answer to my colleague
Mr Austin, but, on your funding, as we know, it is from fees from
industry and you have to compete with other European regulatory
agencies for business. Do you think this creates a situation in
which drug companies are your customers whom your organisation
is competing to please and thereby perverting the priorities of
your Agency away from the protection of public health and more
to the advancement of new and effective drugs and, if your answer
is "no" which I suspect it will be, why?
Professor Sir Alasdair Breckenridge:
There are several parts to that question and let me start it off.
We are part of Europe. There are three ways in which medicines
in Europe can be licensed. Firstly, they can be licensed nationally
and the companies will come to us for a licence and that is quite
clear and I think you understand that. Secondly, there is the
centralised programme—and this is increasing all the time—where
a medicine is licensed within the whole of the EU and what happens
there is that the company will approach the EU and their Scientific
Advisory Committee will decide which of the countries are going
to act as the assessors, as the rapporteurs and the co-rapporteurs,
and that carries money with it, and that accounts for a sizeable
amount of the funding of our Agency. We are one of the biggest
gainers from that system because of the stature which our Agency
does have. So, this contributes quite a lot to the funding that
we do have. The third process by which a drug can be licensed
is the so-called decentralised or mutual recognition process whereby
a company will come to, let us say, the MHRA, to the United Kingdom,
and, if we give it a licence, then it will go into Europe from
there once it has been recognised in one country and mutually
recognised and clearly that is financially beneficial again. So,
you have to balance each of these three systems of funding which
we do have against the incentives which you are talking about
and it is clearly terribly important that we retain and advance
our position in Europe not only from a UK plc point of view but
also from the funding point of view of our Agency.
Q863 Mr Burns: Do you think you have
adequate resources, both financial resorts and in terms of personnel,
to be able to provide the high quality service to which you aspire?
Professor Sir Alasdair Breckenridge:
The funding of the Agency comes from two sources. Firstly, there
is the medicines part which we were talking about just now and
we have discussed the ways in which we fund that and, in many
respects, if we get more user fees, we will get that because of
the excellence of the Agency and the excellence of the service
which we provide. The second part of the Agency—and perhaps
this is not the concern of this Committee—is for medical
devices and medical devices are funded by Government. The very
interesting areas which are now arising as we speak are that there
is a huge interface between medicines and medical devices and
how these are going to be licensed and how these are going to
be regulated. We are in an advantageous position because of the
actions that were taken two years ago to join the Medical Devices
Agency and the Medicines Control Agency and this is an area in
which we are very active just now and we want to make our imprint
in Europe that we are an agency which is looking towards that
possibility and thereby gaining more funding for the Agency in
that way.
Q864 Mr Burns: You have dealt with
funding, what about personnel?
Professor Sir Alasdair Breckenridge:
Let me ask the Chief Executive about personnel.
Professor Woods: We are one of
the larger regulatory agencies worldwide. I think that there are
specific areas within the Agency where we will need to recruit
additional expertise because science marches forward and we need
to ensure that we have the most up-to-date skills and science
base within the Agency. I see that as an incremental process.
I do not think that there are any major shortfalls in our resources
but we will need, over the years, to ensure that, as we recruit
and develop our staff, we are able to handle new technologies,
we are able to keep abreast of developments and we are able, also
in the safety area, to use the latest techniques in epidemiology
to study adverse effects of drugs and devices in the population.
Q865 Mr Burns: Do you think Mr Jim
Thompson's comments from Depression Alliance where it says that
the regulatory body is woefully under-resourced is wrong?
Professor Woods: I think it is
certainly not the case that we are woefully under-resourced. Perhaps
that is a rather rash statement to make but I think that statement
is wrong. Clearly, there are issues that we would wish to pursue
in greater depth, but I think those are within the scope of that
current funding mechanism and, as much as anything, it is a shifting
of resources rather than an absolute shortfall. I really do not
think that we are woefully under-funded and I think that we have
some world-class scientific resources within the Agency, not just
in terms of people but in terms of databases. We have databases
that are absolutely unique in the world and our task over the
next year or two will be to ensure that we have those additional
very rare skills which enable us to exploit them fully.
Q866 Mr Burns: If you look at your
own website say on 1 December 2004, you will see that there are
currently delays in processing certain applications. Why is that
the case if your financial resources and your personnel resources
are fine and would it not have been predicted that there was going
to be a problem and should the necessary measures to seek to minimise
those delays not have been taken? Also, what impact are those
delays having on the overall work and performance of the Agency?
Professor Woods: That is the one
area where we have of late been falling short of our own demanding
performance targets and the history of it is this. There was a
change in the paperwork/documentation required for particular
types of licence application. Before the change came in—and
this related to abridged applications—there was a rush of
applicants wishing to get their applications in before the paperwork
changed, before the common technical document came in. That meant
that there was a short surge in demand which we could have predicted
though in fact it is rather difficult to handle a short surge
in demand because, if you recruit more staff and the demand goes
away again, you have a slight problem. So, there was that initial
surge of demand which knocked us off course. The other factor
which we had not allowed for was that actually the number of applications
coming in year on year is rising too. So, this is not simply a
transient—
Q867 Mr Burns: I am sorry, can I
just pick you up on one point before you carry on. You said—and
there is a logic to your argument—that it would not necessarily
be wise to take on extra staff to deal with a short-term surge,
but why are you taking on more staff?
Professor Woods: If it were a
simple matter of a surge where applications we were expecting
to be spread across a year all turned up in January, then if we
recruited to handle January, we would be overprovided with staff
in February onwards. There is this more complex question that
actually the number of applications coming in has shown a sustained
rise. I have discussed this with the industry associations, firstly
why has it happened and, secondly, can they give us more precise
information about their commercial plans. I think the answer to
your question as to how we cope with this is that, if we can better
understand the commercial drivers from the industry which influences
the timing and the number of applications, we can start to deal
with that but, if we have these rather unpredictable fluctuations,
we have a problem.
Q868 Mr Burns: Finally, we are told
that it takes longer to process applications for generic products
rather than for new chemical entities. Is that factually correct
and, if it is, can you explain that?
Professor Woods: It is predominantly
in that area that this particular difficulty of surges in demand
arises. There is another factor which is that generic products
will suddenly appear on the market when a branded product goes
out of patent. Therefore, there is a starting point when every
company which is going to start producing a generic produces a
generic. So, intrinsically, it is a rather lumpy line of activity
to cater for but, as I say, there is discussion which has been,
I think, productive with the industry association for them to
do work among their own members to give us a forward view of what
those peaks and troughs are likely to be and, if we can map on
to that internally, we can make sure that the absolute number
of scientific staff is right and, on a micro basis, we can actually
move scientific staff from one form of licensing to another as
the demand arises.
Chairman: As you know, we have a shorter
session—hopefully it will be a shorter session though we
are not sure yet—with NICE following on. We have a couple
of brief questions before we conclude.
Q869 Dr Taylor: Do you have a set
scale of fees for licensing pre-marketing trials?
Professor Woods: Yes, we do have
a set scale of fees. All our statutory fees are subject to external
consultation and scrutiny by the Treasury and final agreement
by ministers. It is a set scale. We do provide quite a range of
regulatory activities which have their own fee structures but
they are all, as I say, approved by that process.
Q870 Dr Taylor: So, a huge firm like
Pfizer would be charged the same as a very small firm working
on a specific vaccine, for example?
Professor Woods: The details of
that are a little more complicated. The service fee which we charge,
as it were, for the post-marketing surveillance of products is
influenced by the size of the company, the number of products
and their volume of sales. So, the actual calculation of the fee
does have that variable in it. It is quite a complex fee structure.
Q871 Dr Taylor: That is post-marketing
but not pre-marketing?
Professor Woods: That is right,
yes.
Professor Sir Alasdair Breckenridge:
We could let you have details of the fee structure.
Chairman: That would be helpful.
Q872 Dr Naysmith: My question is
a little similar to Richard's but it was triggered off by what
you said, Sir Alasdair, about the three different routes that
materials can be passed through your Agency depending on whether
it is for UK or it is for Europe or it is for a company which
will start here and then . . .
Professor Sir Alasdair Breckenridge:
Yes, mutual recognition.
Q873 Dr Naysmith: Are they all treated
in exactly the same way?
Professor Sir Alasdair Breckenridge:
Yes.
Q874 Dr Naysmith: The standards are
exactly the same?
Professor Sir Alasdair Breckenridge:
Yes, absolutely. The standards are exactly the same.
Q875 Dr Naysmith: So, it is not easier
for a company to go one route rather than another?
Professor Sir Alasdair Breckenridge:
That is very often a commercial decision for the company. Is it
going to go and get a licence very quickly over the whole of Europe?
The centralised procedure does specify certain areas where they
must go for a centralised procedure such as high-tech products:
anti-cancer drugs, HIV drugs and drugs for diabetes must go centrally.
However, it is still up to the company. If they decide that they
want to try for a licence over the whole of Europe, they can apply
on the centralised procedure.
Q876 Dr Naysmith: It is not that
the European standard imposes higher standards or lower standards
than—
Professor Sir Alasdair Breckenridge:
No because, for a centralised procedure, if we are the rapporteur
or co-rapporteur or even an interested Member State, we will apply
exactly the same standards to assessment and our opinion as we
would to a national licence.
Q877 Dr Naysmith: What do you think
it is that makes a company choose one route rather than the other?
Professor Sir Alasdair Breckenridge:
I wish I knew. I have no idea. I think there are forces within
industry which must make that decision. I guess it may well be
if they are first in the field or if they are, using our vernacular
again, a "me-too" drug. I suspect that these are influences
which may affect them, but I think you would have to ask industry
that rather than us.
Chairman: If there are no further questions
from colleagues, can I thank you for a very interesting session.
We are most grateful to you. If you wish to remain for the subsequent
session, you are very welcome to stay. Thank you very much.
| 
