Examination of Witnesses (Questions 920
- 939)
THURSDAY 3 FEBRUARY 2005
LORD WARNER,
DR FELICITY
HARVEY AND
DR JUNE
RAINE
Q920 Dr Taylor: Are you saying that
the facts we have been given are probably not correct?
Lord Warner: I am happy to go
back and check. I have two colleagues here who are perfectly free
to correct their minister if he has got it wrong and I shall not
be embarrassed, but my understanding is that it is about 95% in
Sweden and it is about 100% in the Netherlands. They are nodding,
so I think it is probably OK. What I was also going to say is
that it is just worth thinking back to the dim and distant past
when there was significant grant aid from the government to a
predecessor body. That was changed because the backlog of licensing
applications was enormous, because the income from fees did not
seem to be very buoyant in terms of maintaining the capacity of
the regulator to deal with the flow of new drugs for licensing.
Under a previous government the move to a trading fund basis was
to generate buoyancy in the fee income. They then kept pace with
the volume of work that was coming into the regulator. That is
an important consideration. I go back to what I said about the
NAO, there is no evidence that this form of funding has in any
way skewed the decision making of the agency. It has also separated
operationally within the agency pharmaco-vigilance from the licensing;
it has separated that work under the chief executive, so you do
not have the same people doing the licensing as are doing the
pharmaco-vigilance in post-licensing. Dr June Raine is actually
the head of the Post Licensing and she has nothing to do with
the licensing applications themselves.
Q921 Dr Taylor: When the regulatory
system came in—and I am old enough to remember the problems
with thalidomide and it came in after the thalidomide episode—was
it funded by industry right from the start? Has it always been
funded by industry? What happened initially?
Lord Warner: I do not know whether
my historians on my left and right will be able to answer that
precisely?
Dr Raine: Yes, the initial operations
were not funded by industry; this was introduced in 1989.
Q922 Dr Taylor: So why does it change?
Dr Raine: For the precise reasons
that the minister has explained, that the operation then was not
capable of delivering new licences, delivering new medicines for
the benefits they bring in a way that was demanded; it could not
meet supply and demand. The funding enables us to match resources
incoming to the staff and other resources that are needed to deliver
new medicines promptly.
Q923 Dr Taylor: So what are saying
is that the only way of getting enough money into a regulatory
system is from the industry. There is no other way.
Lord Warner: I do not think we
are saying that. We are saying that history has shown that using
government grant did not produce buoyant income which enabled
the regulatory body to cope with the flow of applications for
licences.
Q924 Dr Taylor: That must have been
because the government grant was not big enough.
Lord Warner: That could well be
the case. If you go from where you are now, whichever government
is in office, there is a finite sum of money for healthcare. You
now have a judgment call: do you want, for no good grounds, and
with no evidence that the regulators are actually skewed in their
judgment over the licensing or post-licensing surveillance to
take however many millions away from somewhere else in the NHS
to fund the regulator.
Dr Taylor: I am only trying to establish
that with the amount of money that there is available from government
sources, there is not enough to do this, so the only source it
can come from is industry.
Q925 Chairman: Just to clarify the
historic background to this, may I ask Dr Raine a question? You
may not know the answer and it is probably an unfair question.
Do you know, when this change took place, how much more money
was proportionately able to be brought into this process than
was previously available from government? Have you any idea?
Dr Raine: In terms of funding?
I think it would have gone to a figure of around £30 million
per annum to resource the whole of the agency, of course it has
gone up since then.
Q926 Chairman: What was it previously?
Dr Raine: I do not have an overall
figure, but I do know that a new drug costs about £250 to
get the licence and that was not sufficient to recruit and retain
the numbers of staff. There was therefore a delay of around three
years in some cases before getting a new drug out to patients
who needed of it.
Q927 Chairman: It would be very helpful,
if it were possible, for us to have any information on the background
and the proportionate increase as a consequence of these changes.
It is a very important area.
Lord Warner: We are very happy
to provide the historical context for this, but it was basically
driven by this huge backlog.
Q928 Dr Taylor: Did you say that
the total cost was £250.
Dr Raine: No, that was the fee
that was charged.
Q929 Dr Taylor: The fee that was
charged was £250?
Dr Raine: For a new drug.
Q930 Dr Taylor: That is staggering.
That would be helpful.
Dr Harvey: In fact, in terms of
the approach of having the regulator with fees to those who are
being regulated, this is actually the approach which is taken
by many bodies across government. The MHRA clearly is the regulator
for medicines, but there is exactly a similar approach adopted
in many regulators that the government has right the way across
government. It is not an unusual occurrence.
Q931 Dr Taylor: That is very helpful;
thank you. May I go on to transparency, which we have already
touched on a little bit? We are pleased about the clinical trials
register and that all the data from that is going to be openly
posted. Will you be suggesting that the MHRA should make the data
it receives from drug firms open to the public?
Lord Warner: There are two aspects
to this. There is the obligation on the companies which certainly
the ABPI have accepted, that they should be publishing clinical
trials data in the public arena anyway. They are under a legal
obligation to provide information to the regulator anyway which
relates to either an application for a licence or which relates
to a licensed product. What we are keen to do and it was done
very well by the Committee on Safety of Medicines in the case
of Seroxat for example and selective serotonin reuptake inhibitors
(SSRIs), is to make sure that those decisions have the supporting
evidence put in the public arena, which is a slightly different
issue from publishing clinical trials. Instead of the regulator
simply saying "We think the risk benefit balance has changed,
therefore we think a particular product should be withdrawn"
or not, as the case may be, it would actually put the evidence
behind its decision much more fully in the public arena. I cite
the SSRIs as the example where I think that pattern is established.
Certainly I am very keen and the agency knows that the government
is keen, that that information is put in the public arena so there
is no doubt about why the balance was struck. It relates back
to an earlier question about the difficulty of some of these judgments
which have to be made. People will be more convinced that the
judgments have been fairly made, if the supporting evidence for
their judgment is clearly in the public arena.
Q932 Dr Taylor: That is very encouraging.
Does that mean, with the Freedom of Information Act (FoI), that
will be interpreted literally and the MHRA will have to make available
the sort of information that is already available in the United
States?
Lord Warner: This is better linked
to a decision-making process. The short answer is, in all probability,
yes. I am not saying that we feel you need FoI to drag the information
out of the agency. I am saying that it is in our interest and
the agency's interest to publish the data which they relied on
in forming their judgment about whether or not to withdraw a product
which had already been licensed when there were adverse consequences.
Q933 Dr Taylor: We are told as well
that in the States advisory committees actually sit in public,
so everything is known. Is there going to be any move towards
that?
Lord Warner: We have no plans
at the moment. These are always difficult issues here about whether
people feel inhibited in their free and frank discussion about
information in those particular areas. It is an issue we could
consider, but I would not want to make any promises. We do have
a situation here where we are moving these committees to have
more patient representatives in them. We need to take a careful
look at whether that would have advantages or whether it might
actually, in some cases, inhibit people's frank analysis and comments
in some of these areas.
Q934 Dr Taylor: How will you be supporting
extra patient representatives? How are you going to encourage
them to make that possible and to make these representatives really
effective? We have heard about the NICE (National Institute for
Clinical Excellence) citizens' council and we heard early on the
plans that was making. We actually have not heard anything about
how successful that has been. How are you going to empower these
people and put them in so that they really can make a difference
to the process?
Lord Warner: It is a very fair
point. In other fields there is always a great risk that, in these
sorts of circumstances, people become token appointments and get
isolated. We are well seized of the need to have a patient support
mechanism. I think where we are likely to be is having some kind
of over-arching patient advisory body and we actually have patient
support arrangements for the people who are on the particular
committees. We are very clear that there should not be single
patient appointments, that there should not be just one patient
representative on a committee. There is good evidence around in
other fields that that is not a very successful way to get the
best out of patients. We are working with Mr Harry Caton who is
the department's adviser on patient issues to see what support
mechanisms we need to put in place to make this a success. We
accept the point that you are making in your question, that it
needs to be watched very carefully.
Q935 Dr Taylor: From what you have
said, can we take it that you will ensure that the British public
gets the same access to policies and resources that the people
in the States have?
Lord Warner: We shall probably
do things slightly differently. I am certainly not going to go
on the record as saying I am going to copy everything that is
actually done within the framework of the FDA. We will learn from
that.
Q936 Dr Taylor: But you will aim
for the same degree of discussion?
Lord Warner: We are aiming for
transparency in this area in order really to enable the regulator
to demonstrate that their decisions are well founded. The point
I would make is that it is not in anybody's interests to create
a climate in which regulators make decision which are then called
into question because there is not enough transparency about the
way that decision was made.
Q937 Dr Taylor: People need to see
both sides of the argument and they need to hear the dissenting
voices as well as the supporting voices.
Lord Warner: Absolutely. It is
all part of this business of improving public understanding of
the difficult judgments that have been made, which have been touched
on earlier, on some of these products. Getting the right balance
on risk and benefit is very difficult in some of these areas and
the more we can have information demonstrating this in the public
arena, the better it will be for everybody.
Q938 Mr Jones: I think the committee
were very pleased to hear what you said about publishing data
and allowing the public to see what the information is. It is
likely to improve decision making, not least, I should imagine,
probably their competitors would be interested to ensure that
are no glaring faults or missed information in the data. In the
absence of that up to now, the MHRA's reliance on company analysis
and summaries of research findings clearly is not justified, at
least in every case; I can see that it was not justified with
Seroxat for example.
Lord Warner: You have mentioned
a particular product, so I am going to turn to the person who
led the work in this particular area.
Dr Raine: Perhaps to deal first
with the point about the use of summaries. Summary is perhaps
a misnomer: these are very large and very detailed analyses of
what would be otherwise vast amounts of original patient data.
It is the standard practice in European drug regulation, indeed
regulation worldwide, to look at analyses and then to drill into
the detail that is needed, as it is needed. When we say analyses,
we are talking 200 dossiers for an average type of new drug, so
to say "summary" is perhaps misleading your thinking.
Q939 Mr Jones: I do not want to go
into too much detail, but with that particular drug you were not
provided with all the relevant information, were you?
Dr Raine: We were certainly provided
with all the information in order to make a risk benefit judgment
at the time of licensing. Clearly, when the review was conducted
which was published in December 2004, we had access to a far wider
body of information but in addition we carried out re-analyses
of original trials. It has been done in other situations too,
with Epogam, which the Committee has mentioned in the past, we
went back to original data. This is the way that regulation works
and it is quite proper to operate it in that way. The decision
which was published in relation to Seroxat last December took
account of population studies, ADR reports, patient experience,
as well as original clinical trial data re-analyses in order to
make the best balanced judgment that could be made and indeed
it is now in the public domain.
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