Examination of Witnesses (Questions 600-615)|
TUESDAY 11 MARCH 2003
Baroness of Finlay of Llandaff
600. Could you just try to put this quite simply
for me? How could the UK system be simplified to be closer to
the US system, which sounds as though it is more streamlined?
(Dr Chatfield) It is not an issue about the UK system,
it is an issue about the European system, in terms of the existing
agencies and the way they work. Although we have a centralised
procedure, for a biotech product we could not just take it through
the UK procedure; in terms of regulatory approval it has to go
through the centralised procedure. So in order to be able to simplify,
in the end it needs better understanding, better coming together,
better harmonisation of immunisation regimens for instance in
different territories. That is the way you could end up simplifying
601. How much dialogue is there within Europe
between people like yourselves?
(Dr Chatfield) We spend quite a bit of time talking
to different regulatory agencies within Europe. You have to introduce
the national agencies fairly early on to what you are doing in
terms of a product development concept in order to overcome some
of the issues you alluded to. You do not want to leave it until
you have your registration package together and have done all
your pivotal clinical studies then to find that this package may
not be acceptable in one of the territories and you need to go
back and carry out further work. You need to understand those
things early on.
602. I meant people like yourselves as a group
who are doing the research and production. How much of a united
voice is there coming from there into all the European regulatory
bodies that this has to be made simpler?
(Dr Chatfield) There is quite a bit of pressure from
different groups, particularly from the European vaccine manufacturers'
group as well.
(Mr Kingston) The position from the industry's point
of view is a clear one. For us EU harmony in schedules and licence
procedures is good because that means we can bring vaccines and
make them available faster. We will perpetually say the more harmonisation
we get in schedules and requirements, the better. That is the
principle we work to, but in practice you do find in the limit
one country will just be dropped from the procedure because they
are preventing a licence being granted in the other nine or ten.
Lord Lewis of Newnham
603. How many of these licences do you have
to go for? How many countries are involved in this? How disparate
is this particular problem?
(Dr Chatfield) There should be one licence for all
the territories. That is not the issue. There are certain variations
on what might be acceptable in some territories rather than others,
related to immunisation schedules which you have to make sure
you understand early on in the licensing procedure.
604. How many territories would that involve
in the worst scenario?
(Dr Chatfield) The number of members of the European
Community; 15 now and 25 next year.
605. Is there no attempt within Europe to give
you what you are asking for, within the European Union itself,
(Dr Miller) There is the European Medicines Evaluation
Agency for biotech products. That has a central registration process.
There are guidelines about GMP, about avoidance of BSE agents,
which apply across Europe. It is not quite as bleak and as fragmented
as my colleagues have made out. The arguments around it being
easier if everybody were harmonised onto the same immunisation
schedule, have been debated inside out and upside down. That is
not going to happen, simply because epidemiology differs quite
markedly between countries, the way the health services are organised
in different countries means that the opportunities for vaccination
are going to present at different ages. It is a Utopia which will
not happen unless we have a Federated States of Europe and we
all do everything all the same. The solutions have been for the
manufacturers to look at extremes of the schedules which are available
in the European Union and that seems to me a perfectly reasonable
solution. You always get idiosyncratic countries with one medical
assessor who has a particular view. Unfortunately that is a reality
(Dr Chatfield) What we are saying is that as part
of the process, we have to understand what those idiosyncrasies
are in terms of how we design our clinical programmes.
Lord Lewisham of Newnham: May I declare an interest?
The fact that you are having to go to DEFRA for GM does not worry
me in the slightest. I should be very worried if you could get
a GM product onto the market without having to go to DEFRA. They
have set up a process and a protocol which is absolutely essential
if you want to get the public at large to accept GM products.
606. What is progress in Britain? How much work
is going on in developing vaccines for malaria and TB, leaving
aside HIV as perhaps the main killer in the world at the moment.
(Mr Kingston) I shall answer that in my company capacity
for GlaxoSmithKline, if I may, because I cannot speak for all
the other companies' development programmes. Those three diseases
are clearly disease areas which would bring an enormous health
benefit to the developing world. We do have programmes to develop
vaccines for all three of them: HIV, malaria and TB. HIV is probably
at the earliest stage, because technically it is so hard. Those
programmes are managed as part of a large corporation's corporate
and social responsibility bit of the business. The funding would
not be at high price levels and it would be arranged through UNICEF
or through the Bill and Melinda Gates Foundation or GAVI or these
people. There is an active desire and programmes in place to try
to get research breakthroughs on those three disease areas for
the developing world.
607. How does funding research for TB and malaria
compare with funding for research on other vaccines?
(Mr Kingston) At this stage, because we are not into
the final scale of clinical trials, it is comparable. Again speaking
from a GlaxoSmithKline company perspective, of the £150-£200
million annual spend, the vast majority is in late stage clinical
trials on products which, all being well, will be on the market
next year, the year after, the year after that. Until we get to
the phase 3 trials, a lot less actual expenditure is required
in relative terms and the money is there.
608. Is much work going on into vaccine development
for non-infective diseases, cancers and the like?
(Dr Chatfield) Yes, there is a lot of work going on
in that area, particularly in some of the smaller biotech companies,
but it is at a fairly early stage in terms of where it is going.
One or two UK companies are involved in that.
609. Are any of the big pharma companies involved?
(Mr Kingston) There is one particular example on which
two companies are very actively working and my company is one
of them. It is a vaccine against human papilloma virus, which
is an established precursor of cervical cancer. And hepatitis
B vaccine will protect against a disease that will ultimately
lead to cancer of the liver. In terms of therapeutic vaccines
as cures for cancer, again there is some interest but it tends
to be in the big companies, as far as I am aware, at the pre proof
of principle stage.
610. The Gates Foundation has put a lot of funding
for vaccine production in many of the important areas but this
is for a limited time. Who is going to pick up that sort of assistance
on vaccine development when the Gates money comes to an end?
(Mr Kingston) I do not have a specific answer to that.
611. Who should? Let me put it that way.
(Mr Kingston) The Gates Foundation money and the way
they have used it to work with the supplying companies has clearly
shown how many millions of doses can be administered to people
who would benefit from them. Those vaccines are generally supplied
at something very close to the cost of goods, so it is a very
tiny cost compared with what would be charged in a developed country.
Who should fund when the Gates money runs out? I do not know.
Companies themselves clearly have corporate social responsibility
programmes where drugs are donated against specific diseases in
specific territories. UNICEF and the European Union will doubtless
keep having their funding programmes in place. It is not an easy
question but the positive way of looking at it is that we have
now seen what can be done and hopefully before the Gates money
does run out, a longer-term solution will be identified.
(Dr Chatfield) I do not think I have much to add to
that, but maybe we will have to end up with more government consortia
being able to pick up on that funding.
612. We are nearly at the end of our session
but two points, one for Dr Miller. Will the Public Health Laboratory
Service functions with regard to vaccines continue with the HPA?
(Dr Miller) Certainly the intention is not only that
they should continue but they should flourish within the Health
Protection Agency. In the period of transition, particularly with
the return of some PHLS laboratories to NHS management and the
general reorganisation which is happening within the NHS with
the formation of the strategic health authorities and PCTs, we
are concerned that short term there may be an interruption of
the high quality surveillance data that we have. The potential
of having CCDCs as part of the Health Protection Agency and widening
the remit should mean that it becomes better eventually, but we
do see some risks in the short term during this period of change,
upheaval and struggling to identify routes, responsibilities and
accountabilities and keeping information channels flowing.
613. Thank you; that is good news. Could we
ask Mr Kingston to send us some information, especially the list
of vaccines you said are being over-produced, which are not being
taken up? Could you let us have a list of those and also any possible
costings which might be associated with those? I am aware that
it takes funding to development and the costings, which might
be rather hidden in way, for not using them, the loss.
(Mr Kingston) Understood.
614. The question is whether they were too expensive
for the various authorities to use them.
(Dr Miller) It is a bit more complicated. In the case
of varicella for instance, there are risks associated with the
use of the vaccine, longer term risks, which need to be thoroughly
looked at in epidemiological data. It is not just a question of
not spending the money, it is thoroughly evaluating how best to
use them, the most efficient way and the most cost effective way.
Baroness Finlay of Llandaff
615. It may also be useful to have an idea of
some of the future developments as well, to give us an idea how
broad you see future developments. You have spoken of HPV and
a little bit about some of the trials which are going on, but
some of the other agents which are on the stocks which we might
see emerging in five or 10 years would give us a feel of the background
research which has not yet come through into the clinical arena.
(Dr Chatfield) Yes; certainly.
Chairman: Thank you all very much indeed for coming
along. We have covered a wide field and it has been most interesting.
If there are any additional points you feel we have not touched
on and should have touched on, please let us know in writing.
You will receive a transcript of this morning's session and you
will have the opportunity to correct any factual errors. Again,
let me thank you very much and we look forward to hearing from
you, Mr Kingston, in response to our request. Thank you.