Examination of Witnesses (Questions 240-259)
PROFESSOR MARTIN
SHIRLEY, PROFESSOR
ROBIN WEISS
AND MR
MICHAEL STEPHENS
31 MARCH 2008
Q240 Chairman: You feel there should
be a sufficiently rigorous risk assessment process which should
avoid that happening.
Mr Stephens: Absolutely, yes.
Q241 Chairman: Martin, we heard from
the previous panel that a common agreement to have all the regulatory
organisations brought together with a common point of entry was
something which they broadly supported. Is that something you
would broadly support?
Professor Shirley: I think it
is. The Pirbright experience has clearly shaped my judgment on
many things and the more uniformity and standardisation we have
in these areas the better, quite frankly.
Professor Weiss: For laboratory
research yes, but we cannot lump humans and animals together all
the way along the line. If there is an outbreak of a dangerous
pathogen in animals we cull animals, but we do not cull humans.
If we are talking about laboratory containment, yes, that would
make sense, otherwise we have to use common sense.
Q242 Mr Cawsey: Martin, I want to
talk, as I did to the previous panel, about the outbreak at Pirbright
last year which is of course something you went through. Looking
back at it now, was it a failure of the regulatory system or was
it a failure of the people operating the site?
Professor Shirley: I think a lot
of words have been spoken about foot and mouth 2007 and I think
probably Iain Anderson got it about right in looking at a number
of areas where perhaps there were responsibilities. The whole
of Pirbright was complex in terms of its regulation, the licensing
arrangements, the lack of transparency between what was a government
funded research laboratory handling small amounts of virus and
an industrial pharmaceutical company next door. I think the reasons
were multifactorial and certainly we were not sitting idly before
the outbreak not proactively looking at the biosecurity arrangements
and looking at risk assessment for the Institute. There was no
clear transparency of the arrangements with SAPO licence vis-a"-vis
the IAH and Merial next door. What surprised us—you heard
this from the earlier session—was the lack of consistency
in terms of what was permitted under the SAPO licence. Certainly
we tried to get to grips with that to find out what the conditions
were. We have never been told that so our risk assessment was
based on the fact that next door the amount of virus going into
the drains was close to zero. I think we were as shocked as everybody
else was to discover that with some of the non-validated processing
of virus production up to one thousand million virus particles
were being discharged from a production batch of vaccine. That
was very illustrative of the complexity of the situation at Pirbright
and I think there were other factors at play as well, including—as
you saw in the Anderson report—the complexity of governance
and ownership. All these things came into play with some very
long leases underpinning some of this, going back almost 20 years.
It was a situation that probably needed to be reviewed objectively
and more timely than it in fact had been done.
Q243 Mr Cawsey: Do you think the
introduction of a single regulatory framework under the HSE would
be sufficient to ensure that such an outbreak does not happen
again?
Professor Shirley: I think there
have been a lot of changes since August and certainly there has
been further layering of biosecurity, for example, in the Institute
for Animal Health and covering a number of areas. We certainly
welcome the new regulatory body because what will happen is that
it will provide a further kick-start to the way we work; it will
bring consistency with the animals and the human pathogens which
I think is welcome; it will bring in another standard. I think
there will be real positives coming out of the lessons learned
from Pirbright.
Q244 Mr Cawsey: Do other members
of the panel think that as well?
Mr Stephens: Yes, certainly.
Professor Weiss: Yes.
Q245 Mr Cawsey: Martin, in a previous
panel we had quite a good discussion about the re-development
programme and who is going to pay for what and if they ever will.
I thought you might welcome the opportunity to tell the Committee
how important you feel that investment in the Pirbright site is.
Professor Shirley: How long have
you got? I think this is really, really, really important as a
national facility and what the UK needs, I believe, is a proper
facility focussed on these increasingly important pathogens of
livestock, facilities dedicated to these pathogens such as foot
and mouth or blue tongue or African swine fever and many others
which are now coming to our shores. This facility has to be properly
funded into the longer term. Professor Thorns was talking about
the capital cost, but what I want to see is a facility devoted
to animal health research which is not necessarily focussed just
on the exotics but brings together for the benefit of the UK fundamental,
strategic and applied sciences around important pathogens but
also bring together the important biologies around that. That
must be properly funded in terms of state of the art facilities
which I think our science deserves. The Institute for Animal Health
is world-class but we are not operating in world-class facilities.
We need to have proper capital funding but beyond that we have
to have clear transparency over the running of a facility such
as the IAH in the national interest. We are serving the national
interest and we are protecting the UK against a number of disease
incursions which are in fact coming to our shores more and more
frequently. It is absolutely vital that we have this facility,
that it is properly funded and it is funded into the future so
we are not in any way living from hand to mouth.
Q246 Mr Cawsey: Do you therefore
agree with the Anderson idea then?
Professor Shirley: I have no problem
with the Anderson review. What I would want, as Director of the
Institute for Animal Health, is a national facility wherein there
is complete clarity over governance and funding and it is assured
into the future so everybody can plan effectively over the next
five to ten years.
Q247 Chairman: We are not going to
get that, are we?
Professor Shirley: I hope we are
going to get it. The worry would be that we do not get it and
we continue to live trying to run a national facility with some
of the funding coming in on a one yearly basis, which is only
negotiated into the start of the next financial year or into the
current financial year. I believe we have to have this long term-ism
because we are dealing with long term diseases. We only need look
at the blue tongue story to understand exactly where the science
is coming from and this goes back maybe a decade to the recognition
of climate change and global warning when the Institute was in
a position to deliver science through to Defra to help bring the
2007 outbreak under control, be in a position to inform government
as to how to deal with the impending epidemic in 2008.
Q248 Dr Gibson: Robin, you have done
some work on retroviruses and they are a special category of virus.
Are there special dangers perhaps or special hazards? Have you
ever worried about any implications or working with that and the
health of the people who have worked with you?
Professor Weiss: The Aids pandemic
is in a special category; malignancies caused by retroviruses
too. In terms of handling them as dangerous pathogens, they are
not that special. They are an example, as we put in our evidence,
where the HSE regulations for Category 3 laboratories—they
are usually Category 3 but they are bit lower in the United States—predicated
on engineering and air flow and the dangers of needlestick injuries
like working with hepatitis B and other human pathogens. When
we first started working on HIV—it was newly discovered
a few months earlier in Paris—we were very nervous. We devised
a test that went into the blood banks.
Q249 Dr Gibson: Was this pre-Category
4 facilities?
Professor Weiss: It was about
2.5; it has never been Category 4, it has been Category 3. You
just have to get up and do it. We were very nervous. We were gowned
up and in there and we used to test ourselves every three months
because we already knew how it was transmitted—by blood
and by sex—but we did not want to pass it on if we caught
it.
Q250 Dr Gibson: How did the HSE behave
in this whole period of time? What was their attitude to it?
Professor Weiss: This goes back
24 years. They were a mixture of being very helpful and covering
their own backs.
Q251 Dr Gibson: And now?
Professor Weiss: There is a wealth
of experience now. We helped to train officers within HSE and
now they help to train us.
Q252 Dr Gibson: How often did you
see them and how often do you see them now? Has there been a frequency
change?
Professor Weiss: Yes, less often.
Q253 Dr Gibson: Could you be more
specific on that?
Professor Weiss: Not without going
back over the records, no.
Q254 Dr Gibson: Do they come once
a year, once every ten years, once every 24 years?
Professor Weiss: You mean to my
laboratory?
Q255 Dr Gibson: Yes.
Professor Weiss: About once a
year, or communicate once a year.
Q256 Dr Gibson: They see you once
a year.
Professor Weiss: Less than once
a year they actually visit on site; more like once every two years
I would think.
Q257 Dr Gibson: Do you know they
are coming?
Professor Weiss: They have a perfect
right to arrive unannounced.
Q258 Dr Gibson: Do they?
Professor Weiss: No, but our own
biological safety officer does.
Q259 Dr Gibson: Who is the biological
safety officer? How trained are they? Have they worked with the
viruses?
Professor Weiss: No.
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