Examination of Witnesses (Questions 20-39)|
17 MARCH 2008
Q20 Mr Cawsey: So should one body,
for instance, HSE, take responsibility for all aspects of the
regulation of pathogens, including anti-terrorist provisions and
transports, to give laboratories a single point of contact?
Sir Bill Callaghan: It may well
be going a bridge too far to say that HSE would take on all of
the work of the security services. I am told that there is good
contact between HSE and colleagues in the security services, and
that is absolutely right, and is an issue perhaps you would want
to address to my former HSE colleagues, but I do know on other
issues where matters of national security have emerged that HSE
has always played a responsible part in activities of Cobra and
its associated committees.
Professor Griffin: There is another
very interesting and important aspect here as well. if you consider
there are four different types of laboratories at P3 and P4 levelthere
are diagnostic laboratories in hospitals, there are academic laboratories
in university institutions doing research, there is the Ministry
of Defence with biodefence, or bioattack, whatever you want to
call it, and that is three of themand each of those are
inspected. In the Hospital Diagnostic Service inspections are
carried out by private organisations who will come once a year
at the request of the hospital diagnostic facility, and they will
inspect the hoods and the procedures and so on and sign those
off, and if the hospital is happy with that then they continue.
So there is a private sector involved in this. The fourth arm
of this, of course, is industrythe big pharma, antibiotic
development growing dangerous pathogens. So you have four main
sectors from government through to big pharma operating, each
using the same regulations but being inspected maybe in different
ways, and that should be joined together.
Q21 Chairman: Bill, just briefly,
what I certainly did not fully understand, and perhaps you will
clarify this, is that at the moment a university can apply for
a licence. It satisfies the criteria and it gets a licence. It
can then use in a variety of laboratories a particular pathogen,
let's say a Level 3 facility. In fact, it can use that pathogen
in a number of different laboratories without having to have each
of those laboratories licensed. Are you saying that under your
new proposals there would be a risk assessment of each of those
laboratories before, in fact, they were licensed? Is that the
process that you describe?
Sir Bill Callaghan: At the moment
under SAPO licences are given, as I understand it, to individuals
to work in a particular laboratory. Under COSHH and GMO (Contained
Use) there has to be notification, and Mr Cawsey was bringing
out the different bases of who was, as it were, given the notification.
What we are suggesting is that, for work on all pathogens, both
animal and human, there should be a risk assessment conducted
by the duty holder that should then be submitted to HSE.
Q22 Chairman: So it will be, if you
like, the biosafety officer who would be responsible wherever
those pathogens were being used, rather than the individual?
Sir Bill Callaghan: Well, I am
not sure it would necessarily be the biosafety officer; it would
be the body corporate, the university, the hospital, the research
institute, and of course one issue which we touch on is who is
the controlling mind where you have a number of organisations
on one site, but there is someone clearly in charge who has to
put in the application and in health and safety law who would
be responsible. There are then clear responsibilities on the BSO
and other members of staff, but it would not be the BSO, in my
understanding at least, who would be putting in the application:
it would be the body corporate.
Professor Griffin: At the moment
in academia, and I am sure Dr Gibson will concur with this, it
is the head of the institution who is finally responsible, and
if there is a serious incident or accident then the head of the
institution is the one who would bear the brunt.
Dr Gibson: But here it is often the registrar
who delegates his authority to some minion who then gets the boot
thrown at them, and that is quite legal. That is how they slip
out of their responsibility.
Q23 Mr Boswell: I have two questions
about classification. The first one is, are the current risk classifications
of pathogens accurate and sufficiently comprehensive? Have they
in turn been properly risk assessed, and maybe at that point also
is the regime there coming together between zoonoses, human pathogens
and animal pathogens?
Professor Griffin: The risk groupings
are looked at each year by ACDP in the light of new information.
For example, if there were to be a change in resistance patterns
to an antibiotic or an antiviral drug, then the category of risk
for an organism could be moved upwards.
Q24 Mr Boswell: Or virulence of the
Professor Griffin: Exactly.
Q25 Dr Gibson: How would you know
there is a resistance?
Professor Griffin: Because there
is surveillance going on all of the time. For example, in routine
endemic influenza we know that the main drug, Tamiflu, many of
the ordinary strains of influenza now are resistant to Tamiflu,
so it is not just the H5N1 bird flu which is the serious strain
of flu. There is on-going surveillance and assessment.
Q26 Mr Boswell: Without talking about,
as it were, the whole medical profession, which is a separate
issue, in terms of those who are needing to work with these pathogens,
your change of assessment or your annual review of assessment,
that information, would be known to them?
Professor Griffin: Very much so,
Q27 Mr Boswell: And the animal pathogens
under this new regime would tend to adopt the same pattern, and
you would advise the veterinary profession?
Professor Griffin: Yes. When the
assessment is made you take into account many factors. Virulence
is a major one, of course. If there are drugs which can combat
the infection, if there are vaccines against that infection, all
of that comes in, and the CL4 ones are the ones with no drugs
and no vaccine.
Q28 Mr Boswell: So what at least
I think you have reassured me on is that it is not as if there
has been some assessment done in, say, arbitrarily, 1956 about
the virulence of F&M, or indeed a human pathogen like influenza
which is now still applicable. It is looked at every year.
Professor Griffin: Absolutely.
Q29 Mr Boswell: Secondly, how logical
and evidence-based are the current classifications of laboratories
under SAPO, COSHH and GMO(CU)? How well are they understood? That
is partly the training issue, but are they logical and rational
in themselves? You cannot look at them every year, for example.
Sir Bill Callaghan: We did find
some confusion, I must say, talking to laboratories about the
different classifications, but I think foot and mouth disease
virus is at the extreme end of the spectrum as something which
has the highest level of SAPO classification and the lowest level
of ACDP classification because it is unlikely to cause human disease.
One of the reasons for perhaps bringing this together in the round
is that if you say that something is Level 1 it sounds as if it
is not really important, and my opening remarks were trying to
address this issue, that failure at Pirbright led to considerable
Q30 Mr Boswell: Following on from
that, are the principles of design and operation for containment
laboratories at the different levels based on evidence? This presumably
includes economic risk as well as human risk.
Professor Griffin: Yes, there
is good scientific evidence for the procedures carried out. In
fact at the very highest level they are based on good evidence
and they are so secure that they often have failsafe procedures,
such as the heating that we were talking about.
Q31 Mr Boswell: Finally, on the international
perspective of all this, you operate as ACDP and you will clearly
be in contact with professionals in other countries, and there
is a European Directive as well that we are aware of. There is
a huge interest, of course, across the worldeasy transmissibility
by air travel, for example. How much can we be reassured that
there is a common approach to this, even if legal forms or slight
regulatory differences occur, across the major developed countries
at least, and that we are not going to have difficulties where
something gets through because somebody, it may not be in the
United Kingdom, is a weak link in a regulatory chain in relation
to a particular pathogen?
Professor Griffin: This, I must
say, is a concern. We heard three or four weeks ago of the American
gentleman, Dr Sharma, and really we are ahead of the States in
my view in our regulation of CL4, and I will be visiting some
of their sites soon. There is no doubt, however, that we have
a much tighter framework than that in the States, and you remember
he said that anybody who wants to have a CL4 can just build one
on their facility with little in the way of regulation. So we
are ahead in that. In terms of Europe there are two main sites,
one in Marburg and one in Lyon, and there are European regulations
which deal with this, as you say, which keep the developed world
as safe as it could be. At the end of the day, of course, a single
individual travelling on an aeroplane with a pathogen is not covered
by COSHH or SAPO; they are covered by themselves.
Q32 Mr Boswell: At least if we take
the specific answer you gave me earlier about your annual update
of pathogenicity, that information would be immediately transmitted
to your counterparts, and they would take it into account, and
if you had some aberrance or new experience that would go through
the community internationally pretty quickly?
Professor Griffin: Yes.
Q33 Dr Iddon: In your view do we
have enough capacity in the United Kingdom for handling research
on dangerous pathogens, either now or projecting into the future?
Professor Griffin: I do not know
at the moment, and I am just conducting a review on behalf of
the Medical Research Council; it has just started to look at this.
The MRC are charged to look at newly emerging pathogens and dangers
to public health from these, so there must always be surge capacity
available when something like bird flu or another of the emerging
viral infections happens. There probably is enough at the moment
but we are not well endowed. The Ministry of Defence has a facility
at Porton which is largely doing biodefence, of course. There
is spare capacity there, we know, and we would be able to use
that if necessary. The MRC is thinking of a new facility when
it moves in NIMR, as I mentioned, and the question is where would
that be sited. In Boston they have a CL4 facility in the middle
of the city, which is causing great perturbation at the moment,
and this may well be a very important guiding factor for the siting
of future facilities in the United Kingdom.
Q34 Dr Iddon: I am coming to that
aspect in a moment. What about the handling of large animals?
Can we do that in Britain adequately?
Professor Griffin: We can do that
in limited places. We can handle small primates at Porton at the
HPA facility for TB and HIV research and vaccine research. In
terms of large animals such as horses, cows, and maybe sheep,
the Pirbright facility, the new one that I hope you saw, will
be able to do that. Up to that time the only facility in the world,
as I understand, for very large animal Containment Level 4, post
mortem, was in Australia where they were doing work on Hendra
virus, but the new facility at Pirbright when commissioned and
tested will be able to work on cows.
Q35 Chairman: They, in fact, said
that that would not be able to --
Professor Griffin: For cows?
Chairman: Yes. At level 4.
Q36 Dr Iddon: For the CL3 and 4 laboratories,
in your opinion, from what you know and what you have seen in
your experience, is there enough maintenance money to maintain
these facilities in good condition?
Professor Griffin: In academia,
which is my own place of work, there is not. We have to beg and
scrape and get money for routine maintenance; every year we have
to have inspection of cabinets, replacement of filters, and this
is costly, very costly, and this, by and large, has to come out
of either research grants or out of the consumables which the
university has. It costs a great deal of money to keep these facilities
Q37 Dr Iddon: You have mentioned
the HSE a number of times as being a regular agency in this sphere.
Do we know how many CL3 and 4 laboratories we have in Britain
and where they are situated? Who has that knowledge? Who has the
Professor Griffin: That is a very
simple question with a complicated answer, I am afraid. If you
look at CL4 there are elements of security and so on, and so these
lists are not easily available for newspapers and so on for obvious
reasons. Defra has a list of CL4 and SAPO4 which we have all seen
but is not for public consumption; I have a list for the MRC for
this Committee that I am looking at at the moment; there are two
industrial sites which do CL4 work, two vaccine companies, Merial
and Schering. The rest are either government or academe, so we
do know what there is in terms of CL4. In terms of Containment
Level 3, the exact number is round about 350, I do not have that
list, and that is made up of diagnostic facilities in hospitals,
of industry, farmer, academe and government facilities.
Q38 Dr Iddon: Should there be one
body that overlooks this, like the HSE which you have mentioned?
Professor Griffin: I think that
would be incredibly useful and important.
Sir Bill Callaghan: In our report
we note the number of ACDP CL4 facilities, which are eight in
GB, and 352 CL3 facilities. For SAPO there are 68 laboratories
with a SAPO licence, and 10 are for work on pathogens categorised
as Category 4. In my previous existence I was part of a Commission
recommendation to take this information on laboratories out of
the public domain. This was after 9/11, for security reasons.
Q39 Dr Iddon: Professor Griffin,
you hinted at the fuss over a CL4 facility in the middle of Boston.
I understand the Germans are quite happy to have one in the middle
of Berlin, and we are considering putting one in the middle of
London. What is your advice to the authorities on the presence
either of CL3 or 4 in the middle of large conurbations?
Professor Griffin: I will give
you better advice in about three months' time when I have been
around, but at the moment I would try to avoid it, to be quite
frank. I would wish to have high security outside of a major city.