Examination of Witnesses (Questions 220-229)|
31 MARCH 2008
Q220 Dr Iddon: Turning to universities,
do you know of any universities who have asked for a Category
4 facility on their siteagain we need not name sitesor
is the general feeling that if universities need to handle Category
4 viruses there are enough facilities around the country for them
to share other Category 4 laboratories or Category 3 if necessary?
Sir Leszek Borysiewicz: I know
of at least one university which is considering an application
or has already submitted an application in that regard. There
are decisions that have to be made as part of the forward planning
process and this is so important. We have seen an increase in
categorisation of pathogens where the category of pathogens, particularly
of human pathogens, is always escalating because, quite rightly,
we want to operate to the highest possible safety standards for
operators and any release. In certain situations it is interesting
but also quite good that universities might also be forward planning
and thinking that that might become a requirement in the future.
Yes, it does happen; yes, there are European universities that
have such facilities on site as well in very major conurbations
around Europe although I obviously cannot name them directly.
Q221 Mr Cawsey: I would like to ask
you something we have already asked other people and have had
completely contradictory advice so we would be genuinely interested
to know what you would say about this and it is about training
for those working with dangerous pathogens. Should training be
provided locally or should there be a nationally prescribed set
of competencies, perhaps linked to certification? If so, who would
Sir Leszek Borysiewicz: When you
are looking at a Category 3 or a Category 4 facilityI have
actually worked in one for the science I have undertaken so I
am pretty well aware of Category 3 facilities firsthandwhat
is really important is that you have a system where you have biological
safety officers who are a very important group of people who regulate,
often within an organisation, how safety matters are actually
managed. You need a facility manager to make sure that everybody
is competent and you need the actual operators on site as well
as principal investigators who may or may not be directly involved
in the work concerned. The bottom line is that all of them have
to be trained but they all have to be trained to a different extent
in the different elements that are necessary to operate safely
within this environment. At the present time the MRC for biological
safety officers provides the only formal training course and we
have a lot coming in from industry and elsewhere to the courses
that we organise. I understand that we are in discussion with
ISTR and this may well transfer and be part of the course that
they are contemplating in this area. I think it would be helpful
to have a system whereby there is certification of people's training
at different levels. However, there is something we must not overlook
and that is where the primacy of the responsibility for the safety
of the individuals actually participating and working in such
an environment actually resides. I can only give you a personal
anecdote, but if I were running a Category 3 facility I do not
care how many bits of paperwork a technician or a member of staff
actually has, until they prove to me they are competent and are
not endangering themselves or others I will not sign off that
individual to actually operate within that sector. Yes, certification
goes part of the way in showing general competence, but I still
believe that over and above that the people primarily responsible
have to take the responsibility and can assure themselves that
that person is not a danger to himself or to others.
Q222 Mr Cawsey: Some people think
a blank canvas is the best starting point.
Sir Leszek Borysiewicz: Some might,
but I think you have to have a level of competence and knowledge;
you have to understand to a greater or lesser extent. A technician
may not need to understand the regulatory framework in quite the
same detail as a biological safety officer but to have no knowledge
of that I believe would not be very helpful in the current climate
or actually in any good regulatory climate. I would be in favour
of having core training programmes that would be available to
these individuals, but at the end of the day the sign off for
somebody actually running and operating and working within such
a facility would still have to be the responsibility of the investigator
proposing to undertake this work. You cannot escape that. That
would be the view that we would take.
Q223 Mr Cawsey: Is that generally
Dr Stephenson: I would fully support
the MRC's position. In fact in the Health Protection Agency we
run a cascade system of training for pathogens. Everybody coming
into the Agency starts with a training package at Category 2 and
then up to Category 3 and only those people who have been fully
trained in Category 3 and have substantial experienceI
am talking about several years' experiencewould then be
allowed into Category 4. Paper is a useful start but we operate
exactly the same principle that the people who are operating within
those facilities are always trained alongside a trained and experienced
operator and in fact in the Category 4 facilitiesand in
fact most of the Category 3 facilitiesnobody ever operates
alone, you are always operating with other people. We too run
formal training courses both for the NHS and for commercial companies
and we will be building in the very near future a purpose built
training facility on the site at Porton Down to train people right
up to Category 4 in biological containment and emergency response
and a lot of other things as well. I think our position is pretty
much in parallel with the answers already given.
Sir Leszek Borysiewicz: Just to
add one point, it is not just the training, it is maintaining
CPD. We need to make sure that people are current because the
regulations are changing and the pathogens you handle are changing.
There is a difference between the generic training that you can
give and specific training which has to be given on site. Every
one of these facilities handles different pathogens. If you are
working in a prion facility, as Dr Gibson has already raised,
you have to have very specific training and frankly there is only
one place you can get that in the United Kingdom at the present
time and that is why the sign off has to be there. It is a mixture
of generic and specific and I think to be reasonably well certified
in the generic would be a help but that does not absolve anybody
from the very specific training that is required.
Q224 Dr Gibson: There is a view that
new diseases are going to creep up on us. Are we ready for that?
Sir Leszek Borysiewicz: One cannot
argue that that might be one direction. At the present time hopefully
that is not the majority view, but I think disease will always
remain a risk, particularly now that we have seen that they can
jump species in the way that they can and it is something we have
to keep on board all the time. It has happened once. Could I guarantee
it would not happen again? Of course not.
Dr Stephenson: There are new biologies
out there which we are unfamiliar with so we must be prepared
for the unexpected.
Sir Leszek Borysiewicz: We also
have to be careful as to how agents are handled within these facilities
and there the regulations are very important. We know, for example,
flu can jump if you get multiple infections because of the very
nature of its genome. A great deal of care and training is required
specific to the pathogens and not just the prions, although prions
are a very good specific example.
Q225 Chairman: We keep moving to
prions but can I come back to trainees? Dr Stephenson, do you
feel that we have sufficient numbers of trained staff at Category
3 and Category 4 in the UK?
Dr Stephenson: I can only speak
with any authority for the HPA and at Category 3 that is certainly
true. I am not so confident about Category 4. We have only three
or four people in the HPA who are fully trained and experienced
to Category 4 and we have another five who are coming through
the process. They are coming through that training process but
they are not sufficiently experienced to operate alone or to be
in charge of a programme.
Q226 Chairman: Chris, do you agree?
Professor Thorns: On the animal
side at the VLA we have enough people at SAPO 3 and ACDP 3. With
regard ACDP 4 we are looking ahead and we have a person spending
six months in the United StatesTexas, I believelooking
at some of the ACDP 4 facilities there.
Q227 Chairman: Sir Leszek?
Sir Leszek Borysiewicz: Actually
I think we have some shortage and I think the shortage is because
we have to think of the totality of what this means for the UK.
We have a very important pharma sector that is going to be also
engaging in this and they are going to require trained personnel,
particularly if categorisation of pathogens continues to be increased.
From my point of view I think the areas that are really of concern
to me are trained managers and biological safety officers to ensure
that we have actually got the safety profile. I would like to
see an increase in the numbers of people we have with these capabilities
built into the system. I think we do need more staff, particularly
in those two senior positions. We will train operators as need
arises and that can be done in this area, but I think it is these
others who have to take the broader purview of running these facilities.
I do think we need some expansion.
Q228 Chairman: Is it a priority for
you, Mr Visscher?
Mr Visscher: I think the availability
of expertise is thin in some areas. I think Professor Shirley
will be able to give you a better answer to this, but in areas
of blue tongue where IAH leads the world it is a very small team
of people in practice who are holding that level of expertise.
Dr Gibson: Mr Visscher, do you think
with migratory birds carrying these things about the world? That
is what every government minister seems to say when you ask them.
Do you believe that? Are you having a laugh at government ministers?
Q229 Chairman: We want a definitive
answer from you; your whole future depends on it!
Mr Visscher: You are of course
addressing the one person on this panel who is not a qualified
Chairman: You need a policy maker to
make these decisions. This session comes to an end amid laughter
and we thank very much indeed Professor Chris Thorns, Dr John
Stephenson, Sir Leszek Borysiewicz and Mr Steve Visscher. We are
very grateful to you.