Examination of Witnesses (Questions 299-319)
RT HON
DAWN PRIMAROLO
MP, IAN PEARSON
MP, RT HON
LORD ROOKER
OF PERRY
BAR AND
LORD MCKENZIE
OF LUTON
21 APRIL 2008
Q299 Chairman: Could I welcome our panel
of ministers for this, the final session of the Innovation, Universities,
Science and Skills sub-committee work on biosecurity in UK research
laboratories. We welcome this afternoon the Rt Hon Dawn Primarolo
MP, Minister of State for the Department of Health, Ian Pearson
MP, the Minister of State for the Department of Innovation, Universities
and Skills and obviously for science, the Rt Hon Lord Rooker of
Perry Bar, the Minister of State for the Department of Environment,
Food and Rural Affairs and, last but by no means least, the first
time we have met you at this committee or indeed my previous committee,
Lord McKenzie of Luton, the Parliamentary Under-Secretary of State
for the Department for Work and Pensions. This is probably the
first time that we have had four ministers from different departments
on one inquiry, but we are very, very grateful to you for giving
your time. I wonder if I could perhaps start with you, Ian, this
afternoon; if you could chair your panel and if you feel that
a question should be deflected elsewhere could I just ask you
to accept that responsibility, if it is a difficult question it
can go to one of your colleagues, depending on whether they are
on the left or right of the party. We have obviously obtained
a lot of evidence about biosecurity and I wonder if we could start
by saying who do you think is actually in charge within the Government
for biosecurity. We have received, obviously, a memorandum from
four different departments here but who actually is in charge,
who pulls it all together, who actually cracks the whip when things
are not going well?
Ian Pearson: The first thing to
say, Chairman, is thank you for the invitation to attend this
Committee; the fact that you have got four Government ministers
here shows that this is very much a joint responsibility and,
as Spratt reports and Anderson reports, it is clearly demonstrated
with the recommendations that they made there are lessons we have
all learned from the outbreak at Pirbright. First and foremost,
obviously it is the responsibility of individual facilities to
ensure that they conform to good biosecurity practices, whether
that is in an institute or whether it is in a university research
laboratory, and it is the responsibility of regulators to make
sure that sites are operating in conjunction with the terms of
their licence. We have had a number of different reports into
this at the moment and the clear conclusion from those reports
is that there are lessons for all of us to learn.
Q300 Chairman: But who pulls it together,
Ian?
Ian Pearson: We are actually learning
those lessons and you will see that we have actually responded
very positively to Spratt and, recently, we have seen the publication
of the Beringer report and you will be aware of BBSRC's response
to that in the form of the press statement which was issued on
Friday of last week.
Q301 Chairman: When you say "we"
you obviously mean the Government in its collective state but
who actually within Government pulls the thing together? Is it
you, is it DIUS, is it you, Dawn, within health, is it you, Jeff,
within Defra? Who is it?
Ian Pearson: Perhaps if you can
explain what things you are talking about pulling together then
we can try and help you.
Q302 Chairman: Following the Pirbright
situation we have clearly had, for instance, an independent review
that has highlighted Defra's conflict of interest over the shortcomings
of the SAPO regime; who was responsible for picking that up, was
it you in Defra, or was it a mistake that had been made in Defra,
was it an oversight? The point I am trying to make is, is there
nowhere within Government where you all come together as a group,
the four different departments, and actually share information
and actually have some co-ordinating organisation to make sure
that biosecurity and biosafety is something that pervades every
aspect that you are responsible for?
Lord Rooker of Perry Bar: In a
way you have asked a question specific to biosecurity wich is
why I do not think you will get the specific one size fits all
answer that maybe you are looking for. Within our individual departments
we have got laboratories that are our own laboratories, they may
work with others but nevertheless—that happens in Defra,
some of which I am ministerially responsible for, but Pirbright
I am not because it is not a Defra laboratory, we are a customer.
We were also the regulator, we were also the inspector and probably
we were the major customer of course. That perceived conflict
had probably been identified some time before when we were looking
at the review of where laboratories were fitting within Government,
but then the laboratories themselves have their own networks within
departments and across departments and they are looking at things
other than biosecurity—they are looking at the service to
customers, research facilities and capital investment programmes—maybe
where they can be shared—but when it comes down to the actual
nuts and bolts of the biosecurity, wherever the laboratory may
be located,, some of it is pretty basic. If you go back to the
Health and Safety Commission report published in September, when
even the vehicle numbers going on our Pirbright site were not
being recorded and times on and off the site were not being recorded,
about as basic as you can get, no regulator and no inspector can
actually carry the managerial responsibility for that, that has
to be imposed on the site operator and it has to be imposed by
the person either regulating or as the customer giving the set
of parameters, but the actual function of that has got to be the
actual site operators themselves.
Q303 Chairman: The point we are trying
to make here is that whoever is operating the site, under the
aegis of whichever Government department, there perhaps should
be common standards which in fact prevail right across the piece.
Is that not reasonable?
Lord Rooker of Perry Bar: It will
vary from site to site—the location of the site, the risks
around sites: some may be urban, some may be rural for various
historical reasons or indeed customer orientation reasons, but
the basic principles of biosecurity, whether it is a laboratory
or indeed a farm, are quite well known. We do not have to write
and invent the process here. I get annoyed when I go on farms
and it is only when there is a disease outbreak that you get some
biosecurity at the front of the farm. Occasionally there are farms
which have got it 365 days a year and you could argue that that
would be good preventative practice.
Q304 Chairman: The Callaghan review
made it absolutely clear that Defra, the Department of Health,
Health and Safety Executive and other interested parties should
work together much more closely than they were doing at present;
you seem to be giving the impression that all is well, we just
do our own thing and it does not matter.
Lord Rooker of Perry Bar: No,
I do not seek to give that impression at all. First of all, we
fully accept that lessons can be learned both from this outbreak
and indeed others right across Government—this goes way
beyond Government and as Bill might tell you in a way, as a result
of all this, the input of the Health and Safety Executive is much
greater on these areas than hitherto in the past. We can learn
lessons and all I am simply saying is you are asking a question:
who is in charge nationally of biosecurity? Frankly, you cannot
get an answer to that.
Q305 Chairman: But I can get an answer
to the basic question as to who within Government actually pulls
it together when there is a need to do so, to make sure that there
are not in fact errors or in fact problems which are occurring
in particular areas. We do not need another Pirbright, do we,
before we start looking at all this again?
Lord Rooker of Perry Bar: We do
not, but Pirbright is fairly atypical of laboratories. Government
departments have their own laboratories and Pirbright of course
is effectively a charity, partly funded by the Science Research
Council, and it is outwith that normal flow with a separate governing
body I understand. We are a customer as I say, it is not a Defra
laboratory like the veterinary laboratories agency. When you look
at your own laboratories you clearly are responsible as the department,
as the minister, to make sure of the operation of the laboratory
as well as the focus on the finance and the actual research contracts
as well as the other issues relative to biosecurity, but that
does not therefore cover across Government.
Q306 Chairman: I know that Tim is
wanting to come in here and I know Bill that you are wanting to
come in and so is Ian; can I bring you two in and then bring in
Tim?
Lord McKenzie of Luton: I just
wanted to comment briefly, if I can. In answer to the question
who is in overall charge, as my colleagues have said, it depends
in charge of what. It seems to me that some clear issues that
came out of the Callaghan report are that there should be a single
regulatory framework and there should be a single regulator; therefore,
in terms of that part of the equation the way forward is clear,
those recommendations are right and certainly recommendations
which cross-Government we support. That component of it, therefore,
it seems will be in place but at the moment it is split: there
is more than one regulator and the regulations that apply are
not identical within the framework to get one framework.
Q307 Chairman: I am looking at one
stage before the regulator because the regulator regulates something
and it is who pulls together, if you like, the conditions under
which the regulator then inspects and makes sure that they are
applied. Ian, did you want to come in?
Ian Pearson: Just to emphasise
the point that Bill was making really, which is that one of the
clear conclusions that come out of the Callaghan report that has
been accepted by Government is that there does need to be a single
regulatory regime. You have heard very clearly from the people
who have submitted evidence to you and been examined orally as
well that there is very strong support for that approach, and
that is exactly what as a Government as a whole we are doing at
the moment.
Q308 Chairman: Dawn, on this initial
question?
Dawn Primarolo: I absolutely accept
and welcome the Callaghan review points, particularly around the
question of biosafety and who should be, if you like, the regulator
in that. I was listening carefully to the dual point about are
safety and security the same thing in all circumstances and should
they be done by the same body? From the Department of Health's
point of view there is a clear line on safety and on security,
the one on safety is through the HSE, buttressed by the COSHH
regulations, and security is done through the national counterterrorism
security office, Home Office, inspected by the police. What I
was reflecting on briefly as this starts is whether those two
things are exactly the same and whether they should or could be
done by the same body, or how they interlock. All of us have said
in submissions to the Committee that we think on the regulation
side, the safety side, whilst it is the responsibility of the
particular authorities—HPA as an agency for the Department
of Health—to make sure they have got safety, that has got
to be regulated and inspected and the HSE is the way forward.
I am not saying it cannot be done by the same body, I am questioning
what exactly do we mean? Some of the security is very specific
and requires different skills, but that still begs the question
that you started with though, which I do not have an answer to,
should there be one body? Given that it is cross-government and
we have all got—those of us represented here—particularly
Class 4 laboratories, how do you get that departmental link and
tie-in?
Chairman: The line of my questioning
will become more apparent as we move through the questions this
afternoon, because there are other issues we have raised which
actually bring us back to that business of who co-ordinates it
all, but you have been very patient Tim.
Q309 Mr Boswell: Can I begin by apologising
to ministers for being a touch late but I have literally come
up by train because I wanted to talk to you about this. It would
not really be appropriate perhaps if I glossed on what the Chairman
said but I could perhaps introduce a concept which Lord McKenzie
will be familiar with from HSE philosophy about the controlling
mind. It is understandable that in the individual laboratory,
be it owned by Defra, a research council, the Department of Health
or one of its agencies, it would be quite wrong to say that site
security should not be the responsibility of an individual ultimately
and of the management to whom that individual reports, but I would
like to take you on a little further about this idea of what might
be termed strategic biosecurity, by which I am really feeling
after how one would get a better mechanism across government for
setting a set of standards which a single regulator that you have
referred to would then implement, having a discussion about it
and possibly taking that forward into the future. If I could say
one more thing to make it one question for you to respond to,
please do not think that as far as I am concerned this is all
raking over the past, although obviously we are all interested
in learning the lessons of the past. If we are looking forward—and
you will get some more questions about this in a little bit—we
may be wanting to ask perfectly sensible questions across the
public sector about how many category 4 laboratories we need and
how we should have a plan for those—it is a perfectly proper
planning function for government. We cannot do that by a series
of itemised decision-making, somebody has to take the lead on
that and then have a discussion and take advice from HSE as the
regulator—I can see Dawn in particular responding. I wonder
if you could just take me through those thoughts and give me some
comfort as to how we might get a single structure for looking
at some of these issues on a fairly principled basis within Government
or within the public sector.
Dawn Primarolo: I was nodding
in terms of some of the work that I know the MRC has commissioned
that the HPA is working with, and there is a steering committee
and then an independent review. I am happy to join in or answer
it, but I do not know, Ian, whether you want to say what the MRC
decided to do and how this might actually take us down the path
of exactly what this Committee is talking about.
Ian Pearson: Let me comment on
that but firstly let me amplify some of the points that have been
made about security and what we are talking about here. It is
right to draw a distinction between biosecurity in the sense of
safety that we have accepted should be a unified regulatory regime
with the responsibility of the Health and Safety Executive and
the security aspects that would deal with potential threats through
counterterrorism or through proliferation, and it would not be
sensible to put those together into a single regulatory regime
but we do as a Government think it right that the Health and Safety
Executive take responsibility for what you might call the biosafety
aspects. With regard to your broader question about containment
level 4 facilities and how many of them do we need, the Medical
Research Council has commissioned, as Boris said to you during
his evidence session, a study that will look at with regards to
the MRC and I believe the BBSRC as well the scope and likely future
requirements when it comes to category level 4 facilities, but
again it is important that we be clear what we are talking about
here because the sort of research that you might want to do for
medical research or biosciences research or veterinary research
can be very different to some of the other research fields that
might have more of a security aspect to them.
Mr Boswell: To link in with ministers,
if I might—because that is a helpful answer—presumably
albeit it is an MRC show this will report to some kind of inter-ministerial
machinery so that you will make a decision on whether you need
to make a collective decision on some of these issues or whether
it is really too difficult or inappropriate.
Q310 Chairman: It is a point here
that we do not know of any inter-ministerial group that works
in this area despite these big issues.
Ian Pearson: The situation is
that Research Councils are responsible for making detailed decisions
on the level of research that is required across their communities
and they will be responsible for making that assessment and ensuring
that facilities are put in place to meet those, and that is one
of the reasons why the MRC has been actively looking at the future
situation and trying to make an assessment, given that these are
very expensive facilities, whether there are sufficient resources.
As you heard in evidence previously the feeling is that with regards
to the Medical Research Council and the BBSRC as well there is
a sense that the resources that are available at the moment are
adequate for the tasks that are currently envisaged and funded,
but the issue is what might happen in the future which is why
the research has been commissioned.
Q311 Mr Boswell: That again is helpful
but I am not sure it quite meets my point because you started
off by responding to my question about whether there was a single
controlling line of government by saying the MRC is conducting
a survey, and that we understood, but as you went on to refine
that you made it increasingly clear that that was a study which
was confined at least to the relevant research councils and did
not extend across government. I am just wondering, again taking
up what the Chairman said, there is a single body which is prepared
to stand back and say, look, we are a country of a certain size,
there is a distribution of population and we need X number of
facilities. We have got more or less or we could rationalise them
in this or that way or make better use of our facilities, and
generally plan the system. I do not think you have quite given
me that.
Ian Pearson: Firstly let me put
back to you the fact that the sort of research that you might
want to conduct at Porton Down is very different to the sort of
research that you might want to conduct at Pirbright, we always
need to bear that in mind. When it comes to the quantum of research
that any particular institute might want to do and whether that
research should be funded, we then come back to a peer review
process and so the MRC will take some detailed decisions on what
it thinks is the best peer reviewed research that it wants to
undertake, and it will be up to the MRC within its delivery plan
that gets approved by Government to make those decisions.
Q312 Chairman: We do understand that
Ian. May I just ask you all one very simple question? As far as
this inquiry is concerned have you ever met as a team of ministers
on this issue of biosecurity or biosafety? Have you ever met?
Ian Pearson: No.
Q313 Dr Gibson: The Health and Safety
Executive is the regulator and that has been agreed; do you think
they have enough resources to do all the things they might have
to undertake or are there going to be limitations and will they
need other kinds of support, do you think, or are they self-sufficient?
Lord McKenzie of Luton: It is
an important point and the expectation is that resources will
be sufficient. You will be aware that Sir Bill Callaghan's report
proposed a three-phase approach; phases one and two for the additional
work that the HSE would be undertaking, looking at the SAPO regulation,
that Defra has agreed to fund and in relation to phase three Bill's
recommendation was that we enter into a charging process just
like the COMAH sites at the moment; that obviously creates some
challenges, it will be a sensitive issue and will need a lot of
discussion, but that would certainly provide a route for additional
resources. If you looked overall at the settlement for the HSE
under CSR07 it has been the subject of some comment only just
today when the DWP Select Committee probed that in some depth,
but I would summarise again the outcome as being that the three
year review gives the HSE in aggregate something like a little
bit better than flat cash in comparison to the 04 settlement.
In the context of the DWP's minus five per cent real year-on-year
you will see that we have tried to resource the HSE appropriately.
In terms of personnel, at the biological agents unit which provides
the staffing for that I am advised that staffing has increased
over the last six or seven years from about six originally up
to 17 including the three recruitment exercises that are under
way, so in terms of personnel we believe there will be sufficient
personnel to carry out the tasks. I understand that although the
HSE is currently focused on human pathogens, we are really dealing
with containment technology and processes here and they are broadly
common to animal and human pathogens; therefore, since there is
not a hugely new learning curve I guess the final point I would
make is that if you look at the number of institutions for Level
3 containment that HSE is engaged with at the moment it is overall
the highest proportion of those facilities that exist. The number
of those that are SAPO-only regulated is quite small and of the
ten level 4 containment facilities only two of them are currently
SAPO-only regulated, so the HSE is already significantly engaged
with most of them. The answer is yes it will be sufficiently resourced
to do the task.
Q314 Dr Gibson: If I decided to set
up a laboratory of some kind to investigate disease would they
come in and help plan and prevent the problems that might happen,
rather than just picking up the problem once it happens?
Lord McKenzie of Luton: It depends
in part, I guess, on the structure of the regulatory framework
that we end up with because the approaches under COSHH and the
GM containment regulations are slightly different—one is
a permissioning regime, the other is a notification regime whereas
SAPO is a licensing regime. Whichever of those processes is eventually
adopted Bill recommends against a licensing regime.
Q315 Dr Gibson: But there is a bit
of uncertainty in that area, is there, about how it might end
up?
Lord McKenzie of Luton: The final
structure of that regulatory framework is the subject of discussion
at the moment but certainly Sir Bill recommended against a licensing
approach; the extent to which there should be a permissioning
approach or a notification approach should be the subject of on-going
discussion. However it ends up, there would inevitably be an iterative
process between those proposing the establishment and the HSE
because at the end of the day those who propose it want to know
that they are going to get whatever approvals or agreements they
have that the thing can be safely operated.
Q316 Dr Gibson: Has the HSE cut their
ties with Defra for example, who have a heck of an experience
in this area, in certain fields anyway?
Lord McKenzie of Luton: It is
working closely with Defra at the moment or has worked through
stage 1 and as stage 2 kicks in at the end of this month there
is a good working relationship. Obviously those ties will not
be cut and if there is need in particular for veterinary expertise
that would be available and would presumably be brought in, so
we do not see that as being a particular problem.
Q317 Dr Gibson: Could somebody somewhere
walk into an office and look at a sheet of paper or a map about
where these pathogens are going to be localised across the country?
Is there going to be a centralisation in HSE or what?
Lord McKenzie of Luton: It is
right to say at the moment with the existing regulatory structure
one way or another the HSE ends up with a pretty significant database
of what work is going on where across the country. I would hope
that means that somebody could not just wander in and have a browse
at it, but in fact that data does exist and is with the HSE at
the moment.
Q318 Chairman: You mean it does exist
now.
Lord McKenzie of Luton: I believe
it does.
Lord Rooker of Perry Bar: It is
just not published.
Q319 Dr Gibson: Is there a reason
why it is not published? Is it just being remiss or is too risky?
Lord McKenzie of Luton: Some of
it would be I guess highly sensitive, some of it might be commercially
sensitive, and obviously there are national security issues associated
with some of it.
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