Memorandum 14
Submission from the Institute for Animal
Health
The Institute for Animal Health is pleased to
contribute to the information-gathering for the IUSSC Inquiry
on biosecurity and offers the following views on the points to
be considered.
To ensure the UK base for studying epizootic
and/or zoonotic diseases in livestock is ensured for the future,
three key areas need increased attention:
— Sustainable long term funding of
key facilities, that ensures these facilities are not compromised
by short term volatility of grant funding.
— A predictable regulatory framework
that is proportionate and risk based administered by a competent
regulatory authority that is resourced to maintain a supportive
and constructive dialogue with the duty holders.
— Capability and regulatory gaps be
closed in the area of human hazard group 4 organisms affecting
large animals, including livestock species.
THE CURRENT
CAPACITY FOR
RESEARCH ON
DANGEROUS PATHOGENIC
MATERIAL IN
THE UK AND
THE CAPABILITY
TO CONDUCT
RESEARCH ON
THE CAUSATIVE
AGENTS OF
DISEASE THAT
MAY EMERGE
AT A
FUTURE TIME
The capability and capacity of UK facilities
has to be measured against the challenge that dangerous pathogens
pose to the UK. Population growth and population densities, together
with other globalisation issues, increase the threat from newly
emerging and existing pathogens. On average every 18 months, a
new hazard group 3 or 4 pathogen is identified.
The economic damage inflicted by infectious
diseases has the potential to be enormous and the benefits to
be gained by studying infectious diseases exceed the current spend
on infectious disease research by orders of magnitude. High hazard
pathogens exotic to the UK pose a particular threat as there is
no herd immunity and each incursion results in significant damages.
Long distance travel and food miles increase the likelihood of
introducing such diseases to the UK.
Countries that are the most likely source for
these pathogens are predominantly in the developing world and
tend to be preoccupied with other priorities and may not be not
adequately resourced to address the challenges. The first world
is today more vulnerable to accidental or malicious introduction
of new disease agents, even though many are potentially relatively
easy to control by vaccination.
Human versus animal and plant pathogen facilities
Different high containment facilities need to
be distinguished based on the pathogens, the host species, and
the activities they can accommodate (eg small-scale in vitro
lab work, in vivo facilities for work in laboratory or natural
host species, and industrial-scale production facilities).
Veterinary high containment facilities for large
animal in vivo work are concentrated at the Veterinary Laboratories
Agency, Weybridge and IAH, with some facilities at the Moredun
Research Institute. In number and capacity, the largest facilities
are maintained at the IAH for a globally leading research programme
on exotic animal diseases. In capacity and capability these facilities
are adequate for the UK requirements.
The UK has currently no facilities capable of
handling large animals infected with human hazard group 4 viruses
and uncharacterised human hazard group 3 viruses. This is a capability
gap in the UK portfolio but is needed to interrogate the role
of a livestock reservoir for serious human pathogens for existing
and emerging pathogens. During the SARS epidemic rapid progress
was hampered by a lack of facilities that could handle in vivo
a poorly or uncharacterised pathogen, with a brief track record
of high mortality. On a precautionary principle such work would
require access to a large animal Containment level 4 facility.
GAP ANALYSIS OF UK CAPABILITY WORK ON HUMAN
HAZARD GROUP 3+/4 PATHOGENS
/MILES/PKB/DATA/394978/1.eps>
Too small facilities with extremely high overheads
and little or no economy of scale
High containment facilities are always expensive
to build and to maintain. Due to the standard barrier facilities
required, the cost for small facilities is disproportionately
more expensive per unit of contained space. The provision of suitable
resilience for all necessary systems makes them even less viable
financially as a national facility, especially for in vivo
work. The provision of greater capacity in very few large
facilities enables the best use of the facility space over time
and allows scheduled down times to have the smallest possible
effect on the research programmes.
The administrative burden for such facilities
is a significant factor and there is no economy of scale in smaller
facilities. The net cost per 1m2 can be more than triple in small
facilities, which translates into very high costs for full economic
costing. In state-of-the art SAPO4 facilities, the net cost per
1m2 of animal room may be between £30k and 90k and translates
into significant costs for capital and depreciation under rules
of full economic costing.
There are no facilities in the UK for work on
human hazard group 3+ and 4 pathogens in livestock species
The UK capability for high containment work
was discussed at a workshop convened by the former government
chief scientist, Sir David King, in March 2005 (the report from
this workshop is available from the HSE). In brief, there are
no in vivo facilities capable of accommodating a national
research effort on a newly emerging hazard group 4 pathogen that
infects humans through contact with infected livestock species,
(eg horses, cattle, sheep and pigs).
Synergies between Diagnostic and Research Facilities
are underutilised
Facilities essential for a national emergency
response to human and animal disease outbreaks are able to draw
on a competent workforce working in a complementary manner (eg
BBSRC-funded fundamental research at IAH Pirbright Laboratory
complements the Defra-funded surveillance work in times of trouble
and maintain this work force to further scientific progress in
"peace" times. In the interest of specialisation, the
activities of fundamental research and diagnostics have been separated
completely in many Laboratories. In low-containment facilities
with lower overheads, this concept may work, while in high containment
facilities a capacity for suitable skills cannot be maintained
with only diagnostic work. The risk is a shortage of skills in
times of a national emergency if the numbers of science workers
with the necessary competency are too low.
Science Hotel Concept
The high costs of high-containment facilities
naturally limit the number and size of these facilities in the
UK. Rather than having a (large number) of facilities scattered
in the UK for in vivo work, better value for money is achieved
by maintaining a small number of larger, very well equipped facilities,
and to make these more accessible to the academic community. There
are many benefits in a science hotel concept, but these have to
be balanced against other issues like security, health and safety
obligations and liabilities.
THE STATE
OF BIOLOGICAL
CONTAINMENT FACILITIES
IN THE
UK
UK investment into biocontainment facilities
has been very restricted for some years and the UK has, as a result,
fallen behind many international competitors as measured in scientific
output on high hazard pathogens. Recent introduction of full economic
costing was not matched with an increase in government funding.
This has left government funded research facilities under resourced.
Laboratory inspection regimes and the rationale
and practicalities of the licensing system
The Callaghan Review used prosecutions as a
measure of the effectiveness of the regulatory framework. Prosecutions
are expensive and often compromise the effective working relationship
between the regulator and the duty holder. The interface between
duty holder and regulator should be suitable to identify problems
before they require prosecution. However, this situation requires
suitable competence and resource within the regulatory authority
in order to advise the duty holders in good time.
At least in the past the regulators (HSE and
DEFRA) have not been resourced to inspect in any detail the infrastructure
underpinning containment laboratories.
Licensing System
Any licensing system can only be as good as
it is resourced and competent for the task. The principle of a
licensing system is good in that it means shared responsibility
between the regulator and the licensee. Thus the requirements
for the operation have to be clearly defined by the regulator
and, in turn, the licensee has clear performance targets.
A notification and consent system gives full
responsibility to the dutyholder. However, unlike a licensing
system which by definition is restrictive, it gives the dutyholder
control over their facilities and site, encouraging scientific
development and flexibility. But it requires a good relationship
with a well resourced regulator to work well.
Where the regulatory requirements for facilities
change, it is important that new rules are introduced with a sufficient
lead time to be implemented.
BIOSAFETY TRAINING
PROVISION FOR
STAFF WORKING
IN CONTAINMENT
FACILITIES
Training staff in biosafety is an essential
element for the safe operation of any high containment facility.
Biosafety training is not currently available as a UK approved
standard, resulting in inconsistency across institutes especially
at higher containment. This means that such training is unfortunately
not always transferrable from/to other facilities and retraining
in local arrangements is generally required.
The cost benefit struggle
IAH believes that good safety training is an
essential complement to good facilities and is even more important
in poorer facilities and the institutional culture has to reward
good safety culture and competence at least equally high to scientific
achievements.
DANGEROUS PATHOGEN
STORAGE AND
TRANSPORTATION
During the past few years much attention has
been paid to the security of pathogen storage and transportation.
Because pathogens can replicate and the mechanisms for quantifying
infectivity are only approximations, absolute quantities of pathogens
cannot be recorded in a meaningful way. Laboratory biosecurity
( as defined by WHO and RCUK) has to become a new regulatory requirement
for dangerous pathogens. It is important that the requirements
for laboratory biosecurity are not conflicting with HSE requirements
and the regulatory expectations are clearly communicated and proportionate
to the risk. The risk is reduced by either reducing the likelihood
and/or the severity of this risk. The severity can only be reduced
by preventing the removal from the facility, while the likelihood
will depend on a number of factors, such as the trustworthiness
of the staff with access to the pathogens—not just the pathogen
storage facilities and the layers of intruder protection around
the pathogen storage facilities that prevent forced entry and
removal.
The key issue is the trustworthiness of the
staff with access to the pathogens and how this can be maintained
and assured. A competitive salary that draws in the best talents,
a vetting procedure that identifies high risk candidates and a
secure system for assuring protection to those put under pressure
from outside to source material from a containment facility are
necessary requirements.
The effort that is put into protecting access
to the critical pathogen storage is not much different from that
for the pathogen handling laboratories, where the pathogen is
cultured. This effort has to be evaluated against the difficulty
of accessing such infectious material in the field:
For many diseases it is very difficult to source
the infectious material in the field because they are rare and/or
highly lethal without appropriate safety precautions and equipment.
Cost of Transportation
Transportation of Dangerous Pathogens is now
very expensive and restricts the beneficial exchange of clinical
samples between developing countries and the UK.
The security of pathogens kept in the laboratory
has to be balanced against the availability of pathogens in the
field.
Any risk mitigation measures must be considered
in light of the reduction in risks that they achieve. If a dangerous
pathogen is abundant and available outside of the laboratory (ie
in the field), security measures within the laboratory may not
reduce substantially the overall risk, regardless of the extent
and cost of the measures taken. For example, some veterinary high-risk
pathogens are common in many countries and can be recovered easily
from field with only limited scientific and technical expertise
and, if the pathogen is not a zoonotic, with no risk to the individual.
In contrast, many high-risk pathogens of humans are very difficult
to obtain in the field without substantial risk to the individual.
MEASURES IMPLEMENTED
WHEN PATHOGENIC
MATERIAL CANNOT
BE ACCOUNTED
FOR
The requirements for inventories have to ensure
that they are easily complied with to prevent costly investigations
into data recording errors.
THE ROLE
OF UNIVERSITIES
IN OVERSEEING
SECURITY CLEARANCE
FOR RESEARCH
STUDENTS WORKING
WITH DANGEROUS
PATHOGENS
ATAS—Academic Technology Approval
Scheme (ATAS)
There is a need to balance the accessibility
of UK facilities for the essential training of diagnosticians
from developing countries against the possibility of malicious
staff/visitors/students.
A central security clearance of people with
access to high containment facilities is desirable as the means
of an individual university or institute are limited and cannot
match government intelligence. It is important that this effort
does not create an insurmountable impediment (in terms of time
and cost) that could compromise the benefits gained from academic
exchange. Reference laboratories for infectious diseases are also
important training centres for diagnosticians and researchers
from other countries that do not have the critical mass to maintain
a cohort of competent staff from their own resources. While scientists
and technical staff from other countries may pose a small risk,
this is counterbalanced by their contributions to tackling key
diseases at source in developing countries. The risk of natural
introductions would be increased greatly without training centres
overseas being maintained and populated with skilled persons.
January 2008
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