Select Committee on Innovation, Universities, Science and Skills Written Evidence

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 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.



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.


  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.


  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.


  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.


  The requirements for inventories have to ensure that they are easily complied with to prevent costly investigations into data recording errors.


  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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