Memorandum 17
Submission from the Academy of Medical
Science
1. The Academy welcomes the opportunity
to respond to the Innovation, Universities and Skills Committee
inquiry regarding "Biosecurity in UK Research Laboratories".
The Academy of Medical Sciences promotes advances in medical science
and campaigns to ensure these are translated as quickly as possible
into benefits for society.
2. Overall, the Academy considers that existing
regulations and standards of security and safety in UK laboratories
are good. We emphasise that it is essential for the UK to maintain
its excellent reputation for highly competitive research into
dangerous pathogens and to attract the best researchers from around
the world. The Academy also stresses that high quality research
into dangerous infectious agents is essential to equip the UK
to deal with public health emergencies and any bioterrorist threats;
the risks associated with this research are low and far outweighed
by the benefits. However, we are aware that the consequences of
accidental release of a hazardous pathogen may be severe, thus,
measures must be taken to ensure that all high category facilities
are adequately monitored, managed and well maintained.
3. 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 UK maintains a competitive edge in fields
of research concerning dangerous pathogenic material. However,
whilst the current capacity of category 2 and 3 labs in the UK
is sufficient, the Academy considers that capacity in category
4 labs should be improved for continued prominence in these research
fields. At present, the majority of category 4 facilities are
focused in the South of England and provision of a greater number
of such facilities in the North of England would be beneficial.
We consider that these facilities should be fully integrated with
reference and research laboratories.
4. The uncertain nature of future threats
and continuing risk of emerging zoonotic diseases also underscores
the need for adequate infrastructure in the UK that can support
a broad range of human and veterinary research, despite the considerable
cost of building and maintaining category 4 units. A system of
upgrading category 3 facilities to category 3+ could be considered
in line with an assessment of the need to develop a greater number
of category 4 facilities. We also note that a balance must be
maintained between capacity for both hazardous bacterial pathogens
and pathogenic viruses.
5. UK expertise was mobilised rapidly during
the outbreak of Severe Acute Respiratory Syndrome (SARS) in 2002-03,
particularly by HPA, but this would not necessarily have been
possible for other pathogens. Additionally, in this case, funds
for SARS research were mainly mobilised from University sources.
The time required to fulfil containment regulations would have
made it difficult to initiate a SARS primate study rapidly in
the UK, if it had been necessary. Thus, the use of a generic Home
Office project licence for the UK could be considered in order
that imperative research may proceed, should the public health
need arise.[22]
The emergence of SARS in 2002, combined with the recent outbreak
of Foot-and-Mouth Disease virus (FMDV), demonstrate the need to
mobilise expertise with speed. Thus, in addition to developing
sufficient infrastructure to capitalise on the expertise currently
available, the need to prepare the next generation of expertise
and to maintain a cadre of appropriately trained staff must be
considered.
6. The state of biological containment facilities
in the UK
Overall, the safety record of UK laboratories
is good and inspections carried out by the Health and Safety Executive
(HSE) ensure that bio-containment facilities are functioning appropriately.
However, the accidental release of FMDV at the Pirbright laboratories
in August 2007,[23]
demonstrates the need for effective governance, clear ownership
of research sites and allocation of adequate funds for the maintenance
of high category sites. Maintaining negative pressure required
in a category 3 research laboratory is more challenging in older
buildings and new designs of negative pressure laboratories within
existing rooms may need to be considered, despite the costs entailed.
Inspections should include appropriate checks that infrastructure
is safe and well maintained.
7. Laboratory inspection regimes and the
rationale and practicalities of the licensing system
The Academy welcomes the proposal to develop
a single regulatory framework for the regulation of laboratories
covering the handling of human and animal pathogens.[24]
Use of a single independent regulatory body will improve the clarity
of messages delivered and will unify approaches to research on
human and animal pathogens.
8. The Academy is aware that there is rigorous
attention to compliance with HSE regulations by safety officers
and high safety levels will be assured by good working relationships
between safety officers and HSE representatives. However, we also
note that whilst inspections are a necessary component of ensuring
laboratory safety, a multiplicity of inspections can unduly affect
continuity of research, owing to the need to fumigate and clear
laboratories. Nevertheless, inspection regimes for high containment
laboratories must continue to ensure that access is secure, movements
are recorded and that equipment is functioning appropriately.
9. We are concerned that there is a tendency
for the rationale used by the HSE and relevant bodies regarding
regulations for high containment laboratories to be based on the
concept of preventing aerosol or droplet dissemination. Yet, a
number of hazardous pathogens, such as HIV, are not airborne thus
regulations must take account of other methods of dissemination.
10. Biosafety training provision for staff
working in containment facilities
The Academy considers that biosafety training
provision for staff is generally of a good standard across the
board and supports HSE requirements to ensure adequate standards
of training and record keeping. The majority of training is likely
to take place at the research site, thus standards may vary markedly
between institutions. Nevertheless, laboratory inspections would
ensure that training is appropriate by quickly identifying poor
safety standards.
11. The maintenance and recording practices
surrounding the storage and transportation of dangerous pathogens
Overall, we believe these practices to be adequate
but highlight that responsibility for good practice remains with
the University or research institute. Adequate recording procedures
are assured by logging of samples both prior to entrance into
containment 4 facilities and within containment 4 facilities.
Monitoring of such practice would present significant logistical
issues. Despite this, effective recording of the use and storage
of pathogens could be improved by using currently available monitoring
software. Additionally, both national and international rules
for transport of dangerous pathogens and material assure that
samples can only be shipped if they are properly packed and accompanied
by appropriate documentation. One caveat is that it has become
progressively more difficult and more expensive to transport dangerous
pathogens and improvements could be made to address this. Further
barriers to efficient transport of pathogens would unduly affect
collaboration and the progression of scientific research.
12. Measures implemented when pathogenic
material cannot be accounted for
Samples stored in category 4 facilities are
routinely audited on a monthly and quarterly basis, which would
highlight whether any pathogenic material cannot be accounted
for. Further investigation by the Safety Officer and reporting
to the Home Office and Police would ensure that any discrepancies
are reported and appropriately managed.
13. Continuing dialogue between the HSE
and researchers and/or Safety Officers is important for ensuring
that all pathogenic material is accounted for and appropriate
laboratory practice and waste disposal maintained. Requirements
for appropriate sealing and detailed labelling of transported
material prevents any hazard from being presented in the event
of material being lost during transit.
14. The role of universities in overseeing
security clearance for research students working with dangerous
pathogens
The Academy is concerned by the ability of universities
to refer certain applicants, suspected of attempting to further
knowledge that could threaten national security, to the UK Government's
Foreign and Commonwealth Office (FCO) for security checks through
the Voluntary Vetting Scheme. Between 1998 and 2004, 2,419 individuals
were volunteered under this system and the FCO advised that 260
individuals be declined admission between 2000 and 2004.[25]
We stress that international researchers make an immensely valuable
contribution to the enhancement of scientific knowledge and emphasise
the importance of attracting talented researchers from around
the world to UK research universities. Thus, we consider it essential
that security clearance does not unduly exclude or delay applications
from students or post-doctoral scientists with a particular nationality.
We stress that free international movement of scientists is critical
to scientific collaboration and activity. We also note that the
voluntary nature of referral to this FCO scheme inevitably creates
wide variation between institutions in the extent to which further
security checks are performed.
15. The Academy also wishes to highlight
that free exchange and sharing of scientific findings through
peer-reviewed journals are central to scientific discovery and
must not be limited by further regulation. We stress that the
benefits of enhanced and applied knowledge through the sharing
of research findings far outweigh any risks.
January 2008
The Academy is particularly grateful to Sir
John Skehel FRS FMedSci, Professor Geoffrey Smith FRS FMedSci,
Professor Malcolm Malim FRS FMedSci and Professor Robin Weiss
FRS FMedsci for their helpful contributions to this response.
THE ACADEMY
OF MEDICAL
SCIENCES
The Academy of Medical Sciences promotes advances
in medical science and campaigns to ensure these are converted
into healthcare benefits for society. Our Fellows are the UK's
leading medical scientists from hospitals and general practice,
academia, industry and the public service.
The Academy seeks to play a pivotal role in
determining the future of medical science in the UK, and the benefits
that society will enjoy in years to come. We champion the UK's
strengths in medical science, promote careers and capacity building,
encourage the implementation of new ideas and solutions—often
through novel partnerships—and help to remove barriers to
progress.
22 Academy of Medical Sciences, 2003. Severe Acute
Respiratory Syndrome (SARS). Accessed January 2008 at: http://www.acmedsci.ac.uk/p99puid21.html Back
23
Professor Brian Spratt CBE FRS (August 2007). Independent review
of the safety of UK facilities handling Foot-and-Mouth Disease
Virus. Accessed January 2008 at: http://www.defra.gov.uk/animalh/diseases/fmd/investigations/pdf/spratt_final.pdf Back
24
http://www.defra.gov.uk/corporate/ministers/statements/hb071213.htm Back
25
http://www.fco.gov.uk/Files/KFile/VVS.doc Back
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