House of Commons - Innovation, Universities, Science and Skills

Select Committee on Innovation, Universities, Science and Skills Sixth Report

1 Introduction

1. Dangerous pathogens[1] of humans, animals and plants represent a major threat to public health and the economy. The impact of infectious disease in animals was demonstrated by the outbreaks of Foot and Mouth Disease Virus (FMDV) in 2001 and 2007. An unexpected outbreak of human disease could have similarly devastating consequences. The possibility of a human influenza pandemic has led the Government to formulate a national framework to plan for such an eventuality, describing it as "a real and daunting challenge to the economic and social wellbeing of any country and a serious risk to the health of its population".[2]

2. To combat the threat of known, emerging and re-emerging infectious diseases, scientists are engaged in two types of work. First, research is carried out to increase understanding of known dangerous pathogens and how to detect and treat them, for example using vaccines. Secondly, samples from suspected cases are processed in diagnostic laboratories for detection of pathogens. During an outbreak of an infectious disease, a rapid expansion of such diagnostic capacity is required to identify cases.

3. Pathogens evolve constantly. For example, 38 apparently new species of human pathogen have been recognised in the last 25 years.[3] Climate change is likely to affect the emergence and characteristics of infectious disease and their transmission in the UK.[4] Globalisation and the ease of international travel allow infections to spread rapidly.

4. In addition to the threat from natural infections, dangerous pathogens can be weaponised and the security services are alert to the potential for malicious use of pathogenic material as a terrorist weapon, especially in the wake of the use of anthrax for this purpose in the USA in 2001.[5] The recent Government Foresight project on the detection and identification of infectious diseases demonstrated the threat they pose and also provided a comprehensive analysis of possible future risks.[6]

Managing risk

5. Dangerous pathogens are handled in containment laboratories to reduce the risk of release into the environment and also to protect the handler. The precautions taken depend upon the properties of the pathogens in question, the potential severity of disease and the countermeasures available. Despite the precautions taken, there have been incidents where pathogens have escaped laboratory containment, often as a result of a breakdown in procedure. In 1978 the last fatal case of smallpox in the UK occurred in Birmingham after the virus escaped from a laboratory.[7] The 2007 UK outbreak of FMDV almost certainly originated at a site handling the virus at Pirbright, Surrey.[8]

Background to our inquiry

6. The outbreak of FMDV at Pirbright in 2007 brought the issue of biosecurity to the top of the political agenda. In the aftermath of the outbreak a number of reports were commissioned. The Health and Safety Executive (HSE) led an investigation into any potential breach of biosecurity at the site, and an "Independent Review of the safety of UK facilities handling foot-and-mouth disease virus", chaired by Professor Brian Spratt, published more detailed findings, some of which relied on the investigations carried out by the HSE. The Spratt report contained the caveat that "the amount of hard science that could be applied to our investigation of the source of the outbreak was very limited … identifying the source of an outbreak of this kind with any certainty is always likely to be inconclusive, unless some gross and obvious breakdown in a safety critical feature has occurred".[9] Both reports concluded that release of FMDV through defective effluent pipes was the most probable source of the outbreak. The most likely explanation is that, after release from the drainage system, live FMDV contaminated soil/materials on the Pirbright site which were transferred by vehicles to farms in the vicinity.[10] The source of the virus could not be established conclusively given that the strain in question had been handled by both the Institute for Animal Health (IAH) and a private company Merial, who share the site, although the virus was used in much larger quantities by the latter.[11]

7. Following these reports on the cause of the outbreak, two additional pieces of work were commissioned by the Government. First, Sir Bill Callaghan was asked to review the regulatory framework for human and animal pathogens,[12] and secondly the Prime Minister and Secretary of State for Environment, Food and Rural Affairs commissioned Dr Iain Anderson to lead an independent review of the lessons learned from the response to the 2007 FMDV outbreak.[13]

8. Our inquiry was not intended to be a re-run of the numerous inquiries that followed the FMDV outbreak. Instead, we sought to identify the generic lessons to be learnt from what happened, examining whether further action is necessary to prevent a similar outbreak of infectious disease from occurring again in the UK. Issues surrounding biosecurity in the UK continue to generate interest. The future of Pirbright is yet to be fully resolved since its redevelopment has run significantly over budget.[14] The possibility that the proposed new UK Centre for Medical Research and Innovation (UKCMRI) in central London will handle dangerous pathogens has received significant public attention.[15]

9. It is essential to protect the economy and the health of human and animals by ensuring that appropriate biorisk management occurs at high containment facilities and that they are managed within an appropriate regulatory framework. Safeguards should be proportionate and risk-based to avoid unnecessarily restricting research. High-containment facilities should be resourced sufficiently to be well-maintained which means that funding must be available on a stable, dependable basis. Given the high cost of running high containment facilities, it is important that the UK makes best use of those that currently exist and any duplication is avoided. Clearly defined plans are necessary for immediate implementation in the event of further disease outbreaks. The supply, training and vetting of staff in this area is vital for maintaining the UK's capacity to undertake this vital research. At present the UK enjoys a high international profile in the field of infectious disease[16] which it is essential to maintain. These are factors which underpinned our examination of policy on biosecurity in UK research laboratories.

Our inquiry

Terms of reference

10. We announced our inquiry on 6 December 2007. Those submitting evidence were invited to address the following points:

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 state of biological containment facilities in the UK;

laboratory inspection regimes and the rationale and practicalities of the licensing system;

biosafety training provision for staff working in containment facilities;

the maintenance and recording practices surrounding the storage and transportation of dangerous pathogens;

measures implemented when pathogenic material cannot be accounted for; and

the role of universities in overseeing security clearance for research students working with dangerous pathogens.[17]

SPECIALIST ADVISERS

11. We appointed two specialist advisers to this inquiry:

Professor Joe Brownlie, Professor of Veterinary Pathology (and former Head), Department of Pathology & Infectious Diseases, Royal Veterinary College; and

Professor Colin Howard, Vice-Principal for Strategic Development and Professor of Veterinary Microbiology, Royal Veterinary College. Formerly Professor of Virology at the London School of Hygiene and Tropical Medicine. Member of the Advisory Committee on Dangerous Pathogens.

12. We are grateful to the advisers for their expert advice throughout the course of this inquiry.

CONDUCT OF INQUIRY

13. We received 45 written memoranda and held three oral evidence sessions, hearing from a wide range of stakeholders. The cross-cutting nature of this subject was underlined by the fact that the Government submission combined contributions from eight departments: Home Office, Department for Transport, HSE as a sponsored body of the Department for Work and Pensions, Department of Health, Department for Innovation, Universities and Skills (DIUS), Foreign and Commonwealth Office (FCO), Department for Environment, Food and Rural Affairs (Defra) and Ministry of Defence.

14. The inquiry began with an informal seminar with Sir Bill Callaghan, former chair of Health and Safety Commission and Chairman of the review of the regulatory framework for handling animal pathogens, Professor George Griffin, Chair of the Advisory Committee on Dangerous Pathogens (ACDP), Professor Tony Minson, Head of Virology, University of Cambridge and Pro-vice Chancellor for resources and planning and Dr Sushil K Sharma, Assistant Director, Center for Technology and Engineering, U.S. Government Accountability Office (GAO). In addition, we undertook a number of visits in connection with the inquiry. In Germany we visited the Robert Koch Institute in Berlin, the Friedrich Löeffler Institute on the Isle of Reims and the Federal Agency for Occupational Safety and Medicine (BAUA). On a visit to Pirbright, we visited both the IAH and Merial. Finally, we visited the Health Protection Agency (HPA) Centre for Emergency Preparedness and Response and DSTL at Porton Down. We are grateful to all those we met at these facilities.

Definition of terms

15. There is some confusion over the use of terms that refer to the strategies to ensure dangerous pathogens are successfully contained. Our inquiry refers to 'biosecurity'. The HSE also used this term in its report on the outbreak of FMDV at Pirbright, although the report noted that "there is no accepted definition of 'biosecurity'," and determined that for its purposes:

The term will cover the implementation of a combination of containment measures and working practices, supplemented by management controls, to prevent the inadvertent exposure of susceptible species to biological agents and their distribution in the wider environment. In practice, this requires a comprehensive system of both physical and procedural controls to minimise potential release of a pathogen along with suitable arrangements to minimise its subsequent spread.[

16. Some submissions to our inquiry have differentiated between biosecurity and biosafety as means of preventing what is unauthorised as opposed to unintentional.[19] In their submission, Research Councils UK (RCUK) outline World Health Organisation definitions of the terms:

Laboratory biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins or their accidental release.

17. We also use the term 'biorisk' in this report to encompass both biosafety and biosecurity. Dr Bernd Haas of the Friedrich Loeffler Institute, Germany provided the following definition of biorisk:

Combination of the likelihood of the occurrence of an adverse event involving exposure to biological agents and toxins and the consequence (in terms of accidental infection, toxicity or allergy or unauthorised access, loss, theft, misuse, diversion or release of biological agents or valuable biological material) of such an exposure.

1 A pathogen is a disease causing agent, for example a virus or bacterium Back

2 Pandemic Flu, A national framework for responding to an influenza pandemic, Cabinet Office and Department of Health, November 2007, p 5, www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_080734 Back

3 Office of Science and Innovation, Foresight: Infectious Diseases: preparing for the future, Future Threats, p 25, www.foresight.gov.uk/Drumbeat/Infectious%20Diseases/t1.pdf Back

4 Ev 107, 164; Q 102, Office of Science and Innovation, Foresight: Infectious Diseases: preparing for the future, T7.1: Climate change and diseases of plants, animals and humans: an overview Back

5 USGAO, High-containment biosafety laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States, October 2007, p 1 Back

6 Office of Science and Innovation, Foresight: Infectious Diseases: preparing for the future, Future Threats Back

7 Shooter RA, Report of the Investigation into the cause of the 1978 Birmingham Smallpox Occurrence, London: Her Majesty's Stationary Office, 1980 Back

8 Health and Safety Executive, Final Report on potential breaches of biosecurity at the Pirbright site 2007, 31 August 2007, p2, www.hse.gov.uk/news/archive/07aug/finalreport.pdf; Professor Brian Spratt and review team, Independent Review of the safety of UK facilities handing foot-and-mouth disease virus, August 2007, p 5 Back

9 Professor Brian Spratt and review team, Independent Review of the safety of UK facilities handling foot-and-mouth disease virus, August 2007, p 15, www.defra.gov.uk/footandmouth/investigations/pdf/spratt_final.pdf Back

10 Professor Brian Spratt and review team, Independent Review of the safety of UK facilities handling foot-and-mouth disease virus, August 2007, pp 43-54; Health and Safety Executive, Final Report on potential breaches of biosecurity at the Pirbright site 2007, 31 August 2007, pp 44-46 Back

11 Professor Brian Spratt and review team, Independent Review of the safety of UK facilities handling foot-and-mouth disease virus, August 2007, pp 25-27; Health and Safety Executive, Final Report on potential breaches of biosecurity at the Pirbright site 2007, 31 August 2007, pp 16-19. Back

12 Sir Bill Callaghan, A Review of the Regulatory Framework for Handling Animal Pathogens, 13 December 2007, www.defra.gov.uk/animalh/diseases/fmd/pdf/callaghan-reviewreport071213.pdf Back