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

Memorandum 18

Submission from the Health Protection Agency


  1.  The Health Protection Agency is responsible for most of the ACDP Category IV laboratories in the UK, along with a large number of ACDP Category III laboratories. These laboratories, the National Collection of Type Cultures and the National Collection of Pathogenic Viruses contain all the microorganisms (with the exception of variola) listed in Schedule 5 of the Anti-terrorism, Crime and Security Act 2001 Part 7—Security of Pathogens and Toxins (ATCSA 2001). Work with these organisms contribute to the Agency's remit in public health, including its role in counter-terrorism and its contributions to global public health.

  All of the laboratories in its major research centres have been recently audited by the National Counter Terrorism Security Office (NaCTSO) and no substantially issues have been identified. In addition, most of the regional laboratories which house Schedule 5 microorganisms have been audited by NaCTSO and there is an active dialogue about future registration between the remaining laboratories and NaCTSO.

  All staff which work in high containment laboratories receive extensive training and those which work in ACDP Category IV laboratories undergo security screening.


  2.  The Health Protection Agency is an independent expert organisation established by Parliament in 2003 to protect people from hazards to health, including infections, chemicals or radiation. From 2009 the HPA will also incorporate the standards and biological control functions of the National Biological Standards Board.

  The Agency develops science into sound evidence and advice and provides leadership to ensure that our advice is turned into practice. It also provides a full range of medical, scientific and technical services in support of our health protection role.

  The Agency aims to:

    —  provide independent evidence-based expert advice without bias or prejudice;

    —  act on sound evidence and translate science into new ways of protecting the population—being measured by our impact on public health;

    —  widen the public health base by working with and training others;

    —  provide a trusted effective interface with Government, other health organisations and the public—including vulnerable disadvantaged groups thus helping to reduce inequalities; and

    —  set health protection standards for ourselves and others to employ.


  3.  The Agency has two major research centres which handle and store microorganisms which are pathogenic for humans. The Centre for Emergency Preparedness and Response (CEPR) is located on Porton Down, near Salisbury in Wiltshire and the Centre for Infections (CfI) is in Colindale on the North Western outskirts of London. The Agency's third research centre, the Centre for Radiation, Chemicals and the Environment (CRCE) at Chilton in Oxfordshire does not handle any microorganisms. In addition the Agency provides Local and Regional microbiology services (LARS) organised into 30 Health Protection Units (HPUs) and a Regional Microbiology Network (RMN) of 8 laboratories and 37 collaborating laboratories. The roles of LARS and RMN are summarized in Annex A.

4.   The Centre for Emergency Preparedness and Response

  CEPR has 35 ACDP Category III laboratories covering almost 850 square metres. These laboratories enable work with pathogenic organisms in culture and also small experimental animals, including non-human primates. It also has two ACDP Category IV laboratories covering an area of almost 60 square metres, for working with pathogens in culture using sealed "cabinet lines", and six ACDP Category IV laboratories covering about 150 square metres for work with small experimental animals, including non-human primates. The ACDP category IV laboratories and many of the ACDP Category III laboratories were built over 50 years ago and refurbishment and upgrading work is becoming increasing difficult. Consequently the HPA has begun discussions with DH about the long term strategic redevelopment of the Porton site which will involve the construction of new high containment laboratories. In addition, the Agency has commenced, in conjunction with the MRC, a national review of ACDP category IV and SAPO category IV laboratory facilities within the UK.

5.   The Centre for Infections

  CfI houses 14 ACDP Category III laboratories covering over 450 square metres and one ACDP Category IV laboratory covering almost 65 square metres. These laboratories are suitable for working with cultured microorganisms only.

6.   Regional Microbiology Network

  There are eight Regional microbiology laboratories, some of which handle and/or store schedule 5 organisms. Details of the work of these laboratories can be found in Annex A.


  7.  CEPR, CFI and the NaCTSO-compliant regional laboratories handle and store a wide variety of Schedule 5 organisms and further details can be supplied if the Committee wishes. Several, but not all RMN and LARS laboratories handle or store Schedule 5 pathogens and further details can also be supplied if the Committee wishes.

8.   National Collection of Type Cultures

  The National Collection of Type Cultures (NCTC) supplies reference bacterial cultures of medical, scientific and veterinary importance world-wide to support academic, health, food and veterinary institutions. The collection (which is certified to BS EN ISO 9001:2000) comprises over 5000 bacterial cultures, together with over 100 mycoplasmas and more than 500 plasmids, host strains, bacteriophages and transposons.

  Situated at the Health Protection Agency's Centre for Infections at Colindale (formerly Central Public Health Laboratory), NCTC has ready access to the wide-ranging expertise of an internationally-renowned body of specialists in clinical and environmental microbiology. These experts check each new batch produced by NCTC, ensuring quality control second to none.

  Whilst the collection is maintained and supplied in traditional glass ampoules, some cultures are available as more user-friendly LENTICULE discs, in both qualitative and quantitative formats.

  In addition to the supply of bacterial cultures, NCTC also provides a range of associated services, which include:

    1.  Freeze-drying of customers' own strains.

    2.  International Depository Authority (IDA) patent depository for bacterial cultures.

    3.  Production of cultures and samples for use in EQA schemes.

    4.  Provision of cultures in LENTICULE disc format.

  Founded in 1920, NCTC is the longest-established collection in the world offering a bacterial culture supply service. It is recognised internationally, serving as a European Resource Centre for Plasmids and a United Nations Educational, Scientific and Cultural Organization (UNESCO) Microbial Resource Centre (MIRCEN). It also holds and supplies some of the more popular cultures of the National Collection of Pathogenic Fungi (NCPF).

9.   National Collection of Pathogenic Viruses

  The National Collection of Pathogenic Viruses (NCPV) preserves well-characterised, authenticated human pathogenic viruses in a secure facility. The agents or nucleic acids derived from these viruses are supplied to the scientific community according to national and international guidelines. The Collection is primarily comprised of human pathogenic viruses requiring handling at biosafety levels 3 or 4, but has expanded to encompass hazard group 2 pathogens. Most of the material is in the form of cell-cultured virus stocks, but provision has also been made (where desirable or necessary) for selected clinical material and uncultivable viruses to be archived as serum, tissue or other biological samples, or in the form of cloned material. The Collection contains materials which are not readily available to the wider scientific community, particularly in the area of emerging virus diseases. We expect the Collection to be of benefit in the future development and testing of vaccines and antiviral compounds, in the development and validation of diagnostic test systems, and in the conservation of biodiversity.


  10.  Both CFI and CEPR, including NCTC and NCPV, have been audited by NaCTSO and no significant issues were identified on either site.

  Three RMN laboratories are already registered with NaCTSO. Where registered, RMN laboratories are in ongoing dialogue with local Counter Terrorist Security Advisors (CTSAs) in order to ensure compliance with the 2001 act and subsequent guidance. Most other RMN laboratories do not have to register with the Home Office due to the "diagnostic specimen" exclusion (para 2 (3)(c)(i+ii)2002 SI No.1281). Although not Home Office registered, many HPA RMN labs still have regular CTSA visits as a proactive initiative by NaCTSO and local CTSAs. These have proved beneficial with positive feedback from the laboratory managers on advice they have received. RMN laboratories regularly review any schedule 5 organisms kept for legal reasons to ensure we are registered appropriately for these. Some food, water and environment laboratories have to retain stocks of organisms such as E. coli 0157 and C.perfringens until any prosecutions by local authorities have taken place. Steps are being taken to register these laboratories where appropriate. Some RMN laboratories have historical stocks of schedule 5 organisms retained for research purposes (eg: C.perfringens stored at the Cambridge-based HPA laboratory). Discussions, based on scientific value, are taking place on whether to destroy or register stocks. The CfI Mycology Reference Unit (MRU) embedded in the RMN Bristol laboratory has stocks of the fungi Cladophialophora bantiana and Cryptococcus neoformans. CTSAs already regularly visit and advise the MRU which has resulted in various upgrades to security. Steps are underway to register this laboratory with the Home Office.


  11.  All staff working in any laboratory handling or storing human pathogens receive extensive training at the appropriate level. In addition, the HPA trains staff from other organizations in the handling and storage of human pathogens. Details of these training programmes can be provided if requested.

  All staff working in ACDP category IV laboratories undergo security checks at SC level. The backgrounds of staff in other laboratories are checked as for all government employees, upon appointment.


  12.  In April 2005, the Health Protection Agency Executive Group mandated an HPA stakeholder group to alert the HPA and HPA Collaborating Laboratories to changes in the transport regulations for infectious substances, and to draft best practice guidance. A guidance document "Interim Guidelines on infectious substance transfers at HPA and HPA Collaborating Laboratories, 2005", was distributed by HPA Local and Regional Services. (Copies can be provided if required). This was produced in conjunction with Dr Tony Phillips, a former senior member of staff at the Dstl laboratories at Porton Down.

  These regulations, The Carriage of Dangerous Goods and Use of Transportable Equipment (Amendment) Regulations 2005, entered into force on 22 July 2005, but the Department of Health obtained a derogation for mycobacterium tuberculosis, E. coli 0157 and Shigella dysenteriae to be transported as Schedule B organisms within the UK. Dr. Robert Spencer from the HPA sits on the UN Sub Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals.

January 2008

Annex A



  The LARS Division of HPA was created in 2003 by bringing together the PHLS Regional Laboratories and approximately 100 local and nine regional NHS communicable disease control teams, many with single handed senior members of staff. During the first two years the Division moved towards the provision of an integrated, coherent and consistent national health protection service delivered through front line services in partnership with the NHS, Local Authorities and other agencies across the range of HPA responsibilities and not just communicable disease control. In order to ensure resilience, to provide critical mass for the wider range of health protection threats dealt with by the HPA, and to enable a balanced mix of skills in teams, some 100 small local teams were amalgamated into 30 (as of October 2006) larger Health Protection Units (HPUs).

  In 2005, the HPA Board agreed a series of proposals to further strengthen its frontline services. The "Strengthening the Frontline" policy recognised that the core functions are to be provided by expert multidisciplinary teams, local enough to be sensitive to the needs of communities, but large enough to sustain the expertise and capacity to respond to the full range of health protection threats.

  The policy required a shift of resource to front line Health Protection Units. and that the LARS division is divided into "LARS laboratories" and "LARS Health Protection Units", each with an Executive Director. The creation of two new front line divisions took place in 2006. HPU Heads report to Regional Directors who in turn report to the Director of LARS. The management of the Health Protection Units is now through an executive made up of the regional directors and the LARS director. A common approach is being implemented within regions with each having an executive team made up of the Regional Director and heads of HPUs who will take responsibility for deployment of all regional resources.


  In parallel with "Strengthening the Front Line" in 2005, the Health Protection Agency developed a project to map the activities of its local health protection units. To do this a categorisation of health protection was devised:

Communicable Disease threats

    —  Health care acquired infection and antibiotic resistance.

    —  Vaccine preventable diseases.

    —  Gastrointestinal including food and waterborne.

    —  Respiratory and other systemic infections including tuberculosis.

    —  Zoonoses and other emerging infections.

    —  Sexually transmitted and blood borne infections.


    including chemicals, moulds, plant and food allergens, house dust mites.

Chemicals and Poisons

    —  Chemicals in products.

    —  Poisons.

    —  Pesticides.

    —  Chemical incidents.

    —  Chemicals in waste, water, air, food.

    —  Contaminated land.


    —  Low and high dose ionising radiation.

    —  Non ionising radiation.

    —  Noise.

Extreme Events

    —  Weather (eg winter and summer mortality).

    —  Global warming.

    —  Disasters (eg flooding, bombings etc).

Psychological threats

    (eg psychogenic incidents, terror and the fear of health effects from exposures).

Wider Public Health Issues

    —  Built environment.

    —  Neighbourhoods and incivilities.

    —  Transportation.

  A hierarchy of activity was described, moving from the science base through surveillance, risk assessment to advisory leadership and management.

  In 2006, Health Protection Units assessed their activity within these sub-domains. There was considerable variation between units, explained partly by epidemiology such as higher rates of Tuberculosis in inner cities or distribution of chemical hazards from industrial sites around the country, but mainly it was explained by the way in which the local units were created at the inception of the HPA. In some parts of the country infection control staff came into the HPA bringing their work, and in other parts this did not happen to the same extent.

  In order to develop a specification for the functions and outputs of Health Protection Units, not only the sub domains but the roles, responsibilities and functions and outputs of Health Protection Units needed to be spelled out in relation to the work of other parts of the HPA and other partners in Health protection. To do this, a number of scenarios were developed. The scenario work has exposed the facts that there are areas of activity where clear governance and assurance systems need strengthening. A particular issue was how the HPA Centres were linked to LARS in managing incidents, and what are the lines of accountability. This has been addressed in the new HPA Incident Plan.

  Moving on from the review of current HPU functions, this business plan includes objectives to define the HPU of the future and the processes and systems that must be developed.


  The Regional Microbiology Network (RMN) was established as a Division of the Health Protection Agency in April 2006. The RMN is composed of eight Regional Microbiology Laboratories and 37 Collaborating Laboratories. These Laboratories provide frontline diagnostic and public health microbiology services to NHS Trusts and HPA Health Protection Units. There are 26 Food, Water and Environmental (FW&E) Laboratories of which nine are directly managed by the HPA and 17 are located in Collaborating Laboratories in NHS Trusts.

  The vision for the RMN is "To create an effective and efficient modernised HPA Microbiology Laboratory Network capable of addressing present and future challenges". This will address the main health protection functions outlined in the Chief Medical Officers strategy for combating infectious diseases "Getting ahead of the curve". The Network needs to be robust with strong links to the wider microbiology community to share expertise, capability and capacity. Such a network partnership will enable the HPA to be proactive, flexible, resilient and responsive to future needs and developments in health protection in the UK. A key relationship for the RMN is to continue to work seamlessly with the Local and Regional Services Division to produce the essential data to support frontline health protection activities locally, regionally and nationally. Working in partnership with the Centre for Infections (CfI) will provide the RMN and the HPA with opportunities to improve the responsiveness of diagnostic services to local public health and clinical needs. An example of this is the H5N1, regional capability for not only a rapid local diagnostic service but also the ability to affect rapid public health interventions.

  There are several challenges facing the RMN not least the recent changes in the NHS and in particular the Department of Health "Modernisation of Pathology" programme. The HPA is committed to supporting the programme but must ensure in so doing it secures the outputs needed to deliver its functions. The Carter Report of the Review of NHS Pathology Services is likely to have far-reaching effects on the way in which pathology services in England are configured and delivered. The report identifies changes which will have implications relating to surveillance and not least laboratories. The main risk for future health protection laboratories is that the recommendation of increased plurality of providers, including the private sector, could affect the current flow of information, isolates and samples. However, the RMN together with the CfI has developed service specifications and commissioning arrangements. In addition, the HPA is actively involved in influencing the development of future services and ensuring that health protection functions are a core component of pathology services.

  A major task for 2007-08 for the new RMN Division is developing all the relevant frameworks essential to underpin the necessary activities to deliver a well managed and coordinated Division. These include corporate and clinical governance, frameworks for health and safety, risk management, business support, finance and human resources.

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