House of Commons - Innovation, Universities, Science and Skills

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

4 Facilities and capacity

56. In Switzerland all approved projects using dangerous pathogens are listed in an online database which can be interrogated by the public.[110] In contrast, we found it difficult to get details of high containment laboratories in the UK, largely due to considerations of national security. In response to our call for evidence, the HSE co-ordinated an audit of records to produce a breakdown of the number of organisations and sites operating containment laboratories in the UK as shown in table 1. It was also able to provide details of the regulations under which laboratories were registered (table 2). Table 1

Organisation or site type

Containment level Government Private Research Council University

2 212 230 17 70

3 202 98 7 40

4 5 2 3 0

Table 2

Number of organisations in Great Britain

Containment level COSHH and/or
GMO(CU) regulated only
SAPO regulated only HSE & SAPO combined Total

2 494 7 28 529

3 323 5 19 347

Number of sites

4 1 2 7 10

Source: Ev 52

Note: For CL2/CL3 data shows number of organisations. For CL4 data shows number of sites. Only the highest CL used is recorded.

57. Only ten sites in the UK work with CL4 pathogens and aside from two manufacturers of veterinary vaccines, all are Government-sponsored. However, these facilities vary in capacity and capability, ranging from single rooms to multiple suites of CL4 laboratories on a single site.[111] Whilst the HSE is still in the process of carrying out further work to determine the exact number of CL3 laboratories, it reported that these are more widely distributed amongst universities and research council institutes (around 350) and private companies (around 75). Some large universities and research institutes operate significant numbers of CL3 laboratories; for example, two universities run 84 between them. Finally, the NHS run 170 CL3 laboratories, primarily for diagnostic purposes.[112]

58. In addition to high containment laboratories designed for research or diagnostics, there are two High Security Disease Isolation Units designed for the care of suspected cases of Viral Haemorrhagic Fevers such as Ebola or Lassa.[113] Dr John Stephenson of the HPA told us that the high containment hospital sites were at Coppetts Wood and under development at the Royal Victoria Infirmary site at Newcastle. The Coppetts Wood site, rather than a research lab, would be used, should a post-mortem need to be performed on a deceased individual at CL4.[114]

Quality of facilities

59. We have observed at first hand the extent to which the quality of facilities can vary,[115] even those designated CL4. Some of the UK's facilities are world-class; for example the state-of-the-art facilities at the DSTL, Porton Down. In contrast, we found other facilities, at IAH Pirbright and at the HPA in Porton Down, to be in need of significant investment given their age, and we address these sites specifically in Chapter 5 of this Report. Our observations were supported by many witnesses who highlighted the deterioration of such laboratories.[116] The SGM went as far as to describe the state of the UK's central large animal facilities as "deplorable".[117]

Capacity for high containment research in the UK

60. The UK requires both the capacity to carry out ongoing research and surveillance, and the capacity to deal with the unexpected in an outbreak or after the emergence of a new pathogen. A clearly defined system of surveillance must also be in operation. During this inquiry we found that because of the way in which containment facilities vary in size and capability, the sufficiency of the UK's current facilities was hard to determine. Opinions on capacity at level 4 varied. The Academy of Medical Sciences and the Institute of Biology/Biosciences Federation suggested that capacity was lacking[118] but the Institute of Safety in Technology in Research, VLA and the Biotechnology and Biological Sciences Research Council (BBSRC) believed that capacity was sufficient.[119] The Medical Research Council (MRC), HPA, Defra and VLA told us that they have enough capacity for their current needs.[120] However, Dr John Stephenson of the HPA emphasised that this was only the case "if all the facilities which we have in hand are capable of running at full capacity … but that is a very big 'if'."[121] The UK has a larger number of CL3 laboratories, and no problems of capacity were highlighted at this level, although the lack of detail available makes it impossible to be certain.

61. Whilst a number of facilities are able to handle animals at SAPO4, the UK does not currently possess a facility able to handle large animals infected with human ACDP4 pathogens or uncharacterised CL3 viruses.[122] There are few laboratories of this type in the world but Germany considers the capability important enough to have included it in the redevelopment of the Friedrich Löeffler Institute on the Island of Reims.[123] In the UK, Defra held discussions about the inclusion of such a facility as part of the redevelopment project at Pirbright[124] but Professor Martin Shirley, Director of the IAH told us that it was not included on the basis of cost,[125] particularly the "very high recurrent running costs needed to maintain the physical, intellectual and technical competency."[126]

62. Ian Pearson MP, the Minister of State for Science and Innovation told us that ultimately "it is for the experts to come to conclusions about whether a large animal facility … is needed."[127] The BBSRC did not believe there to be a research need for such a facility at Pirbright.[128] Defra convened a meeting in March 2005 to discuss the need for an provision of such a facility in the UK.[129] A subsequent HSE survey of facilities indicated that:

130

63. Professor Chris Thorns of the VLA told us "nobody has come to me yet to say that we need large animal Category 4 facilities." He considered that such a facility is not necessary for the UK and stressed the need to "consider facilities in Europe and elsewhere".[131] However, he admitted that he was not aware of a facility able to conduct post mortem examination of large animals infected with CL4 pathogens and suggested that such examinations would be done in the field. It is unclear what would happen if that pathogen infects large animals and is classified as an ACDP4 pathogen that infects humans. This point was emphasised by Sir Leszek Borysiewicz, Chief Executive of the MRC, who told us that "where there is a possibility of transmission between species, particularly to the operator - then there is a need for such a Category 4 facility."[132]

Co-ordination and oversight of capacity

64. It is vital that the UK maintains the ability to undertake high containment science to counter the threat from infectious disease. Estimating the necessary capacity and capabilities to maintain ongoing research and diagnostics and then to provide surge capacity in the event of a disease outbreak is a difficult task. Any surplus of provision should be avoided, considering the high cost of running high containment facilities and issues of biosecurity. These factors make it important that there is adequate oversight and co-ordination of capacity. However, no comprehensive, cross-Government attempt has yet been made to determine what capabilities are required for the future and no organisation is charged with keeping track of current facilities.

65. From evidence submitted to the inquiry it appears that co-ordination of resources in high containment science is lacking. We have concluded that various Government departments sponsor high containment facilities in silos without reference to each other, and Rt Hon Lord Rooker, Minister of State for sustainable food and farming and animal health, Defra underlined this by telling us that:

When you look at your own laboratories you clearly are responsible as the department, as the minister, to make sure of the operation of the laboratory as well as the focus on the finance and the actual research contracts as well as the other issues relative to biosecurity, but that does not therefore cover across Government.[

133

66. We were particularly struck when visiting Porton Down that the MOD redeveloped the high containment facilities at DSTL without co-ordination with the HPA whose facilities are within sight and in need of significant capital investment.[134] In addition, as we discuss in detail below, the redevelopment of IAH Pirbright is continuing whilst the future of the IAH, and animal health in general are still uncertain. We received evidence of spare capacity at DSTL Porton Down[135] and elsewhere at CL3, with the HSE informing us that they "often see laboratories that are under-utilised."[136] This suggests that more strategic planning may be needed. However, the HSE was unwilling to share information about spare capacity with other organisations to prevent needless facilities being built.[137] Dr Paul Logan considered that "I do not think it is the job of the regulator … to be looking at having an overview as to whether there is sufficient capacity."[138]

67. At an informal level there are arrangements between organisations about how facilities might be used. Dr Nick Coulson of Defra told us that facilities would be shared on an informal basis if the need arose:

139

HPA and VLA co-operate in relation to influenza[140] and both are members of Interlab Forum, "a collaborative agreement between six Public Sector Research Establishments".[141] Whilst it is encouraging that facilities would probably be available if need arose, we do not believe that current arrangements are as clear and as formalised as they should be.

68. Beyond co-ordination, we also heard calls for an "overarching national strategy" to consider the future capacity for work on dangerous pathogens (BBSRC)[142] and a "UK-wide strategic review" (VLA).[143] At the moment, as Dr Nick Coulson of Defra told us, "there is not somebody with that strategic ability to take control at the moment," although an ad hoc group was convened by the deputy chief veterinary officer to look at the redevelopment of Pirbright.[144]

69. In the USA, the USGAO concluded that no single government agency has oversight of the provision of containment laboratories, indicating that a similar lack of oversight is an issue internationally.[145] We do not believe the lack of strategic oversight to be acceptable.

INTERNATIONAL CO-ORDINATION

70. There is clearly an international dimension to the provision of containment facilities. As well as training scientists from around the world,[146] UK laboratories such as those at the VLA, HPA and IAH are international centres of excellence, acting as world reference or European reference laboratories.[147] Given the costs of high containment research, we believe there to be greater potential for shared-use of facilities on a European basis, than is currently the case. For example, as we have noted, Professor Chris Thorns of the VLA suggested that this might be possible in the case of ACDP4 large animal facilities.[148]

The Griffin review of CL4 facilities

71. The MRC has recently commissioned the HPA to undertake a review of the provision of CL4 facilities in the UK, chaired by Professor Griffin, head of the ACDP.[149] BBSRC and Defra have since expressed an interest in the review, with BBSRC, MRC and HPA currently committed to fund it, although arrangements are not finalised. The Department of Health, Defra, MRC, BBSRC and HPA are represented on the steering committee which will agree the terms of reference and oversee the process. Those organisations represented on the steering committee will receive the final report which is scheduled for October 2008.

72. The draft terms of reference of the Review are as follows:

To obtain, and keep secure, a definitive list of all ACDP CL4 or SAPO4 facilities currently in operation across the UK, their location, capacity and capability in terms of the type work they support;
To obtain information on the life expectancy and plans for refurbishment/new build of these existing facilities, to identify organisations which have an interest in using or providing ACDP CL4/SAPO4 facilities in the future and which may be planning their construction;
To undertake a strategic horizon scanning programme in order to identify scientific and technology drivers that will define future needs and access requirements, in terms of capacity, technologies, safety, security and regulation, over a 10-20 year period. This will also consider the scope and constraints for introducing flexibility and sharing of the facilities available;
To consider possible exemplars in Europe and North America particularly with respect to trends in likely physical infrastructure (suited versus cabinet line laboratories), location (urban versus remote sites) and security requirements;
To identify the manpower and skills requirements for specialist personnel employed in ACDP CL4/SAPO4 facilities and all aspects (including costs) of the reaccreditation of both staff and facilities;
To identify opportunities for collaboration and synergy to optimise effective and efficient provision, and value for money, in delivering UK high level containment needs for research and public health protection; and
To submit a review report to the sponsors within eight months.[150]

PREVIOUS REVIEWS OF CAPACITY

73. As described above, Defra previously convened a workshop to "to form a view on the need for an ACDP CL4 facility" for handling large animals once this was identified as a gap in the UK's capabilities. HSE subsequently reviewed the potential to convert existing facilities to be able to carry out work on large animals and sent a draft report to the Defra Chief Scientific Adviser.[151] When asked by ourselves Defra were unable to locate a finalised copy of this report and the Department appears not to have taken any further action on this issue.[152]

Improving co-ordination and oversight of high containment laboratories

74. The Government should know the location, capacity and capability of all high containment laboratories in the UK. We accept that individual agencies are obliged to ensure they possess sufficient facilities for their own needs. However, given the costs of building and maintaining high containment laboratories, efficient use of facilities is essential.

75. While we commend the MRC for instigating the review of CL4 facilities currently underway under the chairmanship of Professor Griffin, we are disappointed that having started the process of identifying gaps in the UK's provision of high containment facilities, Defra did not act to address these. We believe it to be more appropriate that the Government lead a review of CL4 facilities than the MRC, given that the scope of those represented on the steering committee is somewhat wider than the MRC.

76. We recommend that the Government form a standing inter-agency body responsible for the strategic planning and co-ordination of containment level 4 facilities. Its members would include representatives of the Research Councils and Government departments that sponsor high containment facilities.

77. We recommend that within a year this inter-agency body undertake a detailed audit of the CL4 facilities currently available in the UK to determine capacity and capability, drawing on Professor Griffin's review. Capacity at CL3 should be assessed subsequently.

78. We recommend that the inter-agency body regularly review the capacity available for research at high containment and that it be consulted during redevelopment or building projects to look strategically at the need for new facilities, the potential for their shared use and whether particular capabilities should be included to provide what the UK requires. Early considerations should include the provision of post mortem facilities and facilities to handle large animals at ACDP4. It should also consider plans for the best use of high containment facilities during disease outbreaks.

79. We recommend that where possible, co-operation take place at a European and international level to promote burden-sharing and to investigate whether some facilities could be provided and shared at a European level where this is practicable.

80. We recommend that every two years the Government present to Parliament a report outlining the UK's readiness in the face of the threat posed by dangerous pathogens. This should include an analysis of the capacity and capability for research at high containment, set out the contingency plans for unexpected outbreaks of disease or the emergence of novel pathogens and how UK facilities will be used following such an event and include an updated long-term strategy for research and surveillance, accounting for climate change and other factors affecting the pathogens threatening the UK.

Ministerial oversight

81. We asked the Ministers who appeared before us whether they had ever met on the issue of biosafety or biosecurity. They had not.[153] Lord Rooker from Defra told us "you are asking a question: who is in charge nationally of biosecurity? Frankly, you cannot get an answer to that."[154]

82. We are disturbed that Ministers have not met to discuss the issue of biosecurity, especially given that no organisation or Government department has oversight in this area or responsibility for planning for future requirements, for example in the areas of surge capacity and anti-terrorist provision. We do not accept the view held by Lord Rooker that it is satisfactory for no Minister to have overall responsibility for biosecurity. We recommend that in view of the cross-cutting nature of these issues, the Government establish a ministerial group to meet periodically to discuss issues of biosecurity. A single Minister, for example the Minister for Science and Innovation, should take responsibility for co-ordinating biosecurity and the provision of high containment laboratories and should act to convene this ministerial group and the inter-agency body we have recommended be set up.

Ownership of high containment laboratories by universities

83. In the UK no university runs a CL4 laboratory[155] (see table 1) but this is not the case elsewhere in the world, for example in the USA[156] or in Germany (in Marburg). We understand that a UK university has expressed an intention to develop a CL4 laboratory.[157] Dr Paul Logan of the HSE cited their reasoning as being that:

158

84. None of our witnesses expressed objection in principle to a university running a CL4 laboratory, with Michael Stephens of the Institute of Safety in Technology and Research (ISTR) stating that:

159

Ian Pearson MP agreed that there was no reason "to believe that universities are any less reliable than a government institute when it comes to running containment level four facilities."[160]

85. One significant barrier to such an application to run a CL4 laboratory could be the availability of sufficient long-term funding to maintain such a facility safely. Professor Robin Weiss, President of the SGM, told us that:

161

86. An alternative is to provide CL4 facilities at centralised sites where they could be used as a 'science hotel' by university staff. Given the economies of scale involved, some witnesses argued that this would be more resource efficient and flexible.[162] This option was also preferred by Professor Griffin, Chair of ACDP who, when asked whether universities should operate CL4 facilities, told us that:

163

87. If such a system were to be in place, the universities must be assured of reliable access to these facilities. An example of such a shared resource is the Diamond Light Source, funded by the Science and Technology Facilities Council and the Wellcome Trust, where beamtime is allocated via a peer review process and is free at the point of use to academic users.[164] Similar systems operate at the Central Laser Facility[165] and ISIS,[166] also at the Rutherford Appleton Laboratory near Oxford.

88. CL4 facilities are expensive to run and larger facilities benefit from economy of scale. We recommend that the body designated to co-ordinate CL4 capacity in the UK look at mechanisms by which spare capacity at existing facilities can be made reliably available to university researchers wishing to work at CL4, rather than allowing an unnecessary proliferation of facilities. Nevertheless, so long as sufficient resources are available to build, run and maintain a CL4 laboratory in the long-term to the required high standards, we have no objection in principle to universities operating these facilities.

Location of facilities

89. Currently, all of the UK's ten CL4 facilities are located in the south of England, although CL3 facilities are widely distributed.[167] Some CL4 facilities, such as IAH Pirbright and the laboratories at Porton Down, are situated in relatively isolated locations but this is not the case for all. A number of CL4 laboratories exist in large cities around the world, including three in London which have been in operation for some time.[168] Germany is currently building new high containment laboratories for human pathogens at the Robert Koch Institute in Berlin,[169] and the Minister for Science and Innovation told us that "there are more than a dozen cities around the world where containment level four facilities do operate. I am not aware that there are any security or biosecurity issues as a result of those."[170]

90. Whilst CL4 facilities may already exist elsewhere in large cities, the question must be whether these are ideal locations for future developments. For example, the provision of additional biosecurity was the primary reason for the movement in the early 20^th century of the Friedrich Löeffler Institute in Germany onto the Isle of Reims. Modern biorisk management strategies mean that isolated or island locations are not essential for high containment laboratories but location is still a consideration. In the USA, for example, there has been controversy over the possibility that the Department for Homeland Security will move FMDV research from its current location on Plum Island, off Long Island in New York, to a mainland location. The USGAO has concluded that evidence is lacking that such research can be done safely on the mainland. It cites the outbreak at Pirbright as the best evidence that that an island location is preferable since it can help prevent spread of the virus should an accidental release occur.[171] In addition, in Boston in the USA, there has recently been controversy over the location of a CL4 laboratory in the city and the adequacy of the analyses of worst case scenarios and alternative locations.[172]

91. These issues have acquired resonance in the UK with the announcement in December 2007 by the MRC, Cancer Research UK, the Wellcome Trust and University College London of their intention to establish the UK Centre for Medical Research and Innovation (UKCMRI), next to the British Library and St Pancras station in central London. Work carried out at the MRC's National Institute for Medical Research (NIMR) will move to the new site as determined by a scientific planning committee chaired by Sir Paul Nurse, President of Rockefeller University, New York.[173] At present the NIMR runs the only MRC-owned CL4 laboratory,[174] but whether this work will move to the UKCMRI is undecided. Sir Leszek Borysiewicz, the MRC Chief Executive told us that

175

The UKCMRI project has also precipitated the Griffin review of CL4 facilities described earlier.

92. The idea of locating a CL4 laboratory at the UKCMRI has generated significant concern in the area and in the media.[176] Professor Griffin sympathised, when asked about locating CL4 laboratories in urban areas:

177

He later qualified this by telling us that:

178

93. As the regulator, the HSE is content that it would be safe to have a CL4 laboratory operating in London "as long as it was designed, operated, maintained and run properly".[179] Professor Chris Thorns of the VLA concurred, telling us that:

180

94. We heard general agreement that consulting the HSE at an early stage was advisable when building new CL3 and Cl4 facilities.[181] Dr Paul Logan of the HSE told us that its inspectors "are consulted about plans for level four facilities. For level three facilities we encourage people to approach HSE … At the moment we would have the powers to stop the level four facility if we thought it was not going to be able to operate safely."[182] Lord McKenzie told us that he did not believe that the HSE's approval should necessarily be required for a proposed high containment laboratory.[183] However, there is an argument that the HSE should be required to approve an application to build a CL3 or CL4 laboratory early in the planning process to ensure that it is likely to meet the required standards, preventing the possible waste of resources.

95. We consider that there is no reason in principle why CL4 laboratories should not be built in urban areas, provided that the correct risk assessment is undertaken and biorisk is managed appropriately. As each case will be unique, we recommend that such applications be treated on an individual basis.

96. We recommend that the HSE be a statutory consultee in any planning application for a CL3 or CL4 laboratory.

110 Ev 147 Back

111 Ev 162 Back

112 Ibid. Back

113 Ev 162 Back

114 Q 213 Back

115 Ev 63, 77 Back

116 Ev 68, 117, 156; Qq 168, 281 Back

117 Ev 156 Back

118 Ev 98, 114 Back

119 Ev 63, 68, 101 Back

120 Ev 92; Qq 204-208, 371 Back