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

Conclusions and recommendations

Implementation of the Callaghan Review

1.  We support the conclusions reached by Sir Bill Callaghan and believe that a single, unified regulatory framework for human and animal pathogens based on risk assessment is the appropriate step forward. We urge the Government to ensure that regulation of work on dangerous pathogens is simplified as far as is practicable with the minimum number of bodies involved, although it may be appropriate for some specialist areas such as counter-terrorist inspection to be administered separately in accordance with the common framework. The Government should co-operate with the devolved administrations to ensure that a similarly high standard of regulation occurs across the UK. (Paragraph 32)

2.  We recommend that the new unified regulatory framework be a permissioning regime such that approval by the regulator should be required before work can start where an application for work at CL3 or CL4 has been submitted. (Paragraph 33)

Categorisation of pathogens and containment measures

3.  We support a common set of containment measures for animal and human pathogens and urge ACDP, in drawing up these measures, to protect the principles of evidence-based risk assessment. They should consider the implications for the viability of important research if unnecessary containment measures are imposed. We expect ACDP to maintain its regular review of required containment measures and the classifications of pathogens under the new framework. (Paragraph 37)

Responsibility for biosecurity

4.  There should be complete clarity over who is responsible for biosecurity, especially on a site of mixed ownership or sponsorship such as at Pirbright. The 'controlling mind' must be clearly identified and be expected to manage the risks that it creates. Ultimate responsibility for biosecurity rests with managers of a facility. A strong safety culture is essential for good biosecurity and all those who fund and operate high containment laboratories should ensure that this exists. (Paragraph 43)

5.  We support the role of Biological Safety Officers in enforcing biosecurity and recommend that the Government and the HSE in particular look at ways to support and reward this profession appropriately given the level of responsibility it holds, firstly by establishing a formal accreditation process. (Paragraph 44)

The HSE in its new role

6.  The Government must ensure that the HSE is sufficiently resourced to enforce the new regulatory framework properly. The shift of responsibility to the HSE for regulating animal pathogens following the Callaghan review should be accompanied by an appropriate increase in the resources the Government provides for this work. The HSE must ensure that it has the necessary veterinary expertise to allow it to regulate the use of animal pathogens and must co-operate with Defra to achieve this. The Government should review the additional resources needed to enable the HSE to deliver the new regulatory framework and publish this, accompanied by the rationale for the resource allocation. (Paragraph 48)

Engagement by the regulator

7.  We urge the HSE to engage as early as possible with those building and operating high containment facilities to avoid resorting to enforcement action. The HSE should review its procedures to consider how best to encourage reporting of incidents and near-misses. (Paragraph 51)

Information held by the regulator

8.  We recommend that the new regulatory framework require the HSE to maintain records of work on dangerous pathogens at a more detailed level than is currently the case and introduce clear guidelines as to whether organisations notify the regulator at a laboratory, site or organisational level. The new framework should be retrospective and should compel all those working with dangerous pathogens to notify the regulator. We urge the HSE to build relationships with those that may require access to such information, such as the animal and public health authorities and security services. (Paragraph 55)

Improving co-ordination and oversight of high containment laboratories

9.  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. (Paragraph 74)

10.  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. (Paragraph 75)

11.  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. (Paragraph 76)

12.  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. (Paragraph 77)

13.  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. (Paragraph 78)

14.  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. (Paragraph 79)

15.  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. (Paragraph 80)

Ministerial oversight

16.  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. (Paragraph 82)

Ownership of high containment laboratories by universities

17.  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. (Paragraph 88)

Location of facilities

18.  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. (Paragraph 95)

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

Funding of high containment laboratories

20.  The costs to human or animal health and to the economy of a breach of biosecurity at a high containment laboratory are devastating, as seen at Pirbright in 2007. We urge all those who fund high containment research to consider more seriously the cost of maintaining and running high containment laboratories. All funders of high containment laboratories must ensure that long-term funding for running costs is provided, sustained and protected to ensure risk management can take place effectively. The Government has a particular responsibility in this regard. UK research laboratories should be maintained by their operators to a high, internationally acceptable standard. (Paragraph 103)

Pirbright redevelopment project

21.  The Pirbright redevelopment is of considerable national importance. We recommend that as a matter of urgency DIUS (via the BBSRC and Large Facilities Capital Fund) and Defra settle how they are to share the cost of the Pirbright redevelopment project as it now stands. At the very least, the final settlement should be announced by the time the Government responds to this report. (Paragraph 107)

Future structures for animal health

22.  The future of the Pirbright site and IAH and the question of its merger with the VLA must be settled as a matter of priority and in any case by April 2009 in line with the Beringer report recommendation on the ownership and management of the site (see below). Whilst Pirbright is undergoing redevelopment, we urge the Government to use the opportunity to develop a long term plan for animal health, considering the recommendations of the Anderson and Beringer Reviews. (Paragraph 111)

23.  The question of the creation of a national centre at Pirbright, a national research strategy for animal health with a new funding body and a new national agency for animal health arose late in our inquiry and does not fall strictly within our terms of reference. However, we recognise that it is an issue of great importance and we recommend that as a matter of urgency the Government produce a White Paper to clarify its strategy for the future of animal health and welfare in the UK, provision of containment laboratories for research and diagnostics and how these would be used in an outbreak. (Paragraph 112)

Core funding and clarity of governance

24.  We support the provision of long-term core funding for the redeveloped laboratories at Pirbright. Whatever the future of the Pirbright site, we support Sir John Beringer's recommendation that by April 2009, Defra and BBSRC should settle the long-term ownership and management of the Pirbright site; otherwise the issue should be referred to the Cabinet Office for resolution. (Paragraph 117)

25.  The Government should set out clearly its policy on the provision of core funding to research institutes with reference to the Research Council Institute and Public Sector Research Establishment Sustainability Study. (Paragraph 118)


26.  It is not acceptable that scientists at HPA Porton Down are asked to work in such ageing facilities. We recommend that the Department of Health consider the redevelopment of the HPA's Porton Down site a priority. Any redevelopment could be viewed as an opportunity to look at the UK's likely future wider requirements for containment facilities. (Paragraph 120)

Supply of staff

27.  The specialist field of high containment biology is critical to the national interest of the UK. We recommend that, through the inter-agency body we have recommended be set up, the Government review the retention of staff and the incentives available for those working in this area to ensure that supply is sufficient for current and future needs. (Paragraph 124)


28.  We recommend that the Government co-ordinate the funding and development of training schemes for those working with dangerous pathogens, building on schemes currently in existence. These should provide certification that a minimum level of competency has been reached and should be designed as a base from which staff can be further trained locally in the safe use of specific pathogens in a particular laboratory. Training programmes should be tailored to the needs of laboratory staff, principal investigators or BSOs whose training needs differ. (Paragraph 131)

29.  We recommend that DIUS engage with the higher education sector to ensure that undergraduate and masters programmes in relevant subjects include instruction in biorisk management. (Paragraph 132)

Vetting of staff

30.  Security-vetting is intended to minimise the risks of deliberate misuse of dangerous pathogenic material. This risk exists regardless of the ownership and governance of a laboratory or the country of origin of researchers and other staff. We therefore recommend that the Government provide access to Government vetting programmes so that all those working with CL4 pathogens can be reliably security-vetted to a consistent, high standard. (Paragraph 139)

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