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)
HPA
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)
Training
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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