Appendix: Government response
1. Introduction
1.1 The Government welcomes the report by the
House of Commons Select Committee on Innovation, Universities,
Science and Skills into biosecurity in UK research laboratories.
The Government agrees that it is essential to maintain the capacity
and capability to undertake research on dangerous pathogens as
well as to be able to anticipate and respond to outbreaks of infectious
diseases of human and animals. The Government also agrees that
facilities in which this work is carried out must have proportionate
measures in place to avoid accidental or deliberate release of
dangerous pathogens.
1.2 The Committee endorses many of the actions
that the Government is taking to improve the control of dangerous
pathogens, such as moving to a single regulatory framework for
human and animal pathogens. However, it also offers thoughtful
and constructive comments on areas where further improvements
could be made. The Government's response addresses recommendations
under the same broad themes as the Committee's report. The response
draws upon the views of relevant Government departments and agencies,
the Research Councils and the Scottish Executive and Welsh Assembly
Government.
2. The regulatory framework and implementation
of the Callaghan review
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).
2.1 The Government welcomes the Committee's support
for implementing the conclusions of the "Callaghan review"
of the regulatory framework for the handling of animal pathogens.
That review recommended that there should be a single regulatory
framework, with the containment measures used based on risk assessment,
and that the Health and Safety Executive (HSE) should become the
single regulatory body for work involving the intentional handling
of both animal and human pathogens. It recognised that the Health
and Safety Executive already operates a robust permissioning system
for work with genetically modified organisms at containment levels
3 and 4.
2.2 The Callaghan review advocated a common set
of containment measures, to be developed by the Advisory Committee
on Dangerous Pathogens, to accompany the single regulatory framework.
It also recommended that the new framework should be of a permissioning
nature, requiring notification by the operator and approval by
the regulator before work at containment level 3 or 4 can start.
The Committee supported the recommendations of the Callaghan review
and stressed the need for the measures to be proportionate.
2.3 The Government is continuing to implement
the Callaghan recommendations. The HSE is now leading the final
phase of work to introduce a single regulatory framework, in liaison
with Defra and other relevant Government Departments, the devolved
administrations and interested parties.
UNIFIED INSPECTION AND ENFORCEMENT
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).
2.4 In England, the inspection and enforcement
functions for work with animal pathogens are currently being carried
out by the HSE on Defra's behalf -
(a) the Specified Animal Pathogens Order 2008
came into force on 28 April 2008. It extends the enforcement powers
available to inspectors and aligns them as closely as possible
with powers given to HSE inspectors regulating human pathogens
under the Health and Safety at Work etc. Act 1974 (HSWA); and
(b) an agency agreement has been made between
the Secretary of State for Environment, Food and Rural Affairs
and the HSE.
2.5 Currently Wales, Scotland and Northern Ireland
have a different approach as responsibility for the legislation
on specified animal pathogens is devolved. The HSE is continuing
to work with the Scottish Executive and the Welsh Assembly Government
to reach similar agency agreements with them. The Northern Ireland
Executive will also be introducing a single regulatory framework
and will be liaising with the HSE in doing so.
SINGLE REGULATORY FRAMEWORK
2.6 The first stage of introducing a single regulatory
framework has been to identify the legal basis required for the
HSE to propose new regulations for animal pathogens. This is a
complex process but the HSE has identified the necessary steps
to amend the HSWA, through a Legislative Reform Order, to provide
that legal basis.
2.7 While that work is on-going, the HSE will
simultaneously lead more detailed work to shape the regulatory
framework. New secondary legislation will replace three existing
pieces of legislation (the Specified Animal Pathogens Order, the
Genetic Modification (Contained Use) Regulations) and relevant
parts of the Control of Substances Hazardous to Health Regulations.
The aim is for the new regulatory framework to be in place by
early 2010.
2.8 In developing the new secondary legislation,
the HSE will explore a permissioning regime, requiring the operator
to notify (prior to approval) all work with human and animal pathogens
at containment levels 3 and 4. This may be done in a similar way
to that which applies to work with genetically modified organisms.
2.9 The work will also cover other aspects of
the regulatory framework. For example, emphasis will be placed
on providing a single point of contact for duty holders and the
establishment of a clear and consistent approach to risk assessment,
containment and control.
2.10 Other Government departments, the Scottish
Executive, the Welsh Assembly Government and appropriate bodies
in Northern Ireland are being consulted about and are involved
with the development of the proposals. The HSE will also be seeking
dialogue and involvement with external stakeholders and will consult
more widely once their proposals are firmer.
UNIFIED CONTAINMENT FRAMEWORK
Categorisation of pathogens and containment measures
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).
2.11 The Advisory Committee on Dangerous Pathogens
(ACDP) has set up a formal Working Group, chaired by Professor
George Griffin, to develop a common set of containment measures
for human and animal pathogens based on risk assessment. Members
of the Working Group have been identified and invited to contribute
to the work. The first meeting of the Working Group took place
on 9 September. As well as relevant technical and scientific expertise
in assessing the relative hazards of both human and animal pathogens,
the ACDP has experience of applying this knowledge and selecting
appropriate and proportionate containment and control measures.
Once the containment measures have been developed, the ACDP will
continue to keep them under review in the light of developments.
COUNTER-TERRORISM INSPECTION
2.12 These actions aim to simplify the regulatory
framework as far as is practicable. However, as the Committee
recognised, it is appropriate for some specialist areas such as
counter-terrorist inspection to continue to be administered separately.
Part 7 (Security of Pathogens and Toxins) of the Anti-terrorism
Crime and Security Act 2001 will continue to apply to facilities
that handle dangerous human and animal pathogens. The National
Counter-Terrorism Security Office (NaCTSO) will therefore continue
to discharge its statutory responsibility to deliver a bespoke
service regarding counter-terrorism security advice to operators
of such facilities.
RESPONSIBILITY FOR BIOSECURITY
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).
2.13 The Government endorses the Committee's
view that there should be complete clarity over who is responsible
for biosecurity, especially on sites of mixed ownership or sponsorship.
The Government also agrees that a strong safety culture is essential
for good biosecurity and that responsibility for this rests with
the managers and operators of a facility. The Callaghan review
concluded that the primary responsibility for managing risks must
lie with top managers of any facility where work on dangerous
pathogens is carried out. This has been achieved through clearer
and more robust licensing requirements.
2.14 Experience has shown that senior level buy-in
is instrumental to developing a robust site safety and biosecurity
culture. This is encouraged by the HSE and NaCTSO through advice,
guidance and inspections as well as legislation.
2.15 The Management of Health and Safety at Work
Regulations 1999 impose duties on employers for co-operation and
co-ordination where a workplace is shared, whether permanently
or temporarily. Subject to the outcome of consultation, the new
legislative framework may include similar provisions to those
regulations, or a cross-reference to them, to address the issue
of the 'controlling mind'.
CERTIFICATION OF BIOLOGICAL SAFETY OFFICERS
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).
2.16 The Government acknowledges the important
role played by Biological Safety Officers and shares the Committee's
view that their role should be embedded within employers' organisational
safety arrangements and be more formally recognised and rewarded.
It is for the industry to take the responsibility for creating
and developing appropriate accreditation schemes. The Government
welcomes the work being done by the Institute of Safety in Technology
and Research to develop an accreditation system for minimum competence
standards for Biological Safety Officers and the HSE is supporting
this initiative. This system is due to be launched in October
2008.
3. The HSE in its new role
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).
RESOURCES
3.1 The Committee makes an important point about
the need to ensure that the HSE is sufficiently resourced to enforce
the new regulatory framework properly. The HSE's Board welcomes
opportunities to take on additional regulatory responsibilities
where they complement the organisation's core role and are properly
resourced. Although no formal review has been undertaken, the
HSE has already considered the resources it will need. Until the
new regulatory framework is introduced, Defra is funding the HSE's
inspections of facilities handling animal pathogens in England
and has agreed in principle to fund inspections in Wales when
the HSE undertakes them. Discussions are taking place with the
Scottish Executive about parallel arrangements for Scotland. Defra
will also continue to provide veterinary expertise and advice
to the HSE.
3.2 The Callaghan review recommended that the
new regulatory framework should incorporate a cost recovery scheme
to fund the HSE's responsibilities in this area. Proposals for
this scheme will be developed and included in the HSE's consultation
on the single regulatory framework. In addition, the HSE is working
with Defra and the Veterinary Laboratories Agency to identify
the level of veterinary expertise required and the most appropriate
way of providing it. As Lord McKenzie confirmed in his evidence
to the Select Committee, the Government is satisfied that the
HSE will have sufficient resources to deliver the new regulatory
framework for human and animal pathogens.
ENGAGEMENT BY THE REGULATOR
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)
3.3 The Government welcomes the Committee's acknowledgement
that a good regulator should engage as early as possible with
those building and operating high containment facilities to avoid
resorting to enforcement action. It is common practice for the
HSE to be involved in early discussions about new build facilities.
In the new single regulatory framework the HSE will explore how
best to formalise the notification of new premises at an early
stage. Enforcement action must always remain an option for a regulator
but only in those circumstances where it is merited. Any action
taken by the HSE is in line with the HSE's published Enforcement
Policy Statement, which is consistent with principles set out
in the Macrory and Hampton reports, the Enforcement Concordat
and the new statutory Regulators' Compliance Code.
3.4 We acknowledge the Committee's view that
the HSE should review its procedures to consider how best to encourage
reporting of incidents and near-misses. The Reporting of Injuries,
Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) requires
the reporting to the HSE of certain incidents and near misses
involving high hazard biological agents that pose a risk to human
health. The reporting of defined accidents involving genetically
modified organisms is also required under the Genetically Modified
Organisms (Contained Use) Regulations 2000, as amended. The Government
does not believe that there needs to be a change to RIDDOR but
in developing the new single regulatory framework, the HSE intends
to retain the requirement in the Genetically Modified Organisms
(Contained Use) Regulations and extend it to include incidents
and near misses involving animal pathogens. The HSE will continue
to take every opportunity (through inspections, guidance and publicity)
to raise the profile of reporting incidents and near misses with
its stakeholders.
INFORMATION HELD BY THE REGULATOR
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)
3.5 The Government agrees with the Committee
that the new legislative framework should enable the HSE to maintain
records of work on dangerous pathogens at a more detailed level
than is currently the case and provide clarity as to whether notifications
should be made at laboratory, site or organisational level.
3.6 Following the foot and mouth disease outbreak
at Pirbright, the HSE immediately set up a project to scrutinise,
update and improve the robustness of information already held
relating to work with biological agents, to check alignment with
the current regulatory framework. All dutyholders were contacted
and the HSE's records were subsequently updated to ensure accurate
details of all facilities working with biological agents were
recorded.
3.7 The new single regulatory framework will
build on this database by including an integrated notification
system that covers all work undertaken on human and animal pathogens
and genetically modified organisms. A proposed transitional period
of three to six months will allow dutyholders to notify retrospectively
all existing activities. This will help to ensure that regulators
have a full picture of the sites and laboratories where work is
taking place and with which pathogens.
3.8 The HSE maintains close links with other
Government departments and agencies that have an interest in the
work being carried out with pathogens, such as the Health Protection
Agency and the Security Services, and will continue to build on
these as the new regulatory system is developed. The HSE has begun
to build new relationships with organisations and agencies working
in the field of animal pathogens, such as the Veterinary Laboratories
Agency. For example, HSE inspectors will be giving presentations
and attending the VLA's annual conference.
4. Facilities and capacity
Coordination of overview of capacity
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)
4.1 The Government does know the location, capacity
and capability (equipment, suitably trained staff) of all high
containment laboratories in the UK and agrees that the efficient
use of publicly funded facilities is essential. The Government
welcomes the Committee's acknowledgement that individual agencies
must be responsible for ensuring that they possess sufficient
facilities for their own needs. For example, in considering the
research required to support the development and implementation
of its policies, Defra has considered, and will continue to consider,
the specific requirement for containment level 4 facilities for
animal pathogens, including those capable of handling large animals.
However, the Government agrees that there would be benefits from
greater collaboration and coordination of high containment research
capacity and associated issues.
INTER-AGENCY GROUP
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)
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)
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)
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)
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)
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)
4.2 The Government shares the Committee's view
that it would be useful to have a regular forum for those Government
stakeholders and Research Councils that sponsor high containment
facilities. Regular dialogue would improve mutual understanding
and support a strategic approach to the UK's science capacity
and capability, while enabling individual departments and agencies
to retain responsibility for their own requirements. As the Committee
recognises, there are a number of issues that the group could
usefully consider. For example, they might consider whether there
is scope for better use of existing facilities (including making
spare capacity available to others such as university researchers),
the need for a large animal facility, the recruitment and retention
of staff, a common approach to security vetting, the scope for
international cooperation, and future demands. Although funding
issues may be discussed, responsibility for decisions in this
area would continue to rest with the individual departments and
agencies.
4.3 However, decisions on the group's terms of
reference and agenda items are premature. As the Committee noted,
Professor Griffin, Chairman of the Advisory Committee on Dangerous
Pathogens, is leading a review to assess the provision of facilities
for human and animal diagnostics and research at the highest biological
containment levels. He is also considering a number of associated
issues, such as skills requirements, the scope for collaboration
with others (within the UK and internationally) and likely future
needs.
4.4 Professor Griffin's review has been commissioned
by the Health Protection Agency following a proposal from the
Medical Research Council (MRC). Defra, the Department of Health
(DH), the HSE, the MRC and the Biotechnology and Biological Sciences
Research Council (BBSRC) are represented on the review's Steering
Committee. The review is due to conclude in October 2008 and should
provide a good basis for determining the subsequent work of the
inter-agency group. Detailed consideration will therefore be given
to the terms of reference and the issues for the inter-agency
group once we have received Professor Griffin's report.
4.5 The Government does not agree with the Committee's
conclusion that having started the process of identifying gaps
in the UK's provision of high containment facilities, Defra did
not act to address these gaps. A series of detailed discussions
took place between senior representatives of Defra, the HSE, Institute
for Animal Health/BBSRC, Ministry of Defence and DH specifically
on the provision of ACDP 4 large animal high containment facilities.
The conclusion of those discussions was that there is not a gap
in the provision of this type of facility and that Defra would
be able to undertake any new work, if a new disease emerged, within
existing facilities of other Government departments.
MINISTERIAL RESPONSIBILITY
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)
4.6 Much of the work of the inter-agency group
of Government and Research Council officials will comprise relatively
technical issues relating to scientific capacity and capability.
Where scientific and technical issues are involved, the Chief
Scientific Advisers' Committee is best placed to oversee cross-cutting
issues and receive reports from the inter-agency group from time
to time.
4.7 We agree with the Select Committee that a
collective Ministerial overview would be appropriate, at least
until Ministers are confident that coordination by officials and
Chief Scientific Advisers is working well. We will therefore establish
a Ministerial group, to be convened when the need arises. Where
wider considerations (policy, resource, etc.) need to be taken
account, Ministerial involvement will be appropriate and officials
and departmental Chief Scientific Advisers will alert their Ministers
to significant issues as appropriate. For non-controversial issues,
agreement to key decisions and plans or resolution of differences
will be obtained through periodic write-rounds to the Ministerial
group.
SINGLE MINISTERIAL RESPONSIBILITY
4.8 The Ministerial group will comprise Ministers
from the departments with the most significant interest in biosecurity
issues (Defra, DH, the Department for Innovation, Universities
and Skills, the Department for Work and Pensions, the Home Office
and the Ministry of Defence). In the short term, the Minister
for Science and Innovation will take responsibility for coordinating
biosecurity issues and writing round to or convening the Ministerial
group. In the longer term, the agenda may indicate that it would
be more appropriate for another Minister to lead. Alternatively,
if the other coordinating arrangements are working well, there
may no longer be a need for a Ministerial group.
REPORT TO PARLIAMENT
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)
4.9 We note the Committee's recommendation that
the Government should present to Parliament every two years a
report outlining the UK's readiness in the face of the threat
posed by dangerous pathogens.
4.10 Much of the information that the Committee
wished to see will be classified, particularly where it relates
to containment level 4 facilities, and there would be security
concerns if it were to be made publicly available. Nevertheless,
Parliament will wish to be reassured that biosecurity issues are
being addressed and kept under review. The Government therefore
intends to report to the Select Committee before the end of September
2009 to explain how the new mechanisms (inter-agency group, scientific
overview by Chief Scientific Advisers and the Ministerial group)
are delivering their objectives. At that time, we will also consider
whether there continues to be a need for collective Ministerial
overview and whether there would be value in providing subsequent
reports to Parliament.
4.11 In addition, the Government has recently
published for the first time a National Risk Register. The National
Risk Register sets out the Government's assessment of the likelihood
and potential impact of a range of different risks that may directly
affect the resilience of the UK and is designed to encourage individuals
and organisations to think about their own preparedness. It also
includes details of what the Government and emergency services
are doing to prepare for emergencies. It draws upon the National
Risk Assessment, a classified cross-government document which
assesses the impact and likelihood of the major risks that the
country could face over a five year period.
LOCATION OF FACILITIES
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)
We recommend that the HSE be a statutory consultee
in any planning application for a CL3 or CL4 laboratory. (Paragraph
96)
4.12 The Government supports the Committee's
view that there is no reason in principle why containment level
4 laboratories should not be built in urban areas, and that such
applications should be treated on an individual basis. Whatever
the location, it is essential that the facilities have robust
security measures in place and that they are appropriate to the
location. Those measures must be sufficient to minimise hazards
to health and the environment in the event of a breach.
4.13 The Anti-terrorism, Crime and Security Act
2001 requires laboratory operators to notify the Home Office if
they intend to work with any of the pathogens listed in Schedule
5 of the Act (ie those at containment levels 2, 3 and 4). Counter
Terrorism Security Advisers review the security of the facilities
and sites and provide any necessary advice on measures relating
to personnel and physical security. If an operator fails to introduce
suitable measures, the Act provides powers for the counter-terrorism
security adviser to dispose of the pathogens and/or require closure
of the facility.
4.14 NaCTSO and the Home Office have produced
specific guidelines for laboratories which will handle pathogens
at containment levels 2 and 3. This document is entitled 'Security
Standards for Laboratories Subject of Part 7 of the ATCSA 2001'.
It is currently being reviewed to take account of the Part 7 of
the Anti-terrorism, Crime and Security Act 2001 (Extension to
Animal Pathogens) Order 2007, which brings animal pathogens as
well as human pathogens within the scope of the Act. Generic advice
is not produced for containment level 4 laboratories; instead
the National Counter Terrorism Security Office provides bespoke
advice on all aspects of the facility (such as the structure,
security equipment and staffing).
4.15 The Government acknowledges the recommendation
that HSE should become a statutory consultee in planning applications
for laboratories at containment levels 3 and 4. Although we do
not propose to amend the current requirements for planning permission,
in developing proposals for the new single regulatory framework
the HSE will consider the information that should be provided
to the regulator. As part of this, the HSE will consider, with
other Government departments and the devolved administrations,
the extent of any consultation which may be required for a new
facility or a change of use of an existing facility.
5. Resourcing
Funding
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)
5.1 The Government fully accepts the need to
ensure funding for modern research and surveillance facilities
and agrees that they should be maintained and operated to an internationally
acceptable standard. The Government has recognised the need for
improved research facilities. The Science Budget, which funds
research in universities and Research Council Institutes, has
doubled in real terms since 1997 and will be £4bn a year
by 2010.
REDEVELOPMENT OF THE INSTITUTE FOR ANIMAL HEALTH,
PIRBRIGHT
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)
5.2 The Government agrees with the Committee
that the redevelopment of the Institute for Animal Health at Pirbright
is of prime importance. It has been the subject of significant
capital investment in recent years and the BBSRC is spending £22
million to improve facilities there prior to the redevelopment
of the site. The current building programme is progressing, but
since the outbreak of foot and mouth disease and the need for
increased biosecurity measures, the costs of the redevelopment
are being re-examined[1].
GOVERNANCE OF THE INSTITUTE FOR ANIMAL HEALTH
5.3 In addition, the BBSRC Council recognised
in 2006 that the governance of the Institute for Animal Health
needed to be re-examined. The Institute for Animal Health is a
private company limited by guarantee with charitable status. It
is constitutionally autonomous. However, the BBSRC employs all
of the Institute's staff, and provides the bulk of funding. The
Beringer report advised that this arrangement was not appropriate
because it was not clear whether accountability for decisions
lay with the BBSRC or the governing board of the Institute. To
address this, the BBSRC has agreed to become corporate trustee
for the Institute for Animal Health.
FUTURE FUNDING AND GOVERNANCE
5.4 DIUS, Defra and the BBSRC have been in discussion
over the best way forward for the longer-term ownership and management
of the Pirbright site and how best to ensure the provision of
long-term core funding for its redeveloped laboratories. Decisions
will take account of the recommendations from the Anderson and
Beringer Reviews. Although the Government is keen to make a decision
as quickly as possible, the issues are complex and it is important
that they are resolved appropriately.
FUTURE STRUCTURES FOR ANIMAL HEALTH
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)
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)
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)
5.5 Although not a focus of its report, the Government
recognises the Committee's desire to see a clear strategy for
the future of animal health and welfare, including the provision
of containment laboratories for research and diagnostics and their
use in a disease outbreak. As part of its responsibility and cost-sharing
agenda, Defra is proposing to consult in the late autumn on future
governance and funding arrangements for animal health in England.
The consultation is likely to explore the option of establishing
a new independent public body that would exercise the functions
currently exercised by the Secretary of State in respect of animal
health. If established, such a body would assume Defra's customer
requirements for research and diagnostics in this area. Animal
health and welfare policy is a devolved matter within the UK,
although the Animal Health Agency (an executive agency of Defra)
operates on a GB wide basis, working closely with the devolved
administrations in Wales and Scotland. In order for the EU single
market to operate effectively, animal health and welfare policy
is made in Brussels. The UK plays an active role in helping to
shape this policy.
5.6 The Animal Health and Welfare Strategy for
GB was published in 2004 with the aim to: "develop a new
partnership in which we can make a lasting and continuous improvement
in the health and welfare of kept animals while protecting society,
the economy, and the environment from the effect of animal disease".
The England Implementation Group is an independent advisory group
appointed by the Government to drive forward delivery, in England,
of the Strategy. The Group is currently being reviewed by David
Evans CB and will report in December 2008. His recommendations
will inform Defra's decision, in early 2009, on the future of
the Group.
CLARITY OF GOVERNANCE AND FUNDING
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)
5.7 The Government notes the Committee's desire
for clarification of 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. Responsibility for Research Council Institutes and Public
Sector Research Establishments rests with an individual Research
Council or Government department. In those circumstances, the
sponsors, as part of their normal management activities, should
consider how the Institutes or Establishments can deliver the
science required in both the short and longer terms.
5.8 The "PSREs and the Science Base: A Policy
for Sustainable Trading and Joint Strategic Investment in PSRE
Infrastructure" report explained that—
"Research Council Chief Executives and Permanent
Secretaries of Government departments, working through Chief Scientific
Advisers, should be jointly accountable for developing joint scientific
and investment strategies for their cross-boundary research interests.
As a minimum, such an interest exists if the Government department
procures 15% or more of a Research Council institute's turnover.
Once agreed, those joint strategic plans should be deemed to place
a commitment on a Government department's science budget holder
to honour the joint agreement. The Research Councils UK and the
Chief Scientific Advisers' Committee should jointly review such
strategies every five years."
5.9 The "Science & Innovation Investment
Framework 2004-2014" noted that the Government supported
the report's recommendations.
5.10 To help the Institutes and Establishments
assess their long term sustainability, DIUS runs a regular annual
Research Council Institute and PSRE Sustainability Study monitoring
exercise. This assessment, which research establishments agree
with their sponsor department, enables research establishments
to identify changes in their funders' priorities and help assess
their long term sustainability in terms of their delivery of strategic
profile, income, infrastructure and staff.
HPA PORTON DOWN
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)
5.11 The Government notes the recommendation
that the Health Protection Agency's site at Porton Down should
be redeveloped as a priority. The Department of Health has already
considered a strategic outline case for this redevelopment and
the Health Protection Agency is currently developing a detailed
business case for the project. The Department of Health expects
to receive the business case in the second half of 2009 and will
then consider it in the light of both the Health Protection Agency's
and wider national strategic requirements.
6. Staff working on dangerous pathogens
Supply of staff
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)
6.1 The Government agrees with the Committee
that the recruitment and retention of suitably qualified staff
is an issue that should be addressed by the inter-agency group.
The group's discussions will be informed by Professor Griffin's
review of issues relating to the UK's capability for research
into the highest containment levels of human and animal pathogens.
TRAINING
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)
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)
6.2 The Government agrees that adequate training
is essential if staff are to work with dangerous pathogens safely
and competently. Although the responsibility for training staff
must rest with the operators of laboratories, the Government recognises
that there may be merits in providing more formal training and
qualifications as well. We therefore welcome the development of
a certification scheme for Biological Safety Officers. In the
light of Professor Griffin's recommendations on the skills requirements
for research into the highest containment levels for human and
animal pathogens, the inter-agency group will review the need
to encourage the industry to extend this scheme to others working
with or supervising work with dangerous pathogens. The group will
also consider the level of training that might be required as
part of undergraduate and Masters programmes and, if appropriate,
DIUS will engage with the higher education sector to take this
forward.
VETTING OF STAFF
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)
6.3 The Government agrees with the need for a
consistent, high standard of security vetting for all those working
with dangerous pathogens, including the application of national
security vetting for those working in laboratories handling containment
level 4 pathogens. National security vetting is a requirement
for laboratories handling containment level 4 pathogens covered
by the Anti-terrorism, Crime and Security Act 2001. Those working
in laboratories handling level 4 pathogens covered by the Specified
Animal Pathogens Order are not currently required to undergo national
security vetting unless the pathogens are also listed in Schedule
5 to the Act. However, the Government will review the arrangements
in place for such laboratories.
6.4 While the vetting of staff is obviously important,
subsequent and on-going awareness of security issues is essential.
Thus laboratory managers are advised to maintain personnel security
by way of on-going good management and reporting and the creation
of a 'security aware' environment.
1 Further note supplied by DIUS on 3 November 2008:
A resolution is actively being pursued on the redevelopment
of the Institute for Animal Health at Pirbright and of the Institute's
future governance. These matters remain of primary importance
to the Government. Although meetings are continuing between the
relevant Government departments, in the current circumstances
it is not possible to give a firm date for an announcement on
the way forward.
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