13 Bio-preparedness
(28815)
11951/07
COM(07) 399 | Green Paper on bio-preparedness
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| Legal base | — |
| Document originated | 11 July 2007
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| Deposited in Parliament | 23 July 2007
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| Department | Cabinet Office
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| Basis of consideration | EM of 10 September 2007
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
13.1 The Commission says that terrorism is seen as one of the
key challenges facing the Community today, and may include the
use of non-conventional means, such as biological weapons, which,
although they may present a statistically low risk, could have
devastating effects involving more than one Member State. It notes
that a comprehensive legal framework has been put into effect
in many relevant sectors, such as the food industry and general
workplace safety, but it suggests that imperfect implementation
and the existence of security gaps —
for example, through dual-use expertise and technology —
may continue to pose a risk which needs to be addressed now, before
any incidents occur. It has therefore sought in this Green Paper
to stimulate a debate on how this might be achieved, and to invite
suggestions from a range of stakeholders.
The current document
13.2 The Commission's assumption is that the potential
risks involved need to be addressed through a biological "all-hazards"
approach, aimed at threats from a terrorist attack, as well as
from other intentional releases, accidents or naturally occurring
diseases, which it says would help to generate the necessary safety
culture. This would also cover a comprehensive range of aspects,
such as prevention, protection, first response capacity, prosecutions,
surveillance, research capacity, response and recovery. The Green
Paper accordingly addresses these issues under the following broad
headings.
OVERVIEW OF RELEVANT COMMUNITY POLICIES
13.3 The Commission notes that combating biological
risks requires a cross-cutting approach, involving cooperation
in areas such as disarmament and non-proliferation, and at multilateral
and regional levels (where it suggests that the Community can
enhance the collective response capacity). It also suggests that
virtually everything done to anticipate a possible defence against
bio-terrorism is relevant, including disease surveillance and
detection systems, international laboratory cooperation, the sharing
of medical counter-measures, and in particular enhanced cross
border cooperation and communication, both within the Community
and more widely through other international fora (such as the
UN and NATO).
13.4 It goes on to identify a number of specific
measures taken at Community and Member State levels which could
provide a basis for coping with deliberate attacks. These include:
- European wide exercises, training
and exchange of experts under the Community Mechanism for Civil
Protection Assistance (which, together with the Civil Protection
Financial Mechanism, provides a legal and financial framework);
- measures (such as early detection, sound traceability
systems, rapid control and eradication measures, and contingency
plans) to deal with the introduction of pathogens or contaminants
into the animal or food supply chains, particularly if this occurred
simultaneously in a number of locations, and the illegal import
of animals, animal products and non-animal products;
- cooperation between public health laboratories,
with the sharing of information on emergency plans (for example,
for smallpox), the creation of a directory of experts to provide
advice when harmful agents and pathogens (such as anthrax) are
deliberately released, and guidance from the European Medicines
Evaluation Agency on the treatment of those exposed to them; and
- the protection of workers from risks related
to exposure to biological agents at work.
In addition, the Commission draws attention to the
proposal[31] it put forward
in December 2006 for a Council Directive on the identification
and designation of European Critical Infrastructure.
POLICY OPTIONS AND DELIVERABLES
Key principles
13.5 The Commission says that, in view of the large
and comprehensive legal framework which already exists, tools
such as peer evaluations, awareness raising campaigns and supportive
financial programmes should be used in the first instance, rather
than new legislation, and that this should involve existing structures.
It also suggests that measures should be proportionate, affordable,
sustainable and reliable in relation to the threat posed, and
that the private sector and research institutes should be involved,
for example within the European Security Research and Innovation
Forum, with the biotechnology industry and bioresearch community
also needing to be part of any European solution in those areas
where it could pose problems. The Commission says that the aim
of the Green Paper is to contribute to improving security whilst
fostering a safety culture and building on safety rules and best
practices, and it suggests that, in addition to the efforts of
Member States' national authorities, action could be enhanced
by the establishment of a European Bio-Network, which would pull
together relevant expertise on bio-preparedness, and recommend
possible guidelines and codes of conduct.
Prevention and protection
13.6 The Commission is concerned that levels of compliance
may differ as between individual stakeholders. It therefore suggests
that Member States should consider raising awareness based
on identified best practices; and that minimum standards and
procedures should be introduced on a European basis for physical
security at facilities housing non-military collections of pathogens
which could pose a threat. It adds that these would cover physical
protection and access control, an agreed list of bio-agents with
the potential for terrorist misuse, rules for certifying and registering
facilities, the reporting of life science work involving hazardous
bio-agents, procedures for security checks on those working with
such agents, facilitating the secure and safe exchange of samples
and sensitive research results, and the application, on a proportionate
basis, of European bio-security arrangements to third country
nationals.
Security issues related to biological research
13.7 The Commission suggests that it might fund new
expertise at Community level for analysis and modelling which
contributes to the reduction of biological risks, and that there
should be discussions between national experts to identify dangerous
organisms likely to pose a particular challenge to the Community's
response and recovery capabilities. It also looks at the security
issues relevant to biological research, and suggests that a set
of bio-security and bio-safety guidelines could be developed to
ensure that publicly funded research complies with common security
standards without unduly hindering scientific advances. This would
be accompanied by a professional code of conduct, aimed at building
up a strong culture of awareness and compliance with bio-standards,
for example as regards dual-use consequences and the potential
misuse of research results.
Improving surveillance capacity
13.8 The Commission notes that, in the Single Market,
capital, goods and people can circulate relatively freely, and
that it is crucial for security and health reasons to have in
place appropriate arrangements to ensure prompt notification of
security threats and terrorist attacks, to facilitate action to
stem the possible spread of infectious disease and environmental
contamination, to ensure mutual assistance between Member States
and European institutions in the diagnosis and management of bio-incidents,
to facilitate laboratory and epidemiological investigations, and
to ensure flexible and effective public health and civil protection
responses. It adds that surveillance could be further enhanced
to ensure effective monitoring of unusual disease outbreaks, with
Member States and the Commission also improving their monitoring,
early warning and detection capabilities: and it says that there
could be an analysis of Member States' laboratory capacity to
handle crises, especially in identifying pathogens and diseases.
Response and recovery
13.9 The Commission says that cooperation between
civilian health, civil protection and law enforcement authorities
at both Member State and Community level should be further strengthened,
and bio-preparedness contingency plans drawn up. It also advocates
the organisation of cross-border training, and more regular exercises,
similar to those which already take place for animal health contingency
plans, could be further developed to assess whether the measures
in place are adequate. Finally, the Commission notes the problems
involved in the development of new vaccines, and the need to establish
antigen or vaccine banks and/or antiviral stocks for the control
of known highly contagious and dangerous pathogens. It says that
discussions on the stockpiling of vaccines are continuing, and
that certain minimum levels should be considered, with the Member
States and Commission possibly giving financial support for their
purchase and storage.
The Government's view
13.10 In his Explanatory Memorandum of 10 September
2007, the Minister for the Cabinet Office (Ed Miliband) says that,
since the Commission believes that existing legal measures are
robust enough to ensure bio-safety and civil protection, the proposals
in the Green Paper will have no impact on UK law. As regards particular
aspects, he says that the Government considers that the development
of enhanced surveillance and detection methods and systems is
a research priority; and that it also supports national awareness
campaigns and peer evaluation, moves to improve analytical and
modelling capacity, the development of a professional code of
conduct for life science research workers (with the proviso that
these should be developed by professionals, and not centrally
imposed), cross-national training and exercises, and the enhanced
scope for vaccine development (though it believes that the World
Health Organisation might be better placed to handle stockpiles).
However, the Minister says that the UK has reservations over the
establishment of a European Bio-Network (where it would wish to
be assured that this would add value to existing arrangements,
including the European Centre for Disease Control); the drawing
up of a Community list of biological agents (given the poor security
across the 27 Member States), where it says that it would be unlikely
to accept any obligatory participation; and the proposed certification
of facilities and researchers, which it points out could impede
international cooperation. He also comments that the proposals
in the Green Paper are not formulated in any detail, which makes
it difficult at this stage to assess their impact or financial
implication. However, he suggests that, as currently framed, they
would have only a negligible impact on businesses.
Conclusion
13.11 This Green Paper clearly deals with a subject
of some importance, and sets out, in a somewhat discursive way,
a number of ways in which existing arrangements might be adapted
and developed to deal with the threats posed by a biological attack
by terrorists (or by other intentional releases, accidents or
naturally occurring events). As such, it bears some similarities
with the proposal which the Commission put forward in December
2006 for the protection of critical infrastructure, which was
debated on the Floor of the House on 2 May 2007, following the
recommendation in our Report of 21 March 2007.
13.12 However, the Government's Explanatory Memorandum
makes clear that, unlike that earlier document, this Green Paper
is not proposing further legislation, and indeed the Commission
stresses the need to use existing structures and measures. It
would also appear that, although the Government has certain reservations
on a number of the detailed proposals, it is general content with
what is being proposed, and does not see these, as currently drafted,
having any major impact. Consequently, although we think it right
to draw the document to the attention of the House, we see no
reason to withhold clearance.
31 (28184) 16933/06: see HC 41-x (2006-07), para 8
(21 February 2007) and HC 41-xv (2006-07), para 2 (21 March 2007).
HC Deb, 2 May 2007, cols 1518-1542. Back
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