Green Paper on bio-preparedness
Date: 2007-07-11
Institutions: European Commission
Subjects: EU publication, biological weapon, environmental risk prevention, public safety, terrorism

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.7.2007 
COM(2007) 399 final 

GREEN PAPER 

ON BIO-PREPAREDNESS 

(presented by the Commission) 

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GREEN PAPER 

ON BIO-PREPAREDNESS 

1. 

OBJECTIVES AND BACKGROUND 

This  Green  Paper  intends  to  stimulate  a  debate  and  launch  a  process  of  consultation  at 
European level on how to reduce biological risks, and to enhance preparedness and response 
("bio-preparedness"). This consultation may lead to concrete actions within the ambit of the 
Community's  and  Union's  competence,  in  the  field  of  bio-preparedness  in  2008.  Concrete 
actions  may  have  to  be  presented  and  developed  separately  in  specific  strands  of  work 
following  the  applicable  decision-making  procedures  and,  where  appropriate,  impact 
assessment. 

In order to improve the ability of the EU to prevent, respond to and recover from a biological 
incident  or  deliberate  criminal  activity,  the  coherence  of  actions  in  different  policy  sectors 
requires  that  all  relevant  stakeholders  in  Member  States  and  at  EU  level  be  consulted  e.g. 
national  authorities  responsible  for  risk  prevention  and  response,  public  health  (i.e  human, 
animal and plant health), customs, civil protection, law enforcement authorities, the military, 
bio-industry, epidemiological and health communities, academic institutions and bioresearch 
institutes.  

The  feedback  from  stakeholders  to  the  policy  options  and  deliverables  outlined  in  this 
document is essential for the Commission to evaluate the mechanisms and frameworks which 
are  already  in  place  and  how  they  are  implemented,  identify  possible  shortcomings  and 
subsequently propose specific actions where needed and in accordance with the principle of 
subsidiarity as set out in art 5 of the EC Treaty. Stakeholders should also consider where they 
see existing gaps and deficits, and what should be further improved.  

Europeans regard terrorism as one of the key challenges the European Union is facing today.1 
The  attacks  in  Madrid,  London,  New  York  and  elsewhere  in  the  world  made  it  clear  that 
terrorism is a threat to all States and to all peoples. Terrorists target our security, the values of 
our  democratic  societies  and  the  basic  rights  and  freedoms  of  our  citizens.  Terrorists  may 
resort  to  non-conventional  means  such  as  biological  weapons  or  materials.  Some  of  these 
materials  have  the  capacity  to  infect  thousands  of  people,  contaminate  soil,  buildings  and 
transport assets, destroy agriculture and infect animal populations and eventually affect food 
and  feed  at  any  stage  in  the  food  supply  chain.  The  risk  of  "bioterrorist"  attack  has  been 
statistically  low,2  but  its  consequences  can  be  devastating.  If  a  deliberate  introduction  of 
deadly  pathogens  or  a  naturally  occurring  disease  outbreak  were  to  occur  in  the  European 
Union or be imported from a third country, it is possible that it could affect several Member 

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See for example the Eurobarometer survey on public opinion in the EU: 
http://ec.europa.eu/public_opinion/archives/eb/eb64/eb64_en.pdf. 
After the terrorist attacks of 11 September 2001, the first 10 confirmed cases of inhalational anthrax 
caused by intentional release of Bacillus anthracis were identified in the United States. In this context, 
Europe also faced the challenge of numerous anthrax-related hoaxes. 

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States  simultaneously  or  spread  across  borders  and  have  considerable  economic  and  social 
impact.  

While it is clear that the benefits of scientific development in some areas may outweigh any 
possible  security  concerns,  with  the  global  development  of  life  sciences  and  biotechnology, 
some dual-use expertise and technology could become available to criminal political entities 
and  terrorists,  potentially  enabling  a  group  to  carry  out  disruptive  biological  attacks.  In 
parallel,  naturally  occurring  diseases,  laboratory  accidents  or  other  inadvertent  releases  of 
disease agents and pathogens pose a threat which can also disrupt our societies and harm our 
economies. 

A comprehensive legal framework has been put in place in many relevant sectors (such as the 
food industry, safety at the workplace, etc.) to ensure an adequate level of safety. However, in 
some domains imperfect implementation of safety measures and the existence of security gaps 
may  continue  to  pose  a  risk.  Europe  cannot  wait  until  accidents  with  severe  consequences 
happen or for these gaps to be exploited by terrorists. 

2. 

APPROACH AND DEFINITIONS 

For  the  reasons  mentioned  above,  risks  from  dangerous  biological  materials  and  pathogens 
have  to  be  reduced  and  preparedness  enhanced  in  Europe  through  a  biological  all-hazards 
approach – generic preparedness within overall crisis management capability. Indeed, such an 
approach  aims  at  taking  into  consideration  all  potential  risks,  from  a  terrorist  attack,  other 
intentional release, accident or naturally occurring disease, so as to be prepared to handle all 
crisis  situations  relating  to  food  supply  chain  protection.  The  reason  for  taking  a  biological 
all-hazards  approach  is  that  appropriate  security  practices  cannot  be  built  without  a  strong 
safety culture. Moreover, in the early stages of an incident it is very often difficult to identify 
the causes and sources of a disease. In the case of an intentional release, law enforcement will 
have an important role to play. 

The  term  "preparedness"  is  used  in  a  generic  way  covering  all  aspects  such  as  prevention, 
protection,  first  response  capacity, prosecution  of  criminals/terrorists,  ,surveillance,  research 
capacity,  response  and  recovery.  The  term  will  also  cover  the  steps  taken  to  minimise  the 
threat of deliberate contamination of the food supply through biological agents3 and to protect 
against biological warfare.4 

This is distinct from food safety, which focuses on setting standards regarding the safety of 
food, good manufacturing practices and quality control of agricultural products at all steps of 
the  processing  chain.  It  is  also  distinct  from  food  security,  which  is  defined  by  the  World 
Health  Organisation  as  access  to  sufficient,  safe  and  nutritious  food.  Nonetheless,  bio-
preparedness covers a broad scope of activities relating to the protection of public health. In 
other  contexts  –  laboratory  environments,  the  research  community,  health  care  as  well  as 
manufacturing facilities, field investigations and transport – bio-safety and bio-security may 
also  be  understood  in  a  different  way.5  The  aim  of  bio-preparedness  is  not  to  duplicate  the 

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Including live animals and biological agents causing zoonotic diseases. 
Biological  warfare  can  be  defined  as  the  deliberate  use  of  micro-organisms  or  toxins  derived  from 
living organisms to induce death or disease in humans, animals or plants. 
For concrete definitions of the terms "bio-safety" and "bio-security" see the WHO’s Laboratory 
Biosecurity guidance, available at: 

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legal framework set up to ensure food and product safety, including emergency measures in 
cases  of  accidents  or  of  new  information  about  the  safety  of  a  specific  product,  but  to 
complement  this  framework  to  improve  security  and  the  prevention  of  deliberate  criminal 
acts, accidents as well as the response to naturally-occurring outbreaks.  

In 2006, the Commission held two seminars on European Bio-Preparedness and a workshop 
on  Transport  and  Traceability  of  Bio-materials.  The  results  and  recommendations  emerging 
from these discussions have been fed into this Green Paper. In particular, the following issues 
of  concern  were  raised:  awareness  about  the  existing  legislative  framework,  existence  and 
application  of  minimal  security  standards,  deficits  in  European  analytical  capacity  for 
reducing biological risks,  potential misuse of research, a lack of detection capabilities, need 
for multi-agency and multi-sectoral cooperation, etc.  

3. 

CONSULTATION 

The Green Paper will be published on: 

http://ec.europa.eu/justice_home/news/consulting_public/news_consulting_public_en.htm. 

Responses  should  be  sent  by  1  October  2007.  Stakeholders  may  use  the  following  e-mail 
address: Biopreparedness@ec.europa.eu or the following mailing address: 

European Commission 
Bio-preparedness consultation 
LX-46 3/093 
1049 Brussels, Belgium 

Responses  from  both  public  and  private  sectors  will  be  published  on  the  Commission’s 
internet site unless respondents explicitly state that they wish to keep particular information or 
the whole response confidential. 

4. 

OVERVIEW OF RELEVANT EU POLICIES 

Combating  biological  risks  relies  on  cross-cutting  commitments:  disarmament  and  non-
proliferation  cooperation  and  assistance.  From  this  point  of  view,  a  holistic  biological  risk 
reduction approach combining the 1972 Biological and Toxins Weapons Convention, the non-
proliferation suppliers group, Australia Group and public health assistance tools, would offer 
a  unique  benefit,  linking  security  and  development.  EU  external  action  instrument  have  a 
concrete  added-value  in  this  regard.  At  multilateral  and  regional  level,  the  EU  aims  at 
enhancing the collective response capability to a biological event, including bio-terror acts. 

Virtually everything that is done at the different levels to anticipate a possible defence against 
biological  risks  and  bioterrorism  is  of  relevance.  A  number  of  policies  could  be  usually 

http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf. 
Further information is also available at: 
http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf and 
http://www.who.int/csr/labepidemiology/projects/biosafety/en/index.html.  

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strengthened to this effect: improving disease surveillance6 and detection systems, enhancing 
laboratory 
cross-border  cooperation  and  communication, 
cooperation,  and  developing  mechanisms 
sharing  of  medical 
for 
countermeasures.  Such  actions  are  already  in  place  and  could  be  further  enhanced  to  the 
benefit the EU as a whole in the event of a naturally-occurring outbreak or a bio-terror attack. 
Cross-border cooperation is critical to any effective preparedness strategy and response. For 
this reason a European-level approach is necessary and appropriate as are efforts to coordinate 
activities in order to reduce biological risks and enhance preparedness. 

facilitating 
international 

international 

This  should  also  be  done  in  the  spirit  of  broader  international  cooperation.  The  EU  and  its 
Member  States  should  continue  working  with  and  further  strengthen  cooperation  on  bio-
preparedness  within  various  international  fora  such  as  UN  structures,  the  Biological  Toxins 
and Weapons Convention, Australia Group, G8, NATO, etc. Within the international context, 
particular  emphasis  could  be  placed  on  enhancement  of  early  recognition  and  detection  of 
diseases  on  the  global  scale  and  on  better  promotion  of  European  approaches  to  biological 
risks. 

Many  specific  measures  exist  at  EU  and  Member  State  level  to  ensure  bio-safety  and  civil 
protection, but need to be adapted to cope with deliberate attacks. Therefore, any new actions 
to address possible deliberate releases may be built on existing measures.  

European wide exercises, training and exchange of experts dealing with the preparedness and 
response  to  terrorist  scenarios  were  organised  under  the  Community  Mechanism  for  civil 
protection assistance [Council Decision 2001/792/EC, Euratom]. In 2007, the legal basis for 
the  Mechanism  was  updated  and  a  Civil  Protection  Financial  Instrument  was  established  [ 
Council  Decision  2007/162/EC,  Euratom].  These  developments  provide  a  clear  legal  and 
financial  framework  for  the  continuation  and  reinforcement  of  current  activities.  It  is  also 
important to recall the existing crisis management and European solidarity mechanisms.7 

The key challenge to the food supply chain and agro-industry is the introduction of a pathogen 
or contaminant into the animal or food supply chains. Mitigating actions are the same as for a 
natural outbreak e.g. early detection, sound traceability systems, rapid control and eradication 
measures,  contingency  plans  and  overall  coordination.  Nevertheless,  our  tools  could  be 
developed 
introduced 
to  face  bio-terror  attacks  during  which  pathogens  could  be 
simultaneously  in  a  number  of  different  locations  across  the  EU  and  to  cope  with 
simultaneous outbreaks of different diseases which could overpower the established response 
capacities and thereby affect public health and have an important negative trade and economic 
impact for the Member States and the Union as a whole. 

As  regards  contaminants  in  foodstuffs,  the  EU  has  already  taken  measures  to  minimise  the 
risks. The basic  principles of EU legislation on chemical contaminants in food  are  found in 
Council  Regulation  (EEC)  No  315/93.  Other  legislative  instruments  adopted  in  the  field  of 
Food  Safety  could  also  be  of  relevance.  In  particular,  traceability  is  ensured  through 
Regulation (EC) No 178/2002, which makes it an obligation for food business operators to be 

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A practical example is the network for epidemiological surveillance and control of communicable 
diseases in the Community setup by Decision 2119/98/EC of the European Parliament and of the 
Council of 24 September 1998.  
See the Solidarity Fund regulation (EC) 2012/2002. While the present Regulation is limited to "major 
natural disasters", the Commission proposed in 2005 to widen the scope and to also cover "public 
health emergencies" and "acts of terrorism" (see COM(2005) 108final). 

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able to identify any person from whom they receive food/raw materials. The operators must 
also  be  able  to  identify  businesses  to  which  they  supply  products.  The  same  requirements 
apply  to  importers  with  this  “one  step  back –  one  step  forward”  approach.  Regulation  (EC) 
No 178/2002 also provides for emergency measures and crisis management.  

Other  measures  which  are  not  part  of  either  criminal  or  anti-terrorist  mitigation  measures 
contribute  to  containing,  controlling  and  eradicating  animal  diseases.  For  instance,  animals 
are  identified  either  individually  with  ear-tags  or  electronic  identification,  or  in  batches. 
Moreover, most livestock holdings are registered and animal movements recorded within and 
between Member States. These practices secure a high degree of traceability (e.g. TRACES, 
the TRAde Control and Expert System).  

Concerning  possible  illegal  imports  of  animals  and  animal  products,  the  control  regime 
centres  and  the  legislative  framework  requires  the  approval  of  third  countries  and  third 
country  establishments,  through  official  certification  of  imports  and  mandatory  checks  at 
border inspection posts. Provisions exist also for non-animal products through the labelling of 
establishments  and  country  of  origin,  and  traceability  by  batches.  Customs  and  anti-fraud 
efforts are equally important for protecting the health and safety, in particular due to their role 
in controlling smuggling and counterfeiting activities. 

On the public health front, various actions have already been undertaken, such as the creation 
in 2002 of the Health Security Committee of High-Level Representatives from Member States 
and  the  Commission,  a  platform  for  co-operation  between  public  health  laboratories  in  all 
Member  States,  a  system  for  the  sharing  of  information  on  smallpox  emergency  plans 
between Member States and the Commission, as well as a directory of experts for advice and 
investigation in cases of deliberate release of harmful agents and pathogens. Moreover, lists 
are  kept  of  possible  biological  and  chemical  agents  and  pathogens  that  may  be  used  by 
terrorists  (smallpox,  anthrax,  botulinum  toxin,  etc.),  and  a  guidance  document  on  the 
treatment  of  patients  exposed  to  pathogens  has  been  produced  by  the  European  Medicines 
Evaluation Agency (EMEA).  

In this context it is also important to mention the Directive (EC) No 2000/54 on the protection 
of workers from risks related to exposure to biological agents at work. This Directive refers to 
biological  agents  rather  than  micro-organisms,  and  includes  those  which  have  been 
genetically modified,8 cell cultures and human endoparasites, which may be able to provoke 
infection, allergy or toxicity. Although toxicity and allergenicity are included in the definition 
of biological agents, the four risk groups are based on the level of risk of infection.  

Regarding the enhancement of security, a Commission proposal for a Council directive on the 
identification  and  designation  of  European  Critical  Infrastructure  and  the  assessment  of  the 
need to improve their protection9 should also be mentioned. The proposal considers the health 
sector to be one of the critical infrastructure sectors. On the other hand, this paper deals with 
much broader issues and different set of questions compared to the proposal on the European 
Critical Infrastructure. Nonetheless, there may be points of contact such as protection of bio-

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The following legislation on genetically modified organisms is also of relevance: Directive (EEC) No 
90/219 as amended by Directive (EC) No 98/81 on the contained use of genetically modified micro-
organisms provides for rules on the classification of installations, as well as for contingency plans, with 
a cross-border dimension. 
COM (2006) 787 final. 

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laboratories and bio-agents. Hence, appropriate coordination of the relevant actions will take 
place between these two initiatives. 

All  this  is  complemented  by  the  inspections  carried  out  by  the  Food  and  Veterinary  Office 
(FVO),  which  is  part  of  the  European  Commission's  Directorate-General  for  Health  and 
Consumer  Protection,  the  TRACES  System,  as  well  as  11  sectoral  Rapid  Alert  Systems 
(RAS),  operational  24  hours/7  days  a  week,  such  as  the  Rapid  Alert  System  for  Food  and 
Feed (RASFF), the RAS-BICHAT alert system for bio- and chemo-terrorism, the monitoring 
and  information  centre  of  the  Community  mechanism  for  civil  protection,  and  ARGUS,  the 
secure general rapid alert system.  

Collaboration  with  and  within  the  private  sector  should  also  be  highlighted.  The  sharing  of 
best practices is encouraged among the pharmaceutical and food industries and large catering 
companies, but also between corporations and SMEs involved in the food supply chain. These 
organisations  should  be  able  to  rely  on  effective  response  and  mitigating  systems  when 
intelligence and countermeasures fail.  

5. 

POLICY OPTIONS AND DELIVERABLES FOR THE WAY FORWARD 

5.1. 

Key principles of bio-preparedness 

Tools  such  as  peer  evaluations,  awareness  raising  campaigns  and  supportive  financial 
programmes should in the first place be used rather than new legislation, bearing in mind that 
a  large  and  comprehensive  legal  framework  already  exists  in  many  cases,  at  either  EU  or 
national  level.  Existing  structures  and  expert  groups  should  be  used  for  implementation. 
Measures should be proportionate, affordable, sustainable and reliable in terms of the threat 
they  seek  to  minimise  and  respond  to.  They  will  also  take  into  consideration  impacts  on 
imports  of  agricultural  products  from  Developing  Countries  and  in  particular  from  Least 
Developed Countries.  

The  private  sector  and  research  institutes  should  be  involved  in  this  process  through  an 
intensive  Public-Private  Security  Dialogue.  With  regard  to  research,  this  dialogue  is  in  the 
process  of  being  established  within  the  European  Security  Research  and  Innovation  Forum 
(ESRIF). It will cover security research and innovation issues. The European biotechnology 
industry  and  bioresearch  community  need  to  become  part  of  the  European  solution  to  the 
problems posed by biological risks.10 It is understood that activities in the field of life sciences 
and biotechnology are extremely diverse in their scope,11 and not all applications represent a 
threat in the context of bio-preparedness. For example, the use of biotechnological methods to 
produce  biodegradable  plastics  does  not  entail  the  same  risks  as  work  on  pathogens.  The 
Commission is committed to supporting the development of life sciences and biotechnology, 
which represent a great potential for the EU. The objective of the present Green Paper is to 
contribute to improving security while fostering a safety culture and building on safety rules 
and best practices. 

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The Public-Private Security Dialogue was introduced by the Commission in its Communication on 
prevention, preparedness and response to terrorist attacks (COM(2004)698). The work will also take 
into consideration the envisaged framework for Public Private Dialogue concerning issues related to 
security research and innovation. 
Communication on the mid term review of the Strategy on Life Sciences and Biotechnology, 
COM(2007)175 of 10. 4. 2007. 

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Member  State  authorities  at  national  level  would  provide  leadership  and  coordination  in 
developing and implementing a consistent approach within their jurisdictions, which will be 
for the benefit of bio-preparedness in the EU as a whole.  

Implementation  of  the  results  and  recommendations  arising  from  this  consultation  could  be 
enhanced  by  a  European  Bio-Network  (EBN).  The  EBN  would  be  an  advisory  structure 
which  would  pull  together  European  expertise  on  bio-preparedness  from  different  sectors  – 
the  research  community,  private  and  public  sectors  (including  the  security  and  intelligence 
community, civil protection authorities and first responders). Its role could be to recommend 
possible guidelines and codes of conduct for researchers concerning materials and resources 
for  education  about  effective  and  secure  bio-standards  and  best  practices.12  The  Network 
would promote and support the development of bio-standards at EU level.  

The European Community has already put in place tools and mechanisms, initially developed 
for food safety and the fight against fraud. These instruments could be built on and used for 
the  purpose  of  further  reducing  biological  risks,  including  bio-terrorism.  In  order  to  be 
prepared to prevent bio-terrorism or natural outbreaks, new approaches should be considered 
in addition to existing tools where necessary.  

Questions 

Is a comprehensive approach to European biological risk reduction and preparedness 

1. 
required? 

How  could  the  EU  bridge  the  perceived  gap  between  non-proliferation  and 
2. 
international cooperation in a dual-use field such as biology?3. 
Can  the  current  defence 
mechanisms for facing natural and non-intentional crisis situations become more sufficient to 
cope with deliberately provoked mass-scale and simultaneous crisis situations? 

4. 
How  could  the  European  Centre  for  Disease  Prevention  and  Control,  as  well  as  the 
European Food Safety Agency contribute to this endeavour?5.  Would  peer  evaluation 
methods be useful in addressing existing shortcomings across Europe? 

6. 

What role should be played by the private sector in a public-private partnership? 

Should  an  EBN  (European  Bio-Network)  be  created  in  order  to  support  the 

7. 
implementation of the results of this consultation? 

How  could  cooperation  among  relevant  authorities  and  agencies  at  EU  level  be 

8. 
improved? 

5.2. 

PREVENTION AND PROTECTION 

Awareness 

Research  institutes,  researchers  and  small-size  bio-companies  with  limited  resources  may 
have  difficulties  in  following  the  new  adjustments  of  rules  and  restrictions  applicable  to 

12 

Such codes of conduct should also take into account where relevant, the legal situation within the EU 
and in third countries, including rules on export controls for dual-use technologies in the 
biological/biotechnology area. 

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certain  activities  in  the  field  of  life  sciences  (e.g.  rules  on  export  of  dual  use  goods, 
transportation  of  bio-agents,  safety  requirements).13  As  a  consequence,  the  level  of 
compliance  with  these  regulations  may  differ  across  Member  States  as  well  as  between 
stakeholders.  For  this  reason,  Member  States  with  the  support  of  the  Commission  could 
consider  developing  national  awareness  campaigns  based  on  best  practices  identified  across 
Member States.  

Questions 

9. 
Should  awareness  among  stakeholders  be  increased  about  possible  risks  related  to 
biological research and commercial activities and about the rules they have to comply with? If 
so, how? 

Do you experience difficulties in following new adjustments of rules and restrictions? 

10. 
If so, which ones? 

Minimum standards and procedures 

Physical security at facilities housing non-military collections of pathogens could be enhanced 
and improved. A peer evaluation method covering all Member States could be used to assess 
application levels and practices with regard to bio-standards used in research, by industry and 
public bio-laboratories working with dangerous pathogens. This could include the assessment 
and identification of obligatory common minimum-security standards for bio-laboratories and 
the  pharmaceutical  industry.  Internationally  accepted  bio-standards  could  be  enhanced  in 
developing  schemes  for  the  accreditation  and  certification  of  laboratories.  Again,  in  areas 
where such schemes exist and function well, work should not be duplicated. Relevant parts of 
the OECD work on Biological Resources centres could be used to this effect. 

On the basis of what is already done,14 these standards could include:  

•  European  guidelines  for  the  physical  protection,  access  control  and  accounting  of 
collections  of  dangerous  pathogens  and  cultures  (including  those  synthesised  in 
laboratories) that could threaten public health or national security.  

•  An  agreed  EU  list  of  “identified  bio-agents”  with  a  specific  focus  on  potential  terrorist 

misuse.15  

•  European  rules  for  national  certification  and  registering  of  facilities  with  regard  to 
compliance  with  bio-standards  and  the  credentials  and  competences  required  of 
researchers.  

•  Systems  where  stakeholders  report  nationally  on  types  of  life  science  work  that  is  being 

performed involving hazardous bio-agents usable for terrorist purposes. 

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For example, lack of awareness about the EU legal framework relating to export controls on dual-use 
items and technology was mentioned by exporters themselves at the conference on the reform of the EU 
regime for exports of dual-use items held on 26 January 2007. 
See for example the Commission proposal regarding the changes to the EU legal framework of export 
controls for dual-use items (COM 2006 829) and in particular Article 23 thereof. 
Several lists exist. However, they are often too general, do not necessarily suite European circumstances 
or are not terrorism-relevant. 

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•  Member  States'  procedures  for  security  checks  on  scientists  and  technicians  who  wish  to 
work  or  already  work  with  hazardous  bio-agents  identified  in  an  EU  list.  The  level  of 
clearance and the number of persons requiring this would have to be assessed in order not 
to  impede  research  and  access  of  relevant  expertise  from  outside  the  EU  to  European 
research facilities.  

•  A  European  and  possible  future  international  system  for  certifying  reliable  and  trusted 
facilities  and  researchers,  facilitating  secure  and  safe  exchange  of  samples  and  sensitive 
research results. Such a system could help to avoid obstacles which would create critical 
bottle  necks  in  scientific  exchange  and  development.  Common  minimum  standards  and 
certification methods are required.16 In the first stage of this process, EU best practices for 
defining of what is "in the public domain" and what is "basic scientific research" could be 
adopted, as called for by the Commission when reviewing the EC regime of export control 
on dual-use items and technology.17  

•  International exchanges of researchers and inflows of experts as well as students from third 
countries  into  the  EU  have  a  positive  impact  on  the  development  of  life  sciences  and  on 
European  competitiveness.  Third-country  nationals  should  be  required  to  comply  with 
European  bio-security  arrangements  and,  when  deemed  necessary,  with  security 
provisions.  Security  procedures  should  be  proportionate  in  order  not  to  hamper  scientific 
progress. 

16 

17 

Research results concerning listed dual-use technologies (in EC Regulation 1334/2000, as amended by 
Regulation 394/2006) and in some cases on non- listed dual use technologies might require the Member 
State's authorisation prior to being shared with other researchers/industry in third countries.  
See COM (2006) 829. 

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Questions 

Should  common  minimum  bio-standards  and  the  exchange  of  best  practices  be 

11. 
developed at the EU level? 

12.  Would you be interested in developing rules for national certification and registering 
of  facilities  and  researchers  which  could  facilitate  European  and  international  exchange  of 
samples and expertise? 

13.  What should be included in national registers – agents, facilities, activities – ensuring 
that there are no loopholes and that the security and oversight requirements avoid damaging 
health, safety, research or industrial activities? 

Should a limited number of bio-researchers possess security clearance? If so, on what 

14. 
basis would you identify them? 

Should  a  specific  and  limited  number  of  laboratories,  health  institutions,  production 
15. 
establishments,  pharmaceutical  and  food-processing  plants  be  accredited  on  the  basis  of 
compliance with minimum security standards? 

5.3. 

ENHANCING  ANALYSIS  AND  SECURITY  ISSUES  RELATED  TO 
BIOLOGICAL RESEARCH  

Developing a European analytical capacity for reducing biological risks18  

The Commission could fund new expertise at EU level by developing a European capacity for 
analysis  and  modelling  contributing  to  the  reduction  of  biological  risks  from  future  bio-
threats,including  risk  analysis  and  risk  classifications.  Where  relevant,  minimum  standards 
could  be  considered.  New  knowledge  and  competences  could  contribute  to  improving  and 
developing new countermeasures and to enhancing protection of the food supply chain. The 
number of  technical experts would  also increase. This would lead to adequate and effective 
response  mechanisms  through  multi-sector  cooperation  e.g.  between  food,  military,  law 
enforcement,  customs,  health,  environmental  and  agricultural  authorities.  EU  funding  could 
be made available for joint training and awareness raising. 

Some lists of dangerous biological agents and pathogens have been developed, such as during 
the  negotiation  of  a  "verification  protocol"  to  the  1972  Biological  and  Toxins  Weapons 
Convention.  Some  are  categorised  according  to  infection  hazard  and  others  based  on  their 
dual  use  nature  and  potential  for  weapons  production.  In  order  to  conduct  adequate  policy 
development  discussions  and  secure  adequate  support  for  Member  States,  it  would  be 
necessary to conduct classified discussions between national experts in order to identify and 
agree  on  a  list  of  organisms.  Biological  agents  and  pathogens  which,  from  a  security 
perspective,  are  of  concern,  and  which  would  pose  a  particular  challenge  to  the  Union  and 
Member States' response and recovery capabilities, should be further identified and listed.  

18 

At European level, numerous relevant research activities have been developed within the 6th Research 
Framework Programme, Preparatory Action for Security Research, and the current call under the 7th 
Research Framework Programme. 

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Questions 

Do  you  agree  that  an  enhanced  EU-level  capacity  for  analysis  of  biological  risks  is 

16. 
necessary or is the present situation satisfactory? 

17. 

Should there be EU funding for joint training and awareness raising? 

Should  EU-level  lists  of  biological  agents  of  special  security  concern  be  developed 

18. 
jointly by the Member States and the Commission? 

19. 
If  you  believe  that  each  Member  State  should  have  its  own  pathogen  lists,  do  you 
agree  that  interaction  with  other  Member  States  on  this  topic  could  be  beneficial  for  your 
organisation? 

Is  the  current  level  of  research  activities  on  bio-preparedness  sufficient  in  the  EU? 

20. 
Which research activities should be prioritised? 

Security issues related to biological research  

Scientific progress is assured by the free exchange of research results and the ability to verify 
them. Research and access to biological material by authorised and legitimate personnel, e.g. 
in laboratories and the scientific community is a highly valuable and necessary endeavour and 
should  not  be  hindered.  Today  mainly  national  rules  exist  for  the  exchange  and  access  to 
biological  material.  Intra-Community  transfer  and  transnational  exchange  are  only  partially 
covered by these rules. The goal to render the dissemination and use of dangerous pathogens 
secure should not be a hindrance to scientific research. Methods could be explored in order to 
monitor  bio-research  and  the  dissemination  of  pathogens  for  scientific  use  more  effectively 
without  impairing  the  privacy  of  the  citizen.  Security  concerns  should  not  prejudice 
competitiveness within the research community or bio-industry. Close cooperation will have 
to be established with the ESRIF which will set up a strategic agenda for security research and 
innovation. 

A  set  of  bio-security  and  bio-safety  guidelines19  could  be  developed  to  ensure  that  publicly 
funded research is complying with common security standards. The EBN could contribute to 
the  identification  of  these  guidelines.  For  EU  funded  research  projects,  clear  ethical  review 
procedures  already  exist  based  on  the  principles  set  out  in  the  Research  Framework 
Programmes.  Specific  bio-security  and  bio-safety  guidelines  could  strengthen  but  not 
supersede these review procedures.20 

Organisations  such  as  not-for-profit  organisations,  foundations  and  trusts  which  provide 
funding for scientific biological research could play an important role. Research grants should 
not only be conditioned upon the quality of a proposal, but also upon the ability of the given 
applicant  to  comply  with  bio-standards  as  well  as  possible  future  security  guidelines. 
Scientific journals which publish research papers could be made aware of potential security 
risks relating to the misuse of these scientific results.  

19 
20 

For the definition of the terms "bio-safety" and "bio-security" see footnote 5. 
A detailed explanation of the ethical review process can be found on 
http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=73 

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Existing  Member  State  and  Commission  rules  on  security  which  lay  down  the  process  for 
transmitting and storing classified information and holding classified meetings with relevant 
actors in both the public as well as the private domain must be respected. A specific procedure 
could  be  applied  by  Member  States  and  the  Commission  in  association  with  the  scientific 
community  where  sensitive  dual-use  research  results  could  be  published  in  two  different 
versions: (1) a public version with no publishing restrictions (without sensitive content), and 
(2) a restricted version containing the sensitive parts published in a manner allowing access 
only  for  relevant  and  secure  bio-stakeholders.  The  EBN  could,  for  example,  support  the 
preparation of these measures.  

The  aim  of  the  proposed  actions  is  not  censorship  of  biological  science.  Free  scientific 
thinking and research is a fundamental principle that should be respected, and research has a 
huge potential to contribute to the objectives of bio-preparedness.  

Questions 

Should public and private funding for research on bio-substances be made conditional 

21. 
on the compliance of bio-standards? 

Do  you  agree  that  a  publication  procedure  should  be  applied  where  sensitive 

22. 
biological dual-use research should be published in two versions: 

- 

a public version with no publishing restrictions (without sensitive content) and 

a restricted version containing the sensitive parts of the research with access only for 

- 
relevant bio-stakeholders? 

Could the EBN assist in the development of bio-security and bio-safety guidelines for 

23. 
publicly funded research?  

Professional code of conduct 

The  goal  is  to  build  up  a  strong  culture  of  awareness  and  compliance  with  bio-standards 
already for first- and second-year life sciences and biotechnology students at university level. 
Compulsory academic courses in life sciences could focus on dual-use consequences of bio-
research  and  on  ethics  of  bio-research.  The  courses  could  cover  issues  such  as  the  risks  of 
misuse  of  research  results  in  relation  to  biological  terrorism  and  warfare  and  professional 
responsibility as well as liability.  

In  this  context,  it  is  important  to  mention  that  expert  groups  of  the  Biological  and  Toxin 
Weapons  Convention  recommended  that  codes  of  conduct  should  involve  all  actors  dealing 
with bio issues and be broad enough to cover any unforeseen research and results in terms of 
technological development and new situations. Currently, researchers in life sciences do not 
have  a  professional  code  of  conduct.  Graduate  students  involved  in  sensitive  biological 
research could be required to sign a professional code of conduct.  

The  EBN  could  help  develop  a  professional  code  of  conduct  at  EU  level.  These  elements 
should  be  part  of  all  EU-funded  threat  reduction  programs  involving  redirection  of  former 
weapons scientists, such as International Science and Technology Centre ISCT. 

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13 

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Questions 

Should mandatory academic courses on bio-standards and best practices become part 

24. 
of the university curriculum in the field relevant to life sciences?? 

25. 

Should researchers in life sciences be obliged to adopt a professional code of conduct? 

Should the above-mentioned professional code of conduct be developed at EU level? 

26. 
If so, by whom? 

5.4. 

IMPROVING SURVEILLANCE CAPACITY 

In the Single Market, capital, goods and persons can circulate relatively freely. For a number 
of security and health reasons it is crucial that appropriate mechanisms and arrangements are 
in place:  

–  To  ensure  prompt  notification  and  exchange  of  information  in  case  of  security 

threats and terrorist attacks;  

–  To facilitate action at EU or Member State level being taken at source in order to 
stem the possible spread of infectious diseases and environmental contamination;  

–  To ensure mutual assistance between Member States and European Institutions for 

the diagnosis and management of bio-incidents;  

–  To facilitate necessary laboratory and epidemiological investigations;  

–  To ensure flexible and effective public health and civil protection responses.  

Public  and  animal  health  surveillance  could  be  further  enhanced  to  ensure  effective 
monitoring of unusual outbreaks of human and animal disease and develop practical methods 
of co-ordinating European and international responses to major events that may involve bio-
weapons.  

As regards surveillance and detection, the Member States and the Commission could further 
improve their monitoring, early warning and detection capabilities, e.g.:  

–  Comprehensive  detection  systems  concerning  the  introduction  of  pathogens  into 

humans, livestock or crops;  

–  Improving the speed of laboratory testing; 

–  Better means to attribute responsibility through advanced bio-forensic methods, in 
particular  in  co-operation  with  third  countries  (US  Centres  for  Disease  Control 
and Prevention, Russia, China, etc.) and international organisations (WHO, FAO, 
OIE). 

Member  States,  with  the  support  of  the  Commission  and  the  European  Centre  for  Disease 
Prevention  and  Control  (ECDC),  could  carry  out  a  European  analysis  of  Member  States' 
laboratory capacity to handle crisis situations, especially the European reference laboratories, 
which are essential in crisis situations for the identification of pathogens and diseases. Mobile 
bio-laboratories  or  pen-site  tests  supported  by  qualified  expertise  may  be  required  for  early 

EN 

14 

   EN 

 
intervention  and  identification  anywhere  in  the  European  Union  or  internationally,  in 
compliance with Australia Group norms and the EC Dual-use regulation 1334/2000. Mobility, 
versatility and flexibility are important factors in preventing disasters of a biological nature. 
In  such  a  context,  the  EU  should  define  an  approach  combining  non-proliferation  and 
international cooperation and assistance 

New priorities could  include  technical  assistance and  expertise, e.g. exchange of pathogens, 
culture  collection  inventories  and  the  security  of  these  collections,  or  increasing  laboratory 
capacity in order to identify disease and enhance disease surveillance systems. 

Detection  and  tools  for  detection  are  essential  for  early  warning,  especially  as  regards  first 
responders, in identifying a hazardous pathogen. The Member States currently lack sufficient 
detection  tools  to  test  live  and  dangerous  bio-substances  and  pathogens.  The  EU  could 
consider further supporting the development of such detection tools and own capacity in order 
to strengthen its preparedness, but also its bio-competitiveness. In the context of detection and 
surveillance, the potential of new information and communication technologies could also be 
further explored.  

In  January  2007,  the  Commission  concluded  a  public  consultation  on  a  Green  Paper  on 
detection  technologies  in  the  work  of  law  enforcement,  customs  and  other  security 
authorities.21  Future  action  in  this  area  may  be  relevant  for  the  further  enhancement  of 
European bio-preparedness.  

Questions 

27. 
Each Member State depends on the bio-preparedness of others. In view of this, should 
the  current  early  warning  mechanisms  within  the  European  Union  and  Member  States  be 
further adapted? If so, in what respect? 

28. 
How  could  the  EU  coordinate  the  different  initiatives,  at  national,  NATO,  G7  and 
WHO  level,  in  order  to  increase  the  overall  consistency  and  effectiveness  of  an  EU 
capability?29.  Do  you  consider  that  coordination  of  existing  warning  and  detection 
capabilities, as well as the exchange of best practices in bio-preparedness, should be enhanced 
at EU level? 

Should  the  EU  look  into  the  possibility  of  developing  a  capacity  for  test  detection 

30. 
tools on live and dangerous substances? 

5.5. 

RESPONSE AND RECOVERY 

Cooperation  between  civilian  health,  civil  protection  and  law  enforcement  authorities, 
between  Member  States  and  at  EU  level  should  be  further  strengthened.  Medical  and  law 
enforcement  actions  are  needed  to  ensure  good  co-ordination  and  communication  between 
Member  States’  national  health  services,  law  enforcement  agencies,  rescue  services  and  the 
military  in  order  to  draw  up  necessary  bio-preparedness  contingency  plans.  Member  States 
could further integrate epidemiological and law enforcement cooperation in their contingency 
planning. The Commission could actively participate in and support such cooperation.  

21 

Further details can be found under: 
http://ec.europa.eu/justice_home/news/consulting_public/news_consulting_public_en.htm. 

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Organisation  of  cross-border  training/workshops,  at  EU  level  and  between  Member  States, 
could be intensified. These training activities/workshops could include co-operation between 
law  enforcement  organisations  and  epidemiologists  for  joint  initial  assessments  of  threats, 
suspected  items  and  pathogens,  and  of  incidents  of  uncertain  origin.  The  EU  and  the 
Commission could participate in these training sessions/workshops.  

Regular trans-national, multi-sector training courses on preventing, preparing for, containing, 
and  responding  to  bioterrorism  and/or  naturally  occurring  disease  outbreaks  could  be 
developed and conducted by the Member States and the Commission.  

More regular exercises, both at EU level and in Member States, could be further developed in 
order to assess whether the measures in place are adequate and appropriate, as is already done 
with animal health contingency plans. In this way weaknesses identified can be remedied. The 
goals are to:  

1. 

2. 

3. 

4. 

5. 

Strengthen  national  and  international  capabilities  to  identify  and  quickly  detect 
outbreaks  with  an  epidemiology  profile  which  could  indicate  a  bio-terrorist  attack. 
The purpose is to share this information quickly with appropriate Member States and 
EU  organisations.  When  applicable  and  relevant,  the  UN  Secretary-General 
investigation  mechanism  for  alleged  use  of  biological  weapons  or  suspicious 
outbreak of disease could be used. 

Improve  multi-sector  interoperability  between  food,  civil  protection,  military,  law 
enforcement, health, animal health, environmental and agricultural agencies in order 
to  prepare  for  and  combat  bio-terrorist  threats  and  to  recover  a  previously  disease-
free status for trade purposes.  

Increase cooperation on countermeasures and development of effective national and 
international  countermeasures  to  contain  the  spread  of  deliberately  released 
pathogens. 

Develop and test effective risk communication strategies.  

Depending  on  the  scope,  magnitude  and  time  pressure  of  the  bio-attack,  define 
responsibilities and standard operating procedures according to scenario analysis. 

Questions 

Should co-operation among relevant authorities and agencies at Member State and EU 

31. 
level be improved? If so, how? 

Are  regular  exercises  and  training  courses  a  good  approach  to  enhance  bio-

32. 
preparedness or should other additional actions be pursued? 

Preserving and developing a European response to biological risks and threats 

It is a very expensive and lengthy procedure to develop and test a new vaccine. This kind of 
capacity cannot be built up within weeks or even months. Additionally, capacity building and 
formal approval of medicinal products is not only a Member State matter. The private sector 
plays an essential role in bio-research. If there is no market for a vaccine, private industry will 
neither  develop  one,  nor  maintain  facilities  in  expectation  of  a  biological  crisis  situation. 
Emphasis  could  therefore  be  put  on  the  establishment  of  antigen  or  vaccine  banks  and/or 

EN 

16 

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antiviral  stocks  for  the  control  of  known  highly  contagious  and  dangerous  pathogens.  The 
EU's Foot and Mouth Disease antigen bank or the vaccine bank for classical swine fever and 
bluetongue could be used as examples.  

The  challenge  of  today's  bio-threats  requires  advance  planning  and  a  long-term  policy 
approach.  Therefore,  beyond  efforts  already  undertaken  by  Member  States,  including  in  the 
military sector, the Member States and the Commission could support the development of a 
public-private  business  model  for  medical  countermeasures  for  which  there  is  no  natural 
market in Europe. Suitability of approaches of other countries could be considered. 

The discussions on the stockpiling of vaccines are ongoing. Subsidising full solidarity stocks 
has  been  proposed.  However,  limited  and  minimum-level  EU  solidarity  stocks  could  be 
considered. Member States and the Commission could give financial support for the costs of 
purchasing  and  storing  of  such  stocks.  This  is  already  the  case  in  animal  health  through 
Council  Decision  90/424/EEC.  Thus  there  would  be  no  need  to  build  new  storage  capacity, 
and citizens' protection levels would be enhanced. These solidarity stocks would be released 
in a crisis situation and shipped, respecting time limits, to the Member State or Member States 
affected. 

Questions 

Do you agree with the need to build up a European capacity for developing medical 

33. 
countermeasures including vaccines and prophylactics? 

Do  you  agree  that  the  creation  of  limited  EU  solidarity  stocks,  as  already  exist  for 

34. 
animal health, supported by Community funding, would be a way forward? 

Are  the  provisions  already  in  place,  such  as  antigen  and  vaccine  banks,  or  reagent 

35. 
banks, sufficient?  

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