Communication from the Commission to the Council and the European Parliament on cooperation in the European Union on preparedness and response to Biological and Chemical agent attacks (Health security)
Date: 2003-06-02
Institutions: European Commission
Subjects: EU programme, biological weapon, chemical weapon, health control, health policy, international cooperation, terrorism

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 2.6.2003
COM(2003) 320 final

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE
EUROPEAN PARLIAMENT

ON COOPERATION IN THE EUROPEAN UNION ON PREPAREDNESS AND
RESPONSE TO BIOLOGICAL AND CHEMICAL AGENT ATTACKS
(HEALTH SECURITY)

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE
EUROPEAN PARLIAMENT

ON COOPERATION IN THE EUROPEAN UNION ON PREPAREDNESS AND
RESPONSE TO BIOLOGICAL AND CHEMICAL AGENT ATTACKS
(HEALTH SECURITY)

TABLE OF CONTENTS

1.

2.

3.

3.1.

3.2.

INTRODUCTION ........................................................................................................4

RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU ....5

PUBLIC HEALTH PREPAREDNESS AND RESPONSE .........................................6

Mechanism of alert and information exchange.............................................................8

Detection and identification of biological agents .........................................................9

3.2.1.

Lists of agents .............................................................................................................10

3.2.2.

Laboratories: inventory and cooperation ....................................................................11

3.2.3. Clinical guidelines for case recognition and management .........................................11

3.3.

3.4.

3.5.

4.

4.1.

4.2.

4.3.

4.4.

5.

5.1.

5.2.

6.

7.

7.1.

7.2.

7.3.

7.4.

Chemical agents..........................................................................................................12

Emergency plans and modelling.................................................................................12

Directories of experts for advice and assistance.........................................................13

AVAILABILITY AND STOCKPILING OF MEDICINES ......................................14

National stockpiles......................................................................................................15

Options and issues regarding possible EU-level stockpiles........................................15

Policy considerations on smallpox vaccines...............................................................17

Current situation and actions foreseen........................................................................18

RESEARCH ...............................................................................................................18

R&D Expert Group on countering the effects of biological and chemical terrorism .18

The 6th Framework Programme (FP6)........................................................................19

BUILDING A MULTI-SECTOR RESPONSE..........................................................19

INTERNATIONAL COOPERATION.......................................................................21

Ottawa initiative..........................................................................................................21

Cooperation with the WHO ........................................................................................21

Enlargement candidates ..............................................................................................22

NATO .........................................................................................................................22

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8.

9.

9.1.

9.2.

9.3.

CONCLUSIONS AND PERSPECTIVES .................................................................22

ANNEXES..................................................................................................................24

Annex 1.......................................................................................................................24

Annex 2.......................................................................................................................26

Annex 3 (LEGISLATIVE FINANCIAL STATEMENT) ..........................................28

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1.

1.

2.

3.

4.

5.

1

2

INTRODUCTION

Soon  after  the  unprecedented  terrorist  attacks  in  the  USA  in  September  2001,
governments and international entities with responsibilities related to health protection
reviewed their means across the various policies and sectors of activity to prevent and
counter  threats  and  mitigate  the  effects  of  such  attacks.  They  immediately  embarked
upon reinforcing such means and devising new and adapted ones to face up to a new
type of threat, that of deliberate releases of  biological and  chemical agents with their
potential to go undetected until many individuals have become contaminated and fallen
seriously ill.

The  response  of  the  European  Union  and,  in  particular,  of  the  Council  and  the
Commission, has been swift. It has been summarised in two communications issued by
the  Commission,  the  first  on  28  November  2001  on  “Civil  protection:  state  of
preventive  alert  against  possible  emergencies”1  and  the  second  on  11  June  2002  on
“Civil Protection - Progress made in implementing the programme for preparedness for
possible  emergencies”2.  On  20  December  2002,  the  Council  and  the  Commission
adopted  a  joint  programme  to  improve  cooperation  between  Member  States  in  the
evaluation  of  Chemical,  Biological  and  Radio-Nuclear  (CBRN)  risks,  alerts  and
intervention,  the  storage  of  means  of  intervention  and  in  the  field  of  research  as
requested by the European Council at  its meeting in Ghent on  19  October 2001. The
programme  reviews  measures  and  actions  already  in  place  and  those  planned  for  the
future and sets out the strategic objectives for fighting chemical, biological and radio-
nuclear terrorism in all EU policies.

This  communication  deals  with  the  health  aspects  of  the  EU  action  against
bioterrorism.  It  describes  the  steps  that  have  been  taken  by  Health  Ministers  and  the
Commission to strengthen health defences against deliberate releases of biological and
chemical  agents  and  their  co-ordination  efforts  at  EU  level.  It  refers  to  the  problems
and  challenges  on  preparedness  and  response  facing  the  health  sector  on  which  the
onus  of  rapid  detection  of  agents  and  early  detection  and  treatment  of  exposed
individuals  falls.  It  then  describes  the  actions  that  have  been  undertaken  in  the
framework of the programme on health security that is currently being implemented in
close collaboration between the Commission and the Member States.

The communication also reports on the initiative launched to address the issue of the
availability  and  stockpiling  of  medicines  which  are  indispensable  for  mounting  an
effective response to bioterrorist attacks. It describes the issues involved and presents
the  results  of  the  work  carried  out,  the  current  situation  and  perspectives  for  further
work in this area. Brief reference is also made to actions in other policy areas and in
particular  food  and  water  safety  which  are  crucial  for  health  protection.  It  finally
outlines the main features of the initiatives for international cooperation in this area.

Work  on  health  security  at  EU  level  is  not  finished  by  any  means.  It  has  already
produced  valuable  and  promising  results.  It  will  have  to  be  adapted  to  developments
and  events  and  will  be  evaluated  at  regular  intervals.  Important  conclusions  have,
nevertheless, already been drawn concerning the accomplishment of the objectives set,

COM (2001) 707 final
COM (2002) 302 final

4

                                                
2.

6.

7.

8.

9.

the  changing  needs  of  the  Member  States  and  the  influence  of  international
developments.  On  the  basis  of  these  considerations  perspectives  for  future  EU
activities and the resources  and structures  needed are discussed  in the  conclusions  of
the communication.

RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU

Events

Shortly after the terrorist attacks of 11 September 2001, the US was hit by a spate of
bioterrorist incidents involving anthrax  spores.  The  bacillus  anthraxis  spores  released
through  the  US  postal  system  resulted  in  23  cases  of  anthrax,  of  which  eleven  were
inhalation cases that led to five deaths, as well as eight confirmed and four suspected
cutaneous cases. Investigations suggest a single source for the deliberate releases and
the  strains  of  anthrax  detected  are  indistinguishable.  The  perpetrators  remain
unidentified,  and  the  risk  of  recurring  deliberate  releases  remains  high  until  they  are
captured.

The  terrorist  events  took  place  in  the  United  States  but  had  a  world-wide  impact.  In
Europe, civil protection, security and armed forces were put on alert, and public health
systems  had  to  manage  numerous  items  of  mail  containing  powders  suspected  or
claimed to be contaminated with anthrax. Neither terrorist attacks nor anthrax cases or
contamination  occurred  in  Europe,  apart  from  a  contaminated  letter  found  in  the  US
Embassy  in  Vienna,  Austria,  suggesting  contamination  within  US  government  postal
facilities. However, the pressure on European countries was high, as they quickly had
to devote scarce public health resources to face a new type of threat.

Preparations  for  incidents  in  Europe  were  soon  to  be  tested.  On  7  January  2003,
following raids two days earlier in premises in London, the UK authorities announced
that  a  small  amount  of  material  found  in  those  premises  had  tested  positive  for  the
presence  of  ricin,  a  toxic  substance  that  can  be  fatal  if  ingested,  inhaled  or  injected.
The incident served as a sharp reminder to security and health authorities to intensify
their  efforts  to  plan  and  be  ready  for  the  deliberate  dissemination  of  biological  and
chemical agents.

Health Council

At  the  Council  meeting  of  15  November  2001,  following  agreement  by  the  Health
Ministers, the Belgian Presidency issued conclusions which requested the Commission
to  develop  an  action  programme  of  cooperation  on  preparedness  and  response  to
biological  and  chemical  agent  threats,  which  would  have  to  address  the  following
priorities:

(a) 

(b) 

(c) 

Develop a mechanism for consultation in the event of a crisis linked to the bio-
terrorist risk and a capacity for the deployment of joint investigation teams;

Set  up  a  mechanism  for  information  on  the  capacities  of  European  laboratories
with respect to the prevention of and fight against bio-terrorism;

Set up a mechanism for information on the availability of serums, vaccines and
antibiotics,  including  concerted  strategies  for  developing  and  using  those
resources;

5

10.

11.

12.

13.

(d) 

Set  up  a  European  network  of  experts  responsible  in  the  Member  States  for
evaluating, managing and communicating risks;

(e) 

Promote the development of vaccines, medicines and treatments.

The  conclusions  stressed  that,  in  developing  this  programme,  initiatives  must  be
closely co-ordinated with those linked to the setting up of a Community co-ordination
mechanism  for  civil  protection  measures  and  must  take  account  of  confidentiality
requirements in the case of sensitive data.

Ottawa initiative

On  the  international  scene,  the  bioterrorist  attacks  were  the  subject  of  high-level
contacts  and  meetings.  Of  particular  importance  was  the  meeting  in  Ottawa  on
7 November  2001  of  Health  Ministers  from  the  G7  group  of  countries  with  the
participation  of  the  Health  Minister  of  Mexico  and  Mr  Byrne,  Member  of  the
Commission  responsible  for  Health  and  Consumer  Protection.  The  meeting  agreed  a
concerted global action initiative to strengthen the public health response to the threat
of  international  biological,  chemical  and  radio-nuclear  terrorism.  Progress  with  the
implementation of this initiative is outlined in a separate section below.

Commission response

In response to the call by the European Council and in line with the priorities identified
by Ministers in the Council, the Commission launched a series of co-ordinated actions
across the  civil  protection,  health,  enterprise  (pharmaceuticals),  research,  nuclear  and
transport  and  energy  fields.  These  were  reported  in  the  communication  on  “civil
protection:  state  of  preventive  alert  against  possible  emergencies”  issued  on
28 November  2001.  The  main  advances  made  in  developing  and  implementing  the
civil protection co-ordination mechanism, the health  security  initiatives  and  activities
in key complementary sectors such as research and pharmaceuticals, were summed up
in  the  communication  of  11  June  2002  on  “Civil  Protection  -  Progress  made  in
implementing  the  programme  for  preparedness  for  possible  emergencies”.  The
Commission  also  completed  a  study  on  the  vulnerabilities  of  the  EU  from  scientific
and technological advances related to bioterrorism.

Finally, the Commission joined efforts with the Council in inventorying measures and
actions  across  European  Union  policies  to  face  up  to  chemical,  biological  and  radio-
nuclear terrorist threats and setting up the strategic objectives for future action. These
are  set  out  in  the  joint  programme,  agreed  on  20  December  2002,  to  improve
cooperation  in  the  European  Union  for  preventing  and  limiting  the  consequences  of
such threats.

3.

PUBLIC HEALTH PREPAREDNESS AND RESPONSE

Preparedness

14.

Deliberate releases of biological and chemical agents to cause harm can be overt, with
in  which  widespread
immediately  apparent,  or  covert, 
effects  and  victims 
contamination  of  people  and  the  environment  can  occur  before  effects  become
manifest. Mitigating the effects of such releases requires early detection of the agents
implicated  and  case  recognition  of  those  affected.  Only  then  can  a  multi-sector

6

response  be  activated  and  its  success  will  depend  on  the  speed  and  accuracy  of  the
agent detection and case identification. Health authorities and agencies have a crucial
role  in  identifying  agents  released  in  various  environmental  compartments,  including
built-up  environments  such  as  dwellings,  subways  and  transport  infrastructure,  and
distribution chains such as for food, water,  air and mail. They are responsible for the
timely recognition of cases and identification of persons likely to have been affected.
For  this,  they  must  establish  effective  surveillance,  familiarise  clinicians  with  the
syndromes to look out for,  disseminate  case  management  guidelines  and put in place
effective  arrangements  for  prompt  notifications  to  the  authorities  in  charge  of
collecting and evaluating epidemiological information and co-ordinating public health
responses.  Identification  and  clinical  recognition  rely  on  high-quality  laboratory
diagnostic tests based on validated techniques and protocols so that deliberate releases
can be rapidly confirmed or excluded. Laboratory expertise and capacity must, in turn,
be  available  to  cope  with  high-risk  agents  and  complex  technology  and  methods  as
well  as  a  surge  in  demand  in  case  of  multiple  threats  or  attacks.  Proper  and  safe
arrangements  must  be  in  place  for  the  collection  and  transportation  of  samples,
reagents  and  specimens.  Field  investigation  must  be  rapidly  available  to  analyse
relationships  between  cases  and 
the  extent  and  distribution  of
to  establish 
environmental exposures, and co-ordinate contact tracing and  additional case finding.
This  is  key  to  determining  potentially  exposed  groups  of  people  who  would  require
antibiotic prophylaxis, vaccination and / or monitoring depending on the agent. Tracing
the  source  of  covert  deliberate  releases  requires  combining  data  from  human  and
environmental  epidemiology  with  information  from  security  and  law  enforcement
services.  Finally,  the  public  health  system  has  to  be  prepared  for  conducting  at  the
local,  regional  or  national  level,  triage,  contact  tracing,  testing,  diagnosis,  treatment,
and prophylaxis, for large numbers of people, and for implementing other public health
measures based on accurate predictions about the propagation of releases or disease.

Response

clinicians,  microbiologists, 

For threats and overt attacks, measures for physical protection and assistance need to
be taken immediately and an initial assessment be made of consequences and risks so
that  appropriate  interventions  could  be  initiated  forthwith.  Covert  attacks  would  be
picked up by ad hoc monitoring or by identification of cases by the health authorities.
Health  authorities  would  then  undertake  preventive,  remedial  and  treatment  action,
such as decontaminating exposed persons,  taking swabs for  analysis or administering
prophylactic  treatments.  Emergency  plans,  tested  with  exercises  ensuring  the  smooth
toxicologists,
interdisciplinary  working  between 
epidemiologists, communicable disease control physicians, and radiation biologists and
physicists  with  the  civil  protection,  security  and  law  enforcement  services  would
provide  a  high  degree  of  confidence  in  the  capacity  to  mount  a  proportional  multi-
sector  response.  First  responders  and  all  other  staff  engaged  in  activities  likely  to
expose them to risk from the release and its sequels have to be shielded from direct or
indirect effects. Health response staff need to be properly equipped and organised and
have  timely  recourse  to  sufficient  quantities  of  medicines,  other  medical  supplies,
protective and decontamination equipment, detection kits and sampling equipment, and
laboratory  and  medical  services.  Their  numbers,  means  of  response,  especially
communication, command and control systems, and their deployment capability must
be  strengthened  to  cope  with  the  upsurge  in  demand  that  will  follow  an  attack  with
many  victims and withstand  the  pressures  from  the  occurrence  of  multiple  attacks  or
incidents.

7

15.

16.

17.

3.1.

18.

Co-ordination in the European Union

The European Union is a border-free space in which products, services and people can
circulate  without  hindrance.  It  is  essential  in  such  a  space  that  appropriate
arrangements  be  put  in  place  to  ensure  prompt  notification  and  exchange  of
information in case of threats and attacks, action at source be undertaken to stem the
spread of disease and environmental contamination, mutual assistance be provided for
diagnosis and management of cases, access to special laboratory services and expertise
for epidemiological investigations be secured, and public health responses be put into
effect.  This,  in  turn,  requires  sharing  of  knowledge  and  good  practice,  laboratory
facilities,  equipment  and  products,  experts  and  intervention  personnel  across  the
Member  States  of  the  EU,  as  well  as  good  co-ordination  and  interoperability  of
preparedness  and  response  plans.  The  importance  of  joint  action  in  the  EU  to
complement national measures led to the establishment on 26 October 2001 of a Health
Security Committee, comprised  of  high-level  representatives  of  the  Health  Ministers,
to  serve  as  the  main  instrument  for  cooperation  in  countering  deliberate  releases  of
biological  and  chemical  agents  to  cause  harm  and  the  setting  up  in  2002  of  a  Task
Force of national experts and Commission officials to implement an action programme
to  enhance  health  security.  To  give  effect  to  the  request  of  the  Health  Ministers  of
15 November  2001  the  Committee  agreed  on  17  December  2001  a  programme  of
cooperation  on  preparedness  and  response  to  biological  and  chemical  agent  attacks
(health  security),  code-named  BICHAT,  comprising  25  actions  grouped  under  four
objectives:

(a) 

(b) 

(c) 

(d) 

Set up a mechanism for information exchange, consultation and co-ordination for
the handling of health –related issues related to attacks;

Create  an  EU-wide  capability  for  the  timely  detection  and  identification  of
biological and chemical agents that might be used in attacks and for the rapid and
reliable determination and diagnosis of relevant cases;

Create a medicines stock and health services database and a stand-by facility for
making  medicines  and  health  care  specialists  available  in  cases  of  suspected  or
unfolding attacks;

Draw-up rules and disseminate guidance on facing-up to attacks from the health
point  of view and co-ordinating the EU response and  links  with  third  countries
and international organisations.

The programme is being implemented since May 2002 and results so far are presented
below.

Mechanism of alert and information exchange

This  mechanism  consists  of  the  Health  Security  Committee  and  a  rapid  alert  system
established to deliver alert notification and information necessary and  appropriate for
co-ordinated  responses  to  attacks  and  threats.  The  Health  Security  Committee  is
charged  with  exchanging  information  on  health-related  threats,  sharing  information
and experience on preparedness and response plans and crisis management strategies,
communicating  rapidly  in  case  of  health-related  crises,  advising  on  preparedness  and
response as well as on co-ordination of emergency planning at EU-level, sharing and
co-ordinating  health-related  crisis  responses  by  Member  States  and  the  Commission

8

19.

20.

3.2.

21.

and  facilitating  and  supporting  co-ordination  and  cooperation  efforts  and  initiatives
undertaken at EU-level.

The Committee has forged partnerships and collaborations to face up to the new type
of threat  in  the  health  field  and  established  thematic  working  groups  on  laboratories,
biological products, chemicals, clinical  guidelines, emergency plans and modelling to
allow recourse to expertise and flexible deployment of resources in Member States.

Rapid Alert System

A  dedicated  rapid  alert  system  is  in  operation  since  June  2002  for  notifications  of
incidents  involving  the  deliberate  or  threatened  release  of  biological  and  chemical
agents to cause harm (code-named RAS-BICHAT). The system links the members of
the  Health  Security  Committee  and  contact  points  designated  by  its  members  to
provide round the clock coverage and urgent recall in an emergency. It is linked to and
complements  the  system  established  by  Commission  Decision  2000/57/EC  of
22 December 1999  3 on the early warning and response system for the prevention and
control  of  communicable  diseases  under  Decision  No  2119/98/EC  of  the  European
Parliament and of the Council 4 and the civil protection mechanism (Council Decision
2001/792/EC, Euratom of 23 October 20015 establishing a Community mechanism to
facilitate  reinforced  cooperation  in  civil  protection  assistance  interventions).  RAS-
BICHAT  is  fully  operational  and  uses  agreed  notification  procedures  and  criteria  for
the  classification  of  events  according  to  the  type  of  the  release  and  the  severity  of
consequences, using an incident scale agreed also in the context of the Ottawa Global
Health Security initiative. It has been used on five occasions and tested five times and
is being developed and adjusted in the light of experience and the lessons learnt so far.
Effective links have been established with the other health protection-related EU rapid
alert systems. The system is also linked to existing Commission systems that scan and
summarise information made available through news agencies, other news media and
specialised  sources  onto  the  World  Wide  Web.  This  capability  will  be  extended  to
involve other sources of information, the objective being to facilitate the creation of an
integrated information system where data are housed and processed to detect rapidly,
track  and  assess  threats  so  that  advance  warning  could  be  provided  before  official
confirmation or news break out.

Detection and identification of biological agents

Detection  of  deliberate  releases  of  biological  agents  relies  first  and  foremost  on
Member  States’  surveillance  systems  for  monitoring  the  occurrence  of  infectious
diseases. Member States, but also other countries, are developing new diagnostics for
rapid  detection  which  is  a  key  requirement  for  effective  response.  In  particular,
advances  in  environmental  detection  and  monitoring  of  information  related  to  agents
and  disease  outbreaks  would  enhance  the  ability  to  identify  a  release  early.  Co-
ordination  of  these  surveillance  systems  at  EU  level,  especially  for  notification  and
exchange of information on outbreaks, is conducted under the framework of Decision
2119/98/EC  of  24  September  1998  on  the  surveillance  and  control  of  communicable
diseases.

3

4

5

OJ L 21 , 26.01.2000, p. 32
OJ L 268, 03.10.1998, p. 1
OJ L297, 15.11.2001, p. 7

9

                                                
3.2.1.

Lists of agents

22.

23.

24.

Although any biological or chemical agent capable of causing harm  to  health may in
theory  be  used  for  terrorist  purposes,  a  number  of  considerations,  such  as  ease  of
production and dissemination, would point to some being more likely to be used than
others.  It  is  thus  crucial  to  develop  agreed  and  updateable  lists  of  biological  and
chemical  agents  that  might  be  used  in  attacks  or  threats,  together  with  their
characteristics and associated symptoms and diseases and indications that permit their
timely detection and identification with agreed levels of certainty.

Lists in the area of Public Health

Biological agents in relation to bioterrorism have already been prioritised on the basis
of  certain  criteria,  such  as  infectiousness,  virulence,  persistence  in  the  environment,
ease  of  manipulation  and  dissemination  and  existence  of  defences  to  counter  their
propagation  and  effects.  The  European  Agency  for  the  Evaluation  of  Medicinal
Products  (EMEA)  has  referred  to  the  list  published  by  the  US  Centers  for  Disease
Control and Prevention in the advice it has given concerning vaccines and treatments
(Annex  1).  Commission  Decision  2000/96/EC6  of  22.12.1999,  under  Decision  N°
2119/98/EC of the European Parliament and of the Council, concerning diseases to be
progressively  covered  by  the  European  Union’s  communicable  disease  surveillance
network, contains many of the agents singled out by the CDC. A Commission decision
has been proposed adding Bacillus anthracis (for anthrax), Franciscella tularensis (for
tularemia), Coxiella burnetii (for Q-fever), and Variola major (for smallpox) to the EU
lists  and  amending  Commission  Decision  2002/253/EC7  which  lays  down  case
definitions  for  reporting  communicable  diseases  to  the  EU  network.  For  other
pathogens  that  are  potential  candidates  for  attacks,  various  approaches  are  being
improved  clinical  alerting  mechanisms  and  syndrome-based
studied,  such  as 
surveillance  systems.  Moreover,  in  order  to  compile  the  different  actions  needed
against  biological  agents  that  might  be  used  for  deliberate  releases  in  a  single
presentation, a matrix has been developed  for use by national authorities.  The matrix
serves to identify for each agent the actions that need to be accorded priority.

Export control lists

Council  Regulation  N°  1334/2000  setting  up  a  regime  for  the  control  of  exports  of
dual-use  items  and  technology8,  as  amended  and  updated  by  Regulation  (EC)
N° 2432/2001  of  20.11.2001  9,  lays  down  lists  of  biological  and  chemical  agents  for
which  strict  provisions  linked  to  international  non-proliferation  regimes  and  export
control arrangements apply. The latter are agreed by international mechanisms, one of
them  being  the  so-called  Australia  Group  10,  an  international  informal  group  of
countries that base their activities on the biological and chemical weapon conventions
regarding  the  minimisation  of  the  risk  of  chemical  and  biological  weapons
proliferation. The agreements are linked to the aforementioned Council Regulation and
have to be transposed onto EC law. The latest meeting of the Australia Group in June
2002 decided to add new agents to the control lists. However, because of the adverse

6

7

8

9
10 

OJ L28, 3.2.2000, p.50
OJ L86,3.4.2002, p.44
OJ L159, 30.6.2000, p.1
OJ L338, 20.12.2001, p.1
http://www.australiagroup.net

10

                                                
impact  that  controls  may  have  on  public  health  activities,  such  as  delays  in  the
transport  of  agents,  samples,  reagents  and  specimens  for  laboratory  tests  and
comparisons, consultations are taking place with the Member States aimed at agreeing
a common position at the Australia Group for the adoption of appropriate criteria for
placing  agents  in  control  lists  and  for  exemptions  from  the  export  control  rules  of
transfers made by public health institutes, laboratories, agencies and centres.

3.2.2.

Laboratories: inventory and cooperation

25.

26.

Capability  for  fast  and  accurate  characterisation  of  biological  agents  is  unevenly
distributed in the EU. Remedying shortcomings in this area requires the development
and  use  of  special  surveillance  methods  and  arrangements  to  use  limited  laboratory
resources efficiently. There are six safety level 4 laboratory facilities in four Member
States  of  the  EU  that  are  suitable  for  the  handling  and  confirmation  in  samples  and
specimens of high-risk agents such as haemorrhagic fever viruses. A network has been
formed between these laboratories to provide quality-assured diagnostic services to all
Member States, identify viral haemorrhagic fever and pox agents, establish an on-call
availability  of  24  hours  seven  days  a  week,  communicate  rapidly  with  national
authorities and the Commission, develop a structure for sending/receiving and handling
samples  and  organise  training  and  skill  development.  For  smallpox  diagnostics,
collaboration  between  safety  level  3  and  4  laboratories  would  be  necessary.  To  this
end, Member States’ experts have been convened by the Commission and developed a
cooperation  platform,  including  a  quality  assurance  system.  Collaboration  of  high
safety  level  laboratories  is  also  being  pursued  in  the  context  of  the  Ottawa  Global
Health  Security  initiative,  where  a  network  has  been  set  up  to  share  protocols  and
standard operating procedures, exchange reagents and control material and promote the
harmonisation and standardisation of diagnostic methods.

The anthrax attacks in the US and the spate of hoaxes using letters and packages that
followed there and in Europe showed also how easily national laboratory systems can
be overwhelmed by a spike in demand over a short period of time. It is thus crucial to
ensure  proper  back  up  and  mutual  support  between  laboratory  facilities  of  the  EU
Member  States  to  avoid  situations  of  saturation  and  inability  to  cope  with  a  surge  in
demand  for  analyses.  To  this  end,  the  Commission  is  promoting  the  conclusion  of
memoranda  of  understanding  or  cooperation  agreements  between  the  national
laboratory systems of the Member States. The existing EU database IRIDE set up with
help  from  the  Commission  and  data  collected  through  a  questionnaire  sent  to  the
competent  authorities  of  the  Member  States  will  be  used  to  specify  the  terms  of
cooperation agreements.

3.2.3. Clinical guidelines for case recognition and management

27.

28.

Clinical guidelines for the recognition and case management of diseases related to the
pathogens that may be used in deliberate releases are being prepared on the basis of a
consensus process.  The  process  involves  review  by  a  group  of  experts  designated  by
the Health Security Committee and final approval by the latter prior to publication and
dissemination to Member States.

Ten  manuscripts  have  been  drafted  covering  anthrax,  smallpox,  botulism,  plague,
tularemia, haemorrhagic fever viruses, brucella, Q fever, encephalitis viruses, glanders.
They  have  been  modified  following  comments  by  Member  States’  experts  and
endorsed  by  the  Health  Security  Committee  as  a  useful  tool  for  the  guidance  of

11

3.3.

29.

30.

31.

3.4.

32.

clinicians  and  other  health  professionals.  The  intention  is  to  publish  them  following
peer-review in a scientific journal.

Chemical agents

Work on chemicals aims at providing Member States with a sound basis for planning
and assisting each other for attacks and threats using these substances.

A matrix to aid Member States to identify priorities in this area has been drawn up by
the compilation of a series of lists of chemical threats to arrive at groups of substances
requiring  the  same  public  health  and  medical  approaches.  The  matrix  takes  into
account  the  international  cooperation  on  the  preparation  of  a  list  of  chemical  agents
agreed within the Global Health Security Action Group. It also takes into account data
on  dangerous chemicals  collected by the Joint  Research  Centre  pursuant  to  Directive
96/82/EC on the control of major accident hazards involving dangerous substances (the
Seveso Directive). The risk grading of substances in the matrix takes into account the
relevant  provisions  of  the  Council  Directive  98/24/EC  for  health  and  safety
requirements at the workplace concerning chemical agents11.

Work  is  focussing  on  the  clinical  and  toxicological  aspects  of  chemical  incidents,
national inventories of chemical experts who can be made available, the inventory of
special  treatment  facilities,  clinical  review  papers  and  training  issues.  Close  working
relationships have been developed with national and international organisations active
in these, including the National Focus for Response to Chemical Incidents in the UK,
the  International  Programme  on  Chemical  Safety  (IPCS)  run  by  the  World  Health
Organisation  (WHO)  and  the  Organisation  for  the  Prohibition  of  Chemical  Weapons
(OPCW).  Cooperation  with  the  European  Association  of  Poison  Control  Centres  and
Clinical  Toxicologists  (EAPCCT)  has  been  initiated  for  the  preparation  of  clinical
review documents on syndromes and treatment of chemical agents that might be used
in attacks. Data from a survey of poison centres conducted by the Commission are used
to compile an inventory of clinical and laboratory-related expertise in the EU. Finally,
a guidance document on the use of antidotes and pharmaceuticals has been requested
from EMEA.

Emergency plans and modelling

Immediately  after  the  bioterrorist  attacks  in  the  US,  EU  Member  States  were  forced
urgently to review their emergency plans and to adjust them to face up to a new threat,
that of a covert release possibly without warning or signals of impending danger. They
had to make certain key assumptions and reckon with various scenarios: discovery of
unusual or suspicious objects which could not simply be taken away for destruction for
fear of spreading agents; discovery of biological products in the wrong place or in the
wrong  product;  the  possibility  of  threat  or  terrorist  attack  with  or  without  demands,
before or after harm or damage became manifest; an abnormal outbreak of disease or
unusual  clustering  of  cases  without  indications  of  link  to  normal  or  adventitious
exposure; or, worse, obvious foul play or likely foul play in incidents that resulted in
prompt or delayed harm to people, environment or property. They had to amplify and
refine  general  emergency  plans  to  cater  for  specific  types  of  agents  representing

11

OJ L 131, 05.05.1998, p. 11

12

                                                
33.

34.

3.5.

35.

different sets of demands, as evidenced by the anthrax releases and the possibility that
a smallpox case may break out at home or abroad.

Consultations at the EU level and internationally showed that the process of adjusting
and complementing emergency  plans  or  devising  new  ones  is  not  yet  complete,  with
some  Member  States  more  advanced  than  others.  Member  States  and  other  countries
are  keen  to  share  knowledge  and  experience  and  compare  assumptions,  scenarios,
criteria  and  principles  for  introducing  particular  counter-measures  at  appropriate
phases. They want to have plans based on carefully considered policy options. These
would include the WHO’s “search and containment” policy for outbreaks of infectious
diseases such as smallpox which advocates ring vaccination. Different responses to an
outbreak  would  have  to  be  considered,  depending  on  whether  it  occurred  in  one’s
territory or abroad, as well as responses to multiple outbreaks spread widely, switching
between responses, or the scaling -up of existing counter-measures. Member States are
also keen to develop models to make predictions about the  progress of disease under
different scenarios and variable quantitative and qualitative information on movements
of  people,  social  habits,  various  geographical,  weather  and  transport  and  utility
conditions.  They  need  sound  strategies  for  the  deployment  of  data  capture  and
information 
and
decontamination equipment, detection and sampling/monitoring devices and about the
implementation potential and impact of counter-measures, such as medical  treatment,
vaccination, isolation and quarantine, evacuation and interdiction of premises, taken in
isolation or in combination.

systems,  medicines,  medical 

supplies,  protective 

flow 

It  has  now  become  a  priority  under  health  security  programme  to  intensify  work  on
emergency  planning  and  promote  modelling,  so  as  to  permit  the  refinement  and
strengthening of emergency and strategic plans for threats and attacks. To this end, a
compilation of national emergency plans is in progress which will serve to share and
co-ordinate specific measures and a common mathematical model and data resource is
being  developed.  An  EU-  wide  exercise  will  be  carried  out  next  year  to  evaluate
communications and compatibility of national plans. Commission participation in the
exercise  this  year  to  evaluate  smallpox  plans  and  communications  involving  the  G7
countries  and  Mexico  will  provide  lessons  for  the  conduct  of  the  EU  exercise.  A
central  element  in  both  efforts  is  the  identification  of  needs  for  further  EU  co-
ordination  across  the  whole  spectrum  of  policies  that  would  be  affected  by  a  global
health  emergency,  such  as  a  smallpox  outbreak,  and  the  consolidation  of  responses
within an overall EU plan.

Directories of experts for advice and assistance

Knowledge  about  bioterror  agents  and  corresponding  diseases  and  their  clinical  and
epidemiological management  and associated laboratory analysis is  limited.  Hence the
need to identify relevant experts in the EU and list them in a directory to be shared by
the  authorities  of  the  Member  States.  An  expert  could  be  made  available  by  one
Member  State  to  another  on  request  to  the  authorities  of  the  Member  State  of  the
expert. A questionnaire has been sent to Member States to identify experts that can be
made available for advice or for missions when arrangements for this type of operation
have been established. Experts will be designated by the Health Security Committee in
accordance with criteria on qualifications and experience that have already been drawn
up. They will have to express their interest and availability to be placed in the directory
and  participate  in  investigations,  as  well  as  readiness  to  respond  in  good  time  and  at
short  notice.  Other  appropriate  instruments  such  as  codes  of  conduct,  terms  of

13

36.

4.

37.

38.

reference  and  procedures  for  the  consultation  of  the  directory  in  strict  respect  of
confidentiality will also be developed.

The  directory  will  be  managed  in  collaboration  between  the  Member  States  and  the
Commission. It will be co-ordinated with the inventory held by the Commission’s civil
protection  mechanism  and  the  roster  kept  by  the  WHO’s  Global  Outbreak  Alert  and
Response  Network ,  as  well  as  with  the  Joint  Research  Centre’s  group  of  experts  on
EU  vulnerabilities  to  biological  and  chemical  terrorism,  and  arrangements  will  be
made to  have  recourse  to  lists  held  by  the  authorities  of  the  Member  States.  Regular
updates will be made of contact details of all experts and new experts will be identified
and added at regular intervals.

AVAILABILITY AND STOCKPILING OF MEDICINES

Immediately  after  the  bioterrorist  attacks  in  the  USA  attention  focussed  on  the
availability  of  medicines  in  the  EU  and  the  capability  of  industry  and  Member  State
agencies  and  laboratories  to  make  good  any  shortcoming  in  production  and  supply.
Subsequent  action  served  also  to  gather  data  that  would  be  useful  for  obtaining  the
general  information  on  medical  resources  in  the  Member  States  as  laid  down  in
Council Decision 2001/792/EC, Euratom (reference N°5).

A  consultation with the pharmaceutical  industry  was  launched  in  November  2001.  A
joint  Commission  services  -  pharmaceutical  industry  task  force  was  established  in
December 2001 to address availability, production capability, storage and distribution
capacity  and  development  plans  for  vaccines  and  other  medicines  used  for  the
treatment  or  prevention  of  disease  in  the  event  of  a  biological  attack.  In  the  same
month,  a  specific  network  was  also  created  via  the  Pharmaceutical  Committee12,
comprising contact points in the 15 Member States to look at stocks and availability in
the Member States. At the request of the Commission, the EMEA has established two
expert groups. One expert group developed guidance on the use of medicines against
potential  pathogens13  and  the  other  expert  group  produced  a  report14  on  second
generation15  smallpox  vaccines,  based  on  hearings  held  with  six  major  vaccine
manufacturers,  and  guidance  on  the  development  of  vaccinia  virus  based  vaccines
against small pox16.

39.

In  Annex  2  an  overview  has  been  compiled  of  the  general  findings  on  availability,
product  development  and  production  capabilities  within  the  European  Union  of  the
different  medicinal  products  for  the  treatment  or  prevention  of  diseases  caused  by  a
number  of  pathogens17.  It  is  not  exhaustive  and  will  be  updated  as  necessary.  It

12

13

14

15

16

17

established by Council Decision 75/320/EEC
EMEA/CPMP  guidance  document  on  use  of  medicinal  products  for  treatment  and  prophylaxis  of
biological  agents  that  might  be  used  as  weapons  of  bioterrorism  (http://pharmacos.eudra.org  or
http://www.emea.eu.int  ).  Treatment/prophylaxis  recommendations  are  given  for  all  pathogens  in  the
current  CDC  list.  All  agents  from  the  list  were  included  (see  Annex  1)  Additional  pathogens  were  also
included, which were thought to pose a potential threat.
EMEA Vaccines expert group confidential report on small pox vaccines CPMP/493/02.
Vaccines  against  smallpox  are  sometimes  classified  according  to  their  state  of  development  into  first,
second or third generation vaccines. An explanation of this classification is in Annex 1.
EMEA /CPMP/1100/02 Note for guidance on the development of vaccinia  virus  based  vaccines  against
small pox.
Mainly the A-category pathogens of the CDC list (see Annex 1).

14

                                                
incorporates the recommendations from the guidance document of the Committee for
Proprietary Medicinal Products (CPMP).

40.

Several options were studied as part of these parallel efforts, prominent among which
was the establishment of a Community-level stockpile of authorised or to be authorised
second  generation  smallpox  vaccines,  manufactured  according  to  current  quality
standards. The views of the Member States on this possibility were sought  in several
consultations,  starting  with  an  exchange  of  views  between  Ministers  at  the  Health
Council  on  23  June  2002  and  continuing  with  the  representatives  of  Ministers  in  the
Health Security Committee and in technical ad hoc groups.

4.1.

National stockpiles

Antibiotics

41.

42.

43.

4.2.

44.

There is stockpiling of antibiotics at national level in many of the Member States, but
not in all. Some rely on requirements placed on pharmacists, distributors or hospitals
but  these  do  not  necessarily  cover  those  most  suitable  for  countering  bioterrorist
attacks.  Two  of  the  larger  Member  States  have  offered  to  share  stocks  with  other
Member States. However, the majority of the other Member States did not wish to take
up the offers made and the sharing scheme was not discussed further.

Smallpox vaccine

An assessment of national smallpox stockpiles has been carried out which showed that
most  Member  States  have  existing  or  are  acquiring  stockpiles  of  smallpox  vaccines.
First  generation  vaccines  have  been  in  storage  since  the  1970s.  One  Member  State
resumed production of first generation (calf lymph)  vaccines  in January 2002. A few
countries have ordered or are planning to order new (second generation) vaccines when
they  become  available.  Some  Member  States  are  considering  diluting  their  stock  of
first generation vaccines so that it can provide a greater number of doses.

From the information received so far, the sizes of the national stockpiles in relation to
the  national  population  range  from  enough  to  provide  a  dose  for  every  citizen  in  the
Member State to enough for one citizen in thirty. A national stockpile providing total
coverage for the population does not necessarily imply a mass vaccination policy – it
may reflect a political decision to provide reassurance for the population and to be able
to respond to an anticipated public demand. In line with WHO guidelines, all Member
States  have  indicated  that  they  have  a  targeted  vaccination  policy,  vaccinating  only
close  contacts  of  infected  cases.  An  important  feature  in  some  Member  States’
smallpox  plans  is  the  preventive  (before  any  release)  vaccination  of  key  health  and
emergency  services  staff.  The  US  and  Canada  are  also  carrying  out  vaccinations  of
such staff as a preventive measure. It is envisaged in the US to extend vaccinations to
all health and emergency services staff in case of a smallpox outbreak and, eventually,
following  satisfactory  results  from  the  vaccination  programme,  to  make  the  vaccine
available to the public on demand.

Options and issues regarding possible EU-level stockpiles

The Commission  services-pharmaceutical  industry task force and  the Member States,
through  the  Pharmaceutical  Committee  network  and  through  the  Health  Security

15

45.

Committee,  considered  the  need  for  the  establishment  of  a  Community  stockpile  of
smallpox vaccines, antibiotics and antivirals.

As  regards  antibiotics,  a  Community  stockpile  could  comprise  a  sufficient,  versatile
range of antibiotics to cover as many of the potential pathogens as possible. The stock
could include generic products as in most cases the corresponding original products no
longer  have  patent  protection.  Foreseeable  advantages  of  a  Community  stockpile  of
antibiotics have  been  considered  to  be increased purchasing power and  economies of
scale, increased comfort level from knowing there is a reserve and industry preference
to  deal  with  a  central  contact  and  a  single  large  contract.  Problems  likely  to  be
encountered include  difficulties getting agreement on  the  choice  of  antibiotics  within
the different therapeutic classes  and on the  choice  of final manufactured  product, the
likely  high  cost  and  difficulty  in  managing  a  stockpile  of  a  number  of  different
products at  Community  level  and  issues  relating  to  the  language  of  the  labelling  and
other product information.

46.

As regards smallpox  vaccines,  several  issues  were  identified in the context of setting
up and administering a Community-level stockpile, including:

– 

– 

– 

– 

– 

such  stockpile  should  exist  in  addition  to  national  stockpiles  and  any  national
sharing arrangements and should not replace them;

it should provide equivalent access to all and should ensure equity for all citizens
of the EU;

it should take future EU enlargement into account;

it  should  be  suitable  for  the  needs  of  the  Community  for  at  least  the  next  ten
years, when third generation vaccines may become available;

it should only contain second generation vaccine(s) which are authorised or to be
authorised according  to  the  criteria  of  safety,  quality  and  surrogate  markers  for
efficacy established by the EMEA expert group on vaccines.

The  size  of  a  Community  stockpile  would  be  influenced  by  national  vaccination
strategies, in place or foreseen, the size and precise content of the national stockpiles
and modelling data predicting likely responses to a deliberate release of smallpox.

Foreseeable advantages of a Community level stockpile of smallpox vaccines include
equity for all EU citizens, increased purchasing power and economies of scale, reduced
overall costs up front by having  a proportion of stockpile as bulk product and  by  re-
launching production as necessary in response to an emergency, increased leverage to
encourage  companies  to  develop  new  vaccines,  industry  preference  for  dealing  with
one  central  contact  and  boost  to  confidence  from  knowing  that  there  is  a  reserve  of
vaccine.

However,  a  number  of  issues  remain  unresolved,  such  as  the  significant  budgetary
requirement to buy and maintain a stockpile against a low probability event such as a
bioterrorist attack with appreciable impact. The pharmaceutical industry has indicated
that  there  would  be  a  sliding  scale  for  costs  per  dose,  depending  on  the  size  of  the
order.

47.

48.

49.

16

50.

Moreover,  the  issue  of  sharing  and  distribution  from  the  stockpile  in  case  of
simultaneous  Member  States  needs  could  result  in  several  options  to  be  studied,
including  allotting  a  predetermined  amount  to  each  Member  State  or  requiring  the
operators of the stockpile to maintain national stores. Also, an alternative to a distinct
Community stockpile could be a “virtual” stockpile co-ordinated and administered by
the  Commission  and  made  up  of  dedicated  proportions  of  national  stockpiles  to  be
pledged by the Member States.

4.3.

Policy considerations on smallpox vaccines

Consultations

51.

52.

53.

Consultations  on  options  for  a  Community  stockpile  or  virtual  reserve  or  a  strategic
sharing  of  national  stockpiles  showed  that  most  Member  States  would  not  support
either  the  establishment  of  a  Community  level  stockpile  of  smallpox  vaccines  or
formal  arrangements for  sharing national  stockpiles. The Health  Security  Committee,
at  its  meeting  on  22  October  2002,  confirmed  its  interim  conclusion  reached  at  the
previous meeting in June 2002. For different reasons different Member States consider
that  an  EU-level  stockpile  would  not  provide  added  value  over  the  existing  and
planned national stockpiles.

Dilution of existing stocks

As regards the current availability of first generation stocks, the aggregate total number
of  doses  available  in  national  stocks  in  the  European  Union  is  in  the  range  of  200
million.  As  studies  performed  in  the  USA  indicate  that,  under  ideal  conditions  of
storage  and  dilution,  up  to  5  times  dilution  would  result  in  doses  retaining  adequate
potency, there is a presumption that diluted EU stocks would be sufficient to contain
smallpox  outbreaks using  the  search  and  containment  vaccination  strategy.  However,
there  are  doubts  over  the  feasibility  of  dilution  in  real  conditions.  Moreover,  most
Member States expressed  concern  about  the  safety  aspects  of  current  first  generation
vaccines,  necessitating  the  need  for  obtaining  sufficient  amounts  of  vaccinia
immunoglobulin (VIG), which is at present not available.

Second generation vaccines

Second generation vaccines are acknowledged to have superior production and quality
control methodology compared with first generation ones but there is uncertainty about
their safety profile as there are no published clinical data yet about them. The efficacy
of  first  generation  vaccines  (in  combination  with  isolation  and  quarantine)  was
established during WHO’s smallpox eradication campaign, whereas for ethical reasons
it  will  be  impossible  in  present  times  to  establish  the  efficacy  of  second  or  third
generation  vaccines  in  clinical  trials.  However,  protective  efficacy  may  be  inferred
from animal models and from clinical trials that measure surrogate markers of efficacy
such  as  a  relevant  immune  response  or  from  information  to  be  collected  from  the
vaccination  of  first  responders  and  health  emergency  staff  now  being  undertaken  in
certain countries.

17

4.4.

54.

55.

56.

57.

5.

5.1.

58.

59.

60.

Current situation and actions foreseen

With  respect  to  prophylaxis,  there  are  no  authorised  vaccines  in  the  EU  against
pathogens  such  as  smallpox  or  plague.  The  only  authorised  anthrax  vaccine  is  not
widely  available. 
insufficient  supply  of  vaccinia
immunoglobulin (VIG), used for the treatment of serious adverse reactions to smallpox
vaccine  and  there  is  a  need  for  other  medicinal  products  which  are  currently
unavailable or in short supply, such as an anti-botulinum immunoglobulin.

In  addition 

is  an 

there 

New,  safe,  authorised  products  are  needed,  particularly  for  the  prophylaxis  and
treatment  of  smallpox  and  for  prophylaxis  against  anthrax  and  plague.  However,
vaccine  manufacturers  have  made  it  clear  that  they  are  reluctant  to  develop  new
vaccines without strong commercial incentives.

The  need  to  respond  in  an  emergency  following  a  bioterrorist  attack  could  lead  to
demands for the distribution of non-authorised medicines which is currently illegal or
the prescription of off-label or non-authorised medicines, which raises liability issues.
Advantage has been taken of the opportunity presented by the current review of the EC
pharmaceutical  legislation  to  introduce  legal  amendments  in  order  to  remedy  this
anomaly. These amendments are now being examined by the European Parliament and
the Council.

For  the  immediate  future,  actions  are  being  launched  under  the  health  security
programme to address the needs for cooperation on medicines that have been identified
by the Commission following the advice of the Health Security Committee. These are
to  investigate  the  potential  of  diluting  first  generation  vaccines,  to  help  establish
sufficient quantities of vaccinia immunoglobulin (VIG), and to foster the creation of a
platform for European collaboration to develop  and produce biological products such
as  botulinum  antitoxin,  an  improved  vaccine  against  anthrax  and  a  safe  (third
generation) vaccine against smallpox. In addition, developments on the production and
availability of smallpox vaccines will be reviewed at regular intervals.

RESEARCH

R&D Expert Group on countering the effects of biological and chemical terrorism

Further  to  the  conclusions  of  the  Ghent  European  Council  of  19  October  2001,
Research  Ministers  in  the  Council  of  30  October  2001  endorsed  the  Commission
initiative to establish a R&D Expert Group on countering the effects of biological and
chemical terrorism.

The  R&D  Expert  Group  was  formed  by  representatives  from  each  of  the  Member
States coming from relevant Government Departments: defence, health, research, civil
protection  and  from  research  establishments.  It  was  charged  with  looking  at  the
research questions linked to the detection and identification of biological and chemical
agents and the prevention and treatment of attacks from such agents.

The  R&D  Expert  Group  prepared  a  report  comprising  an  inventory  of  the  research
the  basis  of  which  several
activities  undertaken  in 
recommendations  have  been  formulated  as  regards  the  co-ordination  of  research
activities  and  the  need  for  further  research  initiatives.  In  its  working  paper
(SEC(2002)698)  on  this  report,  the  Commission  presented  the  main  findings  and

the  Member  States  on 

18

5.2.

61.

62.

63.

6.

64.

65.

recommendations  of  the  Group  and  formulated  proposals  on  the  way  forward.  The
Commission  continues  to  provide  secretariat  support  to  the  R&D  Expert  Group,
namely  through  a  restricted  access  website  which  is  used  as  a  mechanism  for  the
exchange of information between experts.

The 6th Framework Programme (FP6)

The  development  of  fundamental  knowledge  and  basic  tools  towards  new  rapid
diagnostics  for  identifying  biological  and  chemical  agents  that  might  be  used  for
terrorist purposes and new vaccines and novel therapeutics against such agents, could
be  addressed  in  the  priorities  “life  sciences,  genomics  and  biotechnology  for  health”
and “food quality and safety” under the 6th Framework Programme.

Specific  research  needs  related  to  surveillance,  detection,  prevention  and  treatment
could also be addressed in the “scientific support to policy” section of the programme
where a specific action line has been introduced on “issues related to  civil protection
(including  biosecurity  and  protection  against  risks  arising  from  terrorist  attacks),  and
crisis  management”.  Scientific  support  is  foreseen  to  enhance  surveillance  capacity,
models  and  systems,  to  improve  detection  methods  and  disease  and  risk  assessment
models, to strengthen networking activities for new vaccines  and therapeutics, and to
assess vulnerabilities of modern societies.

The  R&D  Expert  group  will  be  reconvened  in  the  first  half  of  2003  to  discuss  the
results  of  the  first  FP6  calls  for  proposals,  update  the  inventory,  identify  additional
research  needs  which  could  be  addressed  through  subsequent  calls,  and  extend  its
membership to accession countries.

BUILDING A MULTI-SECTOR RESPONSE

Chemical,  biological,  radiological  and  nuclear  terrorism  has  direct  consequences  not
only  for  people,  but  also  for  the  environment,  the  food  chain  and  for  property.
Preventing  terrorist  acts  and  mitigating  their  consequences  requires  a  mobilisation  of
actors and resources in many sectors other than health. The joint programme adopted
by the Council and the Commission on 20 December 2002 reviews the legislative and
other  measures  already  in  place  and  spells  out  future  actions  to  improve  the  multi-
sector response that needs to be mounted against a threat or attack in the EU. Of major
importance to health security are the measures and actions in food, animal, plant and
water safety.

Food safety

The  joint  Council-Commission  programme  notes,  in  this  context,  that  the  EC  has  a
broad body of legislation which covers primary production of agricultural products and
industrial production of processed food. This legislative body provides different means
to  respond  to  situations  in  specific  sectors.  The  measures  that  would  be  taken  in
response to a terrorist act in the food sector are not fundamentally different from those
adopted  by  the  Community  in  response  to  accidents  in  the  recent  past.  There  is
consequently  a  sufficiently  well  developed  body  of  rules  for  alerts  and  contingency
plans  of  action  (both  in  health  and  economic  terms)  to  face  up  to  an  epidemic  of
criminal origin (the only differences between a terrorist act and an accidental epidemic
would be the dimension of the initial phase and the number of primary outbreaks). The

19

66.

67.

68.

various means  that have  been  established  in  order  to  guarantee  safety  throughout  the
whole food chain have functioned in  general well and the ability to respond to crises
has been tested in numerous occasions. There is no need to establish new systems, but
rather  to  adjust  the  current  mechanisms  in  order  to  improve  their  functioning  taking
into account the threat of bioterrorism.

The aspect of the fight against bioterrorism that needs developing in the  future is the
organisation  of  upstream  information,  investigation  and  information-gathering  within
the territory of the Community and third countries as well as an improved cooperation
between authorities and those working in the food chain and their education. Emphasis
should  also be given  to  cooperation  between  the  food  sector  and  other  sectors  of  the
society. In particular, the role of education in guaranteeing safety throughout the food
chain must be underlined.

Animal safety

Numerous  regulatory  measures  have  been  adopted  European  Union  level  to  keep
animal diseases at bay and to combat outbreaks, including Member States contingency
plans  to ensure a  fast and harmonised response to the  most  serious  epidemics.  These
measures apply whether the origin of an epidemic is accidental or the result of terrorist
action.  In  response  to  animal  health  crises,  the  Commission  may  also  adopt  urgent
safeguard measures to supplement existing rules. The Commission manages a bank for
the storage of about 40 million doses of various antigens of the foot-and-mouth disease
virus for the formulation of vaccines that can be rapidly provided to the Member States
in case of emergency. The intention is to reinforce the banks of vaccines against foot-
and-mouth disease, classical swine and avian influenza. The Member States have also
been provided with vaccines against bluetongue. To protect animal health, harmonised
rules on intra-Community trade and imports have been defined for almost all animals
and their products. Imports are subject to strict controls at the Community borders. As
is  the  case  for  food  safety,  there  is  no  need  to  establish  new  systems,  but  rather  to
adjust the current mechanisms in order to improve their functioning taking into account
the threat of bioterrorism.

Plant safety

The use of plant protection products (including pesticides) on crops are part of the food
chain  management.  Structures  specifically  intended  to  prevent  the  abuse  of  plant
protection products are already in place in the Community (including, for  example, a
frequent  sampling)  to  prevent  or  discover  unintended  contamination.  Inspections  for
presence  of  harmful  organisms  are  conducted  as  random  checks  in  the  field,  as
stratified inspections in nurseries  as well as at the outer borders of EU.  Nurseries are
responsible for notifying the local authority if specified harmful organisms are found.
Plants intended for planting and specified plant products from third countries must be
inspected in the third country, have to fulfil specified phytosanitary requirements and
must  be  accompanied  by  a  phytosanitary  certificate  to  be  imported  into  the  EU.
Phytosanitary  laboratories  exist  in  the  Member  States  in  order  to  provide  expert
assistance  in  the  identification  of  plant  diseases  as  well  as  for  regular  inspection  of
certain crops (e.g. potatoes). There is also a system for temporary safeguard measures
in the case of an imminent danger of introduction or spread of harmful organisms. A
notification  scheme  operates  on  the  basis  of  faxes  and  e-mails;  in  each  country  the
authorities  send  and  receive  warnings  to  and  from  the  other  Member States  when  a
harmful organism has been recorded. Crops may be destroyed if the harmful organisms

20

69.

7.

7.1.

70.

71.

7.2.

72.

cannot be controlled in situ. Special attention is paid to plants and plant products that
enter the EU.

Water safety

As  regards  water  safety,  the  joint  Council-Commission  programme  calls  on  the
Member  States  and  the  Community  to  examine  whether  Directives  80/778/EC  and
98/83/EC on the quality of drinking water  and Directive 75/440/EC on the quality of
surface  waters  used  for  drinking  water  abstraction  are  sufficiently  covering  the
requirements  for  constant  monitoring  of  drinking  water  and  other  appropriate
monitoring  and  early  warning  systems,  and  whether  existing  expertise  on  chemicals,
air  and  water  can  be  used  in  order  to  detect  biological  and  chemical  threats  more
effectively  at  an early  stage.  Multi-barrier  systems,  the  use  of  appropriate  markers  at
key  points  and the  introduction  of and  adherence to the HACCP system  by  suppliers
are  being  promoted  in  the  context  of  the  programme  on  health  security  to  enhance
safety and confidence in early detection of infective agents and toxicants.

INTERNATIONAL COOPERATION

Ottawa initiative

Following the meeting of the G7 group of Health Ministers in Ottawa on 7 November
2001 with the participation of the Health Minister of Mexico and Mr. Byrne, a network
of high-level officials was designated for the handling of crises at international level. A
Global  Health  Security  Action  Group  was  also  formed  to  implement  the  concerted
global action plan agreed at Ottawa. The plan foresees the sharing of information and
experience  on  preparedness  and  response  plans,  collaboration  of  laboratories,
development  of  risk  communication  and  management  methods,  promotion  of  mutual
assistance in means to counter attacks and training for health staff.

The Ministers and Commissioner met for the last time in Mexico City on 6 December
2002.  They  agreed  to  hold  an  exercise  in  2003  to  evaluate  smallpox  plans  and
communications, approved an “incident scale” for the severity of deliberate releases of
biological and chemical agents, set up a network of high safety level laboratories and
also  approved  a  plan  for  cooperation  on  chemical  releases.  They  also  agreed  to
strengthen the smallpox vaccine reserves of the WHO from the existing 600000 to 200
million  doses.  The  Global  Health  Security  Action  Group  is  organising  a  number  of
workshops  to  take  forward  these  actions.  The  Commission  fully  participates  in  these
activities  and  constitutes  the  link  with  the  corresponding  activities  at  EU  level.  The
next ministerial meeting is planned for 10 October 2003 in Berlin.

Cooperation with the WHO

In addition to the cooperation with the WHO in the framework of the Ottawa Global
Health Security Action initiative, the Commission is cooperating bilaterally with WHO
on a number of subjects related to countering effects of deliberate release of biological
and chemical agents. Important meetings and consultations have been organised by the
WHO with direct Commission involvement on key aspects of health sector responses
to  biological  and  chemical  terrorism.  Joint  work  is  focussing  on  the  production  of
biological  products,  such  as  VIG,  as  well  as  on  chemical  agents  and  global  health
intelligence.

21

7.3.

73.

74.

7.4.

75.

8.

76.

77.

Enlargement candidates

Following  the  request  of  the  authorities  of  the  enlargement  candidates,  information
sessions on EU action on bio-terrorism were held during the meeting of the High-level
Committee  on  Health  in  Madrid  on  19-20  March  2001  and  the  special  meeting  on
enlargement  in  Luxembourg  on  5  July  2002.  Further  information  sessions  will  be
conducted in the future. It is intended to invite the accession countries, as well as the
EEA  countries,  to  join  the  Health  Security  Committee  at  its  next  meeting  and
participate thereafter in the activities on health security.

One  of  the  activities  of  the  Programme  of  Community  action  in  the  field  of  public
health  (2003-2008)  is  to  promote  exchange  of  information  concerning  strategies  to
counter  health  threats  from  physical,  chemical  or  biological  sources  in  emergency
situations,  including  those  relating  to  terrorist  acts,  and  developing  or  using,  when
appropriate,  Community  approaches  and  mechanisms.  Participation  by  candidate
countries  in  the  programme  will  allow  them  to  benefit  in  particular  from  the
development  of  guidelines  and  manuals  related  to  preparedness  and  response  to
biological or chemical agent attacks.

NATO

Following  requests  from  NATO,  a  number  of  meetings  have  been  held  between
officials from the Council and the Commission, on the one hand, and NATO officials,
on the other. An exchange of papers ensued on the respective frameworks, published
material  and  current  inventories  of  activities  concerning  CBRN  incidents  and  this
could  serve  as  a  basis  for  further  exchange  of  information  and  cooperation  on
deliberate  releases.  Of  particular  value  in  this  respect  will  be  NATO  guidance  and
protocols  on  environmental  sampling  and  assessment  concerning  such  incidents  and
their update.

CONCLUSIONS AND PERSPECTIVES

Since  the  bioterrorist  attacks  in  the  US,  a  series  of  measures  have  been  taken  by  the
Member States, the EU and internationally to reinforce preparedness for and response
to deliberate releases of biological and chemical agents to cause harm. The extent and
degree of implementation of measures varies between countries, as do their resources
in expertise, materials, equipment and facilities.

the  appropriate 

response.  Member  States  are 

Of utmost importance in  countering  bioterrorism is speedy detection of a release and
immediate  transmission  of  alert  and  relevant  information  to  those  charged  with
mounting 
their
epidemiological  surveillance  apparatus  and  their  biological  and  chemical  monitoring
capabilities and have set up national systems of alert and information transmission. At
the European Union level, the Rapid Alert System for biological and chemical attacks
and  threats  was  set  up  to  allow  prompt  transmission  of  alerts  and  exchange  of
information  between  the  Member  States  and  the  Commission.  The  system  needs  to
evolve  and  expand  to  be  able  to  capture  and  interpret  public  health  intelligence  and
provide  advance  warning  of  outbreaks.  Routine  surveillance  will  also  need  to  be
strengthened  and,  to  this  end,  the  Commission  intends  to  adopt  a  decision  on
surveillance of certain bioterror agents in due course.

improving 

22

78.

79.

80.

81.

It is essential that Member States are in a position to consult each other and co-ordinate
their  preparation  and  responses  to  the  highest  degree  possible.  The  European  Union
has,  through  the  Health  Security  Committee,  a  mechanism  for  consultation  and  co-
ordination that can be called to advise and steer joint actions in case of emergency and
provide  coherence  to  counter-measures  throughout  the  Union.  It  also  provides  the
platform  through  which  emergency  plans  and  modelling  are  shared  and  assistance  in
expertise  and  other  resources  can  me  made  available  between  Member  States.  A  lot
more  needs  to  be  done  on  specific  plans  for  certain  agents  and  the  Commission  is
undertaking urgent work to assist Member States in this crucial area.

Adequate  capacity  in  public  health and  health  services  will  be  crucial  in  deciding  on
counter-measures or switching to  different ones. Laboratory  capacity is  not sufficient
in many Member States. It is imperative that Member States share resources and those
with advanced facilities assist those without. The Member States and the Commission
are working together to bring this about. They are also working together to prepare the
health  services  for  emergencies  through  the  issuance  of  guidelines,  the  dispatch  of
expertise and the provision of scientific advice.

to  suitable  medicines.  But 

Shielding people against agents and mitigating the effects of exposure to them requires
the  European  Union’s  pharmaceutical
recourse 
armamentarium  against  pathogens  and  chemicals  that  can  be  used  in  attacks  is
incomplete and insufficient. Stockpiling  at  EU  level  or  under  the  auspices  of  the  EU
has been considered, but Member States have shown preference for and are developing
national stockpiles only. They are however, keen to undertake action at the European
Union  level  for  the  development  of  new  biological  products  such  as  vaccinia
immunoglobulin, anti-toxins and better and safer vaccines.

The implementation of the European Union’s programme on health security helped to
drive  action  on  bioterrorism  forward.  The  programme  is  implemented  by  national
experts  and  Commission  officials  that  work  together  in  the  ad  hoc  Task  Force  on
health  security  under  the  guidance  of  the  Health  Security  Committee.  From  the
experience  gained  so  far,  it  has  become  apparent  that  more  time  is  needed  fully  to
accomplish  the  objectives  of  the  programme  and  fulfil  the  Member  States’
requirements  for  EU  cooperation  than  was  initially  foreseen.  This  would  necessitate
the  continuation  of  the  secondment  of  national  experts  and  also  longer-term
investments to ensure that key functions in health security instituted by the Task Force,
such as the operation of the rapid alert system, the maintenance of the Health Security
Committee consultation and co-ordination mechanism, the updating of plans, models,
guidelines  and  experts’  directories  and  the  organisation  of  training  sessions,  are
properly discharged.

23

9.

ANNEXES

9.1.

Annex 1

82.

83.

84.

85.

EMEA-CPMP guidance on medicinal products and vaccines

CPMP guidance on medicinal products

At  the  request  of  the  European  Commission  and  the  EMEA,  the  Committee  for
Proprietary Medicinal Products (CPMP) produced a guidance document on the use of
medicinal  products  for  treatment  and  prophylaxis  of  biological  agents,  that  might  be
used as weapons of bioterrorism. The first version of the guidance, produced on 16th
January 2002, considered those agents in the US Centre for Disease Control's  (CDC)
list of agents that might be used for the purposes of bioterrorism starting with Category
A  (smallpox  (Variola  major),  anthrax  (Bacillus  anthracis),  plague  (Yersinia  pestis),
botulism  (Clostridium  botulinum  toxin),  tularemia  (Francisella  tularensis),  viral
haemorrhagic  fevers  (filoviruses  e.g.  Ebola,  Marburg  and  arenaviruses  e.g.  Lassa,
Machupo)).  These  high-priority  agents  pose  the  most  serious  risk  to  health  security
because  they  can  be  easily  disseminated  or  transmitted  from  person  to  person,  cause
high  mortality  and  have  the  potential  for  major  public  health  impact,  might  cause
public  panic  and  social  disruption  and  require  special  action  for  public  health
preparedness.

On 21 February 2002 and 21 March 2002 the document was extended to cover agents
in the other two categories of CDC’s list, namely category B agents that are moderately
easy  to  disseminate,  can  cause  moderate  morbidity  and  low  mortality  and  require
specific  enhancements  of  diagnostic  capacity  and  enhanced  disease  surveillance
(brucellosis  (Brucella  species),  toxins  (e.g.  Ricin  toxin  from  Ricinus  communis,
Staphylococcus  enterotoxin  B,  Epsilon  toxin  of  Clostridium  perfringens),  glanders
(Burkholderia  mallei),  melioidosis  (Burkholderia  pseudomallei),  Q  fever  (Coxiella
burnetti),  psittacosis  (Chlamydia  psittaci),  typhus  fever  (Rickettsia  prowazekii),  food
safety threats (Salmonella sp, Escherichia coli 0157:H7, Shigella), water safety threats
(e.g.  Vibio  cholerae,  Cryptosporidium  parvum),  viral  encephalitis  (alphaviruses  e.g.
Venezuelan  equine  encephalitis,  eastern  equine  encephalitis,  western  equine
encephalitis))  and,  finally  category  C  agents  that  could  be  engineered  for  mass
dissemination  in  the  future  because  of  availability,  ease  of  production  and
dissemination and potential for high morbidity and mortality and major health impact
(emerging infectious diseases threats (e.g. hantaviruses and Nipah virus)).

On  25  July  2002  the  document  was  extended  to  include  information  on  nationally
authorised  vaccines  and  immunoglobulins  for  the  prevention  or  post-exposure
prophylaxis of some infections.

This document is not intended to be a comprehensive guideline on the management of
patients and the public health measures that would be necessary in the case of such an
attack. It is confined to the possible drugs and regimens that might be useful in the case
of an attack with each agent listed. There are differences between Member States in the
content of the Summaries of Product Characteristics (SPC) for many of the drugs that
have been suggested for treatment and/or prophylaxis. Few of the drugs mentioned are
authorised for the treatment and/or prophylaxis of the specific diseases mentioned and
the  licensing  status  and  the  actual  availability  of  some  of  the  drugs  suggested  varies

24

between  EU  Member  states.  All  these  factors  may  well  influence  drugs  that  would
actually  be  used  in  the  case  of  an  attack.  Moreover  some  medicines,  including  anti-
toxins,  may  have  to  be  obtained  through  special  access  mechanisms  in  individual
Member  States.  National  prescribing  information  and  guidance  regarding  each  of  the
medicinal  products  suggested  have  to  be  taken  into  account  and  expertise  should  be
consulted  first.  This  guidance  document  will  be  updated  on  a  regular  basis  as
appropriate.

Smallpox vaccines

First  generation  vaccines  were  used  in  WHO’s  world  wide  smallpox  eradication
campaign.  They  are  made  according  to  the  standards  and  techniques  of  the  1970s,
mainly  using  animal  skin  as  a  substrate.  They  have  proven  efficacy,  but  the
manufacturing process does not meet current quality requirements for live vaccines in
terms of quality control testing and batch release. They are known to have major side
effects such as encephalitis, progressive vaccinia and eczema vaccinatum.

The  EMEA  expert  group  on  smallpox  vaccines  agreed  on  a  number  of  points  in
relation  to  first  generation  vaccines,  including  that  they  could  not  be  authorised
according  to  modern  day  standards  and  that  additional  batches  should  not  be
manufactured using the old techniques. However, it was agreed that existing stocks of
first  generation  vaccines  could  be  used  in  an  emergency  until  second  generation
vaccines  are  available  and  have  shown  positive  clinical  study  results  (safety  and
immunogenicity).

Second  generation  vaccines  are  manufactured  using  tissue  culture,  which  results  in
better reproducibility and better compliance with modern production standards (GMP
requirements).  They  are  made  from  similar  strains  as  used  for  the  first  generation
vaccines.

EMEA published in July 2002 a guidance document18 for the manufacture and control
of  second  generation  vaccines,  which  sets  the  standards  against  which  new  products
will  be  assessed.  A  number  of  second  generation  vaccines  are  in  development.  The
EMEA  will  provide  scientific  advice  on  development  if  requested.  The  vaccine
industry is reluctant however to develop new second generation vaccines without being
certain of firm prior orders.

The  next  stage  of  vaccine  development  (third  generation  vaccines)  aims  at  reducing
side effects by attenuation or genetic engineering (gene deletions) of the vaccinia virus
strain.

It is expected that recombinant DNA technologies will achieve an efficacious vaccine
with  an  acceptable  safety  profile.  However,  it  would  be  7  to  10  years  before  an
authorised  product  could  be  available  and,  due  to  the  costs  of  research  and
development, it is unlikely that a commercial company could be persuaded to develop
a biotech vaccine without a firm prior order from Member States or the Community to
purchase the finished product.

86.

87.

88.

89.

90.

91.

18

EMEA/CPMP/1100/02 Note for Guidance on the Development of Vaccinia Virus Based Vaccines against
smallpox.

25

                                                
9.2.

Annex 2

OVERVIEW OF INFORMATION COLLECTED ON THE CURRENT EU PREPAREDNESS STATUS
WITH REGARD TO MEDICINAL PRODUCTS

Industrial Production Capabilities

Probably sufficient capability to
respond to an attack involving
different bacterial pathogens, but
response time probably not fast
enough to meet emergency needs.
Very few manufacturers hold
significant emergency stocks.
Most can step up production,
without compromising other
operations.

Smallpox:

There is potential to produce enough
doses of 2nd generation vaccine
available for every EU citizen within
12-36 months. However there is no
guarantee that the 2nd generation will
be safer than and as effective as the
1st generation vaccines. However,
they will meet current quality
standards for vaccines.

Anti-

biotics

Availability

Suitable authorised
antibiotics available for
use19 against most
bacteriological pathogens
listed in Annex 1,
including Bacillus
anthracis.

Off-label use necessary for
many products. No major
problems with supplies
currently anticipated.

Vaccines No authorised smallpox,

anthrax or plague
vaccines available on the
EU market

Smallpox:

Nearly all Member States
have stockpiles of
unauthorised 1st
generation vaccines for
use in emergency

Anthrax:

At least one Member State
has a stock of unknown
quantity of an authorised
vaccine

19

treatment or prophylaxis

Products in
development

No information
provided in
context of activity
against identified
biological threats

Smallpox: Small
number of 2nd
generation
vaccines in
development. 3rd
generation
vaccines will take
another 7 – 10
years

Anthrax: New
vaccine
development
being considered
by some
companies and
Member State
institutes.
Collaboration to
pool expertise and
technology
necessary

Plague: At least 2
Member State
institutions are
working on a new
vaccine

26

                                                
Anti-
virals

No authorised antivirals
available for the agents
listed in Annex 1

Ribavirin,
cidofovir being
investigated for
activity against
smallpox

Anti-
toxins

Very limited supply of
botulic antitoxin. Only
one commercial producer
now re-launching
production; it will then
take 18 months before
product is available

27

9.3.

Annex 3

LEGISLATIVE FINANCIAL STATEMENT

Policy area:
Activity:

PUBLIC HEALTH
HEALTH SECURITY

Title of action:
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT ON COOPERATION IN THE EUROPEAN UNION ON PREPAREDNESS AND
RESPONSE TO BIOLOGICAL AND CHEMICAL AGENT ATTACKS (HEALTH SECURITY)

BUDGET LINE(S) + HEADING(S)

A-7003 National and international civil servants and private-sector staff temporarily
assigned to the institution

A-701 Missions

A-7030 Meetings

A-705 Studies and consultations

OVERALL FIGURES

Total allocation for action

Part A of the Budget: EUR 5 282 904

1.

a. 

b. 

c. 

d. 

2.

2.1

2.2

Period of application

2003–2008

2.3

Overall multiannual estimate of expenditure

Schedule  of  commitment  appropriations/payment  appropriations 
intervention)(see point 6.1.1)

(financial

Year
n

n + 1

n + 2

n + 3

n + 4

n + 5
and
subs.
years

Total

Commitment
appropriations
Payment appropriations

Technical and administrative assistance and support expenditure (see point 6.1.2)

CA
PA

Subtotal a+b
CA
PA

28

None
None

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure
(see points 7.2 and 7.3)

CA/PA

480 264

960 528

960 528

960 528

960 528

960 528

5 282 904

TOTAL a+b+c
CA
PA

480 264
480 264

960 528
960 528

960 528
960 528

960 528
960 528

960 528
960 528

960 528
960 528

5 282 904
5 282 904

2.4

Compatibility with the financial programming and the financial perspective

Proposal compatible with the existing financial programming

This  proposal  will  entail  reprogramming  of  the  relevant  heading  in  the

financial perspective.

Proposal  may  require  application  of  the  provisions  of  the  Interinstitutional

Agreement.

2.5

Financial impact on revenue

No 

financial 

implications 

(involves 

technical 

aspects 

regarding

implementation of a measure)

OR

Proposal has financial impact – the effect on revenue is as follows:

Note:  All  details  and  observations  pertaining  to  the  method  of  calculating  the
effect on revenue should be included in a separate annex.

EUR million (to the first decimal place)

Budget
line

Revenue

Before
the
action
(year
n-1)

a) Revenue in absolute
terms1
b) Change in revenue2

(cid:1)

Situation following action
Year
n3

n+1

n+2

n+3

n+4

n+5

(Please specify each budget line involved, adding the appropriate number of rows
to the table if there is an effect on more than one budget line)

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
participation

Comp/ Non-
comp
Non-
compulsory
expenditure

Diff/Non-
diff
Non-diff.
appr.

YES/NO
NO

YES/NO
YES

Participation
applicant
countries
YES/NO
YES

Heading
financial
perspective
N° 5

29

4.

LEGAL BASIS

Article 152 of the Treaty

5.

5.1

DESCRIPTION AND GROUNDS

Need for Community intervention20

5.1.1

Objectives pursued

(Describe  the  problem(s)/need(s)  (in  measurable  terms)  that  the  intervention  is
designed to solve/satisfy (the baseline situation against which later progress can be
measured). Describe the objectives in terms of expected outcomes (for example as a
change in the above baseline situation.)

The Ministers of Health have noted that, since the events of autumn 2001, there has
been  a  need  to  intensify  cooperation  between  the  Member  States  and  the
Commission  to  strengthen  health  defences  against  deliberate  releases  of  biological
agents. This Communication reflects the progress made in carrying out the 25 actions
which  form  a  coherent  health  security  programme  and  describes  the  outlook  for
continuation  of  action  at  Community  level  in  this  field.  Health  security  is  a  major
component in the Commission's “stability and security” objective for 2003 et 2004.

The measures pursue the following main goals:

to set  up a mechanism  for  information  exchange,  consultation  and  coordination  for
the  handling  of  health-related  issues  related  to  attacks  in  which  biological  and
chemical agents mightbe used or have been used in attacks;

to  create  a  EU-wide  capability  for  the  timely  detection  and  identification  of
biological  and  chemical  agents  thatmight  be  used  in  attacks  and  for  the  rapid  and
reliable  determination  and  diagnosis  of  relevant  cases,  in  particular  by  building  on
systems already available and aiming at long-term sustainability;

to create  a  medicines stock  and health services database  and  a  stand-by  facility  for
making  medicines  and  health  care  specialists  available  in  cases  of  suspected  or
unfolding attacks;

to  draw  up  rules  and  disseminate  guidance  on  facing  up  to  attacks  from  the  health
point  of  view  and  coordinating  the  EU  response  and  links  with  third  countries  and
international organisations.

20

For further information see separate guidance paper.

30

                                                
5.1.2. Measures taken in connection with ex ante evaluation

(This involves:

explaining how and when the ex ante evaluation was conducted (author, timing and
whether  the  report(s)  is/are  available)  or  how  the  corresponding  information  was
gathered21

describing briefly the findings and lessons learnt from the ex ante evaluation.)

5.1.3. Measures taken following ex post evaluation

(Where a programme is being renewed, the lessons to be learned from an interim or
ex post evaluation should also be described briefly.)

5.2.

Actions envisaged and arrangements for budget intervention

(This point should describe the logic behind the proposal. It should specify the main
actions  to  achieve  the  general  objective.  Each  action  should  have  one  or  more
specific  objectives.  These  should  indicate  the  progress  expected  over  the  proposed
period. They should also look beyond immediate outputs but be sufficiently precise to
allow concrete results to be identified. Specify for each main action:

– the target population(s) (specify number of beneficiaries if possible);

– the specific objectives set for the programming period (in measurable terms);

– the concrete measures to be taken to implement the action;

– the immediate outputs;

– the expected effects/impact on the achievement of the general objective.

Information should also be given on the budget intervention arrangements (rate and
form of the required financial assistance.)

Provision must be made in the Community budget for payment, during an extension
phase (of at least 18 months), of the remuneration of the national experts specifically
seconded to the Commission to carry out actions in connection with health security,
their expenses for the  missions necessary  to  perform  these  tasks,  reimbursement  of
the  travelling  expenses  of  the  members  of  the  Health  Security  Committee  and  its
working groups and costs of specific studies and consultations connected with health
security issues.

5.3.

Implementation arrangements

(Specify  the  methods  to  be  used  to  implement  the  planned  actions:  direct
management  by  the  Commission  using  either  regular  or  outside  staff  only,  or  by
externalisation. In the latter case, give details of the arrangements envisaged for this

21

For the minimum information that must be presented in relation to new initiatives, see document SEC
(2000)1051.

31

                                                
externalisation  (TAO,  agencies,  offices,  decentralised  executive  units,  management
shared with Member States – national, regional and local authorities).

Indicate the effect of the externalisation model chosen on the financial intervention,
management  and  support  resources  and  on  human  resources  (seconded  officials,
etc.).)

The actions will be carried out by permanent and temporary civil servants, auxiliaries
and national experts on detachment.

6.

FINANCIAL IMPACT

Implementation of the health security actions has no other financial impact on Part B
of the Community Budget.

6.1

Total financial impact on Part B (over the entire programming period)

(The  method  of  calculating  the  total  amounts  set  out  in  the  table  below  must  be
explained by the breakdown in Table 6.2.)

6.1.1

Financial intervention

Commitments in EUR million (to the third decimal place)

Year n

n + 1

n + 2

n + 3

n+ 4

Total

n + 5 and
subs.
years

Breakdown

Action 1
Action 2
Etc.
TOTAL

32

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

Year n

n + 1

n + 2

n + 3

n + 4

Total

n + 5 and
subs.
years

1) Technical and
administrative assistance
Technical assistance
offices:

b) Other technical
and administrative
assistance:
intra-muros:
extra-muros:

of which for construction
and maintenance of
computerised management
systems:

Subtotal 1
2) Support expenditure
a) Studies
b) Meetings of experts
c) Information and
publications
Subtotal 2

TOTAL

33

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)22

(Where there is more than one action, give sufficient detail of the specific measures
to  be  taken  for  each  one  to  allow  the  volume  and  costs  of  the  outputs  to  be
estimated.)

Commitments in EUR million (to the third decimal place)

Type of outputs
(projects, files,
etc.)

1

Number of
outputs
(total for years
1…n)
2

Average unit
cost

Total cost
(total for years
1…n)

3

4=(2X3)

Breakdown

Action 1
Measure 1
Measure 2
Action 2
Measure 1
Measure 2
Measure 3

Etc.

TOTAL COST

If necessary, explain the method of calculation.

7.

7.1

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

Impact on human resources

Types of post

Permanent
officials or
temporary staff

A
B
C

Other human resources

Total

Staff to be assigned to management of the
action, using existing and/or additional
resources
Number of
permanent posts

Number of
temporary posts

Total

Description of tasks deriving from the
action

8 national experts
on detachment

8 national experts
on detachment

Implementation of actions to
strengthen health security cooperation;
support for actions to be carried out by
the Commission.

22

For further information see separate guidance paper.

34

                                                
7.2.

Overall financial impact of human resources

Type of human resources

Amounts EUR

Method of calculation *

Officials
Temporary staff

Other human resources
National and international civil servants and private-
sector staff temporarily assigned to the institution
(budget line A-7003)

Total

(8 x 44 316 =)
354 528

354 528

Costs incurred by the Commission for
secondment of 8 national experts for
the specific purpose of promoting
health security cooperation:
EUR 44 316 per expert per year

The amounts are total expenditure for twelve months.

7.3.

Other administrative expenditure deriving from the action

None

Budget line
(number and heading)

Overall allocation (Title A7)
A0701 – Missions
A07030 – Meetings

A07031 – Compulsory committees (1)
A07032 – Non-compulsory committees (1)
A07040 – Conferences
A0705 – Studies and consultations
… Other expenditure (please specify)

Information systems (A-5001/A-4300)

Other expenditure - Part A (specify)

Amounts EUR

Method of calculation

96 000
310 000

EUR 8 000 per month
4 meetings of the Health Security
Committee and 2 meetings of each of
its 5 working groups per year (25
government representatives per
meeting: 15 from the Member States
and 10 from the acceding countries)

200 000

Specific studies and consultations on
health security:
4 x 50 000

Total

606 000

The amounts are total expenditure for twelve months.

(1) Specify the type of committee and the group to which it belongs.

I.
II.
III.

Annual total (7.2 + 7.3)
Duration of action
Total cost of action (I x II)

EUR
Years
EUR

(In  the  estimate  of  human  and  administrative  resources  required  for  the  action,
DGs/Services  must  take  into  account  the  decisions  taken  by  the  Commission  in  its
orientation  debate  and  when  adopting  the  preliminary  draft  budget  (PDB).  This
means that DGs  must show that human resources  can be covered by the indicative
pre-allocation made when the PDB was adopted.

35

Exceptional cases (i.e. those where the action concerned could not be foreseen when
the PDB was being prepared) must be referred to the Commission for a decision on
whether and how (by means of an amendment of the indicative pre-allocation, an ad
hoc  redeployment  exercise,  a  supplementary/amending  budget  or  a  letter  of
amendment  to  the  draft  budget)  implementation  of  the  proposed  action  can  be
accepted.)

8.

8.1

FOLLOW-UP AND EVALUATION

Follow-up arrangements

(Adequate follow-up information must be collected, from the start of each action, on
the inputs, outputs and results of the intervention. In practice, this involves: (i) fixing
indicators for inputs, outputs and results; (ii) establishing data collection methods.)

The actions carried out within the health security programme are intended to achieve
concrete results within a precise timetable. The situation at the end of April 2003 is
as follows:

Key  deliverables  and  milestones  set  at  the  adoption  of  the  programme  and
added in the light of developments and priorities agreed:

TASKS

Status on 30 April 2003

Biological and chemical agent threats network
established and operational

Completed – improvement on-going in a second
phase

List - Inventories of agents

Classification of events and investigation protocols

Lab inventories, requirements and standards

Bioagents : Matrix+Australia Group work done
Chemicals : in progress

Classification: completed -Protocols: in progress
Planning and modelling: in progress

P4 lab network set up-Ring test agreed
National Lab network to be set up-questionnaire sent
15.January 2003-results analysed
Agreements to be done

Experts’ directories and investigation team rules

Questionnaire sent 31 January 2003
Team rules being drawn

Guidelines for health professionals

10 drafts prepared
Peer review and publication in progress

Medicine stock inventories

Health resources and services inventories

Information collected: table compiled on Member
State stocks
Vaccine and antibiotics Stockpile question: work
completed
VIG, smallpox vaccine dilution project on-going
Other biologicals work in progress

Inventory chapters defined
Collection of data being coordinated with DG ENV-
Agreements for assistance to be done

36

Rules on circulation of persons, animals and products

Safety of food, animals, plants: review completed and
reported
Water safety: review completed –follow-up by DG
ENV to be done
Persons : Review in progress with DG JAI

Guidelines on decontamination and restoration

Work initiated

Training modules

Work initiated

Smallpox emergency plans and modelling

EU Smallpox exercise

Adverse event monitoring on vaccinations

Extension to and integration in the cooperation
mechanism and the RAS-BICHAT alert system of
accession and EEA countries

Compilation and comparison completed
Modelling priorities and data needs defined

Specifications prepared – exercise to take place in
2004

System of data collection set up and data to be
collected

Negotiations are being initiated

Patient isolation techniques

Priorities defined and working group to be formed

Installation of a Web-based medical intelligence
system for advance warnings and trend analysis

Collaboration has been started with the JRC and links
made with existing Commission systems

Review and analysis of incidents involving claims of
releases

Pilot project with several Member States has started

Free movement of people and transport rules
impacted by bioterror events

Review on-going

8.2.

Arrangements and schedule for the planned evaluation

(Describe  the  planned  schedule  and  arrangements  for  interim  and  ex  post
evaluations to assess whether the intervention has achieved the objectives set. In the
case of multiannual programmes, at least one thorough evaluation is needed during
the life cycle of the programme. For other activities, ex post or mid-term evaluations
should be carried out at intervals not exceeding six years.)

An interim evaluation is planned for May 2003. This will comprise a self-assessment
report  and  two  evaluation  sessions  by  an  external  expert,  who  must  produce
recommendations  and,  if  appropriate,  a  recasting  of  the  current  or  prospective
actions, especially in the light of developments with regard to international priorities
and technical progress in the field of health security.

Conduct of the evaluation exercise

a. 

Analyse  the  actions,  results  achieved,  failings,  reasons  for  missing  targets  (such  as
changing priorities, new requests or tasks, unforeseen events, imprecise definition of
activities,  new  information,  difficulties  in  collaboration  with  Member  States  and
other services, lack of sufficient resources or timely deployment of resources etc.).

b. 

Revise timetables for actions and deliverables that are propose to be maintained.

37

c. 

d. 

e. 

Propose  new  actions  if  circumstances  and  events  so  require,  giving  reasons,
conditions  for  success  and  risks,  and  providing  deliverables  with  associated
timetable, milestones and resources that will be required.

Re-formulate more precisely existing actions and revise deliverables, timetables and
resources if necessary.

The evaluation should be concluded with the production, if appropriate, of a revised
programme  of  action  that  respects  the  resource  constraints  imposed  by  the
Commission.

9.

FRAUD PREVENTION MEASURES

(Article  3(4)  of  the  Financial  Regulation:  “In  order  to  prevent  risk  of  fraud  or
irregularity, the Commission shall record in the financial statement any information
regarding existing and planned fraud prevention and protection measures.”)

38