The fight against bioterrorism
Outline of the Community (European Union) legislation about The fight against bioterrorism
Topics
These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.
Public health > Threats to health
The fight against bioterrorism (communication)
Document or Iniciative
Communication from the Commission of 2 June 2003 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) [COM(2003) 320 final – Not published in the Official Journal].
Summary
This Communication is a follow-up to the unprecedented terrorist attacks in the USA in September 2001. Governments and international bodies responded to this event by examining the means they had at their disposal to prevent and counter threats and mitigate the effects of such attacks. They also undertook to develop appropriate responses to a new type of threat, that of deliberate releases of biological and chemical agents.
This Communication reports on the health aspects of European Union (EU) action against bioterrorism and reviews the measures taken to strengthen health defences against deliberate releases of biological and chemical agents. It also highlights the challenges facing the health sector in terms of preparedness and response.
RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU
Shortly after the attacks of 11 September, the US was hit by a spate of bioterrorist incidents involving anthrax spores. These terrorist acts had a significant impact in Europe. Civil protection and security forces were put on alert, and public health systems had to deal with numerous items of mail containing powders suspected of being contaminated with anthrax. Although no bioterrorist attack was known to have taken place in Europe, the pressure on European countries was high, as they quickly had to devote resources to preventing a new type of threat. In January 2003, the discovery of ricin — a potentially fatal toxic substance — in a building in London served as a sharp reminder to emergency health services to intensify their efforts in the fight against bioterrorism.
The international community and the EU responded to this new threat by adopting the following measures:
- conclusions of the Health Council of 15 November 2001: the Belgian Presidency adopted conclusions which called on the Commission to develop an action programme of cooperation on preparedness and response to biological and chemical agent threats;
-
Ottawa initiative: a meeting held in Ottawa on 7 November 2001 brought together the Health Ministers from the G7 group of countries, the Health Minister of Mexico and the Member of the Commission responsible for Health and Consumer Protection. The meeting agreed on concerted global action to strengthen the public health response to the threat of international biological, chemical and radio-nuclear terrorism;
-
Commission response: the Commission launched a series of coordinated 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 ” published in November 2001.
On 20 December 2002, the Council and the Commission also 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.
PUBLIC HEALTH PREPAREDNESS AND RESPONSE
Preparedness
Mitigating the effects of deliberate releases of biological and chemical agents requires early detection of the agents implicated and case recognition of those affected. Health authorities and agencies have a crucial role here and must:
- establish effective surveillance;
- familiarise clinicians with the syndromes to look out for;
- disseminate case management guidelines;
- put in place effective arrangements for prompt notifications to the authorities in charge of collecting and evaluating epidemiological information;
- coordinate public health responses.
The necessary laboratory expertise and capacity must be available to cope with high-risk agents and complex technology as well as a surge in demand in case of multiple attacks.
Response
In the event of an attack, measures for physical protection and assistance must be able to be taken immediately and an initial assessment made of consequences and risks so that appropriate action can be initiated forthwith. The health authorities are responsible for taking preventive, remedial and treatment action (decontaminating exposed persons, taking swabs for analysis, administering prophylactic treatments, etc.). In addition, emergency plans provide a high degree of confidence in the capacity to mount an effective multi-sector response. The means of response and the deployment capability of health response staff must be strengthened in order to optimise their ability to cope in the event of an attack.
Coordination in the EU
The EU is a border-free area, so it is essential for appropriate arrangements to be put in place to ensure prompt notification and exchange of information in the event of threats and attacks. The importance of joint action in the EU led to the establishment in October 2001 of a Health Security Committee, comprised of representatives of the Health Ministers, to promote cooperation in countering bioterrorism. The Committee agreed a programme of cooperation on preparedness and response to biological and chemical agent attacks, code-named BICHAT, based on four objectives:
- To set up an alert and information exchange mechanism
This mechanism consists of a Health Security Committee and a rapid alert system. The Health Security Committee is responsible for exchanging information on health-related threats, on preparedness and response plans and crisis management strategies. The rapid alert system (code-named “RAS-BICHAT”) has been in operation since June 2002 for notifications of incidents involving the deliberate release of biological and chemical agents to cause harm;
- To create a capability for the detection and identification of biological and chemical agents that might be used in attacks.
Detection of deliberate releases of biological agents relies first and foremost on Member States’ surveillance systems for monitoring the occurrence of infectious diseases. It is essential that Member States continue to develop new diagnostics for rapid detection. Coordination of these surveillance systems at EU level is conducted in line with a Decision of September 1998 on the surveillance and control of communicable diseases.
Biological agents likely to be used in bioterrorism have already been prioritised on the basis of various criteria. In addition, a Council Regulation (No 1334/2000) lays down various lists of biological and chemical agents for which provisions linked to export control arrangements apply.
Laboratory capacity continues to be insufficient in many Member States. It is therefore imperative that Member States share resources and that those with advanced facilities assist those without;
- To create a database on medicines stock and health services (see next section) and a stand-by facility for making medicines and health care specialists available in case of attack;
- To draw up rules and disseminate guidance on responding to attacks from the health point of view and coordinating the EU response and links with third countries and international organisations. Consultations in the EU and internationally showed that the process of adjusting national emergency plans to the new threat of covert release of chemical and biological agents was not yet complete in the Member States. Moreover, it is a priority to intensify work on emergency planning and promote modelling in order to reinforce emergency plans for threats and attacks.
In February 2007, the Council extended the mandate of this Health Security Committee by three years.
AVAILABILITY AND STOCKPILING OF MEDICINES
The bioterrorist attacks in the USA highlighted the fundamental importance of the availability of medicines in the EU and the capability of industry to make good any shortcoming in production and supply. A joint Commission/pharmaceutical industry task force was established in December 2001 to address issues of availability, production capability, storage and distribution capacity for medicines which could be used in the event of a bioterrorist attack.
National stockpiles
In order to be able to cope with bioterrorist attacks, most Member States have stockpiled antibiotics at national level, or are in the process of doing so. 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.
As the smallpox virus is regarded as the agent of choice for the development of biological weapons – because it is highly contagious and potentially fatal – an assessment of national stockpiles of smallpox vaccines was carried out. The assessment showed that most Member States have or are acquiring stockpiles of smallpox vaccines.
EU-level stockpiles
No medicines have yet been stockpiled at Community level. However, the Commission/pharmaceutical industry task force and the Member States have highlighted the need to establish a Community stockpile of smallpox vaccines, antibiotics and antivirals.
As regards antibiotics, a Community stockpile should comprise a sufficient, versatile range of antibiotics to cover as many of the potential pathogens as possible. In addition to economies of scale, establishing this kind of Community stockpile would enhance the feeling of security among European citizens. However, creating a stockpile of antibiotics may also lead to difficulties concerning the choice of antibiotics within the different therapeutic classes and the choice of final manufactured product.
As regards smallpox vaccines, it has been recognised that such a stockpile should exist in addition to national stockpiles rather than replace them. It should also provide equivalent access to all and should ensure equity for all citizens of the EU. Consultations on options for a Community stockpile showed that most Member States do not support the establishment of a Community-level stockpile of smallpox vaccines.
Planned action
Action has been taken under the health security programme to address the needs for cooperation on medicines. In addition, developments on the production and availability of smallpox vaccines will be reviewed at regular intervals.
RESEARCH
At the initiative of the Commission, an R&D Expert Group on countering the effects of biological and chemical terrorism was set up in 2001. This group prepared a report comprising an inventory of the research activities undertaken in the Member States on the basis of which various recommendations have been formulated.
The fight against bioterrorism is an issue which could be addressed under the Sixth Framework Programme for Research, under the priorities “life sciences, genomics and biotechnology for health” and “food quality and safety”. Specific research needs 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 and crisis management”.
BUILDING A MULTI-SECTOR RESPONSE
Preventing terrorist acts and responding to their consequences requires the mobilisation of actors and resources in many sectors other than health. Sectors which should be given particular attention include the following:
- food safety: the Community has a broad body of legislation which covers primary production of agricultural products and industrial production of processed food. There is therefore 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;
- animal safety: as is the case for food safety, the EU has a very comprehensive body of legislation in this area. It is therefore important to put these existing mechanisms to good use in order to take greater account of the threat of biological and chemical terrorism;
- plant safety: the use of plant protection products on crops is part of the food chain management. Structures specifically intended to prevent the abuse of plant protection products are already in place in the Community in order to prevent or discover unintended contamination;
- water safety: the joint Council/Commission programme called on Member States and the Community to examine whether Community measures on the quality of drinking water and surface waters were sufficient to meet requirements in relation to safety and early detection of infective agents and toxicants.
INTERNATIONAL COOPERATION
At the Ottawa meeting of November 2001, a Global Health Security Action Group was formed to implement the concerted action plan agreed at that meeting. The plan provides for the sharing of information and experience on preparedness and response plans, collaboration of laboratories, training for health staff and the development of risk management and communication methods.
The Commission is cooperating bilaterally with the World Health Organisation (WHO) on a number of subjects related to countering the effects of the deliberate release of biological and chemical agents. Meetings between the Council, the Commission and NATO have led to an exchange of documents on activities related to chemical, biological and radio-nuclear activities. These exchanges could serve as a reference point for further cooperation on the issue.
Related Acts
Commission Green Paper of 11 July 2007 on bio-preparedness [COM(2007) 399 final – Not published in the Official Journal].
Terrorism is considered one of the main challenges currently facing the European Union. The attacks in Madrid, London and New York made it clear that terrorism remains a threat to all countries. Terrorists may resort to non-conventional means such as biological materials, which have the capacity to infect thousands of people, destroy agriculture, infect animals and poison food. The risk of “bioterrorist” attacks is low, but the consequences of such acts can be devastating.
Naturally occurring diseases, laboratory accidents or other inadvertent releases of disease agents are another threat which could also harm European societies.
This Green Paper thus aims to launch a process of consultation at European level on how to reduce biological risks and enhance preparedness and response to biological threats.
The term “preparedness” covers all aspects of the issue, such as prevention, protection, first response capacity, prosecution of criminals, surveillance, research capacity, response and recovery.
This consultation process is mainly aimed at the national authorities responsible for risk prevention and response, public health and customs, law enforcement authorities, bio-industry and epidemiological and health professionals. It may lead to concrete actions in the field of bio-preparedness in 2008.
Replies from stakeholders had to be sent to the Commission by 1 October 2007.
Communication from the Commission of 28 November 2005 on strengthening coordination on generic preparedness planning for public health emergencies at EU level [COM(2005) 605 final – Not published in the Official Journal].
The purpose of this Communication is to assist Member States in developing generic plans for all sorts of public health emergencies, factoring in the EU dimension. The Communication serves as a reference point for the Member States to develop their own plans and identifies the key components to be taken into account when preparing for public health emergencies.
Communication from the Commission of 28 November 2001 entitled “Civil protection – State of preventive alert against possible emergencies” [COM(2001) 707 final – Not published in the Official Journal].
Decision No 2119/98/CE of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [Official Journal L 268 of 03.10.1998].
Another Normative about The fight against bioterrorism
Topics
These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic
Internal market > Single Market for Goods > Chemical products
The fight against bioterrorism (communication)
Document or Iniciative
Communication from the Commission of 2 June 2003 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) [COM(2003) 320 final – Not published in the Official Journal].
Summary
This Communication is a follow-up to the unprecedented terrorist attacks in the USA in September 2001. Governments and international bodies responded to this event by examining the means they had at their disposal to prevent and counter threats and mitigate the effects of such attacks. They also undertook to develop appropriate responses to a new type of threat, that of deliberate releases of biological and chemical agents.
This Communication reports on the health aspects of European Union (EU) action against bioterrorism and reviews the measures taken to strengthen health defences against deliberate releases of biological and chemical agents. It also highlights the challenges facing the health sector in terms of preparedness and response.
RECENT BIOTERRORIST INCIDENTS AND REPERCUSSIONS IN THE EU
Shortly after the attacks of 11 September, the US was hit by a spate of bioterrorist incidents involving anthrax spores. These terrorist acts had a significant impact in Europe. Civil protection and security forces were put on alert, and public health systems had to deal with numerous items of mail containing powders suspected of being contaminated with anthrax. Although no bioterrorist attack was known to have taken place in Europe, the pressure on European countries was high, as they quickly had to devote resources to preventing a new type of threat. In January 2003, the discovery of ricin — a potentially fatal toxic substance — in a building in London served as a sharp reminder to emergency health services to intensify their efforts in the fight against bioterrorism.
The international community and the EU responded to this new threat by adopting the following measures:
- conclusions of the Health Council of 15 November 2001: the Belgian Presidency adopted conclusions which called on the Commission to develop an action programme of cooperation on preparedness and response to biological and chemical agent threats;
-
Ottawa initiative: a meeting held in Ottawa on 7 November 2001 brought together the Health Ministers from the G7 group of countries, the Health Minister of Mexico and the Member of the Commission responsible for Health and Consumer Protection. The meeting agreed on concerted global action to strengthen the public health response to the threat of international biological, chemical and radio-nuclear terrorism;
-
Commission response: the Commission launched a series of coordinated 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 ” published in November 2001.
On 20 December 2002, the Council and the Commission also 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.
PUBLIC HEALTH PREPAREDNESS AND RESPONSE
Preparedness
Mitigating the effects of deliberate releases of biological and chemical agents requires early detection of the agents implicated and case recognition of those affected. Health authorities and agencies have a crucial role here and must:
- establish effective surveillance;
- familiarise clinicians with the syndromes to look out for;
- disseminate case management guidelines;
- put in place effective arrangements for prompt notifications to the authorities in charge of collecting and evaluating epidemiological information;
- coordinate public health responses.
The necessary laboratory expertise and capacity must be available to cope with high-risk agents and complex technology as well as a surge in demand in case of multiple attacks.
Response
In the event of an attack, measures for physical protection and assistance must be able to be taken immediately and an initial assessment made of consequences and risks so that appropriate action can be initiated forthwith. The health authorities are responsible for taking preventive, remedial and treatment action (decontaminating exposed persons, taking swabs for analysis, administering prophylactic treatments, etc.). In addition, emergency plans provide a high degree of confidence in the capacity to mount an effective multi-sector response. The means of response and the deployment capability of health response staff must be strengthened in order to optimise their ability to cope in the event of an attack.
Coordination in the EU
The EU is a border-free area, so it is essential for appropriate arrangements to be put in place to ensure prompt notification and exchange of information in the event of threats and attacks. The importance of joint action in the EU led to the establishment in October 2001 of a Health Security Committee, comprised of representatives of the Health Ministers, to promote cooperation in countering bioterrorism. The Committee agreed a programme of cooperation on preparedness and response to biological and chemical agent attacks, code-named BICHAT, based on four objectives:
- To set up an alert and information exchange mechanism
This mechanism consists of a Health Security Committee and a rapid alert system. The Health Security Committee is responsible for exchanging information on health-related threats, on preparedness and response plans and crisis management strategies. The rapid alert system (code-named “RAS-BICHAT”) has been in operation since June 2002 for notifications of incidents involving the deliberate release of biological and chemical agents to cause harm;
- To create a capability for the detection and identification of biological and chemical agents that might be used in attacks.
Detection of deliberate releases of biological agents relies first and foremost on Member States’ surveillance systems for monitoring the occurrence of infectious diseases. It is essential that Member States continue to develop new diagnostics for rapid detection. Coordination of these surveillance systems at EU level is conducted in line with a Decision of September 1998 on the surveillance and control of communicable diseases.
Biological agents likely to be used in bioterrorism have already been prioritised on the basis of various criteria. In addition, a Council Regulation (No 1334/2000) lays down various lists of biological and chemical agents for which provisions linked to export control arrangements apply.
Laboratory capacity continues to be insufficient in many Member States. It is therefore imperative that Member States share resources and that those with advanced facilities assist those without;
- To create a database on medicines stock and health services (see next section) and a stand-by facility for making medicines and health care specialists available in case of attack;
- To draw up rules and disseminate guidance on responding to attacks from the health point of view and coordinating the EU response and links with third countries and international organisations. Consultations in the EU and internationally showed that the process of adjusting national emergency plans to the new threat of covert release of chemical and biological agents was not yet complete in the Member States. Moreover, it is a priority to intensify work on emergency planning and promote modelling in order to reinforce emergency plans for threats and attacks.
In February 2007, the Council extended the mandate of this Health Security Committee by three years.
AVAILABILITY AND STOCKPILING OF MEDICINES
The bioterrorist attacks in the USA highlighted the fundamental importance of the availability of medicines in the EU and the capability of industry to make good any shortcoming in production and supply. A joint Commission/pharmaceutical industry task force was established in December 2001 to address issues of availability, production capability, storage and distribution capacity for medicines which could be used in the event of a bioterrorist attack.
National stockpiles
In order to be able to cope with bioterrorist attacks, most Member States have stockpiled antibiotics at national level, or are in the process of doing so. 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.
As the smallpox virus is regarded as the agent of choice for the development of biological weapons – because it is highly contagious and potentially fatal – an assessment of national stockpiles of smallpox vaccines was carried out. The assessment showed that most Member States have or are acquiring stockpiles of smallpox vaccines.
EU-level stockpiles
No medicines have yet been stockpiled at Community level. However, the Commission/pharmaceutical industry task force and the Member States have highlighted the need to establish a Community stockpile of smallpox vaccines, antibiotics and antivirals.
As regards antibiotics, a Community stockpile should comprise a sufficient, versatile range of antibiotics to cover as many of the potential pathogens as possible. In addition to economies of scale, establishing this kind of Community stockpile would enhance the feeling of security among European citizens. However, creating a stockpile of antibiotics may also lead to difficulties concerning the choice of antibiotics within the different therapeutic classes and the choice of final manufactured product.
As regards smallpox vaccines, it has been recognised that such a stockpile should exist in addition to national stockpiles rather than replace them. It should also provide equivalent access to all and should ensure equity for all citizens of the EU. Consultations on options for a Community stockpile showed that most Member States do not support the establishment of a Community-level stockpile of smallpox vaccines.
Planned action
Action has been taken under the health security programme to address the needs for cooperation on medicines. In addition, developments on the production and availability of smallpox vaccines will be reviewed at regular intervals.
RESEARCH
At the initiative of the Commission, an R&D Expert Group on countering the effects of biological and chemical terrorism was set up in 2001. This group prepared a report comprising an inventory of the research activities undertaken in the Member States on the basis of which various recommendations have been formulated.
The fight against bioterrorism is an issue which could be addressed under the Sixth Framework Programme for Research, under the priorities “life sciences, genomics and biotechnology for health” and “food quality and safety”. Specific research needs 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 and crisis management”.
BUILDING A MULTI-SECTOR RESPONSE
Preventing terrorist acts and responding to their consequences requires the mobilisation of actors and resources in many sectors other than health. Sectors which should be given particular attention include the following:
- food safety: the Community has a broad body of legislation which covers primary production of agricultural products and industrial production of processed food. There is therefore 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;
- animal safety: as is the case for food safety, the EU has a very comprehensive body of legislation in this area. It is therefore important to put these existing mechanisms to good use in order to take greater account of the threat of biological and chemical terrorism;
- plant safety: the use of plant protection products on crops is part of the food chain management. Structures specifically intended to prevent the abuse of plant protection products are already in place in the Community in order to prevent or discover unintended contamination;
- water safety: the joint Council/Commission programme called on Member States and the Community to examine whether Community measures on the quality of drinking water and surface waters were sufficient to meet requirements in relation to safety and early detection of infective agents and toxicants.
INTERNATIONAL COOPERATION
At the Ottawa meeting of November 2001, a Global Health Security Action Group was formed to implement the concerted action plan agreed at that meeting. The plan provides for the sharing of information and experience on preparedness and response plans, collaboration of laboratories, training for health staff and the development of risk management and communication methods.
The Commission is cooperating bilaterally with the World Health Organisation (WHO) on a number of subjects related to countering the effects of the deliberate release of biological and chemical agents. Meetings between the Council, the Commission and NATO have led to an exchange of documents on activities related to chemical, biological and radio-nuclear activities. These exchanges could serve as a reference point for further cooperation on the issue.
Related Acts
Commission Green Paper of 11 July 2007 on bio-preparedness [COM(2007) 399 final – Not published in the Official Journal].
Terrorism is considered one of the main challenges currently facing the European Union. The attacks in Madrid, London and New York made it clear that terrorism remains a threat to all countries. Terrorists may resort to non-conventional means such as biological materials, which have the capacity to infect thousands of people, destroy agriculture, infect animals and poison food. The risk of “bioterrorist” attacks is low, but the consequences of such acts can be devastating.
Naturally occurring diseases, laboratory accidents or other inadvertent releases of disease agents are another threat which could also harm European societies.
This Green Paper thus aims to launch a process of consultation at European level on how to reduce biological risks and enhance preparedness and response to biological threats.
The term “preparedness” covers all aspects of the issue, such as prevention, protection, first response capacity, prosecution of criminals, surveillance, research capacity, response and recovery.
This consultation process is mainly aimed at the national authorities responsible for risk prevention and response, public health and customs, law enforcement authorities, bio-industry and epidemiological and health professionals. It may lead to concrete actions in the field of bio-preparedness in 2008.
Replies from stakeholders had to be sent to the Commission by 1 October 2007.
Communication from the Commission of 28 November 2005 on strengthening coordination on generic preparedness planning for public health emergencies at EU level [COM(2005) 605 final – Not published in the Official Journal].
The purpose of this Communication is to assist Member States in developing generic plans for all sorts of public health emergencies, factoring in the EU dimension. The Communication serves as a reference point for the Member States to develop their own plans and identifies the key components to be taken into account when preparing for public health emergencies.
Communication from the Commission of 28 November 2001 entitled “Civil protection – State of preventive alert against possible emergencies” [COM(2001) 707 final – Not published in the Official Journal].
Decision No 2119/98/CE of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [Official Journal L 268 of 03.10.1998].