Bioterrorism: the European Union response

1. Bioterrorism: the European Union response George Gouvras Michel Pletschette European Commission

2. HEALTH SECURITY PROGRAMME • Four Objectives-25 actions • Timetable: Started 2002 for an initial period of 3 years; extended to 2008 by the Council and Parliament through the public health programme 2003-2008 • Resources: Task Force of 14 experts, 2 million euros per year from EU, 2-4 million per year from the EU Member States

3. Objectives • Threat awareness and command and control arrangements: Mechanism for information exchange, consultation, co-ordination • Surveillance and detection: Capability for inventorying, detection and identification • Response and recovery: Medicines’ stocks and health services database and arrangements for provision of medicines, specialists, other medical goods and infrastructure

4. Objectives (contd.) • Prevention and Protection: Interdiction of agent movement and critical infrastructure protection • Legislation, rules and guidance • co-ordination of the EU response in other policies • links with third countries and international organisations

5. 1st objective:mechanism • Health Security Committee • 24h/7 days-a-week restricted access alert system RAS-BICHAT • Secure and effective links of the network with the Early Warning and Response System and the networks for external relations, civil protection information exchange, radiological emergencies alert, food, animal and plant safety alert systems

6. 2nd objective:detection • Lists of biological and chemical agents and materials held: • CDC’s, Member States’, EU Matrix • addition to legally-binding pathogen case definitions (anthrax,Q-fever, tularaemia, smallpox) • Council “dual use” regulation on export controls • Biological agents’ Council Directive (1989,amended 2000) :occupational health and safety, public health • Inventory of EU laboratory facilities • Network of P4 and co-operation agreements for laboratories and support in case of emergency

7. 2nd objective (contd.) CHEMICAL AGENTS • Clinical guidelines for event scenarios, case recognition and management • Clinical and toxicological guidelines • Expertise available through Directory • Inventory of treatment facilities • Network of surveillance: Poison Centres and Special Regerence Centres • EMEA guidance on antidotes

8. 2nd objective (contd.) • Directory of experts for interventions-assistance • Procedures for the setting-up of joint investigation teams • Incident investigation and environmental sampling: Protocols for incidents • Planning and modelling

9. Planning : Scenarios and incidents • the discovery of a biological or chemical agent in the wrong place or in the wrong product Type I Incidents • the discovery of an unusual or suspicious object • a threat or a terrorist attack with or without demands, before or after harm or damage is manifested Type II incidents • an abnormal outbreak of disease or unusual clustering of cases without readily available indications or explanations related to natural causes or adventitious exposure • an abnormal adverse event or suspected foul play in an incident which results in prompt (especially for chemicals) or would be likely to result to delayed harm to people, animal or plant health

10. PLANNING AND MODELLING • Smallpox plans and comparisons • Scenarios, criteria for counter-measures • EU-aspects: terminology, movement, vaccination, other counter-measures • Exercise (Global Mercury, intra-EU) • SARS, AI : general plan

11. 3rd objective:stocks-services • Evaluation of existing stocks and production capacities for medicines • Elaboration of concerted stockpiling, siting, availability and recycling strategies • Strategies and instruments to allow the development and deployment of medicines • Dilution of 1st generation smallpox vaccines, problems with the 2nd generation, 3rd generation smallpox vaccines and VIG production

12. 4th objective:Other policy instruments • Research: Expert Group, 6th Framework Programme: diagnostics,detection, new vaccines and therapeutics, decontamination • Food safety • Animal safety • Plant safety • Water safety • Co-ordination of special measures concerning the movement and residence

13. 4th objective:Other policy instruments • Research: Expert Group, 6th Framework Programme: diagnostics,detection, new vaccines and therapeutics, decontamination • Food safety • Animal safety • Plant safety • Water safety • Co-ordination of special measures concerning the movement and residence

14. 4th objective: Co-operation • International co-operation • Ottawa initiative • Incident scale, risk management and communication • Smallpox training,vaccine conference,exercise Global Mercury to evaluate communications and plans and check inter-operability • P4 laboratory co-operation • Chemical threats • patient isolation techniques • Influenza - the SARS paradigm • Co-operation with the WHO • NATO

15. Current priorities • Development of a unified preparedness and response capability through general emergency plans and unified command and control centres • Risk and crisis communication and management • Incident investigation and environmental sampling : protocols and detection • Health resources and mutual assistance : minimum requirements • Exercises and emergency plan evaluation • Public Health intelligence and threat monitoring and assessment in liaison with security and law enforcement services

16. General plan to cover: • Disease outbreaks • Pathogen traffic - foods, pets, laboratory/ research specimens, tyres, etc • Human pressures and cultural habits that spread agents illegally • Inadvertent releases-unauthorised releases • Deliberate (malicious) acts: • terrorist • non-terrorist (vengeance, mental disturbance, etc)

17. General plan: key headings • Information management (surveillance, monitoring, intelligence, sampling, detection, diagnosis, analysis, correlation, identification) • Communications (systems, procedures, command and control, obligations for information and consultation,media, expert groups, public) • Scientific advice (procurement, setting criteria and triggers in support of actions, determine corresponding actions and the resources and ways to implement them)

18. Base for action • Temporal or spatial patternsof disease, illness or syndromes -Temporal or spatial patternsof CBRN agents • Determination of actions at appropriate levels with precise criteria: • Information transmission, forwarding to authorities and agencies (local, national, international) • Stand-by of agents/operators/staff - alert / heightened alert with personnel and resource deployment • Communication to groups and public • Restriction of movement (people, animals, plants, food, water, goods, energy flows) • Transport restrictions • Closure of premises/infrastructure • Requisition of property (land, vehicles, facilities such as labs, hospitals, centres, pharmaceuticals)

19. Support to actions (2) • Medical/police interventions (triage,observation, isolation, forceful administration) • Civil Protection/military support interventions (interdiction, temporary housing and food distribution) • Decontamination interventions • Waste management and disposal interventions • Recovery interventions

20. Health system preparedness • Hospitals • (disaster plan and procedure, safety and hazard control and QA) • Capacity fixes : emergency and casualty, isolation, barrier nursing, intensive care) • preventive and protective measures’ plan for staff • staff numbers, training and assignment in teams • Health centres and mobile units & medical teams • Ambulance support and victim distribution • Rest of patient/victim transport and treatment capacity

21. Public Health Monitoring and Surveillance:Communicable Disease Surveillance Epidemic Intelligence Monitoring Health Status Early warning Health indicators Epidemic response Health Policy Control activities Resource allocation Incidence / trends Administrative data Monitoring diseases Monitoring Health System Inlc.resources diversion and baseline preparedness:e.g.general and burns ICU

22. Information screening Action Verification Communication Important? • Web scanning • Newsgroups • EWRS • Personal communication - RAS-BICHAT - EWRS Specific Communication and Response actions discard no 4 4 yes 6 5 (B) Verification report 1 SANCO EWRS RELEX GOARN 7 verify (A) Screening report Relevant? yes Coordination of response 8 2 3 (C) Outbreak report Confirmed? 9 yes no (D) Evaluation report no • SANCO • RELEX • WHO • Health Authorities discard archive DAILY and FOLLOW-UP verification Frequency DAILY AD HOC WEEKLY Output Input Outcome Process

23. Information sources used in HTU Information screening • Web scanning • Newsgroups • EWRS • Personal communication 1 Relevant? yes no discard • Event selection criteria • 0. Hoax / Not relevant ------------------- Discard • 1. Probable / Possible ------------------- Screening Report • . Likely / Confirmed ------------------- Screening Report • For 1 and 2 consider: • New or unknown disease / event • Relevance to international health • Potential for Community involvement • Potential need for action * This screening frequency is declared by the persons which voluntarily follow these information sources. In case of absence for any reason (mission, holidays etc.), such screening frequency cannot be ensured.

24. Perspectives • Regulation for an EU Centre for Disease Prevention and Control – agreed March 2004 – ECDC Operational in May 2005 • Review of implementation of joint Council-Commission anti-CBRN programme and review of overall anti-terrorism programme • Formulation of a European Security Strategy • The EU Constitution and the expanded powers on health