A PANDEMIC INFLUENZA EXERCISE FOR THE EUROPEAN UNION EXERCISE COMMON GROUND

A PANDEMIC INFLUENZA EXERCISE FOR THE EUROPEAN UNION EXERCISE COMMON GROUND Serial 5.0 Final Reprt 27 March 2006

Table f Cntents EXECUTIVE SUMMARY... 6 Intrductin...6 Cnduct f the Exercise...6 Issues Identified...6 Respnding t the Crisis...7 PART 1 - INTRODUCTION... 8 PART 2 - MAIN THEMES... 9 PART 3 - EXERCISE PLANNING... 12 PART 4 - SCENARIO... 13 PART 5 - EXERCISE EVALUATION... 153 PART 6 - OBJECTIVES, ISSUES IDENTIFIED AND RECOMMENDATIONS... 18 Objective 1 - Test the Executin f the Natinal Plans f the Member States and Examine Their Cmpatibility and Inter-perability....18 Recmmendatin 1...197 Objective 2 - Examine the Rle and Availability f Cuntermeasures...19 Travel Restrictins...19 Scial Measures and Business Cntinuity...20 Surveillance...20 Recmmendatin 2...20 Recmmendatin 3...219 Recmmendatin 4...19 Objective 3 - Determine the Availability and Suitability f Cntainment Measures...21 Recmmendatin 5...24 Objective 4 - Examine the Rle f the EC During an Influenza Pandemic....21 Rles and Respnsibilities...21 Early Warning and Respnse System...231 Health Emergency and Diseases Infrmatin System...242 Telecnferences...242 Final reprt 27 March 2006 Page 2 f 35

Recmmendatin 6...23 Recmmendatin 7...253 Recmmendatin 8...Errr! Bkmark nt defined.3 Recmmendatin 9...23 Recmmendatin 10...27 PART 7 - CONCLUSION... 275 Recmmendatin 11...25 Recmmendatin 12...25 APPENDIX A - OVERVIEW OF PARTICIPATION... 286 APPENDIX B - MASTER EVENTS LIST... 308 APPENDIX C - SAMPLE OF MEDIA INJECTS... 30 Media Inject 1...30 Media Inject 2...30 Media Inject 5...31 Media Inject 6...31 Media Inject 7...32 Media Inject 9...342 Final reprt 27 March 2006 Page 3 f 35

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Executive Summary Intrductin Exercise COMMON GROUND was cnducted by the UK s Health Prtectin Agency (HPA) as a Cmmand Pst Exercise (CPX) ver a tw-day perid n 23 t 24 Nvember 2005. This exercise was the secnd f tw Eurpean Unin exercises cmmissined by the Eurpean Cmmissin (EC) t evaluate the ability and capabilities f Member States t respnd t a health-related crisis, in this case an influenza pandemic. Cnduct f the Exercise The cnduct f this exercise as a CPX prvided scpe fr hundreds f players at tw levels f respnse natinal and internatinal t react t a series f fictitius events as they wuld have t d in the event f a real emergency. (See Appendix A fr the level f participatin by Member states). Players in the exercise included the EC, Eurpean Centre fr Disease Cntrl (ECDC), the 25 Member States, Eurpean Ecnmic Area (EEA) States, Switzerland, Eurpean Agency fr the Evaluatin f Medicinal Prducts (EMEA), Eurpean Vaccine Manufacturers (EVM), pharmaceutical cmpanies and the Wrld Health Organisatin (WHO). The exercise was intended, amngst ther bjectives, t prvide the players with an pprtunity t explre internatinal crdinatin with the EC s Health Emergency Operatins Facility and was based n a realistic mdel f an influenza pandemic develped by the mdellers at the HPA. Issues Identified The experience served t heighten the issues identified n Exercise NEW WATCHMAN, which was cnducted alng similar lines in Octber 2005. The main issues identified during Exercise COMMON GROUND were that: There seems t be sme variability as t what extent Member States, EEA States and Switzerland have included an internatinal dimensin in their Pandemic Influenza Plans; it was nted that many fcused n natinal issues rather than internatinal affairs during the early stage f the exercise. The EC shuld cnsider further develp their generic plan taking int accunt the internatinal dimensin f the natinal plans f Member States t include a checklist f apprpriate measures that have t be taken by Member States and the Cmmunity applicable t each phase / alert level. The rles and respnsibilities f the WHO, the EC and the ECDC during a crisis respnse need t be better understd by the Member States. Existing cmmunicatin tls in the Cmmissin will have t be enhanced and adapted: The Early Warning Respnse System (EWRS) is a rbust system fr the purpse fr which it was intended. Hwever, it was used as a decisin supprt tl during the exercise, which it was nt designed fr. The system needs t be used strictly fr the Final reprt 27 March 2006 Page 6 f 35

purpse it is intended under EC law (Decisin 2119) i.e. ntificatin f cases, infrmatin, cnsultatin and crdinatin f public health measures. A restricted web site fr crisis management and situatinal awareness (Health Emergency and Diseases Infrmatin System HEDIS) which is currently under develpment needs further enhancement. The system needs t be extended t include adequate decisin supprt capacity and analytical tls. Telecnferences during a crisis psed sme difficulties. Member States EEA States and Switzerland need t have adequate cmmand and cntrl centres with gd liaisn systems (audi and vide cnference tls, adequately equipped crisis rms) with ther States, the Cmmissin and partner agencies as well as internatinal rganisatins, in particular the WHO. Respnding t the Crisis There were sme bvius examples f crdinatin effrts by the EC and ECDC during the exercise, particularly the hlding f audi-cnferences with detailed agenda and attentin pints which helped immediate issues. Als, the setting up by the ECDC f a helpful website, which prvided a gd verview f the situatin and reprting frms fr surveillance purpses. Additinally, the EC prvided reprting frms fr the Member States t feed-back n public health measures taken. These initiatives wuld be useful in a real crisis. There were als a number f examples f gd, crdinated cperatin n the develpment f media respnses between Member States but verall it appears that mst respnses t media requests were prvided at the natinal level withut reference t r cnsultatin with thers. Althugh nt required by Cmmunity law, there was n EC crdinatin n messages t the public. It is desirable that such crdinatin takes place. Cperatin in prviding cmmn, crdinated media themes culd be enhanced. Expanding and imprving the capability f the EC t crdinate a respnse t a crisis is highly desirable. The issues identified in Exercise COMMON GROUND are cmplex and their reslutin will nt be easy. Hwever, the value f an exercise is that authrities and rganisatins are able t learn frm their experiences and they have an pprtunity t enhance their capabilities s that respnses t real crises are imprved. The recmmendatins can be fund in part 6 f this dcument. Final reprt 27 March 2006 Page 7 f 35

PART 1 - INTRODUCTION Exercise COMMON GROUND was cnducted as a Cmmand Pst Exercise (CPX) ver a tw day perid frm 23 t 24 Nvember 2005. This exercise was the secnd f tw Eurpean Unin (EU) exercises initiated by the Eurpean Cmmissin (EC) and was intended t evaluate the functins f the respnse, within the EU, during an influenza pandemic. The exercise was cmmissined by the Directrate General Health and Cnsumer Prtectin (DG-SANCO) f the EC with the cntract (General Invitatin t Tender SANCO/C3/2004/05) fr delivery n behalf f the Member States, being awarded t the Health Prtectin Agency (HPA) in the UK. In additin t the 25 Member States and the EC, ther cuntries and rganisatins were invited t take part. Additinally, the newly frmed Eurpean Centre fr Disease Preventin and Cntrl (ECDC) was invited t participate alng with the Eurpean Ecnmic Area States (EEA), Switzerland, the Wrld Health Organisatin (WHO), Eurpean Agency fr the Evaluatin f Medicinal Prducts (EMEA), Eurpean Vaccine Manufacturers (EVM) and pharmaceutical cmpanies. The exercise invlved, primarily, health departments f Member State gvernments with an ptin t include ther elements f gvernment respnse. The exercise cre planning team prvided guidance and the Member States determined the level and extent f this invlvement. As an example f the supprt fr this event, many Member States tk the pprtunity t run an internal exercise alngside Exercise COMMON GROUND. Literally hundreds f players tk part acrss the EU. Appendix A prvides an indicatin f the numbers and the level invlved. Frm early feedback, the HPA takes the view that Exercise COMMON GROUND was a successful event, which identified many issues fr further develpment. In the wrds f Cmmissiner Kyprianu, T my knwledge an exercise n this scale and f this duratin is unprecedented. Many f the delegates frm the Member States, EEA States and Switzerland expressed the view that these types f exercises be repeated n an regular basis. Player participatin Player participatin invlved individuals frm the fllwing cuntries and rganisatins: Eurpean Cmmissin Final reprt 27 March 2006 Page 8 f 35

DG-SANCO Luxemburg Brussels Other DGs f the EC ECDC The 25 Member States Others Iceland EVM Nrway EMEA Switzerland EISS Pharmaceutical Cmpanies WHO - Geneva and Cpenhagen Exercise Objectives The bjectives identified and detailed in the Invitatin t Tender dcument are: Test the executin f the natinal plans f the Member States and examine their cmpatibility and inter-perability Examine the rle and availability f cuntermeasures Determine the availability and suitability f cntainment measures Examine the rle f the EC during an influenza pandemic Planning Prcess The exercise prcess cnsisted f seven phases: Phase 1 First main Planning Cnference which was cnducted n 20 and 21 April 2005. Phase 2 Representatives f the Member States, EEA States and Switzerland engaged in a natinal planning prcess t establish natinal bjectives and agree the participatin in their respective cuntries. Phase 3 Preparatin leading t Planning Cnference Tw n 7 and 8 July 2005. This was used t cnfirm the bjectives and educate Member State representatives in the methdlgy f running the exercise. Phase 4 Final preparatin fr the exercise and Planning Cnference Three n 5 Octber 2005; (with subsequent telecnferences). Phase 5 Cnduct the exercise n 23 and 24 Nvember 2005. Final reprt 27 March 2006 Page 9 f 35

Phase 6 Preparatin leading t the submissin f a First Impressins Reprt t infrm the EC f the main issues identified during the exercise. Phase 7 Preparatin leading t the pst exercise cnference n the 2 February 2006 including the presentatin and discussin f the draft final reprt. Final reprt 27 March 2006 Page 10 f 35

PART 2 - MAIN THEMES The aim f the cntract (SANCO/C3/2004/05 Lt 2) was t develp and cnduct a CPX t explre the respnse t an influenza pandemic. Within the verarching bjectives detailed in the intrductin, Exercise COMMON GROUND was intended t evaluate: Cmpatibility and interperability f respnse plans f the Member States; Surveillance, labratry diagnstics, quality and effectiveness f implementatin f preventive and cuntermeasures t reduce transmissin f risks, including restrictin f mvements f human, and access availability, distributin and use f equipment, prducts (in particular vaccines and antivirals), substances and materials, lgistics, emergency health and scial services measures; The adequacy f resurces and arrangements fr the implementatin f plans; and EU aspects. Final reprt 27 March 2006 Page 11 f 35

PART 3 - EXERCISE PLANNING The planning, cnduct and reprting f the exercise was crdinated by the HPA thrugh the Emergency Respnse Department f the Centre fr Emergency Preparedness and Respnse under cntract t the EC. Planning ran frm award f cntract n the 1 January 2005 t the exercise date. During this perid, three planning cnferences were held at the EC s Jean Mnnet Building in Luxemburg. The Exercise Planning Grup cnsisted f members frm the HPA, the EC, natinal delegates frm each f the Member States, EEA States and Switzerland. The WHO (Geneva and Cpenhagen), EMEA, ECDC, EVM and pharmaceutical cmpanies als tk part. A smaller cre planning team cnsisting f a dedicated HPA exercise team plus experts in pandemic influenza wh helped t advise n the develpment f the scenari was als frmed. During the planning prcess the exercise planning grup was presented with draft versins f the exercise dcumentatin and were requested t prvide feedback and input. A number f different versins were prduced ver the perid with final apprval fr the exercise dcumentatin being given after the third planning cnference (n 5 Octber 2005) during subsequent telecnferences. Planners were prvided with dcumentatin, which described the rles, and functins f players, cntrllers and evaluatrs and a number f briefings n the exercise prcess were given at the three planning cnferences. A secure web-space enabled the HPA cre planning staff t present the different versins f the exercise dcumentatin in a manner that permitted the wider planning grup t review and cmment n the dcumentatin. This system prved invaluable, in that all planners were able t access drafts at their cnvenience. The use f dcument sharing sftware shuld be further explred in future exercises. Final reprt 27 March 2006 Page 12 f 35

PART 4 - SCENARIO The exercise was designed t represent the perid f pandemic influenza ver twenty-six weeks. Time cmpressin was used in the exercise t enable the develpment f exercise events; because the spread f the pandemic was lnger than the actual perid f exercise play, it was necessary t accelerate the passage f time prtrayed in the exercise. T enable the spread f cases in Member States, EEA States and Switzerland t develp arund Eurpe, twenty-six weeks was effectively cncentrated int tw days f exercise play. The use f time cmpressin is always a difficult cncept and may have caused sme prblems in exercise play. Scenari Overview The exercise timeline was delivered in three blcks f time t reflect the different phases f the pandemic cycle. Blck A Cmmand Pst Exercise is designed t evaluate the systems, prcedures, planning and crdinatin capabilities f decisin makers and their supprting staff. The use f time-cmpressin (t allw fr the develpment f the exercise t its fullest extent) impses sme dramatic challenges t exercise players. They seldm have an pprtunity t fully analyse a situatin and implement actins t deal with it befre the next incident ccurs. This pressure is ften deliberate but the results have t be judged i t thi f t 1 represented preparatin and planning; Blck 2 cnsidered the initial respnse phase and final Blck 3 addressed the respnse later in the pandemic phase. CPX Begins CPX Ends 23 Nvember 2005 24 Nvember 2005 A-Day, Perid 1 A-1, Perid 1 A+1, Perid 2 Blck 1 Preparatin and Planning Week 0 (WHO Phase 5) B R E A K 0800 Fcus n 1800 0800 Fcus n 1300 a day a day during during Week 1 Week 5 Blck 2 Initial Respnse Week 4 Fcus n a day during Week 21 Blck 3 Pst Respnse Week 20 1800 Scenari Outline Blck One It is 23 Nvember 2005. Tday, strains f pandemic influenza frm tw patients in Thailand, nt linked by a knwn chain f transmissin were cnfirmed. The subtype has been identified as H5N8 (The exercise virus was identified as H5N8. this was a deliberate artificiality s that players wuld nt becme immersed in the mass f detail available n viruses); preliminary evidence suggests this subtype is able t be transmitted frm human t human. WHO declares glbal pandemic influenza Phase 5 t be in immediate effect. Final reprt 27 March 2006 Page 13 f 35

WHO has urged natinal authrities in all cuntries t be alert that cases f influenza due t H5N8 may appear wrldwide and t implement preparedness measures. Blck Tw It is nw 21 December 2005, fur weeks after the WHO alert level 5 was issued and tw weeks after the WHO alert level was raised t 6. Current numbers indicate in excess f 800,000 new clinical cases in Thailand, in the past week. The attack rate is estimated at between 20 and 25%; apprximately 7,500 persns are reprted t have died suggesting a case fatality rate f 2.5%. First indicatins f influenza activity in the EU have been detected. Several clusters f cases in Denmark, France, Germany, Italy, the Netherlands and the UK have been identified. Prductin f large scale vaccine is still estimated t be several mnths away but the virus is believed t susceptible t frntline anti-virals. Blck Three It is 21 April 2006, twenty weeks after the first WHO alert level 5 was issued. The alert remains 6 and the wrld is in the midst f the secnd wave f the current pandemic. Acrss Eurpe, millins f new cases f influenza are ccurring every week. N cuntry is unaffected and cmmerce and industry in sme areas has grund t a halt as raw materials have run ut. Supplies f the new vaccine are starting t becme available but are severely limited cmpared t the demand frm cuntries wrldwide. Pririty grups need t be established t identify thse mst in need. The scenari, master events list (Appendix B) and the injects were carefully designed t prvide the players with a graduated increase in the number f cases in EU cuntries which wuld accurately reflect an influenza pandemic. Final reprt 27 March 2006 Page 14 f 35

PART 5 - EXERCISE EVALUATION As part f the Invitatin t Tender, the HPA was required t develp an Evaluatin Methdlgy, which was t be used t measure the exercise cmpnents. During the planning prcess, an evaluatin cllectin plan was designed, cmprising a series f checklists, which encmpassed the fllwing: External Cmmunicatins Timeliness Crrectness Clarity f Respnse Accuracy Distributin Internal Cmmunicatins Event Tracking Lg maintenance Handver Effectiveness Assessment f the Situatin Internatinal Aspects f Natinal Plans Internatinal Aspect Effectiveness Cntact Pints Facilities Suitability Space Tls Final reprt 27 March 2006 Page 15 f 35

Staff Each f the participating cuntries and rganisatins were invited t appint their wn evaluatr. Additinally, they were als invited t nminate a cntrller. In sme instances, they were the same individual. As part f the exercise planning prcess, cntrllers and evaluatrs were fully briefed n their rles and the reprting structure. Final reprt 27 March 2006 Page 16 f 35

Exercise Structure It is very imprtant that exercise evaluatin infrms the final exercise reprt, but it is equally imprtant that the evaluatin prcess ccur thrughut the exercise. T this effect, the evaluatrs reprted t Exercise Cntrl (EXCON) at regular intervals during the exercise t prvide the Exercise Directr with a greater verall awareness f the prgress and directin f the exercise. During the curse f Exercise COMMON GROUND, EXCON s Media Staff develped a series f media injects t evaluate the media respnse f the cmmunicatins teams. These injects were directed, as thugh by the real media, twards particular cuntries r rganisatins and were relevant t that particular pint in time and t the scenari. An example f these injects can be fund at Appendix C at the end f this reprt. The injects were develped arund the bjectives and the feedback frm this wrk can be fund in the fllwing sectin. Final reprt 27 March 2006 Page 17 f 35

PART 6 - OBJECTIVES, ISSUES IDENTIFIED AND RECOMMENDATIONS Objective 1 - Test the Executin f the Natinal Plans f the Member States and Examine Their Cmpatibility and Inter-perability. In a cmmunity like the EU, free f internal brders and with many cmmn activities and free mvement f peple and gds, any cuntermeasures taken in ne Member State will be bund t affect at least sme if nt all, ther Member States. (Surce: Specificatins attached t the Invitatin t Tender Dcument, SANCO/C3/2004/05). The first phase f the exercise was intended t give Member States, EEA States and Switzerland the pprtunity t begin implementing their natinal plans fllwing the declaratin f WHO Alert Level 5. T a greater r lesser extent, they identified that their internal plans were fit fr purpse and prvided an pprtunity t test cmmand and cntrl structures. The EC attempted t crdinate and infrm Member States, EEA States and Switzerland f thers preparedness thrugh a questinnaire delivered by the newly develped HEDIS system. The exercise did help Member States, EEA states and Switzerland t identify issues which they had nt cnsidered sufficiently; fr example: Natinal plans fcused n natinal issues. Internatinal aspects required mre cnsideratin. Due t the time cnstraints f the exercise, the internatinal dimensin f natinal plans were nt fully explred. Greater inter-ministerial cllabratin and crdinatin with ther cuntries shuld be cnsidered. Again, the exercise did nt allw the full extent f internatinal cllabratin because f time cnstraints. Cperatin between Member States particularly regarding additinal amunts f vaccines and antivirals needs addressing Issues surrunding expatriates, travel restrictins, restrictin f emigratin f cntact persns and ptential fr scial disrder need further cnsideratin by Member States and discussin in depth with the EC, ECDC and WHO. Prcesses fr mass vaccinatin and quarantining need t be further explred. The EC activated its Eurpean Influenza Plan, with the levels f alert being acknwledged by Member States. The current plan des nt hwever refer t the apprpriate cuntermeasures r cntingency measures that might be applicable t Member States. The EC cannt tell Member States what cuntermeasures they shuld implement, nly recmmend what measures can be taken. Als the EC cannt take respnsibility fr decisins made by the Member States but any decisins taken must be cmpatible with Cmmunity law. Hence the use f the questinnaire which is ne tl available t the EC. Final reprt 27 March 2006 Page 18 f 35

The wider availability and greater familiarity with the WHO Plan meant that during the exercise Member States, EEA States and Switzerland used this plan alng with their wn natinal flu pandemic preparedness plans. Recmmendatin 1 A generic mdel f a natinal plan shuld be further develped fr the Member States. This shuld be develped, taking int accunt the natinal plans f Member States and include a checklist f apprpriate measures applicable t each phase / alert level. In rder t explre the cmpatibility f natinal plans, Media Inject N 2 (Appendix C, p21) was sent t Germany, Greece, Nrway, Malta and Slvenia. It set ut t examine the types f public health messages these cuntries had prepared t release via the media t the public. It went n t ask abut interventins such as masks, use f public transprt and ptential clsure f schls. Malta and Slvenia respnded directly and Nrway and Germany discussed their answers and respnded with a jint statement. Greece respnded but unfrtunately missed the impsed deadline set by the media players. All answers crrespnded well with each ther and prvided sensible health advice. The generic mdel shuld als draw frm the existing EC pandemic influenza plans, the EC generic preparedness planning dcument and take int accunt WHO guidance. The generic pandemic influenza plan wuld prvide a useful tl fr Member States and help t secure greater cmpatibility and inter-perability. Objective 2 - Examine the Rle and Availability f Cuntermeasures. T evaluate surveillance, labratry diagnstics, the implementatin f preventive cuntermeasures t reduce risk f transmissin, including the restrictin n mvement, the access, availability and distributin f vaccines and anti-virals and emergency health and scial services measures. (Surce: Specificatins attached t the Invitatin t Tender Dcument, SANCO/C3/2004/05). Travel Restrictins A general cmment amngst Members States players cncerned the apparent cnfusin n where they stand with reference t Cmmunity law with regards t the implementatin f travel restrictins. The majrity f players were frm health and may nt have been familiar with all the cnventins which exist. There was sme cnfusin expressed by signatries t the Schengen Cnventin n issues f freedm f mbility having t be handled differently accrding t an individuals natinality (Schengen/EC citizen r nt). Member States culd be helped by seminars rganised by the EC t get a better understanding f the legal basis f the prvisins regarding travel restrictins. The issue f brder cntrl and clsure was addressed at the exercise. Fr example, there was serius cncern expressed, due t the lcatin f drug manufacturers, when Switzerland indicated that they might cnsider the clsure f its brders; it was hwever, reassuring t nte that France s brder clsures cntained exceptins fr pharmaceutical and vaccine materials and wrkers. It was als reassuring that France lifted the clsure when the crdinatin meeting held by the EC clarified issues and cncluded that there was n need fr such a measure. Final reprt 27 March 2006 Page 19 f 35

Scial Measures and Business Cntinuity A number f natinal issues were identified which had nt been previusly cnsidered in planning by sme Member States, EEA States and Switzerland. Schl clsures, public rder issues, electricity supply and business cntinuity were all identified. They were nt reslved during the exercise, but shuld be highlighted fr future cnsideratin by Member States, EEA States and Switzerland, as thse wh have cnsidered these issues in detail, culd help t infrm thers. Surveillance There were issues with the demand fr mre technical details n the H5N8 virus (an artificiality intrduced by the exercise planners) and assrted epidemilgical data which were supplied as part f the exercise. These details wuld be needed in the management f pandemic influenza; unfrtunately this aspect f exercise play smewhat detracted frm the principle bjectives which did nt include epidemilgical issues. It was cnsidered by sme Member States that surveillance guidelines fr an influenza pandemic shuld be develped in cllabratin with the WHO. There shuld nt have t be duplicatin f effrt in reprting f cases and interventins, namely t the Cmmissin thrugh EWRS, the ECDC, EISS and WHO Eurpe and WHO Headquarters. Many Member States, EEA States and Switzerland experienced difficulties with EWRS and cmmunicatins in general. In particular, technical prblems such as server failure at bth central and natinal levels were experienced, which accunted fr the lack f respnses. This is a majr cncern and highlights the need t imprve the rbustness and resilience f cmmunicatin systems and ensure business cntinuity in this respect. The issues assciated with EWRS and cmmunicatin by telecnference are given in mre detail n p21-22. T explre issues assciated with surveillance, Media Inject N 9 (Appendix C) was sent t all Member States and sught t identify numbers f deaths and the mrtality rate acrss the Eurpe. It als asked Member States what further cuntermeasures were being planned, such as the banning f public gatherings. Respnses were received frm a number f Member States. The lack f respnses frm ther Member States was attributed t prblems with cmmunicatins; either with EWRS r resilience f cmmunicatin systems within their wn cuntry. Amng thse that replied, there was n evidence f prir cnsultatin r discussin between the players althugh they were aware that the questin had been psed t all players. Recmmendatin 2 The Cmmissin shuld, n behalf f Member States, investigate and clarify the internatinal regulatins during an internatinal infectius disease utbreak. Regulatins regarding restrictins n travel, airprt clsure and brder cntrl shuld be explained in the light f the Schengen Cnventin and the Internatinal Health Regulatins. There needs t be further discussin t clarify the impact f brder clsure, specifically the mvement f drugs and vaccines when brders are clsed. Such measures require further discussin by the Eurpean Cmmisssin and Member States. Final reprt 27 March 2006 Page 20 f 35

Recmmendatin 3 Cllabratin between relevant bdies culd be imprved with respect t the reprting f cases and interventins and a mechanism established t reduce duplicatin. Efficient n-line, real-time data input and access by the relevant bdies is needed in a crisis situatin and wuld alleviate the duplicatin f case reprting. This des nt need t be a stand alne system but culd frm part f the EC s drive t develp imprved cmmunicatins tls. Recmmendatin 4 Backup cmmunicatin facilities in Operatins/Crisis Rms shuld be cnsidered, by the Cmmissin, Member States, EEA States and Switzerland t prvide resilience and business cntinuity in the event f a real emergency. Objective 3 - Determine the Availability and Suitability f Cntainment Measures. t include the adequacy f resurces and arrangements fr the implementatin f plans. (Surce: Specificatins attached t the Invitatin t Tender Dcument, SANCO/C3/2004/05). Specifically, the fllwing activities were evaluated at the exercise: The availability f existing stckpiles f anti-virals and arrangements fr their prcurement and release t Member States The arrangements fr the develpment and prcurement f vaccines, the quantities required and the prjected timeframes The availability f a mechanism fr c-rdinated distributin and use f anti-virals and vaccines and definitin f pririty grups The availability f mechanisms t allcate vaccines and anti-virals between Member States Treatment capacity fr a variable number f casualties, cntingency plans in hspitals The vaccine manufacturers played in the exercise as ne virtual cmpany under the auspices f the Eurpean Vaccine Manufacturer (EVM) in rder t simplify play. The play between EVM and Member States, EEA States and Switzerland, and the EC, WHO, ECDC and EMEA was lively and practive, stimulating many discussins and bringing many imprtant issues t the fre e.g. the decisin making prcess arund the switching frm prductin f seasnal t pandemic vaccine. The antiviral manufacturers played as individual cmpanies in a separate cell. The play Final reprt 27 March 2006 Page 21 f 35

was again, lively, intense and realistic. Many issues were explred arund sharing f antivirals, crss brder mvements f stck and stck sharing. The exercise shwed that Member States appeared smewhat reluctant t share antiviral stcks with each ther, which may have been an exercise artificiality. Crdinatin by EC / ECDC / WHO t ensure fair and equitable distributin f vaccine and antivirals wuld be desirable and in this respect, the rle f the WHO needs t be clarified. It was suggested that there shuld be greater transparency surrunding the lcatin f antiviral stcks and additinally, the mechanism fr priritisatin f these stcks shuld be clearer particularly with the relevant pharmaceutical cmpanies. A greater knwledge f bth wuld then allw fr a mre crdinated distributin. There are plitical issues ver sharing this type f infrmatin but nevertheless, it shuld be further cnsidered. T vercme this hurdle, reassurance needs t be given t Member States, EEA States and Switzerland that the sharing f infrmatin regarding vaccines r antivirals will benefit their wn cuntry and ther Eurpean cuntries. Vaccine and antiviral allcatin in a real pandemic will be much mre challenging when manufacturers are juggling Eurpean and nn-eurpean demands simultaneusly. The EVM, playing as ne unit during the exercise, may have given an ver simplified view f this t sme Member States, EEA States and Switzerland, but this was unavidable in the cntext f the exercise. Cnsideratin shuld be given t the crdinatin f EVM s respnse in the event f a real pandemic. Mst aspects that EVM wanted t cnsider were reinfrced thrugh the exercise, including prductin, allcatin and liability issues. It was felt by EVM that the rle f majr decisinmaking was unclear and uncertain. Fr example, it was nt well defined wh makes the decisin t stp prductin f seasnal vaccines and switch t pandemic prductin. Further, the precise steps and timelines frm islatin f pandemic strain t vaccine delivery are nt clearly identified. Regarding the allcatin f vaccines, the rle f Natinal Advance Purchase Agreements (NAPA) has nt been understd and the Cmmissin shuld have a rle in allcating any excess vaccine capacity that has nt been cmmitted t supplying NAPA. Liability issues are currently being discussed with the Cmmissin. EVM als cmmented that the exercise identified the need fr planned, prepared messages t the media t avid different messages cming frm different surces. As a result f the exercise the EVM are cnsidering establishing a crss-industry grup t prvide central c-rdinatin f vaccine manufacture and supply in the event f a real pandemic. Hwever, there are issues including the prblems with anti-cmpetitive laws which wuld need t be waived fr the pandemic. These recmmendatins are made, in the light f the views and experience btained, frm the exercise, by EVM and nt the Member States, EEA States r Switzerland. T evaluate the implementatin f cuntermeasures, Media Inject N 6 (Appendix C) was sent t the German players. They were asked abut cuntermeasures being taken t prevent the spread f pandemic flu fllwing reprts f an aircraft arriving frm Bangkk with tw very ill passengers n bard. The German players explained that screening f the passengers and crew wuld be carried, but were careful t dampen press speculatin that pandemic flu had arrived in Germany. Final reprt 27 March 2006 Page 22 f 35

Anther media inject was sent ut t address the issue f expatriates. Media Inject N 7 (Appendix C) asked the Spanish Gvernment if they were ging t ffer antivirals t expatriates frm the UK, Germany and ther Eurpean Member States living in Spain. Their respnse was that Spain was asking fr cllabratin frm ther cuntries, especially thse with a large number f citizens living there, t prvide antivirals t help replenish their supply. They wuld hwever ffer antivirals t all peple at risk. Recmmendatin 5 The EC is encuraged t engage with vaccine manufacturers and pharmaceutical cmpanies t reslve thse issues identified under bjective 3 (Determine the Availability and Suitability f Cntainment Measures). Objective 4 - Examine the Rle f the EC During an Influenza Pandemic. including thse mentined in the Cmmissin wrking dcument n pandemic influenza preparedness and respnse planning, published in March 2004. (Surce: Specificatins attached t the Invitatin t Tender Dcument, SANCO/C3/2004/05). It was cnsidered that the exercise was an excellent pprtunity t gain a further practical insight int the internatinal management f pandemic influenza. It was thught, hwever, that in reality, plitical decisin makers wuld dminate the prcess much mre in real life. Rles and Respnsibilities Sharing f tasks between ECDC and DG SANCO was nticeable. Despite this, many Member States cnsidered that there was a need t clarify and cmmunicate, clear and well defined rles and respnsibilities during a crisis. In rder t explre the rle f the EC, Media Inject N 1 (Appendix C) was addressed t the Cmmissin. This set ut t examine the Cmmissin s respnse t the increasing number f cases f H5N8 in Suth East Asia and preparedness in Eurpe. The Cmmissin s Cmmunicatin Officer answered the jurnalist s questins n the telephne and refused t put the Cmmissiner up fr interview. He answered questins abut preparedness, rbustly and authritatively, but refused t disclse hw many cases had been ntified by the WHO. It was cnsidered that he answered at the crrect level and that interviewing the Cmmissiner early n culd cause ver reactin by the media and place unrealistic demands n him ver a ptentially lng timescale. Early Warning and Respnse System The players in this exercise used the Early Warning and Respnse System (EWRS), designed and managed by the Health Threats Unit f DG-SANCO, as a cmmunicatins tl. A small number f key individuals in each Member State and the Cmmissin have access t EWRS. EWRS is the channel used by the Member States fr the exchange f ntificatins and measures/cuntermeasures fr cmmunicable diseases. There are strict perating prcedures in Final reprt 27 March 2006 Page 23 f 35

place fr the ntificatin f suspected n cnfirmed cases which shuld be fllwed by EWRS members. The system functined during the exercise in terms f the players acting accrding t their legal bligatins (Decisin 2119/98/EC infrming each ther n cases and cuntermeasures). Hwever, all rganisatins were hampered by a shrtage f trained experienced users with access t the systems. EWRS was used extensively during the exercise (437 messages and 3672 respnses) t enable cmmunicatin between Eurpean Cmmissin bdies and Member States, EEA States and Switzerland. EWRS was available t all Member States plus Nrway, Iceland and Switzerland. There was cnsiderable verlading and heavy traffic n the system. In the early stages f the exercise, EWRS perfrmed effectively, hwever, as the exercise prgressed the system rapidly became verwhelmed with messages. The resulting criticism frm players was that excessive time and resurce was expended tracking relevant infrmatin and fr sme, this became impssible. This created a great deal f frustratin amngst players. Almst withut exceptin, every participant cmmented n EWRS and the difficulties f extracting infrmatin in a timely and effective manner. As the EWRS was the nly system fr simultaneus pan- Eurpean cmmunicatin available. Member States, EEA States and Switzerland used the system fr all srts f infrmatin exchange when it was develped nly fr fficial ntificatin f cases and measures and crdinatin f the latter as laid dwn in cmmunity Legislatin. It shuld be emphasised that EWRS was nt develped as a crisis management tl but as an early warning and respnse system and it shuld be cnsidered as such. Health Emergency and Diseases Infrmatin System Exercise NEW WATCHMAN identified the need fr the rapid cllectin f cmprehensive infrmatin frm Member States and the need fr an accurate verview f the current situatin. As a result, the Health Emergency and Diseases Infrmatin System (HEDIS), planned fr develpment in 2006, was intrduced and used in Exercise COMMON GROUND. It was hped it wuld assist in reslving these prblems. Part f HEDIS enables Member States t cmplete n-line questinnaire(s) and at the same time see the answers given by their partners. Many Member States fund that cmpleting the questinnaire was very cmplicated and time cnsuming and invlved a duplicatin f effrt in that similar questins were being asked by the EC, by ECDC and WHO. The shrt lead time n the arrival f the new system caused sme prblems and meant that many f the functins were nt used prperly. A further aspect f HEDIS was that f mapping. Maps available shwed incidences f cases per cuntry rather than the actual situatin f small clusters in distinct regins f cuntries. Hence it was nt as infrmative as it culd have been. It shuld be nted that the system was nly at pilt phase and future develpment will imprve the reslutin f the maps; such maps will be f high value nce these definitinal display prblems are reslved. Telecnferences Telecnferencing was als used as a tl fr crdinatin with all Member States and ther rganisatins. Its purpse is t allw the emergence f a cmmn view f the situatin and prmte the reslutin f prblems, incmpatibility f measures and ptential cnflicts. There was general agreement that telecnferencing etiquette had imprved since the earlier exercise. Hwever, it was cnsidered that they were verlng. Additinally, it appears that there is a wide variety f smetimes unsuitable telecnferencing equipment being used in sme Member States, EEA States and Switzerland. Despite the difficulties experienced with these lines f cmmunicatin, several Member States and thers cmmunicated effectively in a bilateral way, using email and telephne. This is likely t reflect Final reprt 27 March 2006 Page 24 f 35

reality where lngstanding agreements and arrangements are in place and are likely t be used in this scenari. Psitive feedback was received n the ECDC website, which was quickly established t give an verview f the situatin frm their viewpint. Recmmendatin 6 Member States, EEA States and Switzerland shuld be given further explanatin as t the rles f rganisatins such as ECDC and WHO Eurpe and WHO Headquarters t enable them t make crdinated and infrmed decisins cncerning, fr example, the mvement f individuals. There shuld be greater clarity n the rle f the WHO in relatin t ECDC and EC and als between WHO Headquarters and WHO Eurpe. Recmmendatin 7 The EC shuld further cnsider the develpment f a new system which allws the rapid cllectin f cmprehensive infrmatin frm Member States and prvides an accurate verview f the current situatin. Health Emergency and Diseases Infrmatin System (HEDIS) is an ptin, and future develpment shuld be carried ut in cnjunctin with Member States. Recmmendatin 8 The functinality f EWRS shuld be reviewed t prvide an peratinal capability r an alternative system shuld be cnsidered (see recmmendatin 7). Enhancement f EWRS may include a classificatin system f messages. Fr example, filing messages by pririty, by categry, by cuntry, by measures, imprving the management flw f incming messages and supplementing it with an n-line cmmunicatin system and a link t an ECDC surveillance system. Mderatin f the number f messages psted n the system shuld als be cnsidered. In the event that EWRS is further develped, the Cmmissin wuld need t build in resilience shuld tw differing utbreaks ccur. There shuld be further frmalised training n the use f EWRS and sufficient numbers f peple shuld be allwed access t EWRS t ensure resilience. Member states shuld decide n wh wuld have access t their wn natinal Fcal pint facilities. Recmmendatin 9 Telecnferences are a vital crdinatin tl in a crisis and a way frward must be fund t make their use mre effective. The EC encurage the purchase f a specified standard f telecnferencing equipment and insist n its use during a crisis. In additin, the Cmmissin shuld publish telecnference prtcls fr use in telecnferences. Each telecnference shuld have a specific purpse, an agenda which clearly utlines discussin pints and a list f thse participating frm the EWRS authrities. Recmmendatin 10 Implement a prcedure fr assisting with the crdinatin and sharing f the key EC-wide Final reprt 27 March 2006 Page 25 f 35

respnses t media queries during a crisis. Additinally, a netwrk f media cntacts shuld be created in the Member States Health ministries (and ther relevant institutins) press ffices and the pprtunities fr this grup t meet, interact and build-up relatinships shuld be increased. In rder t explre media respnses mre thrughly, media representatives shuld be invlved in the planning f future exercises t ensure the interface between peratinal and media play is mre thrughly examined. Final reprt 27 March 2006 Page 26 f 35

PART 7 - CONCLUSION There was a cnsensus that cnsiderable imprvements were made in the mnth after the earlier exercise, Exercise NEW WATCHMAN, reflecting the willingness f the EC and Member States, EEA States and Switzerland t act rapidly t make imprvements nce identified. This allwed Exercise COMMON GROUND t flw mre easily, and imprved the learning utcmes fr the players. Exercises take place t prvide reassurance that apprpriate measures are in place and that plicies, rles, respnsibilities and plans are fit fr purpse, and shuld they be cnsidered lacking that remedial measures are taken. All participating States and Organisatins identified the need fr similar exercises t be carried ut as a rutine training measure. The verall impressin left by Exercise COMMON GROUND was that, nt surprisingly, cmmunicatin is a vital tl in enabling effective crdinatin acrss the EU. The exercise highlighted that systems (hardware, sftware, prtcls, resilience) currently available t facilitate cnnectivity acrss the EU in a crisis need further imprvement t make them mre effective r, if this is nt pssible, be replaced. A cnsiderable amunt f experience has been gained by the planners during the planning phase f this exercise. A great deal f effrt was spent in assembling the planning grup which cnsists f expert representatives frm all the 25 Member States plus EEA and Switzerland. The views and experience f this grup shuld nt be lst and attempts shuld be made t utilise and share the experience gained during the running f these exercises. Recmmendatin 11 The EC establish the need fr, and cnduct, cmplementary exercises which wuld address ther issues, as a rutine training measure. These exercises shuld be develped t include the lessns identified frm previus exercises and shuld be scheduled s as t allw sufficient time fr recmmendatins t be implemented. Objectives fr future exercises shuld be carefully designed t reflect the requirements but als cnsider the limitatins f different exercise delivery methds. In future exercises invlving infectius diseases, mdelled epidemilgical data shuld be made available, in advance, t the WHO, the EC and ther rganisatins in additin t the Member States and ther participating States. This epidemilgical data is required t adapt plans and wuld aid the management f the disease. Recmmendatin 12 The EC shuld cnsider using utilising the experience gained by the planning grup in rder t further develp and infrm their systems and plans. Final reprt 27 March 2006 Page 27 f 35

Cuntry/Organisatin Austria 10 Belgium Cyprus Czech Republic Denmark Estnia Finland France Germany Greece Hungary APPENDIX A - OVERVIEW OF PARTICIPATION Participants 28 in Crisis Rm. 24 Organisatins including Gvernment, Federal, Labratries, Hspitals. (+ 5 n standby) 23 representing 14 Ministries/Services 10 representing 4 Organisatins 13 representing 3 Organisatins: Danish Ministry f the Interir & Health, Bard f Health, Statens Serum Institute 25 n 2 sites 60 representing 18 Organisatins (Ministries, Public Health Institute, Natinal Agency fr Medicines) 70 representing at 5 lcatins and 1 Minister 55 representing 9 rganisatins 12 representing Ministry f Health and Public Health Institutes; plus 10 bservers 35 (Ministry f Health, Chief Medical Office, Natinal Epidemilgical Centre and 20 Reginal Public Health Institutes) Ireland 9 representing Public Health Advisry Team. Apprximately 8 Intergvernmental Grup (representing Plice, Transprt, Justice, Finance Marine, Agriculture, Finance, Freign Affairs). IT, Cmmunicatins/Media. 1 Minister Italy Latvia Lithuania 28 Luxemburg Malta The Netherlands Pland Prtugal Slvakia Slvenia Spain 50 40 representing all Natinal Institutins and Reginal Administrative Organisatins 23 representing 14 Organisatins 1 Minister, High Cmmissiner fr Natinal Prtectin, Media, and First Respnders 4 & by phne: Minister, Plice, Civil Prtectin, CEO, Virlgist, Media, Hspitals, PCT 150 frm 50 Organisatins 50 Central Operatin Rm and 100 in varius Ministries 45 Health Ministry, Internal Affairs, Freign Affairs, Agriculture and Defence 12 frm 3 Organisatins 26 (Ministry f Health, Natinal Institute f Public Health, Health Inspectrate f Republic f Slvenia, Agency fr Medical Prducts and Medical Devices f the Republic f Slvenia, 9 Reginal Institutes f Public Health, General Plice Directrate, Pharmaceutical Chamber f Slvenia, Administratin fr Civil Prtectin and Disaster Relief.) Final reprt 27 March 2006 Page 28 f 35

Cuntry/Organisatin Sweden Participants 7 representing the Natinal Bard f Health & Welfare. 1 Ministry UK 20 frm Department f Health including 1 Secretary f State, 1 Chief Medical Officer and 2 ministers; 4 frm Health Prtectin Agency Iceland 22 Nrway Switzerland 8 EMEA 2 Vaccines Antivirals WHO 17 ECDC EISS 2 Eurpean Cmmissin 150 Several Ministries, 2 Health Regins including Hspitals, Plice, Medicines Agency, 2 Municipalities, 1 Cunty 9 frm 8 Organisatins 4 frm 3 Organisatins (Rche, GSK, Nvartis) 20 (scientific, surveillance, media/it/supprt) 65 frm lcatins in Luxemburg, Brussels and different Directrates; including the Cmmissiner, tw members f his cabinet and the spkesman Final reprt 27 March 2006 Page 29 f 35

APPENDIX B - MASTER EVENTS LIST ID N Insert Date BLOCK 1 Insert Time (GMT) Scenari Day 1.1 23/Nv 08:00 23 Nv 05 Lcal Cntrller 1.2 23/Nv 08:15 23 Nv 05 Lcal Cntrller 1.3 23/Nv 08:20 23 Nv 05 MS & EFTA Cntrller 1.4 23/Nv 08:20 23 Nv 05 EC Cntrller 1.5 23/Nv 12:00 23 Nv 05 EC Cntrller 1.6 23/Nv 13:45 23 Nv 05 Lcal Cntrller 1.7 23/Nv 15:00 23 Nv 05 German Cntrller 1.8 23/Nv 15:15 23 Nv 05 Spain Cntrller 1.9 23/Nv 16:30 23 Nv 05 Lcal Cntrller 1.10 23/Nv T be determi ned BLOCK 2 23 Nv 05 Estnia Cntrller 2.1 24/Nv 08:00 21 Dec 05 Lcal Cntrller 2.2 24/Nv 08:15 21 Dec 05 Lcal Cntrller 2.3 24/Nv 08:20 21 Dec 05 Lcal Cntrller 2.4 24/Nv 09:00 21 Dec 05 EC Cntrller 2.5 24/Nv 09:15 21 Dec 05 Lcal Cntrller 2.6 24/Nv 10:30 21 Dec 05 MS, EFTA & EC Cntrllers 2.7 24/Nv 11:30 21 Dec 05 Lcal Cntrller Inserted By Given T Insertin Means Insertin Place General Descriptin All Players Hand In All Lcatins Opening Scenari fr Blck 1 All Players DVD All Lcatins Newscast Senir Player Senir EC Player Cmmissin er f Health Senir Player German Senir Player Spain Senir Player Script f Telephne Call t Hand In All Member States and EFTA Cuntries Call frm Health Minister's Office requesting infrmatin Hand In EC Frecast f Vaccine Availability and antiviral supply Cpy f Letter Hand In EC Transcript f Berlin Telephne Call Face-t-face Madrid Letter frm WHO Directr-General requesting assistance All Lcatins Cntainment Measures Sick passengers n aircraft Plicy fr Dealing with Freign Natinals All Players Hand In All Lcatins Clsing Public Event - Media Article Estnia Senir Player Hand In Tallinn Update n Orders fr Vaccine Supply All Players Hand In All Lcatins Opening Scenari fr Blck 2 All Players DVD All Lcatins Newscast Senir Player Senir EC Player Senir Player Senir Player Senir Player Hand In Hand In Hand In All Lcatins Management f Initial Cases Luxemburg Public Cmmunicatins Strategy All Lcatins Brder Clsure Face-t-face All Member Sharing f Infrmatin States, EFTA Cuntries and EC Hand In All Lcatins Schedule f Vaccine Delivery Final reprt 27 March 2006 Page 30 f 35

ID N Insert Date BLOCK 3 Insert Time (GMT) Scenari Day 3.1 24/Nv 13:00 12 Apr 06 Lcal Cntrller 3.2 24/Nv 13:15 12 Apr 06 Lcal Cntrller 3.3 24/Nv 13:20 12 Apr 06 Lcal Cntrller 3.4 24/Nv 14:00 12 Apr 06 France Cntrller 3.5 24/Nv 14:30 12 Apr 06 EVM Cntrller 3.6 24/Nv 15:30 12 Apr 06 Lcal Cntrller Inserted By Given T Insertin Means Insertin Place General Descriptin All Players Hand In All Lcatins Opening Scenari fr Blck 3 All Players DVD All Lcatins Newscast Senir Player Senir France Player Senir EVM Player Senir Player Hand In Face-t-face Paris Face-t-face Brussels Hand In All Lcatins Disruptin f Essential Services - Media article Antivirals and Brder Cntrl Vaccine Prductin Prblem All Lcatins Vaccine Issues: Adverse Event and efficacy Final reprt 27 March 2006 Page 31 f 35