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HOPESTRATEGICNOTES

30March2020

HOPE–EuropeanHospitalandHealthcareFederation1|P a g e

COVID19

–CROSS-BORDERTHREAT–

EUROPEANUNION

OnthebasisoftheTreatyontheFunctioningoftheEuropeanUnion,andinparticularArticle168(5),theEuropeanUnion(EU)actioninthisareaisprimarilyintendedtosupportandcomplementactionstakenbyindividualEUcountries.

Monitoring, early warning, and responsive measures to combat serious cross-border threats tohealth are considered essential elements to ensuring a high level of health protection in theEuropeanUnion.

The present HOPE Strategic Note gives a picture of the EU mechanisms as they were when theCOVID-19crisisstarted.Itshouldhelpunderstandingtheirusetoday.

EUCross-borderAction-legislation ThemainpieceoflegislationtakenonthatgroundwastheDecision1082/2013/EUadoptedin2013toimprovepreparednessandstrengthencapacityforacoordinatedresponsetohealthemergencies.

ItsupportsEUcountriestoprepareforandprotectcitizensagainstpossible futurepandemicsandseriouscross-borderthreatsby:

• Strengtheningpreparedness planning capacityat EU level by reinforcing co-ordination andbestpracticeandinformationsharingonnationalpreparednessplanning;

• Improvingrisk assessment and managementof cross-border health threats including fornon-communicablediseasesforwhichnoEUAgencyisincharge;

• Establishingthenecessaryarrangementsforthedevelopmentandimplementationofajointprocurementofmedicalcountermeasures;

• Enhancing the coordinationof anEU-wide responsebyproviding a solid legalmandate totheHealthSecurityCommitteetoco-ordinatepreparedness;

• Strengtheningthecoordinationofriskandcrisiscommunication,andfosteringinternationalcooperation.

HOPESTRATEGICNOTES

30March2020


CrisisManagement TheDecision:

• Supportssharingbestpracticeandexperienceinpreparednessandresponseplanning;• Provides a backbone for developing national plans to address different types of health

threats;• Helps ensure the inter-operability of national plans – through coordination mechanisms,

analysisandcommunicationtools;• Supports the implementation of core capacity requirements for the WHO International

HealthRegulation(IHR)todetect,assess,report,andrespondtopublichealthemergencies.

Under the EU Health Programme support is provided through training and exercises, and byfacilitatingthesharingofexperiences,guidelinesandproceduresacrossEUcountries.TheEuropeanCommission organises regular exercises to test EU and national preparedness plans. This ensuresthatnationalauthoritiesand institutionsareable towork togetherwith theCommission,andoneanother,toshareinformationintheeventofarapidlyevolvingcrisis.

Publichealthriskassessment ThecoordinatedEUriskassessmentmechanismsinvolvemobilisingexpertisefromrelevantEUandinternational bodies, to provide robust scientificadviceto feed into the process of coordinating aresponse.

As a first step serious cross-border threats to health are notified through theEarlyWarning andResponse system (EWRS). EWRS is a confidential computer system allowing EU countries to sendalertsabouteventswithapotential impacton theEU, to share information, andcoordinate theirresponse.

HealthsecurityCommittee TheEUHealthSecurityCommittee(HSC)wassetupin2001attherequestofEUHealthMinistersasaninformaladvisorygrouponhealthsecurityatEuropeanlevel.In2013theDecisionformalisedandstrengtheneditsrole.

The Committee (see expert group) ismandated to reinforce the coordination and sharing of bestpracticeandinformationonnationalpreparednessactivities.MemberStatesalsoconsulteachotherwithintheCommitteewithaviewtocoordinatingnationalresponsestoseriouscrossborderthreatstohealth, including events declared a public health emergencyof international concernbyWorldHealthOrganisationinaccordancewiththeInternationalHealthRegulations.

HOPESTRATEGICNOTES

30March2020


TheCommitteefurtherdeliberatesoncommunicationmessagestohealthcareprofessionalsandthepublic inorder toprovide consistent and coherent informationadapted toMember States' needsand circumstances. It is chaired by a representative of the Commission, which also provides thesecretariat.

TheHSCconvenes twiceayear forplenary,whileothermeetingsareplannedonanad-hocbasis.Flashreportsandminutesofthemeetingsaremadepubliclyavailable.

OnafacetofacemeetingtheHSCconvenedin2019forthelasttimeon11December2019.

On 21 and 22 January a Health Security Workshop looked at improving preparedness for masscasualtiesfromthedeliberatereleaseofopioids.15memberstatesattendedaworkshoporganisedbytheEuropeanCommission’sDirectorate-General forHealthandFoodSafety (DGSANTE)onthenovelthreatofmasscasualtiesfromthedeliberatereleaseofopioids.

On24JanuarytheEuropeanCommissionpublishedonitswebsitealinktoNovelcoronavirus2019-nCoVnowusedtopresentactivitiesrelatedtothecommonEuropeanresponsetotheoutbreakofCOVID-19.

Themostrecentaudio-meetingoftheHSCwason25March2020.

Riskassessment TheHealthSecurityCommitteecanrequesttheEuropeanCommissiontoprovideariskassessment,includingpossiblepublichealthmeasures.

Theriskassessmentiscarriedoutby:

• EuropeanCentreforDiseasesPreventionandControl(ECDC),ifthethreatisofa)biologicalorigin and consists of communicable diseases or antimicrobial resistance and healthcare-associatedinfections;orb)threatsofunknownorigin;

• EuropeanFoodSafetyAuthority(EFSA),inthecaseofaseriouscross-borderthreattohealthfallingunderitsmandate;

• OtherrelevantEUagencies.

Theriskassessmenttakesintoaccount,ifavailable,relevantinformationprovidedbyotherentities,inparticularby theWorldHealthOrganisation (WHO) in thecaseofapublichealthemergencyofinternationalconcern.

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30March2020


CoordinationofresponseEUnationalauthoritiesare required tonotify theCommission through theEWRSno later than24hours after the discovery of a serious cross-border threat to health. The Commission thenworkscloselywithallEUcountriestoensuretheirresponseiscoherent,andwell-coordinated.AnexampleofEUcoordinationinactionwastheEbolaoutbreakinWestAfrica.

Upon the requestof theCommissionor theaffectedcountryrepresentatives fromnationalhealthservicesconsultwithintheHSCinliaisonwiththeCommission,withaviewtocoordinating:

• Nationalresponsestotheseriouscross-borderthreattohealth• Riskandcrisiscommunication,tothepublicandhealthcareprofessionalstobeadaptedto

nationalneedsandspecificities.

Where one EU country intends to adopt public health measures in response to a serious cross-borderthreat,itmustinformandconsultallotherEUcountriesontheirpurposeandscopebeforeapplying them, unless immediate adoption is essential. In this case, it must inform other EUcountriesandtheCommissionimmediately.

Intheeventofaseriouscross-borderthreattohealthoverwhelmingnational responsecapacities,anaffectedEUcountrymayalsorequestassistancefromotherEUcountriesthroughtheCommunityCivilProtectionMechanism(Decision2007/779/EC,Euratom).

Riskandcrisiscommunication Clear and effective information and communicationwith the public and national authorities is anessentialpartofcrisisresponse.TheEuropeanCommissionseekstoclearlyestablishtheselinesofcommunicationby:

• DevelopingEU-widestrategiesforaction;• Betterintegratingcommunicatorsintothecrisis-managementprocess;• Strengtheningtheircooperationwithdecision-makersandriskmanagers.

TheHSCestablishedacommunicators'networkthatbringstogetherrisk-managementexpertsfromEUcountries, theCommission,andEUagencieswhotake the leadoncommunicationaspectsofahealthcrisis.

Thisnetworkfacilitatescooperation:

• During a crisis – by facilitating the exchange ofinformation from the beginning, andcoordinatingcommonstrategiesandpublicmessaging;

• In the longer term – by facilitating the exchange of best practice on health risks/crisiscommunication,andprovidingrecommendationsforpreventativemeasures.

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30March2020


Thenetworkenables theEU to spread information rapidlyworldwide,byconnectingwithexistingcommunicators'networksunder theGlobalHealthSecurity Initiativeand theWHOnetworkundertheInternationalHealthRegulations(IHR).

JointProcurementofmedicalcountermeasures The outbreak in 2009 of H1N1 pandemic influenza highlighted weaknesses in the access andpurchasing power of EU countries to obtain pandemic vaccines and medications. In 2010, theEuropean Council requested the Commissionto start the preparation ofjoint procurement ofvaccinesintheframeofafuturepandemic.

Provisions for the joint procurement of medical countermeasures are included in Article 5 ofDecision1082/2013/EUonseriouscross-borderthreatstohealth.TheJointProcurementAgreement(JPA)wasapprovedbytheCommissionon10April2014,andasofMarch2020hadbeensignedby26EUcountries,NorwayandtheUK(Swedenon2March,Polandon11March,Norway23March).

TheJPA:

• Determinesthepracticalarrangementsgoverningthemechanism;• Definesthedecision-makingprocesswithregardtothechoiceoftheprocedures;• Organisestheassessmentofthetendersandtheawardofthecontract.

Theaimofthejointprocurementmechanismistosecuremoreequitableaccesstospecificmedicalcountermeasuresandan improved securityof supply, togetherwithmorebalancedprices for theparticipatingEUcountries.

Inordertobeadequatelypreparedforanoutbreakofaseriouscross-borderthreattohealth,theinstitutions of the EU, together with countries that have joined the JPA, may engage in a jointprocurementprocedurewithaviewtopurchase:

• Vaccines;• Antivirals;• Medicalcountermeasuresforseriouscross-borderthreatstohealth;• AllkeydocumentsonJointProcurementofmedicalcountermeasures.

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30March2020


Whatarethemostrecentelements? The Report from the Commission to the European Parliament and the Council (on theimplementationofDecisionNo1082/2013/EUoftheEuropeanParliamentandoftheCouncilof22October2013onseriouscross-borderthreatstohealthandrepealingDecisionNo2119/98/EC)wasmadeavailableon7December2015.

It concluded following theEbolaepidemic that«thecooperationamong the relevantCommissionservicesandthecollaborationwiththeCommissionagenciesandMemberStatestoimplementtheframework provided by Decision 1082/2013/EU has worked well during the period. There iscurrentlynoneedtointroduceanychangesinthisrespect.»

Sincethen,from25to27April2018aWorkshoponStateofplayofpreparednessforseriouscross-borderthreatstohealthintheEUwasorganisedbyDGSANTE.About50expertsfrompublichealthandrelevantothersectorsinchargeoftheircountry’spreparednessandresponseplanningfromEUMemberStates,EEAcountriesandtheRepublicofSerbiaparticipated.OtherCommissionservices,includingDGECHOandDGHOME,aswellasECDC,andinternationalagencies(WHO)alsotookpart.

The aim of the workshop was to support the strengthening of the preparedness and responseplanning under Decision 1082/2013/EU on serious cross-border threats, building cross-sectorialcapacityandsharingbestpracticeandexperiencewithintheEUandwithneighbouringcountries.

Themainobjectivesoftheworkshopwere:

• Totakestockofpreparednesscapacitybuilt inEUMemberStates, identifygapsaswellasstrengths and opportunities to achieve a consistent level of preparedness andinteroperabilitybetweennationalpreparednessplansintheEU;

• TopromoteintersectoralcooperationbetweenMemberStates,atEUandregionallevel,toshareanddiscussbestpractices,andidentifysynergisticapproachesaimingatimplementingefficientcollaborationbetweenthehealthandothercriticalsectors.

• To provide an update on the progress made and discuss gaps and challenges towardsstrengtheningtheimplementationoftheWHOInternationalHealthRegulations(IHR,2005),inviewoftheglobalemergencypreparednesscontext.

This project (JointAction EMERGE)was fundedunder theHealth Programme (2014-2020) but theconclusionsarehardtofind…Scientificpublicationshavebeenmade.

On6June2018theEuropeanCommissionAgencyChafeapublishedabookletChafeabookletonEU-funded actions for better preparedness and coordination in health crisis which is not anymoreavailable on the website of DG SANTE and not easily traceable but can be found on the OfficialPublicationwebsite.

Theevaluation thatwill certainly follow theCOVID-19 crisiswill show if thoseprojectshavebeenusefulinthatcontext.

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