european (legal) studies on-line papers633396,en.pdf · 2019-11-28 · daemmrich, pharmacopolitics:...

CETLSONLINEPAPERSERIES,VOLUME4(3) 2015

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European(Legal)Studieson-linepapersQueen’sUniversityBelfast–SchoolofLaw–CentreofEuropeanandTransnationalLegalStudies

http://go.qub.ac.uk/law-cetls

These on-line papers are part of the programme providedundertheJeanMonnetadPersonamChairheldbyProfessorDagmar Schiek, which was part-funded by the EUCommission from September 2011 to August 2014(UniversityofLeeds)

This paper is the pre-print version of a book chapter, andwill be published in: D. Kochenov (ed.),EU Citizenship andFederalism: The Role of Rights (Cambridge: CambridgeUniversityPress,forthcoming2016)

MARKL.FLEAR

ReframingEUPublicHealthGovernance:FromRisk toCitizenshipandParticipationVolume4,Issue3,2015


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Reframing EU Public Health Governance: From Risk toCitizenshipandParticipation

MarkL.Flear∗

I.IntroductionRisk is thedominant framefor theEuropeanUnion’s (EU’s)growingalbeitoftenoverlookedpublichealthgovernance.1Thestartingpointforthischapteristhedistortionofpublichealthprioritiesbyandwithinthisframe.Iarguethatexistingeffortstoidentify,underlineandtacklethedistortionscanbestrengthenedbyreframinggovernanceasamatterofcitizenshipsoastodevelopcitizenpartici-pationindecisionmaking.ThechapterthereforeseekstoaddtodiscussiononEUcitizenshipwithinthis collectionandbeyond,which focuseson judicialdiscourseon interalia rights, responsibilities,needsandentitlements.2Thechapternotonlyraisesawarenessofbutalsooffersanovelproposalformobilisingthediscursivepotentialofkeyelementsofcitizenshipforparticipation.

Inthenext(second)section,IexplainhowEUgovernanceanditsframearefoundeduponArticle168TreatyontheFunctioningoftheEU(TFEU),3elaboratedinpolicystatements,andrelatedtothepro-duction and legitimation of the broader project of European integration. The frame depoliticises,rendersasnaturalandobscuresthetruescopeofEUgovernanceanditsdistortionofpublichealthpriorities. These latter include the skewing of attention and resources towards addressing conse-quencesthrougheffortstocombatrarercommunicablediseases,insteadoftherootcausesthatarevitaltotacklingfarmorecommonanddeadlymajorandchronicdiseases.Thisdistortionofprioritiesis similar to thebroaderglobal trendofemphasisinghealth securityaboveother importanthealthconcerns. Most notable in that regard are the World Health Organisation’s (WHO) InternationalHealthRegulations(IHR)(applicabletotheEU)4andtheGlobalHealthSecurityInitiative(withwhichtheEUcooperates),5bothofwhichattempttostrengthenhealthpreparednessandresponsegloballyinordertoaddressallhazards.

Citizenparticipationindecisionmakingispartofattemptstoidentifyandcorrectdistortionsofregu-latoryprioritiesandenhancetrust inrisk-basedgovernance.However,participationtendstobean

∗Queen’sUniversity Belfast. This paper profited from valuable suggestions byDimitry Kochenov and the anonymouspeerreviewers,whicharegratefullyacknowledged.ManythankstoDagmarSheikfortheopportunitytopresentthepre-publishedversionofthechapterasaCETLSonlinepaper.Theusualdisclaimerapplies.

1SeefurtherM.L.Flear,GoverningPublicHealth:EULaw,RegulationandBiopolitics(Oxford:HartPublishing,2015).

2Inparticular:A.CornwallandV.SchattenCoelho(eds.),SpacesForChange?:ThePoliticsofCitizenParticipationinNewDemocratic Arenas (London: Zed Books, 2007); H.-U. Jessurun d’Oliveira, ‘European Citizenship: Its Meanings, itsPotential’,inR.Dehousse(ed.),EuropeAfterMaastricht:AnEverCloserUnion?(Munich:LawBooksinEurope,1994);D.Kostakopoulou,TheFutureGovernanceofCitizenship(Cambridge:CambridgeUniversityPress,2008);J.Shaw,‘TheManyPasts and Futures of Citizenship in the European Union’ (1997) 22 European Law Review 554; A.Wiener, ‘European’CitizenshipPractice:BuildingInstitutionsofaNon-State(Oxford:OxfordUniversityPress,1998).

3ConsolidatedversionoftheTreatyontheFunctioningoftheEuropeanUnion(TFEU),OJ2012No.C326/47.

4 International Health Regulations (WHA58/2005/REC/1, 23May 2005) (IHR). These requireWHOMember States tonotifytheWHOofanypotentialinternationalpublichealthemergencyandareapplicabletotheEUunderArticle57(1)IHR,whichstatestheIHRandEUTreaties‘shouldbeinterpretedsoastobecompatible’.

5See‘GlobalHealthSecurityInitiative’,http://www.ghsi.ca/english/index.asp.


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underdevelopedandunderpoweredgovernancetool.6LaterinthesecondsectionIpointoutthatalargepartoftheexplanationforthisisthewayinwhichdecisionmakinginrisk-basedEUgovernanceissupportedbyandnecessitatesthegatheringandproductionofscientificandtechnicalknowledge.The latter inturnvalorisesthose inpossessionoftheexpertiseto interpretthatknowledgeforthedeterminationofpublichealthrisks.Inshort,theframingofgovernancebyriskoperates‘top-down’withcomplementarydiscoursesandtechniquestoobscurethestakesforcitizenparticipationinde-cisionmakingwhilealsolimitingitsregulatoryrolethroughtheveryproceduresthatseektofacilitateit.

Ibeginthethirdsectionbynotinghowthefocusonproceduresandalimitedviewontheregulatorypotentialofparticipationisalsofoundinlegalandregulatorystudiesscholarship.Afterwhichbyref-erencetoscienceandtechnologystudies(STS),sociologyandanthropologyIunderlinethevalueofandpotentialfor‘bottom-up’engagementandparticipation.Arelatedkeycontributionofthechap-ter,therefore,istowardsthegrowingbodyofliteraturewhichseekstofrustratethelaw/sciencedis-ciplinarydemarcationsthatlimittheengagementofmuchlegalandregulatorystudiesscholarshipinteasingoutthenormativeanddemocraticimplicationsofthescientificandtechnical.7BydrawingonthesecognatedisciplinesIpointouthowthedistortionofpublichealthprioritiesbyrisk-basedgov-ernance,andtheimportanceofthatgovernanceforthelegitimationoftheEUandthewiderprojectofEuropeanintegration,createspossibilitiesforusingcomponentsofcitizenshipaspartof‘bottom-up’effortstodevelopcitizenparticipationindecisionmaking.

WiththisinmindIturntooutlinemyproposalforaugmentingcitizenparticipationasatoolofgov-ernance.Ipointtocitizenship’spotentialtoreframepublichealthasafieldforcitizenparticipationinlegalandregulatorydecisionmaking,publicdiscussionanddemocraticcontestation.Thediscussionisbasedonanunderstandingof(EU)citizenshipasatechnologyofgovernance(thatis,asanassem-blageofcomponents).Thesecomponentsgobeyondformalrightsrecognised intheEU’sconstitu-tional legal order – such as Article 35 EU Charter of Fundamental Rights (CFR)8 on the right tohealthcare,theEuropeanConventionofHumanRights9andwiderhumanrightsprovisions–toen-compassbioethics,otherdiscourses, techniques,processesandpracticesof governance,which to-gethershapeandprovidetheconditionsofpossibilityforandmediaterelationsbetweenthosesub-jecttoandgovernedbyformallyaccountablepower(suchastheEU).10Inthisunderstandingthe‘cit-izens’mentionedinthischaptercomprisemorethanthosewithrightsundertheEUTreaties11toin-

6 For discussion see: D. Held, ‘Between State and Civil Society: Citizenship’, in G. Andrews (ed.),Citizenship (London:LawrenceandWishart,1991).Citizenandpublicparticipationtendtobeusedinterchangeablyinscholarship:M.L.Flearand M. D. Pickersgill, ‘Regulatory or Regulating Publics? The European Union’s Regulation of Emerging HealthTechnologiesandCitizenParticipation’(2013)21MedicalLawReview39.

7 For instance: E. Cloatre and M. Pickersgill (eds.), Knowledge, Technology and Law (London: Routledge, 2014); A.Daemmrich,Pharmacopolitics:DrugRegulation in theUnited StatesandGermany (ChapelHill,NC:UniversityofNorthCarolinaPress,2006);S. Jasanoff(ed.),ReframingRights:BioconstitutionalismintheGeneticAge (Cambridge,MA:MITPress,2011).

8CharterofFundamentalRightsoftheEuropeanUnion(CFR),OJ2012No.C326/391.

9TheCFRisgiventhe‘samelegalvalueastheTreaties’underArt.6(1)TEU,respectforhumanrightsismentionedinArt.2TEU,andArt.6(3)TEUmakes‘fundamentalfreedoms’asguaranteedbytheECHR(withaccessionprovidedforunderArt.6(2)TEU)and‘constitutionaltraditionscommontotheMemberStates’,generalprinciplesofEUlaw.

10J.Newman(ed.),RemakingGovernance:Peoples,PoliticsandthePublicSphere (Bristol:PolicyPress,2005);A.Ong,NeoliberalismasException:MutationsinCitizenshipandSovereignty(Durham,NC:DukeUniversityPress,2006).

11 In particular Art. 20(1) TFEU states ‘[c]itizenship of the Union is hereby established. Every person holding thenationality of aMember State shall be a citizen of theUnion. Citizenship of theUnion shall be additional to and not


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cludethosethataresubjecttoandenfoldedwithinEUgovernanceandcomprise‘thegoverned’,butwhocanreflexivelyengagewithandgenuinelyshare inpower inordertoshapeandsteergovern-ance.12

Tobeclear,Iamnotproposingthewholesalereplacementofriskbycitizenshipasthemostappro-priatevalueforthedeterminationandregulationofpublichealthrisks.Rather,inthischapterIpointto thepotential of human rights andbioethics – two important regulatorydiscourses and compo-nentsofcitizenship–toanimateandpower‘bottom-up’engagementbycitizensandassistthemintheidentificationandunderliningofdistortionsingovernancepriorities.Onceidentifiedandarticu-latedthroughhumanrightsandbioethics,thedistortionsofgovernanceprioritiesor ‘societalrisks’(i.e.threatsordangerstosociety)canbetransformedintosupplementaryknowledgeon‘institution-alrisks’(i.e.morethanthelegalriskoflitigation,theseincludebroaderthreatsordangerstostand-ingand reputation).13Suchknowledgeof risksnotonly threatens toundermineperceptionsofEUpublichealthgovernancebutalsotodisruptthelegitimationandperpetuationoftheEuropeaninte-gration project. It is the threat of de-legitimation which could impel the integration of citizenknowledge into decision making. The discursive strategy for citizen participation outlined in thischapterpromisestorevealthefullscopeandimplicationsofEUgovernance,enhanceaccountabilitythroughattemptstodemandandcontestthefulfilmentofEUresponsibilities,reshapeandrebalancegovernancepriorities,andimproveregulatoryinterventionsinpublichealth.

II.FramingEUPublicHealthGovernanceasaMatterofRisk

A.LegalCompetence,GovernanceandResponsibilityRiskisconstructedasthedominantframefortheEU’spublichealthgovernancethroughlimitedlegalcompetencewhichiselaboratedinpolicyinordertodelineatetheboundariesofresponsibilityandaccountabilityintheeventoffailure.14ThediscussioninthischapterconcernsEUpublichealthgov-ernancebaseduponArticle168TFEU,ratherthanabroaderconsiderationofthevariousareasofEUcompetencewhich together relate to public health. The internalmarket is probably themost im-portantexampleofanareaofEUcompetencethatrelatestopublichealthand,asIshallnotebelow,Article168playsanimportantroleinfacilitatingitsfunctioning.15Article168(1)TFEUstatesa‘highlevelofhumanhealthprotectionshallbeensured inthedefinitionandimplementationofallUnionpoliciesandactivities’(emphasisadded).Article168(1)isamorespecificinstanceofArticle9TFEU,whichstates‘theUnionshalltakeintoaccountrequirementslinkedto[…]ahighlevelof…protectionofhumanhealth’(emphasisadded)inthedefinitionandimplementationofitspoliciesandactivities.

replacenationalcitizenship’.

12 Foundational to the understanding of citizenship informing the discussion in this chapter is Foucault’s notion thatpowerisrelationalanddispersedthroughoutsociety, includingits institutionsanddiscourses,see:M.Foucault,Power,EssentialWorksofFoucault1954–1984,Volume3(London:Penguin,2002),especially‘Governmentality’.Seefurtherthereferencesinnotes83–86below.

13 Fordiscussion seeH.Rothstein,M.Huber andG.Gaskell, ‘A TheoryofRiskColonisation: The SpirallingRegulatoryLogicsofSocietalandInstitutionalRisk’(2006)35EconomyandSociety91.

14Fordiscussionofrisk-basedregulationandresponsibilityseeJ.Black, ‘TheEmergenceofRisk-BasedRegulationandtheNewPublicRiskManagementintheUnitedKingdom’(2005)PublicLaw512.

15TheestablishmentoftheinternalmarketisrequiredbyArt.3(3)TEU,whichisdefinedinArt.26(2)TFEUas‘anareawithout internal frontiers in which the free movement of goods, persons, services and capital is ensured […]’. FordiscussiononthisandArt.168TFEUseeFlear,GoverningPublicHealth,note1above,ch.2.


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Theseprovisions reflectArticle35CFRontheright tohealthcare, the finalpartofwhichstates: ‘AhighlevelofhumanhealthprotectionshallbeensuredinthedefinitionandimplementationofalltheUnion’s policies and activities’ (emphasis added). According to the ExplanatoryNote for Article 35thisfinalsentencetakesoverArticle168(1).ConsistentwithArticle6(a)TFEU,EUactioninhealthisonlycomplementarytoMemberStatepolicies,and itmustbeof ‘addedvalue’ tocomplywiththeprinciplesofsubsidiarity16andproportionality17underArticle5TreatyonEuropeanUnion(TEU).18

The limitednatureof EUcompetence is evenmoreapparent inArticle168(1)(2) TFEU,whichpro-videsthatEUaction:

shallbedirected towards improvingpublichealth...obviatingsourcesofdanger tophysicalandmental health. Such action shall cover the fight against themajor health scourges, bypromotingresearchintotheircauses,theirtransmissionandtheirprevention,aswellashealthinformationand education,andmonitoring, earlywarningof and combating serious cross-borderthreatstohealth.(Emphasisadded)

ThisprovisionmakesclearthatEUcompetenceextendsbeyondeffortstoaddressthesocialdeter-minantsof ill healthand topromotepreventionof themajorpublichealthproblems,19 to includespecificmentionofpandemicsandotherseriouscross-borderthreats,20 throughthegatheringandproductionof scientificand technicalknowledgeon those threats.However, theclear limitsonEUcompetencearefurtherunderlinedbytherequirementthattheEUmustalsorespectMemberStateresponsibilities over ‘the definition of their health policy and for the organisation and delivery ofhealthservicesandmedicalcare’(emphasisadded)inArticle168(7)TFEU.AfulleranalysiswouldofcourseextendbeyondtheEUleveltolookat interactionsbetweenmultiple levelsofgovernance.21Suchananalysisisnotpossibleinthischapterlengthpiece,whichinanycaseseekstoshedlightontheEUlevelasakeyalbeitoftenoverlookedpartofthatwiderdiscussion.22

WithinthelimitsonEUactionfoundinArticle168TFEUtherearecertainprioritiesforregulatoryat-tention.Specifically,Article168(2)TFEUprovidesthelegalbasisforencouragingcooperationandtheadoptionofmeasures,includingguidelinesandindicators,theexchangeofbestpractice,andmech-anismsforperiodicmonitoringandevaluation.AlthoughArticle168(5)TFEUprecludestheadoptionofharmonisationmeasures,itprovidesfortheadoptionof‘incentivemeasuresdesignedtoprotectand improve human health and in particular to combat the major cross-border health scourges,measures concerning monitoring, early warning of and combating serious cross-border threats tohealth’(emphasisadded).InbuildingonArticle168(1)(2)TFEUtogivepandemicsandotherseriouscross-borderthreatsspecialattention,thelatterprovisionpavesthewayforafocusoneffortstoen-

16Art.5(3)TEU.

17Art.5(4)TEU.

18ConsolidatedversionoftheTreatyonEuropeanUnion(TEU),OJ2012No.C326/13.19ForexamplecancerandHIV/AIDS,seeFlear,GoverningPublicHealth,note1above,chs.3and4respectively.

20Seeibid.,ch.5.

21 Thediscussion focuses on the EU level,which is one level of themulti-level systemof governance. See further: L.HoogheandG.Marks,MultilevelGovernanceandEuropeanIntegration(Oxford:Rowman&Littlefield,2001).

22 The literature on the ‘democratic deficit’ is vast and some of the most salient examples include: C. Harlow,AccountabilityintheEuropeanUnion(Oxford:OxfordUniversityPress,2002);G.Majone,‘Europe’s“DemocraticDeficit”:The Question for Standards’ (1998) 4 European Law Journal 5; F. W. Scharpf, Governing in Europe. Effective andDemocratic?(Oxford:OxfordUniversityPress,1999).


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surepreparednessand response.An importantpieceof legislationadoptedunderArticle168(5) isDecision1082/2013/EU23onseriouscross-borderthreatstohealth,24whichisintendedtostrengthensurveillance and control, and reflects the IHR.25 This skewing of priorities towards cross-borderthreatsissupportedbyandhelpstoexplainArticle168(3)TFEU,whichprovidesthatboththeEUanditsMemberStates‘shallfostercooperationwiththirdcountriesandthecompetentinternationalor-ganisations inthesphereofpublichealth’(emphasisadded).Overall,Article168TFEUprovidesthescope for greater cooperation and coordination betweenMember State law and policy and thusmoreintrusiveengagementinpublichealth.Theoverridingconcerniswiththecirculationofpeopleandthingswithinandintotheinternalmarketbyregulatingthedangersorthreatsthatthreatentoundermineitsoptimalfunctioning.

2007’sTogetherforHealth:AStrategicApproachfortheEU2008–201326buildsontheformallegalbasistoconstructriskasthedominantframeofpublichealthgovernance.TheEU’sstrategypurportsto ‘givedirection toCommunityactivities inhealth’.27The rationale forEUactionbuildsonArticle168TFEUinstatingthatthe:

Member States have themain responsibility for health policy and provision of healthcare toEuropeancitizens.TheEC’s[EuropeanCommunity’sandnowtheEU’s]roleisnottomirrororduplicate their work. However, there are areas where Member States cannot act aloneeffectively andwhere cooperative action at Community level is indispensable.These includemajor health threats and issues with a cross-border or international impact, such aspandemicsandbioterrorism,aswellas those relatingto freemovementofgoods, servicesandpeople.28(Emphasisadded)

EUcompetenceisunderscoredassupportingandcomplementarytothatoftheMemberStatesandfocusedongenerating ‘addedvalue’ throughcooperationto tacklepublichealthproblems.Amongthe latter,pandemicsandothercross-border threats to thecirculationofpeopleandthingswithinand intothe internalmarketare foregrounded.Althoughattentionto thesocialdeterminantsof illhealth remains important via prevention efforts, the rationale for EU action builds on Article 168TFEUtofacilitatetheprioritisationofpreparednessplanningandresponse.Asseenin,forexample,PandemicInfluenzaPreparednessandResponsePlanningintheEuropeanCommunity,this isaimed

23 Decision No.1082/2013/EU of the European Parliament and of the Council of 22October 2013 on serious cross-borderthreatstohealthandrepealingDecisionNo2119/98/EC,OJ2013No.L293/1.

24 These are definedbyArt. 3(g)DecisionNo.1082/2013/EUon serious cross-border threats to health and repealingDecisionNo2119/98/EC,OJ2013No.L293/1,as ‘a life-threateningorotherwiseserioushazardtohealthofbiological,chemical,environmentalorunknownoriginwhich spreadsorentailsa significant riskof spreadingacross thenationalborders ofMember States, andwhichmay necessitate coordination at Union level in order to ensure a high level ofhumanhealthprotection’.

25 Recital 6 of the Preamble to Decision No.1082/2013/EU on serious cross-border threats to health and repealingDecisionNo2119/98/EC,OJ2013No.L293/1.

26EuropeanCommission, ‘WhitePaper,Together forHealth:AStrategicApproach for theEU2008–2013’,COM(2007)630final.27Ibid.,p.3.

28Ibid.,p.2.TheECalongwiththeothertwopillarsoftheEUwereintegratedintoasinglestructureandbecamesimply‘the’EUwiththecomingintoforceoftheTreatyofLisbonon1December2009.


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atensuringthereadinessandresilienceofessentialgovernanceinfrastructuresinthefaceofemer-gencies.29

Elsewhere,rarermajorthreatsareprioritisedasoneofthemainchallengestobeaddressedbyTo-getherforHealth:

pandemics, major physical and biological incidents and bioterrorism pose potential majorthreatstohealth.Climatechange iscausingnewcommunicablediseasepatterns. It isacorepart of the Community’s role in health to coordinate and respond rapidly to health threatsglobally and to enhance the EC's [European Community’s and now the EU’s] and thirdcountries’ capacities to do so. This relates to the [European] Commission's overall strategicobjectiveofSecurity.30(Emphasisadded)

MorebroadlyTogetherforHealthconfigurespublichealthgovernancewithinandordersitsprioritiesinaccordancewiththeoverarchinggoalofgeneratingeconomicoptimisation,growthand jobs. In-deed: ‘This Strategy reinforces the importanceofhealth inpolicies suchas theLisbonStrategy forGrowth and Jobs, emphasising the links between health and economic prosperity’.31Moreover, achiefobjectiveofTogetherforHealthisthatit‘supportstheoverallEurope2020strategy’32(empha-sis added)which ‘aims to turn the EU into a smart, sustainable and inclusive economypromotinggrowthforall–oneprerequisiteofwhichisapopulationingoodhealth’33(emphasisadded).Inotherwords,awiderfunctionoftherisk-basedgovernanceofpublichealthistheproductionandpublicle-gitimationofaveryspecificvisionof theEU’ssociopoliticalorderasbeingbasedonthateconomyandinturntheprojectofEuropeanintegration.34

B.ObscuringtheScopeandImplicationsofEUResponsibilityandLimitingCitizenParticipationUsing riskas the framedepoliticisesandnaturalisespublichealthgovernanceand (likeany frame)shapes perceptions ofwhat constitute relevant, effective and legitimate solutions to public healthproblems.35Abettedbythefactthatmostpublichealthandhealthcareinfrastructuresare(formallyspeaking)partsofMemberStateresponsibilities,theframeobscuresthetruereachofEUpowerandresponsibilityanditsnormativeimplications.Themainconcernisthatframingpublichealthbyriskdistorts regulatoryattentionandresourcestowardsaddressingconsequences insteadof thesocial,politicalandeconomiccausesofpublichealthproblems.36Thisabetstheprivilegingofcommunica-blediseasesandespeciallyrareronesthrougheffortstoensurethepreparednessofgovernancein-frastructuresinthefaceofcross-borderpublichealthemergencies.Theprivilegingofcommunicablediseasesalsomarginalisesmajorandchronicdiseasessuchascancer,heartdiseaseandobesity–the

29EuropeanCommission,‘CommunicationonpandemicinfluenzapreparednessandresponseplanningintheEuropeanCommunity’,COM(2005)607final.

30EuropeanCommission,‘TogetherforHealth’,COM(2007)630final,p.3.

31Ibid.,p.2.

32‘Healthstrategy’,http://ec.europa.eu/health/strategy/policy/index_en.htm.

33Ibid.

34Black,‘TheEmergence’,note14above,519.

35 F. Fischer, Reframing Public Policy: Discursive Politics and Deliberative Practices (Oxford: Oxford University Press,2003);D.A.SchonandM.Rein,Frame/Reflection:TowardtheResolutionofIntractablePolicyControversies(NewYork,NY:BasicBooks,1994).Seefurther:Flear,note1,Chapter8.

36Seefurther:Flear,GoverningPublicHealth,note1above,ch.7.


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diseases which cause the vast majority of morbidities and mortalities37 – and prevention effortswhich address their underlying social determinants, including those ofother (rarer) health threatssuchaspandemics.Thisdistortionofattentionandprioritiesalsosuggeststhatthefearofpotentialharmarisingfromsuchoftenhighlyuncertain(andbecauseofthatprobablyscarier)threatscreates‘institutionalrisks’(suchastostandingandreputation)thatensurestheirmanagementisprioritisedoverthatoffarmorelikely‘societalrisks’(threatsordangerstosociety).38

EUlevelgovernancealsoshapestheconditionsforandlegitimatestheselectionofinterventionsattheMemberStatelevel.Thefocusofrisk-basedgovernanceonregulatingdangersorthreatstothecirculationofpeopleandthings(i.e.regulatingfreemovement)isaparticularinstanceofsecurity–andthatfavourssecurity-orientedresponseswhichareoftenplacedinazero-sumrelationshipwithhuman rights andbioethicsprotections.Risk-basedgovernancealso responsibilises individuals andtargetsthemforblameandregulationthroughparticularlyintrusiveinterventionsincludingcriminallaw sanctions.39 The history of public health demonstrates that it is individuals who are part ofgroups already the subject of social opprobrium,marginalisation anddiscriminationwhoaremostlikely tobe targeted, and that includes itinerant groups40 and thosewhohavebecomeassociatedwithparticulardiseases,suchasHIV/AIDS.41Giventheabsenceofburdensonallthesetargetedin-terventionsarelikelytoremainuncontestedbythemoregeneralpopulation.Moreover,thefocusonmanagingpublichealthemergenciesmeansthatmagicbulletmedicalresponsestendtobefavouredoverpopulation level interventionswhich target rootcauses.Forexample, testingkits, vaccinationandtreatmentadministeredbytriagehavebeenthedominantresponsetopandemicinfluenzaandother rare and emerging diseases, rather than sustained prevention effortswhichwould improvepreparednessandresponseinthelongterm.

Citizenparticipationindecisionmakingispartofattemptstoidentifyandcorrectdistortionsofregu-latoryprioritiesandenhancetrust inrisk-basedgovernance.Therearetwonotableattemptsto in-clude citizens indecisionmaking in theEU’spublic healthdomain. The first example is impact as-sessment(IA),atoolthatisaimedatintegratingconsiderationoftheimplicationsofregulationandpolicy inrelationtopolicydomains– includingpublichealth–and it ‘takes intoaccount inputofawiderangeofexternalstakeholders,inlinewiththeCommission’spolicyoftransparencyandopen-ness towards other institutions and the civil society’42 (emphasis added). IA is about ‘[g]atheringopinionsandinformationfrominterestedparties[and]isanessentialpartofthepolicy-developmentprocess,enhancingitstransparencyandensuringthatproposedpolicyispracticallyworkableandle-

37Forexample,over80%ofdeathsintheWHOEuroperegionareattributableto(generallynon-communicable)majorandchronicdiseases,seeR.Busseetal.,TacklingChronicDiseaseinEurope(WorldHealthOrganisation,2010),p.10.

38SeeRothstein,HuberandGaskell,‘ATheoryofRiskColonisation’,note13above.

39 J. Montgomery, ‘Medicalising Crime – Criminalising Health? The Role of Law’, in C. A. Erin and S. Ost (eds.), TheCriminalJusticeSystemandHealthCare(Oxford:OxfordUniversityPress,2007).

40 For instance: R. Bivens, ‘“The EnglishDisease” or “Asian Rickets”?Medical Responses to Postcolonial Immigration’(2007)81BulletinoftheHistoryofMedicine533;L.Eichelberger, ‘SARSandNewYork’sChinatown:ThePoliticsofRiskandBlameDuringanEpidemicofFear’(2007)65SocialScience&Medicine1284.

41Theinitialprevalenceofthediseaseamongstmenwhohavesexwithmengaverisetothesyndrome’s initialname(Gay-Related ImmuneDeficiencyorGRID) andwhile thename changed and the link has faded, it has provenhard todissolve,evenasitincreasinglyaffectsimmigrantsfromsub-SaharanAfrica,anothermarginalisedgroup.Seefurther:D.F.Musto,‘QuarantineandtheProblemofAIDS’(1986)64MilbankQuarterly97.

42EuropeanCommission,‘ImpactAssessmentGuidelines’,SEC(2009)92,p.6.


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gitimatefromthepointofviewofstakeholders’43(emphasisadded).IAispartofthewiderprocessofshaping the involvement of stakeholders and the definition of their ‘stake’ as well as what is ‘atstake’withintheframeworkofrisk.

Thesecondexample is the ‘dialogueandcollaboration’aroundrisk in thecontextofpublichealth,whichisrecognisedaspartofthe‘newchallengesforriskassessment’,firstunderlinedinEuropeanGovernance(andnotedagainbelow).44Acentralconcernisthat‘[p]ublicopinionhasbecomemoresceptical about the neutrality and effectiveness of science, and there is a growing call for moretransparency’.45Atthesametime,emergingrisksbroughtaboutbytechnologicaldevelopmentsandrarediseasesunderminetheproductionofdataandcauseriskassessorsto‘adaptandapplyappro-priatetoolstoevaluatenewrisks’.Inordertoaddress‘thisincreasedcomplexity’,DGSanté(therel-evantpartoftheCommission,whosenamechangedfromDGSANCOin2014)has‘initiatedriskas-sessmentdialogues’.46However,attheEUlevel,dialogueandcommunicationinrelationtoriskas-sessmentfocusesonrelatingtheviewsofrelevantindividuals–aswiththefirstexample,theseareusually termed ‘stakeholders’ – to scientific and technical knowledge and expertise in order togroundrisk-baseddecisionmaking.47

C.KeyUnderpinningsofCitizenParticipationTheaforementioneddistortionsofregulatoryprioritiessuggestthatcurrentattemptstoidentifyandcorrectregulatoryprioritiesaswellascitizenparticipationindecisionmakingarefarfromadequate.Partofthereasonforthelimitedregulatoryroleforparticipationistheframingofpublichealthasamatterofrisk,whichoperates ‘top-down’toobscureandlimitthesubstanceandstakesforcitizenparticipationindecisionmakingandthespacefordemocraticpolitics.Anotherimportantconstrainton citizen participation arises from the centrality and valorisation of scientific and technicalknowledge and expertise to legal and regulatory decisionmaking. The latter reflects an expert ra-tionality–the‘quasi-guardianship’ofscientificexperts48–whichalthoughunderstandable,implicitlydevaluesand limits thescopeandpotential forandcontributionofcitizenparticipation indecisionmaking.Althoughimpliedintheconstructionofarisk-basedframeforgovernance,thecentralityofscientificandtechnicalknowledgeandexpertise inthepublichealthdomain isunderscoredbythefollowing:

When preparing its policy and proposals relating to consumer safety, public health and theenvironment, the Commission relies on independent Scientific Committees to provide it withsound scientific advice and draw its attention to new and emerging problems. The ScientificCommitteescancallonadditionalexpertisefromapoolofscientificadvisorsandadatabaseofexperts.49

43EuropeanCommission,‘ImpactAssessmentGuidelines’,SEC(2005)791,p.9.

44EuropeanCommission,‘EuropeanGovernance:AWhitePaper’,COM(2001)428final.

45‘Newchallengesforriskassessment’,http://ec.europa.eu/health/dialogue_collaboration/policy/index_en.htm

46Ibid.47Ibid.

48R.A.Dahl,DemocracyanditsCritics(NewHaven,CT:YaleUniversityPress,1989),p.335.

49‘ScientificCommittees’,http://ec.europa.eu/health/scientific_committees/policy/index_en.htm.


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In otherwords, the framing of public health by risk establishes, configures and legitimates hierar-chies and relationshipsbetween scientific and technical knowledgeandexpertise, governanceandregulation,andcitizens.

Thelimitedregulatoryroleofcitizenparticipationisalsobaseduponparticular(andnotunrelated)rationalesfortheinclusionofcitizensinandtheircapacitytocontributetowardsdecisionmaking.Aswithmuchlegalandregulatorystudiesscholarshiponparticipationindecisionmaking,thetwoex-amplesnotedabovefocusonprocedureswhichappeartoprovideopportunitiesforcitizenparticipa-tion,butwhichactuallyregulatecitizensintoprovidingpublic legitimation.50EUlawprovidessomeofthekeyunderpinningsforparticipation:itisproclaimedasacorevalueintheEU’sTreaties,51in-cludingintheEuropeanCitizens’Initiative(atransnationalinstrumentofparticipatorydemocracy52),andinflectedintheCFR.53TheselegalfoundationshavebeenbolsteredbytheAarhusConvention54anditsimplementationinEUlaw,forinstance.55Thelatterinstrumentfocusesonsupportingpartici-pationtoaddresstheenvironmentalimpactsofnewtechnologies,andit isthereforeoflimitedim-portancetopublichealthasitdoesnotdealwiththewidercausesofdiseaseandinfirmity.

Non-binding policy statements are evenmore important to the underpinnings of citizen participa-tion.ThesestatementsfocusmoreclearlyonintegratingparticipationwithinproceduresfortheEU’srisk-baseddecisionmaking and configuring it in relation to scientific and technical knowledge andexpertise.56 Themost important policy statements include the aforementioned European Govern-ance,whichin2001calledforopennessandtransparencyinexpertworkandenhancedpublicpartic-ipation.The latter is tobeachievedpredominantly through theconsultationof stakeholders57 inaprocessofscience-baseddecisionmaking(asintheaboveexamples).58Thecentralobjectiveofthesemovesistoreinforceaccountability,engenderorrestorepublictrustandconfidenceinexpertiseaf-tercrisessuchasthoseoverBSE(bovinespongiformencephalopathy)andGMOs(geneticallymodi-fiedorganisms), and tobolster the legitimacyofgovernanceand in turn, theEU’s integrationpro-ject.59Likewiderattemptstofacilitatecitizeninvolvementinthegovernanceoflifeandsciencena-

50Forareviewsee:FlearandPickersgill,‘RegulatoryorRegulatingPublics?’,note6above.

51Forinstance,democracyisreferredtoasavalueinArt.2TEUandarighttoparticipationinthedemocraticlifeoftheEUinArt.10(3)TEU.

52EstablishedbyArt.11(4)TEUandArt.24(1)TFEU.See:J.Mendes,‘ParticipationandtheRoleofLawAfterLisbon:ALegalViewonArticle11TEU’(2011)48CommonMarketLawReview1849.

53Specifically,Art.25‘recognisesandrespectstherightsoftheelderlytoleadalifeofdignityandindependenceandtoparticipateinsocialandculturallife’whileArt.26‘recognisesandrespectstherightofpersonswithdisabilitiestobenefitfrommeasuresdesignedtoensuretheirindependence,socialandoccupationalintegrationandparticipationinthelifeofthecommunity’(bothemphasisadded).

54ConventiononAccesstoInformation,PublicParticipationinDecision-MakingandAccesstoJusticeinEnvironmentalMatters,Aarhus,25June1998,enteredintoforce30October2001,2161UNTS447.

55 For example: Council Decision 2005/370/EC of 17 February 2005 on the conclusion, on behalf of the EuropeanCommunity,oftheConventiononaccesstoinformation,publicparticipationindecision-makingandaccesstojusticeinenvironmentalmatters,OJ2005No.L124/1.

56Fordiscussion,see:U.Feltetal.,TakingEuropeanKnowledgeSocietySeriously:ReportoftheExpertGrouponScienceandGovernance(Luxembourg:OfficeforOfficialPublicationsoftheEuropeanCommunities,2007),p.52.

57EuropeanCommission,‘TowardsaReinforcedCultureofConsultationandDialogue–GeneralPrinciplesandMinimumStandardsforConsultationofInterestedPartiesbytheCommission’,COM(2002)704final.

58EuropeanCommission,‘EuropeanGovernance:AWhitePaper’,COM(2001)428final,p.8.

59 See, relatedly: G. Sundqvist, ‘Recovery in the Acid Rain Story: Transparency and Credibility in Science-BasedEnvionmentalRegulation’(2003)5JournalofEnvironmentalPolicyandPlanning57.


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tionallyand internationally60– includingdevelopingawarenessoftherelationshipwiththerighttohealth61– theEU’sapproach focusesonareasof riskandscientificuncertaintyandrecognises theneedtotakesocietalconcernsintoaccountthroughtheinputofthosewhoareaffectedbydecisionmakingwhichcannotbebasedonsciencealone.However,asthedetailsofthepolicyreveal,partici-pationhasalimitedregulatoryrole.

Anotherkeydocument,ScienceandSocietyActionPlan,62containssimilarthemestothoseapparentwithin European Governance and related documents.63 Supported by Public Understanding of Sci-ence(PUS)techniqueswhichactivelyseektomeasurepublicopinionandknowledge,64suchastheEurobarometer,65thisdocumentworkstoclarifycitizen/sciencerelationsintheEUandtheirconfigu-ration to decision making. A related technique is public consultation questionnaires, for instancethroughtheStakeholderConsultationonStrengtheningEuropeanUnionPreparednessonPandemicInfluenza.66 These kindsof techniques areused toproduce statistics and reports on strengtheninggovernance,buttheyalsoinvokecitizens,theirunderstandingofpublichealthscience,andthereforethe appropriate relationship between citizens and governance. So-called ‘absent presences’,67 citi-zensarerepresentedand imaginedbyEUactorssoastoprovideademocraticbasis fortheirdeci-sions.Assuch,thefocusisoncommunicationefforts,especiallythroughthepromotionofscientificeducationandculture,publicawarenessandthedevelopmentofresponsiblepoliceswhichwinwid-erconfidenceindecisions.Together,theseconstructa‘deficitmodel’withinwhichparticipationisameanstofurtherthemuchneedededucationofcitizenswhoaredeficientintheirknowledgeaboutsciencebasedissues(likepublichealth).68

The‘deficitmodel’devaluestheknowledgeandexpertisepossessedbythesubjectsofitsregulatoryinterventionsandgovernance– the ‘governed’–marginalising itandtheir role indecisionmaking.

60Fordiscussion,see:H.Gottweis,‘ParticipationandtheNewGovernanceofLife’(2008)3BioSocieties265.

61H.Potts,ParticipationandtheRighttotheHighestAttainableStandardofHealth(Essex:UniversityofEssexHumanRightsCentre,2009).

62 European Commission, ‘Science and Society Action Plan’, COM(2001) 714. See also: European Commission, ‘StaffWorking Paper. Science, Society and the Citizen in Europe’, SEC(2000) 1973; European Commission, ‘Science andTechnology,theKeytoEurope'sFuture:GuidelinesforFutureEuropeanUnionPolicytoSupportResearch’,COM(2004)353final.

63 For example: EuropeanCommission, ‘Life Sciences andBiotechnology:A Strategy for Europe’, COM(2002) 27 final;European Commission, ‘Promoting the Competitive Environment for the Industrial Activities Based on BiotechnologyWithin theCommunity’,SEC(91)629 final.Seealso:EuropeanCommission, ‘WorkingTogether forGrowthand Jobs.ANewStartfortheLisbonStrategy’,COM(2005)24final.

64J.LezainandL.Soneryd,‘ConsultingCitizens:TechnologiesofElicitationandtheMobilityofPublics’(2007)16PublicUnderstandingofScience279.

65 For example, on European attitudes to pandemic planning see: ‘Influenza H1N1’,http://ec.europa.eu/health/communicable_diseases/diseases/influenza/h1n1/docs/eurobarometer_summary_20100224.pdf. See more generally: European Commission, ‘Europeans, Science and Technology’ (Special Eurobarometer 154,December 2001); European Commission, ‘Social Values, Science and Technology’ (Special Eurobarometer 225, June2005).

66 See ‘Stakeholder Consultation on Strengthening European Union Preparedness on Pandemic Influenza’,http://ec.europa.eu/health/preparedness_response/consultations/preparedness_cons_01_en.htm.

67Feltetal.,TakingEuropeanKnowledgeSocietySeriously,note56above,p.58.

68Theideaofthe‘deficitmodel’wasintroducedinch.1.Someofthesamepointsandreferencesarerepeatedhere.See A. Irwin and B. Wynne (eds.),Misunderstanding Science? The Public Reconstruction of Science and Technology(Cambridge:CambridgeUniversityPress,1996).


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Themodel also ignores how individuals come to know things in different ways, possess differentkindsofknowledgeandexpertise,69andarereflexivelyawareoflimitationsintheirabilitytounder-stand,whichtheymayactivelyseektoaddress.70Insum,themodelreflectsandinstilsaveryparticu-larpublicrationalityinpolicyasacomplementtothedominantexpertrationality,andtogethertheyservetokeepcitizensand(theprovisionofknowledgeto)decisionmakingatadistance.71

Overall, the focus is on harnessing scientific and technical knowledge and expertise and thereforeprivilegingthosevoicesindecisionmakingandespeciallyindecisionsonhowissuesareframed.Citi-zenparticipationcan,therefore,bechieflyunderstoodasatechniqueandsupportforthepublicle-gitimationofrisk-basedgovernance.Acentralfunctionofcitizenparticipationistobuildtrust,quietcontestationandmediatetheboundariesofresponsibilityandaccountabilityforfailureinrespectofthegovernanceofpublichealth.72

III.ReframingEUPublicHealthGovernanceasaMatterofEUCitizenship

A. Additional Pitfalls of Risk Governance for Participation and the Potential for‘Bottom-Up’EngagementInthefollowingIhighlightthepotentialforandvalueof‘bottom-up’engagement,73beforeturningtooutlinetheproposaltostrengthencitizenparticipationandpublichealthgovernancethatthedis-cussioninthischapterhasbeenworkingtowards.Akeyinspirationfortheproposalistheideathat,asFoucaultpointedout,governancedoesnotonly function ‘top-down’butalsoproduces ‘biopoli-tics’,74thatis,anarenainwhichcitizenscandemandandcontestdecisionmaking.STS,sociologyandanthropology have built on this insight and developed a growing cluster of terms – ‘moral pio-neers’,75‘geneticcitizens’,76‘biologicalcitizenship’77and‘therapeuticcitizens’78–whichtogetherun-

69A.IrwinandM.Michael,Science,SocialTheory,andPublicKnowledge(Maidenhead:OpenUniversityPress,2003);M.Leach,I.ScoonesandB.Wynne(eds.),ScienceandCitizens:GlobalisationandtheChallengeofEngagement(London:ZedBooks,2005).

70A. Irwin,Citizen Science: A Study of People, Expertise, and SustainableDevelopment (London: Routledge, 1995); R.Lidskog, ‘Scientised Citizens and Democratised Science: Re-Assessing the Expert-Lay Divide’ (2008) 11 Journal of RiskResearch69.

71A.Irwin‘ThePoliticsofTalk:CometoTermswiththe“New”ScientificGovernance’(2006)36SocialStudiesofScience299.

72SeeFlear,GoverningPublicHealth,note1above,ch.1, fn.15,citingFlearandPickersgill, ‘RegulatoryorRegulatingPublics?’,note6above.

73FlearandPickersgill,‘RegulatoryorRegulatingPublics?’,note6above.

74Seeinparticular:M.Foucault,TheBirthofBiopolitics:LecturesattheCollègedeFrance,1978–1979(London:PalgraveMacmillan,2008).Alsosee:T.Lemke,Biopolitics:AnAdvanced Introduction (NewYork,NY:NewYorkUniversityPress,2013).

75R.Rapp,TestingWomen,TestingtheFetus:TheSocialImpactofAmniocentesisinAmerica(London:Routledge,2000).

76 D. Heath, R. Rapp and K.-S. Taussig, ‘Genetic Citizenship’, in D. Night and J. Vincent (eds.), A Companion to theAnthropologyofPolitics(Oxford:BlackwellPublishing,2004).

77A.Petryna,LifeExposed:BiologicalCitizensAfterChernobyl(Princeton,NJ:PrincetonUniversityPress,2002);N.RoseandC.Novas,‘BiologicalCitizenship’,inA.OngandS.Collier(eds),GlobalAssemblages:Technology,Politics,andEthicsasAnthropologicalProblems(Oxford:BlackwellPublishing,2005).Cf.J.Biehl,WilltoLive:AIDSTherapiesandthePoliticsofSurvival(Princeton,NJ:PrincetonUniversityPress,2007).

78V.-K.Nguyen,‘AntiretroviralGlobalism,Biopolitics,andTherapeuticCitizenship’,inA.OngandS.Collier(eds.),GlobalAssemblages:Technology,Politics,andEthicsasAnthropologicalProblems(Oxford:BlackwellPublishing,2005).


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derscore how people come to know and understand themselves and relate to others throughknowledge of their biological and medical risk status. In relation to public health problems, thegroups which can harness their common cause and articulate this position through human rightslinkedtobioethics–andwhichcomprisecitizensunderstoodas‘thegoverned’–includethosewithunderlyingmedicalconditions,limitedaccesstoeducationandeconomicresources,pregnantwom-en, childrenand itinerants.Anothergroup isnon-EUcitizens residing inEurope (includingundocu-mentedmigrants),alargegroupwhichoftenhasdifficultyaccessinghealthservicesandhealthinsur-anceandwhichtendstoexperiencemorehealthproblemsthan‘regular’EUcitizens.

Akeyinsightfromthecognatedisciplinesisthatalthoughcitizensmightnotbeabletouseorunder-standparticularscientificandtechnicaldetails,sincethosedetailsareproducedandarticulatedwith-inbroaderframes,citizenscanneverthelessparticipateas laypeople inrelationtothem.79 Inotherwords,notonlycancitizenscontributetowardsdiscussionsonframingbyrisk,80theycancontributetowardsreflectiononhowthosediscussionsshouldbereframed,81suchasbyqueryingthepurposeofriskgovernance,whomithurts,whomitbenefits,andhowwemightcometounderstandthesesituations.82AlthoughthecurrentinstitutionalisationofcitizenparticipationinEUgovernancemighthelpexplainthepublic’salienationfromregulatoryprocesses,83riskcanprovidethebasisformobili-sationandparticipation.84 Indeed, implicit intheaboveclusteroftermsistherecognitionthatciti-zensareincreasinglyawareoftheirvulnerabilityinthefaceofrisk(includingdangersorthreatspro-ducedbydecisionsabouthowto regulate)anddemonstrate ‘biosociality’85byworking together inordertogeneratethe‘politicsoflifeitself’86andreshapeandevenreframegovernancesothatitad-dressestheirconcerns.87

However, thediscourses that constitutegovernance (suchashuman rightsandbioethics)have re-ceivedlittleattentioninSTSandrelatedscholarshipasavenuesorplatformsforprompting,encour-agingandpowering ‘bottom-up’engagementbycitizensandreframingconcernsasmattersofciti-zenship.Muchdiscussioninthatscholarshipalsooverlookshowparticipationcanbestymiedandits

79 B.Wynne, ‘Uncertainty and Environmental Learning: Reconceiving Science and Policy in the Preventive Paradigm’(1992)2GlobalEnvironmentalChange111.

80B.Wynne,‘RiskasaGlobalising“Democratic”Discourse?FramingSubjectsandCitizens’,inM.Leach,I.ScoonesandB.Wynne(eds.),ScienceandCitizens:GlobalisationandtheChallengeofEngagement(London:ZedBooks,2005).

81 F. Fischer, Reframing Public Policy: Discursive Politics and Deliberative Practices (Oxford: Oxford University Press,2003).

82 S. Jasanoff, ‘Technologies of Humility: Citizen Participation in Governing Science’ (2003) 41 Minerva 223. Fordiscussion see: M. Kusch, ‘Towards a Political Philosophy of Risk’, in T. Lewens (ed.),Risk: PhilosophicalPerspectives(London:Routledge,2007).

83B.Wynne,‘CreatingPublicAlienation:ExpertCulturesofRiskandEthicsonGMOs’(2001)10ScienceasCulture445.

84 In relation to biomedicine see S. Epstein, Impure Science (Berkeley, CA: University of California Press, 1996). Seegenerally:U.Beck,WorldatRisk (Cambridge:PolityPress,2008);R. Löfstedt,RiskManagement inPost-TrustSocieties(London,PalgraveMacmillan,2005);O.Renn,RiskGovernance:CopingwithUncertainty inaComplexWorld (London:Earthscan,2008).

85P.Rabinow,EssaysontheAnthropologyofReason(Princeton,NJ:PrincetonUniversityPress,1996);S.GibbonandC.Novas(eds.),Biosocialities,GeneticsandtheSocialSciences(London:Routledge,2007).

86N.Rose,ThePoliticsof Life Itself:Biomedicine,PowerandSubjectivity in the21stCentury (Princeton,NJ:PrincetonUniversityPress,2007).

87 R. Doubleday and B. Wynne, ‘Despotism and Democracy in the United Kingdom: Experiments in ReframingCitizenship’, inS. Jasanoff (ed.),ReframingRights:Bioconstitutionalism in theGeneticAge (Cambridge,MA:MITPress,2011).


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contributionofvaluablesupplementaryknowledgetodecisionmakingfrustratedbytheriskgovern-anceprocessitself.Inparticular,asexplainedbyPower,withinrisk-basedgovernance,accountabilityhas come to be linkedwith organisation in a single logic throughwhich democratic ideals ‘are in-creasinglypositionedwithinidealsforgoodgovernanceoftheriskanalysisprocess’88(emphasisadd-ed).Consequently,techniquesforaccountabilitysuchasparticipationbecomepartofabroaderpro-cessofrenderingorganisationsauditableandinspectableinthatthey‘areincreasinglyframedasanorganisational strategy tomanage public expectations’89 (emphasis added). Indeed, public percep-tionsareasourceofrisk,andsoriskmanagementispartlyanexerciseingoverning‘unrulypercep-tions’ andmaintaining the ‘productionof legitimacy in the face of these perceptions’90 (emphasisadded). Inshort,thelogicofaccountabilityandorganisationhelpstomaintaintheinstrumentalisa-tionofcitizenparticipationasatechniqueoflegitimationinrisk-basedgovernance.

B.ThePotentialofHumanRightsandBioethicsIsuggestthathumanrightsandbioethics–twokeycomponentsofcitizenshipandimportantregula-torydiscourses–canbeusedtoanimate ‘bottom-up’engagementbycitizenswhichhighlights thedistortionsofgovernanceprioritiesor ‘societal risks’outlinedabove (in section two).Thesedistor-tionsorrisksconstitutesupplementaryknowledgewhich isall tooeasilymissedorunderacknowl-edgedbyrisk-basedpublichealthgovernance.Whatmakeshumanrightsandbioethicssouseful istheir capacity to transformthose (unorunder-addressed) ‘societal risks’ into ‘institutional risks’ (akeypreoccupationofgovernancenotedinsectiontwo)whichneedtobeaddressedinordertore-legitimate EU governance and the European integration project. This proposal therefore leveragestheEU’slegitimationneedsandresiststheinstrumentalisationofcitizenparticipationinthecurrentdesignofrisk-basedgovernance.

HumanrightslawisobviouslycloselyrelatedtocitizenshipanditisfoundationaltotheEU’sconstitu-tionallegalorder.Humanrightshasbeenverysuccessfulasabodyoflawandasabroaderdiscourseindemandsforandcontestationofsocialjusticeissues,91includingintheEU.92Moreparticularly,therighttohealthisclearlyimplicatedinArticle35CFR.93Themeaningandimplicationsofthisprovisionareawaitingjudicialinterpretation,whichonlyaddstoitsindeterminacyanddiscursivepotential.In-deed,Article35mightbedevelopedinlightoftheWHO’sdefinitionofhealthasastateofcompletephysical, mental and social wellbeing and notmerely the absence of infirmity,94 as well as otherright-to-healthprovisionsunderhumanrightslaw,suchasArticles11and13EuropeanSocialChar-ter.95

88M.Power,OrganisedUncertainty(Oxford:OxfordUniversityPress,2007),p.20.

89Ibid.,pp.20–21.

90Ibid.,p.21.

91W.Brown,StatesofInjury(Princeton,NJ:PrincetonUniversityPress,1995);W.Brown,‘SufferingRightsasParadoxes’(2000)7Constellations230.

92Forinstanceforlesbian,gayandtransgendercitizens.See:C.F.Stychin,GoverningSexuality:TheChangingPoliticsofCitizenshipandLawReform(Oxford:HartPublishing,2003),ch.1‘TheSexualCitizen’.

93Fordiscussionsee:T.HerveyandJ.McHale,‘Article35’,inS.Peersetal.(eds.),TheEUCharterofFundamentalRights:A Commentary (Oxford: Hart Publishing, 2015). See further: T. Murphy, Health and Human Rights (Oxford: HartPublishing,2013).

94ConstitutionoftheWorldHealthOrganisation,NewYork,22July1946,enteredintoforce7April1948,14UNTS185.

95EuropeanSocialCharter(Revised),Strasbourg,3May1996,enteredintoforce1July1999,2151UNTS277,ETS163.


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Article13providesthat‘anyonewithoutadequateresourceshastherighttosocialandmedicalassis-tance’ (emphasis added). Article 11 provides that ‘everyone has the right to benefit from anymeasures enabling him to enjoy the highest standard of health attainable’ including throughmeasureswhich‘removeasfaraspossiblethecausesofill-health’and‘preventasfaraspossibleep-idemic,endemicandotherdiseases,aswellasaccidents’(emphasisadded).Developedinthislight,Article35couldinturnshapetheinterpretationoftherespectiverequirementstoensureahighlevelofhumanhealthprotectionasunderArticle9TFEUandreflectedinArticle168(1)TFEU(whichArti-cle35takesover).Shapingtheinterpretationoftheseprovisionscouldbeusefulnotjustinadjudica-tion,butalso(andcrucially)inwiderandpotentiallymoreimportantattemptstodemandandcon-testdecisionmaking,toaddressthedistortionsofgovernanceoutlinedabove.96Indeed,theseprovi-sionscouldbedevelopedandusedinordertocampaignforfurthereffortstoaddressthesocialde-terminantsof illhealth.Forexample, inparticular tocontribute towards lowering the incidenceofmajor and chronic diseases and avoiding regulatory interventionswhich are discriminatory and/orwhichcompoundsocialstigma,marginalisationanddiscrimination.

Tothatend,humanrightscouldbeparticularlyusefulwhenusedincombinationwithbioethics.Bio-ethics(likecitizen/sciencerelations)becameimportantintheEU’sgovernanceofpublichealthandlifeaftertheregulatorycrisesofBSEandGMOsasawayofproducingengagementanddeliberativepractices–ausewhichhasbeenthesubjectofgrowingattentioninSTS97andinlaw.98Ethicsisde-termined by Member State governments and experts, such as those comprising research ethicscommittees for clinical trials99or theEuropeanGrouponEthics in ScienceandNewTechnologies,whichprovides theEuropeanCommissionwitha comprehensive rangeofopinionson ‘all areasoftheapplicationof scienceand technology’.100 Theseopinionsproducevariousexhortatory,persua-siveandbindingconsequences,101suchassupportforcontroversialresearchfunding.102Inthislight,thewiderfunctionofethicsis‘toensurethatthegeneralpubliciskeptproperlyinformed’103(empha-sisadded)andto‘keeptherapidlyadvancingprogressinscienceinharmonywiththeethicalvaluesofallEuropeans’104–withoutwhich ‘Europeancitizenshipcannotbeestablished’105 (emphasisadd-ed).

96T.Murphy,‘Repetition,Revolution,andResonance’,inT.Murphy(ed.),NewTechnologiesandHumanRights(Oxford:OxfordUniversityPress,2009),p.7.

97A.Moore,‘PublicBioethicsandDeliberativeDemocracy’(2010)58PoliticalStudies715.

98J.Montgomery,‘ReflectionsontheNatureofPublicEthics’(2013)22CambridgeQuarterlyofHealthcareEthics9.Seealso,thediscussiononstewardshipbelow.

99Directive2001/20/ECoftheEuropeanParliamentandoftheCouncilof4April2001ontheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMemberStatesrelatingtotheimplementationofgoodclinicalpracticeintheconductofclinicaltrialsonmedicinalproductsforhumanuse,OJ2001No.L121/34.

100CommissionDecision2005/383/ECof11May2005ontherenewalofthemandateoftheEuropeanGrouponEthicsinScienceandNewTechnologies,2005OJNo.L127/17.

101M.Tallacchini,‘GoverningbyValues.EUEthics:SoftTool,HardEffects’(2009)47Minerva281

102Forexample:EuropeanGrouponEthicsinScienceandNewTechnologies,Opinion10onEthicalaspectsofthe5thResearch Framework Programme (11 December 1997); and Opinion 22 on the Ethics Review of hESC FP7 ResearchProjects(13July2007).

103 ‘Mandate 1991–1997’, http://ec.europa.eu/bepa/european-group-ethics/archive-mandates/mandate-1991-1997/index_en.htm.

104Feltetal.,TakingEuropeanKnowledgeSocietySeriously,note56above,p.49.

105Ibid.,p.80,citinghttp://ec.europa.eu/european_group_ethics/archive/1991_1997/bilan_en.htm.


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Bioethicsisthereforeanimportantregulatoryandlegitimatingdiscoursewhichlikehumanrightsisimplicated in the realisation of EU citizenship. In addition, bioethics can be leveraged by humanrightstosupportparticipation.That isnotsimplybecausebioethics is increasingly linkedtohumanrights,asseeninseveralinternationaldeclarations.106Rather,asAshcroftnotes,animportantpoten-tialconsequenceofthelinkbetweenhumanrightsandbioethicsisthecapacityoftheformer,whenin the ‘handsofactivists,at least todisrupt [...]bychallengingthe language, the typesofproblemrecognised [...]andtheworkingmethodsof thepublicbioethicsprocess.Thismightparticularlybethe casewhere the challenge to bioethics comes from groups [such as those noted above]whichhavetried–andfailed–tochallengethepolicyconsensusbyothermethods’107(emphasisadded).

Thedevelopingdiscourseon stewardship responsibility found inhuman rights-inflectedpublicbio-ethics frameworks provides further encouragement for the potential of the link between humanrightsandbioethics tosupportcitizenparticipationthatunderlinesandpromptsefforts toaddressthedistortionsofrisk-basedpublichealthgovernance.Forexample,theWHO’sversionofsteward-shipinWorldHealthReport2000directsattentiontowardsthesocialdeterminantsofhealththroughprevention and efforts to address epidemic, endemic and other diseases by reference to the im-portanceof:‘improvingoveralllevelsofpopulationhealth[…and]objectives[which]arelikelytobeframed in terms of equity, coverage, access, quality, and patients’ rights’.108 Another version ofstewardship responsibility is found in the 2007 report of theNuffield Council on Bioethics, ‘PublicHealth:Ethical Issues’.109ThreeofNuffield’sauthors,Baldwin,BrownswordandSchmidt,notehowstewardshipmeans‘liberalstateshaveresponsibilitiesto lookafter importantneedsofpeoplebothindividuallyandcollectively.Therefore,statesarestewardsbothtoindividualpeople[...]andtothepopulation as awhole’110 (emphasis added). Stewardship is not solely about state responsibilities.Brownsword notes thatwhat he calls ‘super-stewardship’ is ‘a significant item of unfinished busi-ness’111 – and this points towards the responsibilities of international and supranational organisa-tionssuchastheEUforindividualsandthewholepopulation.112

Nevertheless,humanrightsandbioethicsmightalsopresentproblemsforthediscursivestrategyforenhancingcitizenparticipation.Akeypitfallofhumanrightsandbioethicswhichcouldabetthefocusonindividualresponsibilityandself-managementinrisk-basedgovernance,istheirtendencytofocusontheindividualandobscurethewidersocialsourcesofvulnerabilityandtheimportanceofoverall

106Forinstance,theUNEducational,ScientificandCulturalOrganization(UNESCO),‘UniversalDeclarationonBioethicsandHumanRights’(2005),andintheEuropeancontextintheConventionfortheProtectionofHumanRightsandDignityof the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights andBiomedicine(OviedoConvention),Oviedo,4April1997,enteredintoforce1December1999,ETS164,anditsProtocols.

107R.Ashcroft,‘CouldHumanRightsSupersedeBioethics?’(2010)10HumanRightsLawReview639at645.ThisbuildsonT.MurphyandN.Whitty,‘IsHumanRightsPrepared?Risk,RightsandPublicHealthEmergencies’(2009)17MedicalLawReview219.

108‘Governance’,http://www.who.int/healthsystems/topics/stewardship/en/index.html.

109PublicHealth:EthicalIssues(London:NuffieldCouncilonBioethics,2007).

110T.Baldwin,R.BrownswordandH.Schmidt,‘Stewardship,PaternalismandPublicHealth:FurtherThoughts’(2009)2PublicHealthEthics113at115,citingibid.,p.25.

111R.Brownsword,‘SoWhatDoestheWorldNeedNow?ReflectionsonRegulatingTechnologies’,inR.BrownswordandK. Yeung (eds.), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes (Oxford: HartPublishing,2008),p.47.

112 See further: M. L. Flear (ed.), ‘Papers From “A Symposium with Professor Roger Brownsword: Super-StewardshipintheContextofPublicHealth”’(2011)62NorthernIrelandLegalQuarterly.


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healthprotection.113Theseconcernsunderlinethe importanceofreflectingonthe limitsofhumanrightsandbioethicsinordertomitigatethem.Itmightalsobeobjectedthattheparticipatorystrate-gyproposedinthischapterrisksfurthercompromisingpublichealthbyfacilitatingtheextensionofEUmarket-orientednorms intopublic health as a formallynon-marketdomainof collectiveprovi-sion.Yet,sincetheEUisalreadyinvolvedinpublichealth,themainproblemisreshapingitsprioritiessothattheyaremorebalancedratherthanmoreextensive–andhumanrightsandbioethicsprom-isetopiqueandmobilisecitizen interestanddiscussiononpublichealth.114Humanrightsandbio-ethicscanreframegovernanceasamatterofcitizenshipandaspacefordemocraticcontestationofresponsibilities,suchastherequirementstoensureahighlevelofhealthprotectionnotedabove.115Reframingwidensthe‘wayin’forparticipationindecisionmakingprovidedbyreferencestopartici-pationanddemocracyinEuropeanGovernance(whichsensitisedgovernancetothepotentialforciti-zenparticipationasageneratorofviewsandnotsolelyasatechniqueoflegitimation(despitethatbeing its key function)), the EU’s constitutional order, human rights law and discourse. Vitally, re-framingpromisestoproducesupplementaryknowledge,i.e.onthedistortionsofEUgovernancepri-orities.

Take-upofthisknowledgeindecisionmakingisfacilitatedbytwoimportantaspectsofhumanrightsandbioethics.The first is that thesediscoursesarealreadypartof the languageofEUgovernanceandforthatreasonmightpersuadeandconvincethoseformallychargedwithorinfluentialindeci-sionmaking.116Argumentsandclaimsframedintermsofhumanrightsandbioethicsmightbepar-ticularlycompellingforarelatedreason.SincehumanrightsandbioethicsarealsokeylegitimatingdiscoursesforEUpublichealthgovernance,117articulatingargumentsthroughthosediscourseshelpstotransformthedistortionsofpublichealthgovernanceor‘societalrisks’intokey‘institutionalrisks’totheEU’sstandingandreputation.Theseinturnneedtobeaddressed,sincetheythreatentodele-gitimatetheEUandtheintegrationproject.Thelatterbuildsonhowparticipationtendstobeusedasalegitimatingtechniquetoimpelrenewedattemptstointegratecitizendemandsandknowledgeintodecisionmaking–butaspartofongoingattemptstoensuretherelegitimationofgovernanceandtheoverallprojectofintegration.

IV.ConclusionByreframingEUpublichealthgovernanceasamatterofcitizenshipviahumanrightsandbioethics,afullerimpressionofthescopeofEUpowerandresponsibilitycanbebroughtintoview.Inparticular,developingthecontentandmeaningofArticle35CFRandusingitincombinationwithbioethicstoreflectonEUgovernance(asseeninthedevelopingnotionofstewardship)couldhelpinpublicque-ryingofcompliancewiththerequirementtoensureahigh levelofhealthprotectionfound in thatprovision,aswellasunderArticles9and168(1)TFEU (which is takenoverbyArticle35).Through

113 In relation to human rights see the references to Brown, States of Injury, note 91 above, and for bioethics seeAshcroft,‘CouldHumanRights’,note107above,at645.

114InthisveinseeN.Fairclough,LanguageandPower(London:Routledge,2001).

115FordiscussionseeJ.Habermas,TheCrisisof theEuropeanUnion:AResponse (Cambridge:PolityPress,2012).Seefurther: N. Fraser, ‘Transnationalising the Public Sphere: On the Legitimacy and Efficacy of Public Opinion in a Post-WestphalianWorld’,inS.Benhabib,I.ShapiroandDPetranović(eds.),Identities,AffiliationsandAllegiances(Cambridge:CambridgeUniversityPress,2007).

116M.Edelman,PoliticalLanguage:WordsThatSucceedandPoliciesThatFail(London:AcademicPress,1973).

117ApointImakeingreaterdetailinFlear,GoverningPublicHealth,note1above.


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suchqueryinghumanrightsandbioethicscouldthereforehelpcitizenscontestthedistortionofpub-lichealthprioritiesengenderedbyframinggovernanceasamatterofrisk.Overall,reframingpublichealthasamatterofcitizenshipthroughhumanrightsandbioethicscouldhelptoensuretheEUisheldtoaccountandfulfilsitsresponsibilitytoensureequalprotection,justiceandequityforall.AssuchhumanrightsandbioethicscanhelpcitizensalignEUgovernancemorecloselytotheirconcernsand demandswithin the current division of competence between the EU and itsMember States.Thatwould in turnassist in theongoingdevelopmentof theEuropean integrationproject inwayswhichliveuptothedemocraticpotentialofEUcitizenship.

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