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Electronic Systems of Information Exchange as a Key Tool in EU Health Crisis and Disaster Management

Published online by Cambridge University Press:  10 January 2020

Patrycja DĄBROWSKA-KŁOSIŃSKA Open the ORCID record for Patrycja DĄBROWSKA-KŁOSIŃSKA [Opens in a new window]
Patrycja DĄBROWSKA-KŁOSIŃSKA*
Affiliation:
PhD, Marie Skłodowska-Curie Fellow, Health and Human Rights Unit, School of Law, Queens University Belfast; Department of Administrative Law and Public Policy, Faculty of Administration and Social Sciences, Warsaw University of Technology; email: [email protected].
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Abstract

Decision 1082/2013 on Serious Cross-border Health Threats (Health Threats Decision) was adopted in 2013 with the aim of preparing for and responding to serious health threats. In this legislation, the European Union adopts an “all-hazards” approach which strongly relies on the exchange of information as a driver of regulatory activities. This article first demonstrates that the electronic systems of information exchange constitute a key tool in EU Health Crisis and Disaster Management (“EHCDM”). Second, it identifies the distinctive features of these mechanisms in the EU context: the reinforcement of a statutory policy shift towards securitisation of public health, the peculiarity of the EU composite administrative procedures as well as the facilitation of the quality of the sense-making activities. Finally, the article uncovers the possible problems which may affect the adequate functioning of EHCDM and argues the routes for further research. The piece links legal analysis with the interdisciplinary conceptual lens to offer an important contribution to closer characterisation of the EHCDM as a field in its own right together with a better understanding of the EU public health law and administration in the context of transboundary crisis management and health security governance.

Type
Symposium on European Union Governance of Health Crisis and Disaster Management
Information
European Journal of Risk Regulation , Volume 10 , Issue 4: Symposium on European Union Governance of Health Crisis and Disaster Management , December 2019 , pp. 652 - 676
Copyright
© Cambridge University Press 2020

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Footnotes

The financial support of the EU Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 746014 is hereby acknowledged. The earlier version of this text was presented at the Symposium on EHCDM, University of Amsterdam, 6 December 2018. Many thanks to the participants to the Symposium, the anonymous reviewer, and to Agnieszka Nimark for the helpful comments. Any omissions that remain are my own.

References

1 Decision 1082/2013/EU on serious cross-border threats to health [2013] OJ L 293/1 (Health Threats Decision) which repealed Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [1998] OJ L 268/1.

2 See Frischhut, M and Greer, S, “EU public health law and policy – communicable diseases” in Hervey, T et al (eds), Research Handbook on EU Health Law and Policy (Cheltenham, Edward Elgar 2017) at pp 318–325Google Scholar.

3 See Milne, I, Stacking the Coffins Influenza, War and Revolution in Ireland, 1918–19 (Manchester, Manchester University Press 2018) at pp 85–111Google Scholar, especially p 98.

4 See also SL Roberts, “Signals, Signs and Syndromes: Tracing the Digitisation of European Health Security Practices”, in this volume of EJRR.

5 See Nicholl, C, “Health and pandemics: efficient EU response by sharing knowledge” in Joint Research Center Report, The Challenge of Resilience in a Globalised World (Luxembourg, Publications Office of the European Union 2015) at pp 38–39Google Scholar.

6 Compare: Frischhut and Greer, supra, note 2, at p 328; Boin, A et al, Making Sense of Sense-Making: The EU’s Role in Collecting, Analysing, and Disseminating Information in Times of Crisis (Stockholm, National Defence College 2014) at pp 41–42Google Scholar; and E Versluis et al, “The Multilevel Regulation of Complex Policy Problems: Uncertainty and the Swine Flu Pandemic” (2019) 5(1) European Policy Analysis 13.

7 See C Ansell et al, “Managing transboundary crises: identifying building blocks of an effective response system” (2010) 18(4) Journal of Contingencies and Crisis Management 204; Boin, A et al, “Transboundary crisis governance” in Hegemann, H and Bossong, R (eds), EU Civil Security Governance: Diversity and Cooperation in Crisis and Disaster Management (Basingstoke, Palgrave 2014) pp 307–308Google Scholar; JP Schneider, “Basic Structures of Information Management in the European Administrative Union” (2014) 20 European Public Law 89.

8 Art 2(5) in connection with Art 168(5) Consolidated Versions of Treaty on the Functioning of the European Union, [2016] OJ C 202/1; and recital 1 of the preamble, Health Threats Decision. See also the Commission Communication, Improving Health Security in the EU A One Health approach to counteracting the threat from infectious diseases, 12 March 2018, COM Ares(2018)1488883, p 2.

9 See Frischhut and Greer, supra, note 2, pp 318–325, 320.

10 Commission Green Paper on Bio-preparedness, COM(2007) 399 final. See also F Kuhlau, “Countering Bio-Threats: EU Instruments for Managing Biological Materials, Technology and Knowledge” (2007) 19 SIPRI Policy Paper 1 and Lakoff, A (ed), Disaster and the Politics of Intervention (New York, Columbia University Press 2010)Google Scholar.

11 See Nimark, A, “Post-Lisbon Developments in EU Crisis Management: The Integrated Political Crisis Response (IPCR) Arrangements” in O’Mathúna, D and de Miguel Beriain, I (eds), Ethics and Law for Chemical, Biological, Radiological, Nuclear & Explosive Crises (Cham, Springer 2019)Google Scholar.

12 Art 1(2) in connection with Arts 4 and 6–11, Health Threats Decision. Emphasis added.

13 See Art 1(1) in conjunction with Arts 6–8, 15, 17, and recitals 8, 10, 14–16, 19, Health Threats Decision.

14 Cf Nimark, A, “The EU’s Role in Crisis and Disaster Management within the Union: Post-Lisbon Developments” in Dąbrowska-Kłosińska, P (ed), Global Safety Governance: Challenges and Solutions (Warsaw, ASPRA-JP 2015) at p 162Google Scholar.

15 See L Bengtsson and M Rhinard, “Securitisation across borders: the case of ‘health security’ cooperation in the European Union” (2019) 42(2) West European Politics 346; and further P Dabrowska-Kłosińska, “Tracing Individuals under the EU Regime on Serious, Cross-border Health Threats: An Appraisal of the System of Personal Data Protection” (2017) 8(4) EJRR 700; and de Ruijter, A, “Mixing EU Security and Public Health in the Health Threats Decision” in de Ruijter, A and Weimer, M (eds), EU Risk Regulation, Expert and Executive Power (Oxford, Hart Publishing 2017)Google Scholar.

16 See point 4 of the Preamble, Art 4(4), Health Threats Decision.

17 See Commission Communication, Improving Health Security in the EU, at p 2.

18 Recital 3 of the preamble, Health Threats Decision.

19 Art 2 para. 1; Art 3 point g, Health Threats Decision.

20 Art 2(1), recital 3 and 6 of the preamble, Health Threats Decision. See also Brem, S and Dubois, S, “Different perceptions, similar reactions: Biopreparedness in the European Union” in Katona, P et al (eds), Global Biosecurity Threats and Responses (Oxford, Routledge 2010)Google Scholar.

21 See also ML Flear and A de Ruijter, “Introduction: European Governance of Health Crisis and Disaster Management”, in this volume of EJRR.

22 There are important exceptions to this claim, see the pioneering works of Vos, E, Institutional Frameworks of Community Health and Safety Legislation: Committees, Agencies and Private Bodies (Oxford, Hart 1999)Google Scholar and Hervey, TK and McHale, JV, Health Law and the European Union (Cambridge, Cambridge University Press 2004)CrossRefGoogle Scholar. See also de Ruijter, A, EU Health Law & Policy The Expansion of EU Power in Public Health and Health Care (Oxford, Oxford University Press 2019)CrossRefGoogle Scholar; Flear, ML, Governing Public Health: EU Law, Regulation and Biopolitics (Oxford, Hart Publishing 2015)Google Scholar; Frischhut and Greer, supra, note 2; Hervey, TK and McHale, JV, European Union Health Law: Themes and Implications (Cambridge, Cambridge University Press 2015)CrossRefGoogle Scholar.

23 See eg Antoniadis, A et al (eds), The European Union and Global Emergencies: A Law and Policy Analysis (Oxford, Hart Publishing 2011)Google Scholar; Alemanno, A (ed), Governing Disasters: The Challenges of Emergency Risk Regulation – Beyond the European Volcanic Ash Crisis (Cheltenham, Edward Elgar 2011)CrossRefGoogle Scholar; Govaere, I and Poli, S (eds), EU Management of Global Emergencies: Legal Framework for Combating Threats and Crises (Leiden, Boston, Brill 2014)CrossRefGoogle Scholar. Note that G Venturini, “International Disasters Response Law in Relation to other Branches of International Law”, at p 57, mentions a parallel development of global health law and international disaster response law, but M Gestri “EU Disaster Response Law”, at pp 105–128, and F Casolari, “The External Dimension of the EU Disaster Response”, at pp 129–154, do not mention health policy in the EU context, see De Guttry, A et al (eds), International Disaster Response Law (The Hague, Springer 2012)CrossRefGoogle Scholar.

24 See eg Boin, A et al, The European Union as Crisis Manager: Patterns and Prospects (Cambridge, Cambridge University Press 2013) at pp 118–120CrossRefGoogle Scholar; Boin et al, supra, note 6, at pp 37–42; S Zandén Kjellén, “Rapid Alerts for Crises at the EU Level” in S Olsson (ed), Crisis Management in the European Union: Cooperation in the Face of Emergencies (Dordrecht, New York, Springer 2009).

25 O’Mathúna, D and de Miguel Beriain, I (eds), Ethics and Law for Chemical, Biological, Radiological, Nuclear & Explosive Crises (Cham, Springer 2019)CrossRefGoogle Scholar; R Orford et al, “EU alerting and reporting systems for potential chemical public health threats and hazards” (2014) 72 Environment International, Special Issue, Recent developments in assessing and managing serious health threats 15; SL Roberts, “Big Data, Algorithmic Governmentality and the Regulation of Pandemic Risk” (2019) 10(1) EJRR 94.

26 See L Bengtsson et al, “Assembling European health security: Epidemic intelligence and the hunt for cross-border health threats” (2019) 50(2) Security Dialogue 115; L Bengtsson et al, “European security and early warning systems: from risks to threats in the European Union’s health security sector” (2018) 27(1) European Security 20; Bengtsson and Rhinard, supra, note 15.

27 Ansell et al, supra, note 7; see also Boin et al, supra, note 6.

28 See Majone, G, Evidence, Argument, and Persuasion in the Policy Process (New Haven, Yale University Press 1989)Google Scholar.

29 G Majone, “The New European Agencies: Regulation by Information” (1997) 4(2) JEPP 262, at p 264.

30 See M Eliantonio, “Information Exchange in European Administrative Law: A Threat to Effective Judicial Protection?” (2016) 23(3) Maastricht Journal of European and Comparative Law 531; Versluis et al, supra, note 6.

31 See D-U Galetta et al, “Information Exchange in the European Administrative Union: An Introduction” (2014) 20(1) European Public Law 65.

32 See Majone, supra, note 29, at pp 270–271.

33 Cf Galetta et al, supra, note 31, at p 66.

34 See Table 2 below for a summary of the systems, their legal bases, users and responsible authorities.

35 See also Brem and Dubois, supra, note 20, at pp 150–152; Flear, supra, note 22, at pp 133–138 and 151–158; and the works cited in supra, note 26.

36 See also Dąbrowska-Kłosińska, supra, note 15.

37 Cf Art 1, Health Threats Decision; and European Centre for Disease Prevention and Control, Annual report of the Director – 2017 (Stockholm, ECDC 2018) at pp 12–43.

38 See eg Art 4(1)–(2), Art 6(3), Art 7(1); Art 8(1), Health Threats Decision.

39 Compare the wording of Art 6 and Art 8 of the Health Threats Decision which establish “a network for epidemiological surveillance” and “Early Warning and Response System” respectively.

40 The following internal ECDC documents, requested under the provisions of Regulation (EC) No 1049/2001 regarding public access to documents, have been referred to in the content of this section: (i) the ECDC Internal Procedure on Response Operations, ECDC/IP/98 (“ECDC IP 98”), consulted by the Senior Management Team 03.12.2015, pp 1–48; as revised by (ii) the ECDC IP 98 - SRS - Response Operations: Internal Procedure - Risk assessment workflow, first revision, October 2018 (“ECDC/IP/98 – Rev.1”), issued 24.04.2019, pp 1–16; as accompanied by the RRA [Rapid Risk Assessment] Work instructions (consistent with IP 98), pp 1–26.

41 Cf classification in Schneider, supra, note 7, at pp 91–92.

42 Art 4(2)(a)–(c), Health Threats Decision.

43 Art 4(4), Health Threats Decision. See also Flear, supra, note 22, at pp 151–153.

44 Commission Implementing Decision No 2014/504/EU implementing Decision No 1082/2013/EU of the European Parliament and of the Council with regard to the template for providing the information on preparedness and response planning in relation to serious cross-border threats to health, OJ 2014 L 223/25.

45 Art 4(1) and 4(6), Health Threats Decision. For an earlier account, see also Flear, supra, note 22, pp 151–153.

46 Report on the implementation of Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC, COM (2015) 617 final, p 4 (“The 2015 Report”).

47 European Court of Auditors special report no 28, Dealing with serious cross-border threats to health in the EU: important steps taken but more needs to be done (Luxembourg, Publications Office of the European Union 2016) p 19 (“The Court of Auditors 2016 Report”).

48 The 2015 Report, supra, note 46, at pp 5–6.

49 ibid, at p 5; see also the Court of Auditors 2016 Report, supra, note 47, at p 23; European Centre for Disease Prevention and Control, ECDC country preparedness activities, 2013–2017 (Stockholm, ECDC 2018) at pp 14–18.

50 See European Centre for Disease Prevention and Control, Health emergency preparedness for imported cases of high-consequence infectious diseases (Stockholm, ECDC 2019); European Centre for Disease Prevention and Control, HEPSA – health emergency preparedness self-assessment tool – user guide (Stockholm, ECDC 2018); European Centre for Disease Prevention and Control, Public health emergency preparedness – Core competencies for EU Member States (Stockholm, ECDC 2017).

51 Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [1998] OJ L 268/1. For a useful historical overview, see eg Frischhut and Greer, supra, note 2.

52 Art 6(1)–(2), recitals 2 and 5 of the preamble, Health Threats Decision. See also Flear, supra, note 22, at p 155 and pp 135–137, 156–158.

53 The 2015 Report, supra, note 46, at p 6.

54 See <ecdc.europa.eu/en/publications-data/european-surveillance-system-tessy>, accessed 4 December 2019.

55 The 2015 Report, supra, note 46, at p 7.

56 ECDC IP 98, supra, note 40, at p 25; and <ecdc.europa.eu/en/publications-data/epidemic-intelligence-information-system-epis>, accessed 4 December 2019.

57 The 2015 Report, supra, note 46, at p 6; see also <www.ecdc.europa.eu/en/surveillance-atlas-infectious-diseases>, accessed 4 December 2019.

58 See <ec.europa.eu/jrc/en/scientific-tool/medical-information-system>, accessed 4 December 2019.

59 See <medisys.newsbrief.eu/medisys/homeedition/pl/home.html#>, accessed 4 December 2019.

60 Schneider, supra, note 7, at pp 91–93.

61 ECDC/IP/98 – Rev.1, supra, note 40, at p 8.

62 ECDC IP 98, supra, note 40; see also Bengtsson, Borg and Rhinard, supra, note 26; and Schneider, supra, note 7, at p 103.

63 Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [1998] OJ L 268/1; see also Zandén Kjellén, supra, note 24.

64 See Art 8, 16 and 20, Health Threats Decision, and the EU implementing legislation available at <ec.europa.eu/health/communicable_diseases/early_warning/comm_legislation_en.htm>.

65 Schneider, supra, note 7, at pp 92 and 101.

66 Art 9, para 1, Health Threats Decision. See also Art 4, Regulation (EC) No 851/2004 establishing a European Centre for Disease Prevention and Control (ECDC Regulation) [2004] OJ L 142/1.

67 Art 2, para 1, Commission Implementing Decision (EU) 2017/253 laying down procedures for the notification of alerts as part of the early warning and response system established in relation to serious cross-border threats to health and for the information exchange, consultation and coordination of responses to such threats pursuant to Health Threats Decision [2017] OJ L 37/23.

68 Art 9, para 1, points a–c, Health Threats Decision.

69 Boin et al, supra, note 6, at pp 38–40 and the Court of Auditors 2016 Report, supra, note 47, at pp 30–34.

70 See Recital 8 and 16 of the Preamble, Art 9.4, Health Threats Decision. See also the Commission document, Structure for preparedness and response to cross-border health threats, annexed to impact assessment SEC(2011) 1519 final.

71 Flash report of the Plenary Meeting of the Health Security Committee, 5 July 2019, at p 12.

72 Flash report from the Plenary Meeting of the Health Security Committee, 9 November 2017, at p 5; the Court of Auditors 2016 Report, supra, note 47, at pp 31–33; and also Bengtsson et al, supra, note 26, at pp 30–34.

73 Flash report of the Plenary Meeting of the Health Security Committee, 5 July 2019, at p 12.

74 Art 7, para 1, Health Threats Decision.

75 Cf also Flear, supra, note 22.

76 Cf Galetta et al, supra, note 31, at pp 68–69.

77 ibid, pp 66–68. See also Hofmann, HCH, “Composite decision-making procedures in EU administrative law” in Hofmann, HCH and Türk, AH (eds), Legal Challenges in EU Administrative Law (Cheltenham, Edward Elgar 2009)CrossRefGoogle Scholar.

78 Cf Dąbrowska-Kłosińska, supra, note 15.

79 Bengtsson et al, supra, note 26, at p 30; ECDC IP 98, supra, note 40.

80 Art 8, para 2 and Art 10, para 1, ECDC Regulation 851/2004; and The 2015 Report, supra, note 46, at p 9.

81 Art 9, para 3, Health Threats Decision.

82 Art 9, para 3, points i–j.

83 Recital 5 and 16 of the preamble, Arts 2(1), 6(1) and 10(1) respectively, Health Threats Decision; ECDC Regulation 851/2004.

84 Cf Schneider, supra, note 7, at p 105; Bengtsson et al, supra, note 26; ECDC IP 98, supra, note 40.

85 Bengtsson et al, supra, note 26, at p 32.

86 Cf Majone, supra, note 29, at pp 264–267.

87 Arts 6(1) and 8(1), Health Threats Decision.

88 See documents cited supra, note 40.

89 Majone, supra, note 29.

90 Art 10(1a), Health Threats Decision; see Schneider, supra, note 7, at p 105.

91 See Boin et al, supra, note 24, at p 120.

92 Bengtsson et al, supra, note 26, at p 116.

93 ibid, at p 127.

94 ibid, at p 125. See also Bengtsson and Rhinard, supra, note 15.

95 Ansell et al, supra, note 7, at p 201.

96 ibid.

97 Cf Nimark, supra, note 14.

98 Boin et al, supra, note 6, at p 13. See also A Boin, “The Transboundary Crisis: Why we are unprepared and the road ahead” (2019) 27(1) Journal of Contingencies and Crisis Management 97.

99 Versluis et al, supra, note 6.

100 Boin et al, supra, note 6, at pp 14–15.

101 Boin, supra, note 98.

102 See ECDC/IP/98 – Rev.1, at pp 9–11.

103 Cf M Eliantonio, “Judicial Review in an Integrated Administration: the Case of “Composite Procedures” (2014) 7(2) Review of European Administrative Law 65; and Dąbrowska-Kłosinska, supra, note 15.

104 Hofmann, supra, note 77, at pp 149–163.

105 See Schneider, supra, note 7, at pp 102 and 105.

106 Art 6(3)–(5), Health Threat Decision; Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related special health issues to be covered by epidemiological surveillance as well as relevant case definitions [2018] OJ L 170/1; ECDC IP 98, supra, note 40.

107 ECDC IP 98, supra, note 40; see also Versluis et al, supra, note 6.

108 The 2015 Report, supra, note 46, at p 7.

109 See the documents, cited supra, note 40.

110 The 2015 Report, supra, note 46, at p 7, but see also the The Court of Auditors 2016 Report, supra, note 47.

111 See Ansell et al, supra, note 7, at p 203.

112 Cf Bengtsson et al, supra, note 26, at pp 120, 125–126 and 127.

113 ibid, pp 120, 123, 125. See the Report on Operation of the Early Warning and Response System (EWRS) of the Community Network for the epidemiological surveillance and control of communicable diseases during 2006 and 2007 (COM(2009) 228 final) and the weaknesses outlined in The Court of Auditors 2016 Report, supra, note 47, at pp 19–21 and 35.

114 R Rentjes, “Variation matters: Epidemiological surveillance in Europe” (2012) 37(6) Journal of Health Politics, Policy and Law 954.

115 See Eliantonio, supra, note 30, at pp 534–537.

116 See Majone, supra, note 29, at pp 263 and 270–274.

117 See Versluis et al, supra, note 6.

118 ECDC/IP/98 – Rev.1, at p 12.

119 ibid, at p 8. See MBA van Asselt and E Vos, “Wrestling with uncertain risks: EU regulation of GMOs and the uncertainty paradox” (2008) 11(1)–(2) Journal of Risk Research 281.

120 See Art 10.1, Health Threats Decision and ECDC/IP/98 – Rev.1, at p 13.

121 See also EM Speakman, “Pandemic legislation in the European Union: Fit for purpose? The need for a systemic comparison of national laws” (2017) 121 Health Policy 1021.