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Break or Bend in Case of Emergency?: Rule of Law and State of Emergency in European Public Health Administration

Published online by Cambridge University Press:  14 January 2020

Filipe Brito BASTOS
Affiliation:
Postdoctoral researcher at the Amsterdam Centre for European Law and Governance, Amsterdam Law School, University of Amsterdam, email: f.britobastos@uva.nl.
Anniek DE RUIJTER
Affiliation:
Associate Professor at the Amsterdam Centre for European Law and Governance, Amsterdam Law School, University of Amsterdam, email: A.deRuijter@uva.nl.

Abstract

In this article, we ask what the impact is of the role of the EU administration in responding to emergencies in terms of (changes to) the rule of law. A response to an emergency in some cases creates exceptions to rule of law guarantees that bind the authorities to procedural rules and fundamental rights. These exceptions can become more permanent and even change the constitutional order of the EU. We articulate the legal framework for health emergencies, and discuss how the EU court has interpreted and developed this framework in two key decisions. We then ask whether this framework offers adequate safeguards for upholding the rule of law in cases of major health emergencies. We conclude that public health emergencies can bend and even break rule of law requirements for the EU administration, and advocate for more legal guidance on proportionality, which may offer better safeguards suited for protecting the rights of affected parties.

Type
Symposium on European Union Governance of Health Crisis and Disaster Management
Copyright
© Cambridge University Press 2020

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Footnotes

We want to thank our colleagues and the reviewers for their invaluable comments on this article. We also thank Mark de Wilde and the colleagues participating in the Amsterdam emergency “book club” for the interesting discussions on constitutional emergency theory.

References

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2 The first legislative instruments on the common agricultural policy provided for urgent measures in case of abrupt shifts in market prices. See for instance Art 22 of Regulation 19/62, on the progressive establishment of a common market in cereals.

3 See Case C-270/12, United Kingdom v European Parliament and Council, EU:C:2014:18, where the powers of the European Markets and Securities Authority to address certain emergencies in financial markets were challenged by the British government.

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39 See, for instance, Cases C-291/89, Interhotel, EU:C:1991:189, para 14; C-367/95 P, Sytraval, EU:C:1998:154, para 67; C-286/95 P, Imperial Chemical Industries, EU:C:2000:188, para 51; and T-240/10, Hungary v Commission, EU:T:2013:645, para 70.

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43 Some authors dispute the extent to which the wording of the provision in the Charter actually corresponds to the formulations used in prior case law. See Rabinovici, supra, note 40.

44 Lenaerts, K and Vanhamme, J, “Procedural Rights of Private Parties in the Community Administrative Process” (1997) 34 Common Market Law Review 531, at p 568.CrossRefGoogle Scholar

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46 See Arts 53 (1) and (2) and 54 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. The Court has had the opportunity to clarify that the Commission is not required to adopt such measures upon the request of a Member State where the risks to human health, animal health, or the environment, are not evident (Case C-111/16, Fidenato, EU:C:2017:676, para 30). The urgent measures at stake must be “based on a risk assessment as complete as possible in the particular circumstances of an individual case” (Joined Cases C-58/10 to C-68/10, Monsanto, EU:C:2011:553, para 77).

47 It is worth pointing out that these administrative procedures are also applicable in cases involving genetically modified food and feed (see Art 34 of Regulation 1829/2003).

48 Art 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

49 Art 20(3) Regulation (EC) No 726/2004.

50 Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation).

51 Art 31(5) SSMFR.

52 Mihaescu, B, The Right to Good Administration at the Crossroads of the Various Sources of Fundamental Rights in the EU Integrated Administrative System (Nomos 2015) pp 392 and 463CrossRefGoogle Scholar and Hofmann, H and Mihaescu, B, “The Relation between the Charter’s Fundamental Rights and the Unwritten General Principles of EU Law: Good Administration as the Test Case” (2013) 9(1) European Constitutional Law Review 73, at p 92CrossRefGoogle Scholar. In the case law, see Case T-731/15 Klyuyev, EU:T:2018:90, para 103.

53 Case C-16/90, Nölle, EU:C:1991:402.

54 Cases T-443/11, Gold East Paper, EU:T:2014:774, para 123; T-355/13 easyJet, EU:T:2015:36, para 19; and T-574/14, European Association of Euro-Pharmaceutical Companies, EU:T:2018:605, para 76. See also Case C-269/90, Technische Universität München, EU:C:1991:438, para 14.

55 Cf Mendes, J, “Discretion, Care and Public Interests in the EU Administration: Probing the Limits of the Law” (2016) 53(2) Common Market Law Review 419, at p 431 ff.Google Scholar

56 See Opinion of AG Poiares Maduro in Joined Cases C-402/05 P and C-415/05 P, Kadi, EU:C:2008:11, para 49 and, more recently, the General Court’s ruling in Case T-138/14, Randa Chart, EU:T:2015:981, para 112.

57 For an overview of the case law developing the duty of care, see Craig, P, EU Administrative Law (Oxford University Press 2012) p 333 ff.CrossRefGoogle Scholar

58 Council Directive 85/511/EEC of 18 November 1985 introducing Community measures for the control of foot-and-mouth disease.

59 Case C-28/05, Dokter, EU:C:2006:408.

60 Dokter, supra, note 59, paras 74–75; Duijkersloot, T, “Consequences of the Violation by Administrative Authorities of the Right to be heard under EU Law: the Case M.G. and N.R.” (2014) 7(1) Review of European Administrative Law 81, at p 89CrossRefGoogle Scholar. See also Case C-418/11, Texdata Software, EU:C:2013:588, paras 83–84; C-383/13 PPU, MG and NR, EU:C:2013:533, para 33.

61 As the Court put it, “if the competent authority were not able to take measures against foot-and-mouth disease unless all potentially concerned parties had previously been given the opportunity to familiarise themselves with the facts and documents on which those measures are based and had expressed a view on those facts and documents, that authority could be prevented from acting promptly and effectively” (Dokter, supra, note 59, para 76).

62 Dokter, supra, note 59, para 76. See Binder, Tet al, “Emergency! But What about Legal Protection in the EU?” (2018) 9(1) EJRR 99, at p 113CrossRefGoogle Scholar and Keessen, A, European Administrative Decisions: How the EU Regulates Products on the Internal Market (Europa Law Publishing 2009) p 25.Google Scholar

63 See for instance Joined Cases C-317/08, C-318/08, C-319/08 and C-320/08, Alassini, EU:C:2010:146, para 63; Case C-619/10, Trade Agency, EU:C:2012:531, para 55; and Case C-249/13, Boudjlida, EU:C:2014:2431, para 43.

64 Council Directive 92/59/EEC of 29 June 1992 on general product safety. The Directive was replaced by Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, which is still in force.

65 See Arts 50–52 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. On the mechanism, see Weimer, M and Vos, E, “The Role of the EU in Transnational Regulation of Food Safety: Extending Experimentalist Governance?” in Zeitlin, J (ed), Extending Experimentalist Governance: The European Union and Transnational Regulation (Oxford University Press 2015) p 137.Google Scholar

66 Case T-177/02, Malagutti-Vezinhet, para 30.

67 Malagutti-Vezinhet, supra, note 66, para 52.

68 Malagutti-Vezinhet, supra, note 66, para 53.

69 Malagutti-Vezinhet, supra, note 66, para 54.

70 Alexy, R, A Theory of Constitutional Rights (Oxford University Press 2010) p 47.Google Scholar

71 The various dimensions of proportionality explained here closely follow the analysis of Barak, A, Proportionality: Constitutional Rights and their Limitation (Cambridge University Press 2012).CrossRefGoogle Scholar

72 On the provision and its interpretation, see Gross, O and Ní Aoláin, F, “From Discretion to Scrutiny: Revisiting the Application of the Margin of Appreciation Doctrine in the Context of Article 15 of the European Convention on Human Rights” (2001) 23(3) Human Rights Quarterly 625.CrossRefGoogle Scholar

73 For many, see Marzal, T, “From Hercules to Pareto: Of bathos, proportionality, and EU law” (2017) 15(3) International Journal of Constitutional Law 621CrossRefGoogle Scholar and Lenaerts, K, “Limits on Limitations: The Essence of Fundamental Rights in the EU” (2019) 20 German Law Journal 779.CrossRefGoogle Scholar

74 Decision No 1082/2013/EU, supra, note 11.

75 “European Commission, Commission Staff Working Document, Health Security in the European Union and Internationally (SEC(2009)1622 Final) Brussels, 23/11/2009”.

76 European Commission Staff Document, “European Commission Staff Document, Regulatory Process for the Authorization of Antiviral Medicines and Vaccines in the Protection against Pandemic Influenza H1N1 2009, Accompanying Document to the Communication to the Commission to the Council, the European Parliament and the European Economic and Social Committee and the Committee of Regions, Pandemic Influenza H1N12 2009 (COM(2009) 481-SEC(2009)119 Final)”.

77 Commission Proposal, “Commission Proposal for a Decision of the European Parliament and of the Council on Serious Cross-Border Threats to Health Brussels (COM (2011)866 Final)”.

78 Decision No 1082/2013/EU, supra, note 11, at para 8.

79 ibid, at para 9.

80 Art 18 Health Threats Decision; ibid, 30. However, Art 5(4) of Regulation (EU) No 182/2011, particularly where it concerns issue of human health, limits the power of the Commission where the Committee on Serious Cross-Border Threats has not delivered an opinion.

81 Art 12 Health Threats Decision, para 31, and see Art 8 Regulation (EU) No 182/2011.

82 Art 11 Health Threats Decision.

83 Art 2(4) Health Threats Decision.

84 Art 12(1)(a) Health Threats Decision.

85 Art 12(1)(b)(i) Health Threats Decision.

86 Art 12(1)(b)(ii) Health Threats Decision.

87 Art 13 Health Threats Decision.

88 Art 2 of Regulation (EC) No 507/2006; Art 21 of Regulation (EC) No 1234/2008.

89 This was when the medicinal legislation was still dependent on a WHO declaration of emergency (The Health Threats Decision currently provides the possibility for declaring an emergency at EU level) “Commission Staff Working Document, Regulatory Process for the Authorisation of Antiviral Medicines and Vaccines in the Protection against Pandemic Influenza (H1N1) 2009 Accompanying Document to the Communication from the Commission to the Council, the European Parliament, and the European Economic and Social Committee and Committee of the Regions, Pandemic Influenza A (H1N1) 2009 (COM(2009) 481 Final)”.

90 Persson, Iet al, “Risks of Neurological and Immune-Related Diseases, Including Narcolepsy, after Vaccination with Pandemrix: A Population- and Registry-Based Cohort Study with over 2 Years of Follow-up, January 2014” (2014) 1 Journal of Internal MedicineCrossRefGoogle Scholar; Verstraeten, Tet al, “PandemrixTM and Narcolepsy: A Critical Appraisal of the Observational Studies” (2016) 12 Human Vaccines & Immunotherapeutics 187CrossRefGoogle Scholar; Bangerter, Aet al, “Longitudinal Investigation of Public Trust in Institutions Relative to the 2009 H1N1 Pandemic in Switzerland” (2012) 7 PLoS ONE e49806.CrossRefGoogle Scholar

91 Persson et al, supra, note 90.

92 Art 14 Health Threats Decision.

93 Art 17 Health Threats Decision.

94 Decision No 1082/2013/EU, supra, note 11, Recital 17.

95 ibid, Recital 21.

96 ibid, Recital 22.

97 Art 10(2) Health Threats Decision.

98 Turner, M, “Vaccine Procurement during an Influenza Pandemic and the Role of Advance Purchase Agreements: Lessons from 2009-H1N1” (2016) 11 Global Public Health 322.CrossRefGoogle Scholar

99 Art 8 Regulation (EU) No 182/2011.

100 Art 14; Art 18 Health Threats Decision.

101 When the EU identifies public health risks, this is a central reason for denying a person entry to EU under the Dublin procedures.

102 Dąbrowska-Kłosińska, P, “Tracing Individuals under the EU Regime on Serious, Cross-Border Health Threats: An Appraisal of the System of Personal Data Protection” (2017) 8 EJRR 700.CrossRefGoogle Scholar

103 Art 16 Health Threats Decision, and see ibid.

104 Fioritto, supra, note 12, p 115.

105 T-75/06, Bayer CropScience, EU:T:2008:317 paras 81–84; T-35/01, Shanghai Teraoka Electronic, EU:T:2004:317, paras 48–49.

106 Dokter, supra, note 59, para 71.

107 This is the point of view emphasised by Binder et al, supra, note 62.

108 Joined Cases C-58/10 to C-68/10, Monsanto, EU:C:2011:553, para 77.

109 Fioritto, supra, note 12, p 96 ff.

110 Agamben, G, State of Exception (University of Chicago Press 2005) pp 2526.Google Scholar

111 Annex to Council Directive 92/59/EEC of 29 June 1992 (previous general product safety regulation), point 3.

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