1 See the CJEU’s old ruling in Case 23-75, Rey Soda, EU:C:1975:142, where at para 11 the conferral of “wide powers of discretion” onto the Commission is justified in view of it being able to continually monitor the implementation of policies and “act with urgency as the situation requires”.

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.

4 J Waldron, The Rule of Law and the Importance of Procedure, New York University Public Law and Legal Theory Working Papers, Paper 234 (2010) p 17.

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16 ibid, p 39.

17 See ibid, pp 25, 237–240.

18 ibid, p 240.

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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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42 See Joined Cases T-191/98, T-212/98 to T-214/98, Atlantic Container Line, EU:T:2003:245, para 138. See also Curtin, D, “Constitutionalism in the European Community. The Right to Fair Procedures in Administrative Law” in Human Rights and Constitutional Law. Essays in Honour of Brian Walsh (Round Hall Press 1992) p 293, at p 301Google Scholar and E Barbier de la Serre, “Procedural Justice in the European Community Case-law concerning the Rights of the Defence: Essentialist and Instrumental Trends” (2006) 12(2) European Public Law 225, at p 233.

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.

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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

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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

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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

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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, “Pandemrix^TM 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

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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

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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

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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 25–26.Google Scholar

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