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From Integration to Exclusion: EU Composite Administration and Gaps in Judicial Accountability in the Authorisation of Pharmaceuticals

  • Sabrina RÖTTGER-WIRTZ and Mariolina ELIANTONIO

Abstract

In the EU, pharmaceuticals are subject to a marketing authorisation requirement that, depending on the type of product concerned, can be obtained either centrally through a Commission decision with EU-wide effects or in the Member States, potentially subject to mutual recognition in composite authorisation procedures. These composite decision-making processes can nowadays be considered a standard way of administrative decision-making in the EU internal market. Yet, judicial supervision remains anchored in the separation of jurisdictions between the national and the EU level, and between national levels. This article explores the challenges posed to judicial review in the case of pharmaceutical marketing authorisations when European administrative composite structures are used.

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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

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*

Assistant Professor EU Law, Maastricht Centre for European Law (MCEL), Maastricht University; email: s.roettger-wirtz@maastrichtuniversity.nl

**

Professor of European and Comparative Administrative Law and Procedure, Maastricht Centre for European Law (MCEL), Maastricht University.

Footnotes

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1 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 28, Regulation (EC) No 726/2004 OJ L 136, 30 April 2004, pp 1–33, Art 3(1). Norway, Iceland and Liechtenstein, which constitute the European Economic Area (EEA), also accepted the European pharmaceutical acquis and, wherever a Commission decision regarding a marketing authorisation is adopted, the three countries will take a corresponding decision allowing for the marketing of the product. EEA Joint Committee, Decision of the EEA Joint Committee N74/1999 of 28 May 1999 amending Protocol 37 and Annex II (technical regulations, standards, testing and certification) to the EEA Agreement, OJ L 284, 09.11.2000, pp 65–70.

2 For a discussion of the development of EU executive federalism see R Schütze, “From Rome to Lisbon: “Executive Federalism” in the (new) European Union” (2010) 47 Common Market Law Review 1385.

3 Schmidt-Aßmann, E and Schöndorf-Haubold, B (eds), The European Composite Administration (Intersentia 2011); Hofmann, H, et al, Administrative Law and Policy of the European Union (Oxford University Press 2011) p 406 ff; H Hofmann, “Decision-making in EU Administrative Law – the Problem of Composite Procedures” (2009) 61 Administrative Law Review 199; M Eliantonio, “Judicial Review in an Integrated Administration: the Case of ‘Composite Procedures’” (2014) 7 Review of European Administrative Law 65. Della Cananea discussed the phenomenon under the term mixed administration: G Della Cananea, “The European Union’s Mixed Administrative Proceedings” (2004) 68 Law & Contemporary Problems 197.

4 Schmidt-Aßmann and Schöndorf-Haubold, supra, note 3.

5 Eliantonio, supra, note 3, p 68.

6 F Brito Bastos, “Derivative Illegality In European Composite Administrative Procedures” (2018) 55 Common Market Law Review 105.

7 Hofmann, supra, note 3.

8 J Mendes and C Eckes, “The right to be heard in composite administrative procedures: lost in between protection?” (2011) 36 European Law Review 651.

9 Hofmann, supra, note 3; Eliantonio, supra, note 3; Türk, A, “Judicial review of integrated administration in the EU” in Hofmann, H and Türk, A (eds), Legal Challenges in EU Administrative Law: Towards an Integrated Administration (Edward Elgar 2009) p 218 . The question of the competent court in composite procedures has recently been considered by the Court of Justice in Case C-219/17, Silvio Berlusconi and Fininvest v Banca d’Italia, ECLI:EU:C:2018:1023 concerning the Single Supervisory Mechanism.

10 Case C-279/09, DEB, ECLI:EU:C:2010:811; Case C-12/08, Mono Car Styling, ECLI:EU:C:2009:466. See further S Prechal and R Widdershoven, “Redefining the Relationship between ‘Rewe-effectiveness’ and Effective Judicial protection” (2011) 4 Review of European Administrative Law 31.

11 H Hofmann and A Türk, “The development of integrated administration in the EU and its consequences” (2007) 13 European Law Journal 253.

12 Eliantonio, supra, note 3, p 96.

13 C-557/16, Astellas Pharma GmbH, ECLI:EU:C:2018:181. See also Opinion of AG Bobek in Case C-557/16, Astellas Pharma GmbH, ECLI:EU:C:2017:957. The case revolves around the data exclusivity period in the context of the decentralised procedure.

14 See eg J Feick, “Learning and interest accommodation in policy and institutional change: EC risk regulation in the pharmaceuticals sector” ESCR Centre for analysis of risk and regulation (CARR) Discussion Paper 25, January 2005; Krapohl, S, Risk Regulation in the Single European Market – The Governance of Pharmaceuticals and Foodstuffs in the European Union (Palgrave 2008); Permanand, G, EU Pharmaceutical Regulation: The Politics of Policy-Making (Manchester University Press 2006) p 49 ; Shorthose, S, Guide to European Pharmaceutical Regulatory Law (Kluwer 2013) p 105 ff; Manley, M and Vickers, M (eds), Navigating European Pharmaceutical Law (Oxford University Press 2015) p 79 ff.

15 An exception is Collatz, which however dates from 1996 and does not reflect the current procedures and developments of Court jurisprudence: Collatz, B, Die neuen europäischen Zulassungsverfahren für Arzneimittel (Editio-Cantor-Verlag 1996). For some remarks on judicial reviewability see Krapohl, supra, note 14, p 90.

16 See also Della Cananea, supra, note 3, pp 204–205.

17 For an analysis of the procedure and the hurdles to judicial accountability this can create see Chamon, M and Wirtz, S, “Complex procedures as hurdle to accountability: verticalization of pharmaceutical enforcement” in Luchtman, M and Scholten, M, Law Enforcement by EU Authorities – Political and Judicial Accountability in a Shared Legal Order (Edward Elgar 2017) p 141 . Exemplary in this regard is a claim brought by Roche before the UK Court of Appeal against the UK Medicinal and Health Care Products Regulatory Agency (MHRA) which had inspected the Roche premises upon request of the EMA: R (Roche) v Secretary of State for Health [2014] EWHC 2256 (Admin), at [77]; R (Roche) v Secretary of State for Health [2015] EWCA Civ 1311.

18 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 6 jo 17 and 18; Regulation (EC) No 726/2004 OJ L 136, 30 April 2004, pp 1–33, Art 3(1). For more information on the national procedure see: European Commission, “Notice to Applicants” Volume 2A – Procedures for marketing authorisation, Chapter 1 Marketing Authorisation, June 2018, available at <ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf> (accessed 25 June 2019); Shorthose, supra, note 14, p 133 ff; Manley and Vickers, supra, note 14, pp 80–81.

19 For more information on the mutual recognition and decentralised procedure see European Commission, “Notice to Applicants”, supra, note 18; Manley and Vickers, supra, note 14, p 81 ff; Shorthose, supra, note 14, p 127 ff.

20 See extensively J Feick, “Regulatory Europeanization, national autonomy and regulatory effectiveness: Marketing authorisation for pharmaceuticals”, MPIfG discussion paper, No 02/6, available at <www.econstor.eu/bitstream/10419/43181/1/359456413.pdf> (accessed 25 June 2019).

21 C-120/78, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein, ECLI:EU:C:1979:42 (Cassis de Dijon case).

22 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 28(2).

23 ibid, Art 28(3).

24 The CMDh is responsible for medicinal products for human use, while a corresponding group CMDv is responsible for veterinary drugs.

25 Feick, supra, note 14, p 15 ff.

26 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 28(3).

27 The cMSs will each validate the application, declaring that the required documentation was received and the fees paid.

28 See European Commission, “Notice to Applicants”, supra, note 18, p 2.

29 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 28(5).

30 ibid, Art 29(1). For a definition of “potential serious risks to human health” see European Commission, “Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC”, OJ C 133/5, 8.6.2006. Mutual recognition may not be refused on other grounds: see Case 452/06, Synthon, ECLI:EU:C:2008:565.

31 European Commission, Notice to Applicants Volume, supra, note 17, p 17. Potentially, a so-called break out session will be held in the CMDh to resolve disputes.

32 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 28(3).

33 ibid, Art 28(4).

34 ibid, Art 28(5).

35 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 29(1). Only a positive assessment of the rMS will be referred to the CMDh. If the rMS concludes that no authorisation should be granted, even if a cMSs want to approve the product, the procedure will end with a negative decision of the rMS and all cMSs are obliged to take a negative decision. See CMDh, “Questions and Answers” CMDh Referrals, CMDh/167/2005, Rev 11 February 2016, available at <www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_167_2005_Rev11_2016_02_clean.pdf>.

36 European Commission, “Notice to Applicants”, supra, note 18, pp 25–27.

37 Opinion of AG Bobek in Astellas Pharma Gmbh, supra, note 13, para 70.

38 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 29(1).

39 European Commission, “Notice to Applicants”, supra, note 18, p 6. Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 27.

40 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 29(3).

41 ibid, Art 29(3) jo 28(5).

42 ibid, Art 29 (4).

43 ibid, Art 32 (1).

44 Regulation (EC) No 726/2004 OJ L 136, 30 April 2004, pp 1–33, Art 61(1).

45 The EMA, for this reason, has been characterised as a network: R Dehousse, “Regulation by Networks in the European Community: the Role of European Agencies” (1997) 4 Journal of European Public Policy 246; Spina, A, “The Regulation of Pharmaceuticals Beyond the State: EU and Global Administrative Systems” in Chiti, E and Mattarella, B (eds), Global Administrative Law and EU Administrative Law (Springer 2011) p 249 .

46 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 32(1).

47 ibid, Art 32(4).

48 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers, OJ L 55, 28 February 2011, pp 13–18.

49 For more information see: European Commission, “Notice to Applicants”, supra, note 18.

50 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Arts 33 and 34.

51 ibid, Art 34(3); European Commission, “Notice to Applicants”, supra note 18, p 7.

52 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 34(3).

53 For a discussion of the centralised procedure see Manley and Vickers, supra, note 14, p 89 ff; Shorthose, supra, note 14, p 117 ff.

54 Regulation (EC) No 726/2004 OJ L 136, 30 April 2004, pp 1–33, Art 3(1) jo Annex.

55 ibid, Art 3(2).

56 ibid, Art 4.

57 Committee for Medicinal Products for Human Use, Rules of Procedure, EMEA/45110/2007, Art 6.

58 ibid, Art 6(3).

59 Regulation (EC) No 726/2004 OJ L 136, 30 April 2004, pp 1–33, Arts 5(2) and 6(3). Additionally, Regulation (EC) No 726/2004 provides for the possibility to grant a conditional marketing authorisation (Art 14(7)) which is reviewed annually, and a marketing authorisation under exceptional circumstances (Art 14(8)), which contains certain obligations with regard to the safety of the product.

60 Committee for Medicinal Products for Human Use, Rules of Procedure, EMEA/45110/2007, Art 8.

61 ibid, Art 9(1)–(3).

62 ibid, Art 10.

63 See also T Gehring and S Krapohl, “Supranational Regulatory Agencies between Independence and Control. The EMEA and the Authorisation of Pharmaceuticals in the European Single Market” (2007) 14 Journal of European Public Policy 208, at p 216; Feick, supra, note 14, p 14.

64 Regulation (EC) No 726/2004, OJ L 136, 30 April 2004, pp 1–33, Art 13–14.

65 See also Eliantonio, supra, note 3, p 75.

66 T-326/99, Fern Olivieri v Commission and EMEA, ECLI:EU:T:2003:351, paras 93–95.

67 Case 294/84, Parti écologiste “Les Verts” v European Parliament, ECLI:EU:C:1986:166.

68 Art 47 of Charter of Fundamental Rights of the European Union.

69 In the Olainfarm case a challenge brought by a competitor required the Court to examine whether a generic product can be authorised by reference to a product which has been authorised on well-established use basis, or whether this would provide too little safety and efficacy information. The Court found in favour of the generic authorisation: Case C-104/13, Olainfarm, ECLI:EU:C:2014:2316. Not related to a safety concern but to unfair commercial practices, the generics company Teva alerted the French competition authority to unfair commercial practices of Sanofi-Aventis, which actively discouraged the prescription of generics for their clopidogrel product Plavix: see <www.autoritedelaconcurrence.fr/user/standard.php?id_rub=483&id_article=2091>.

70 Directive 2001/83/EC, OJ L 311, 28 November 2001, pp 67–128, Art 10.

71 See C-557/16, Astellas Pharma GmbH, ECLI:EU:C:2018:181, which exemplifies this situation.

72 Opinion of AG Bobek in Astellas Pharma Gmbh, supra, note 13, para 92.

73 ibid, para 90.

74 Case C-97/91, Oleificio Borelli SpA v Commission, ECLI:EU:C:1992:491. The same position has been more recently reiterated in Case C-562/12, Liivimaa Lihaveis MTÜ v Eesti-Laüti programmi 2007-2013 Seirekomitee, ECLI:EU:C:2014:2229.

75 Case C-97/91, Oleificio Borelli SpA v Commission, para 10.

76 See further on this F Brito Bastos, “The Borelli Doctrine Revisited: Three Issues of Coherence in a Landmark Ruling for EU Administrative Justice” (2015) 8(2) Review of European Administrative Law 269.

77 Opinion of AG Bobek in Astellas Pharma Gmbh, supra, note 13, para 49.

78 Case C-613/14, James Elliott Construction, EU:C:2016:821, para 47 and case law cited therein.

79 Case T-295/16, Symbioflor v EMA, ECLI:EU:T:2017:147.

80 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2001] OJ L 311/67.

81 Case 60/81, IBM v Commission, ECLI:EU:C:1981:264.

82 The expression is borrowed from Brito Bastos, supra, note 6, p 101–134.

83 Case 60/81, IBM v Commission, ECLI:EU:C:1981:264, para 12.

84 Case C-680/16 P, Dr August Wolff GmbH v Commission, ECLI:EU:C:2019:257.

85 Case T-326/99, Fern Olivieri v Commission and EMEA, ECLI:EU:T:2003:351, para 55. See also the example of Dr August Wolff GmbH v Commission, supra, note 84.

86 Joined Cases C-622/16P to C-624/26P, Scuola Elementare Maria Montessori Srl v European Commission, ECLI:EU:C:2018:873, para 29.

87 Case 25/62, Plaumann & Co v Commission ECLI:EU:C:1963:17.

88 Case C-386/96 P, Société Louis Dreyfus & Cie v Commission, ECLI:EU:C:1998:193, para 43.

89 ibid.

90 Case C-321/95 P, Stichting Greenpeace Council (Greenpeace International) and Others v Commission, ECLI:EU:C:1998:153; Case T-122/96, Federazione nazionale del commercio oleario (Federolio) v Commission, ECLI:EU:T:1997:142.

91 Case 191/82, EEC Seed Crushers’ and Oil Processors’ Federation (FEDIOL) v Commission, ECLI:EU:C:1983:259; Case T-12/93, Comité Central d’Entreprise de la Société Anonyme Vittel and Comité d’Etablissement de Pierval and Fédération Générale Agroalimentaire v Commission, ECLI:EU:T:1995:78.

92 Joined Cases T-447/93, T-448/93 and T-449/93, Associazione Italiana Tecnico Economica del Cemento and British Cement Association and Blue Circle Industries plc and Castle Cement Ltd and The Rugby Goup plc and Titan Cement Company SA v Commission, ECLI:EU:T:1996:174; Case T-380/94, Association internationale des utilisateurs de fils de filaments artificiels et synthétiques et de soie naturelle (AIUFFASS) and Apparel, Knitting & Textiles Alliance (AKT) v Commission, ECLI:EU:T:1996:195; Case T-229/02, Osman Ocalan acting on behalf of Kurdistan Workers’ Party (PKK) v Council of the European Union, ECLI:EU:T:2008:87.

93 Joined Cases 67/85 R, 68/85 R and 70/85 R, Kwekerij Gebroeders van der Kooy BV and others v Commission, ECLI:EU:C:1985:173; Case T-84/01, Association contre l’horaire d'été (ACHE) v Council of the European Union and European Parliament, ECLI:EU:T:2002:5.

94 On this problem of extraterritoriality see also Opinion of AG Bobek in Astellas Pharma Gmbh, supra, note 13, paras 83 and 94.

95 Evidence that this process is taking place already is scattered and difficult to collect, but nevertheless exists. See the Forabosco case, in which the French Council of State declared itself competent to review a measure, issued in the context of the Schengen Information System, originating from the German authorities: judgment of 9 June 1999, no 190384.

* Assistant Professor EU Law, Maastricht Centre for European Law (MCEL), Maastricht University; email:

** Professor of European and Comparative Administrative Law and Procedure, Maastricht Centre for European Law (MCEL), Maastricht University.

From Integration to Exclusion: EU Composite Administration and Gaps in Judicial Accountability in the Authorisation of Pharmaceuticals

  • Sabrina RÖTTGER-WIRTZ and Mariolina ELIANTONIO

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