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Competition of Agencies in European Pharmaceutical Law – Does It Exist, Is It Desirable and How to Handle It?

Published online by Cambridge University Press:  20 January 2017

Abstract

Rarely has international law been investigated from a Business to Agency (B2A) or even Agency to Agency (A2A) perspective. In recent years, the “mushrooming” of agencies at European level has triggered the importance of looking more closely into the relationship of the agencies towards each other. Is there a struggle over competences and regulatory objects, and would such competition lead to desirable outcomes? In this paper I will first show that, due to the historical development of administrative law in Europe and the USA, the perception of the desirability of agency competition differs. I will then contrast these findings with EU pharmaceutical law and show that it tends to avoid competition. Also, in practice, competition among agencies is still exceptional for European pharmaceutical regulation. Finally, I conclude these findings and hint at the limits of the desired process for further coherence. Although a move towards even greater convergence in European risk regulation is desirable, it does have its limits set by the principle of conferral in Article 5 (1, 2) EU read in conjunction with the areas of shared competence and the competence to support, coordinate and supplement.

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Copyright © Cambridge University Press 2010

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References

1 See for a profound overview with respect to European law Gernot Sydow, Verwaltungskooperation in der Europäischen Union (Tübingen: Mohr Siebeck 2004), at. pp. 118 et sqq.

2 See, inter alia, Article 6 European Parliament and Council Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, OJ 2008, L 218/30, which establishes the principle of non-competition among national accreditation bodies within the “new approach” regime.

3 See, for example Gerber, C. V., Grundzüge eines Systems des Deutschen Staatsrechts (Leipzig: Verlag von Bernhard Tauchnitz 1865).Google Scholar see also Jounjan, O., “Carl Friedrich Gerber at la constitution d’une science du droit public allemand”, in Beaud, /Wachsmann, (eds), La science juridique française et la science juridique allemande de 1870 à 1918 (Strasbourg: Presses Universitaires de Strasbourg 1997).Google Scholar

4 See for a profound analysis of the interrelationships of European law, kingdoms and their family connections Berman, Harold, Law and Revolution – The Formation of Western Legal Tradition (Cambridge (MA)/London: Harvard University Press 1983) at pp. 404 et sqq.Google Scholar

5 See, to this end, de Tocqueville, Alexis, L’Ancien régime et la révolution (Paris 1856).Google Scholar (Gilbert, Stuart trans., The Old Régime and the French Revolution, New York: Doubleday 1955).Google Scholar Part II, chapter 2.

6 Lindseth, Peter, “‘Always Embedded’ Administration: The Historical Evolution of Administrative Justice as an Aspect of Modern Governance”, in Joerges, Christian, Stråt, Bo and Wagner, Peter (eds), The Economy as Polity – The Political Constitution of Contemporary Capitalism (London: UCL Press 2005), pp. 117 et sqq., at pp. 119 et sqq.Google Scholar

7 A term still used nowadays in German language. In this respect also Hans-Wolfgang Micklitz, “From Social Justice to Access Justice: the European Challenge”, to be published as EUI Law working paper.

8 See Purnhagen, Kai P., “Rechtslage zur Verbrauchinformation in Großbritannien und Nordirland”, in Micklitz, Hans-Wolfgang (ed.), Informationszugang für Verbraucher in Europa und den USA – Recht und Praxis (Baden-Baden: Nomos 2009), at pp. 407425.Google Scholar

9 See, in this respect, the transition of administrative law in the UK from a totally secret administration in order to protect state secrets from the people to a rather open, informing administration for the people, in this respect Böhnlein, Anja and Purnhagen, Kai P., “Rechtslage zur Verbrauchinformation in Großbritannien und Nordirland”, in Micklitz, Hans-Wolfgang (ed.), Informationszugang für Verbraucher in Europa und den USA – Recht und Praxis (Baden-Baden 2009), at pp. 251255.Google Scholar

10 One example is the protection of the civil servant's special status in Article 34 of the German constitution. This trust of Germans in authorities has been subject to humorous critique by the German judiciary, see, for example, the AG Schöneberg, 16 D 370/89, who mocked this German attitude by writing its judgment on such matters in old-fashioned Old German poetry: “Denn wer uber alles entscheyden thett/von den er keyn ahnung hett/der ist grad der richtig man/der dise sach entscheyden kann./und wer im staate hat ein ambt/der hat dazu auch den verstandt.

11 See Mashaw, Jerry, “Reluctant Nationalists: Federal Administration and Administrative Law”, 116 Yale Law Journal (2007), pp. 100 et sqq.Google Scholar

12 See, in this respect, already Cafaggi, Fabrizio and Micklitz, Hans-Wolfgang, “Administrative and Judicial Collective Enforcement of Consumer Law in the US and the European Community”, EUI Working Paper LAW, No. 22 (2007), p. 2.Google Scholar

13 See, for an overview, Peter Lösche, “Macht und Ohnmacht der Exekutive”, in Politisches System der USA, 283 Informationen zur Politischen Bildung (2008), p. 18.

14 Id.; see also Jerry Mashaw, “Reluctant Nationalists: Federal Administration and Administrative Law”, supra note 11, pp. 100 et sqq., who detects these discussions back to the early 19th century.

15 See Jerry Mashaw, “Administration and ‘The Democracy’: Administrative Law from Jackson to Lincoln, 1829–1861”, 117 Yale Law Journal (2008), pp. 1566 et sqq., clearly shows that presidential democracy and administration were complements.

16 See Robert Post, “Federalism, Positivism, and the Emergence of the American Administrative State: Prohibition in the Taft Court Era”, 48 William and Mary Law Review (2006), pp. 1 et sqq., at p. 11, who illustrates the problematic interplay of these features in the process of building federal administrative law in the USA on the example of prohibition.

17 See, inter alia, Cafaggi, Fabrizio, “Product Safety, Private Standard Setting and Information Networks”, EUI Working Papers LAW, No. 17 (2008).Google Scholar

18 See for a comprehensive analysis Vibert, Frank, “Better Regulation and the Role of EU Agencies”, in Weatherill, Stephen (ed.), Better Regulation (Oxford: Hart 2007), pp. 387 et sqq. Google Scholar; Trimidas, Takis, “Community Agencies, Competition Law and ECSB Initiatives on Securities Clearing and Settlement”, in Eeckhout, Piet/Trimidas, Takis (eds), 28 Yearbook of European Law (Oxford: Oxford University Press 2009), pp. 216 et sqq., at pp. 230–255Google Scholar; for an overview in Majone, Giandomenico, “Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform”, 1 European Journal of Risk Regulation (2010), pp. 5 et sqq., at pp. 16–19.CrossRefGoogle Scholar

19 See Table 1.

20 The European Fundamental Rights Agency (FRA) was established in Vienna in 2007.

21 The European Agency for Safety and Health at Work (EU-OSHA) was established in Bilbao in 1996.

22 Article 2 a) of Council Regulation (EC) No 58/2003 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes, OJ 2003 L 11/1.

23 In this respect also Groß, Thomas, “Die Kooperation zwischen europäischen Agenturen und nationalen Behörden”, Europarecht (2005), p. 57.Google Scholar

24 The pure form of direct regulative enforcement that we most prominently know from agencies in the USA does not exist at European Union level. In fact, the Commission still formally issues the respective decision in all kinds of administrative actions. There are certain areas existing, however, where the whole decision process is carried out within the agencies to such an extent that the Commission in fact has only very few possibilities to control the rightfulness of the draft decision. The Commission’s part in these processes is regularly narrowed down to a formal act of undersigning the draft decision prepared by the agency.

25 European Governance – A White Paper, COM(2001) 428 final.

26 See also the website of the EU, available on the Internet at <http://europa.eu/agencies/index_en.htm>.

27 Szawlowska, Karolina, “Risk Assessment in the European Food Safety Regulation: Who is to Decide Whose Science is Better? Commission v. France and Beyond”, 5 German Law Journal (2005), pp. 1295 et sqq., available on the Internet at <http://www.germanlawjournal.com/pdf/.Vol05No10/PDF_Vol_05_No_10_1259-1274_EU_Szawlowska.pdf.>.Google Scholar

28 See Council Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136/1, last amended by Regulation (EC) No 470/2009 of the European Parliament and of the Council; see further on the centralised procedure inter alia Heselhaus, Sebastian, “Individualrechtsschutz in Genehmigungsverfahren der Europäischen Gemeinschaft im Recht der Biotechnologie”, in Nowak, Christian/Cremer, Wolfgang (eds), Individualrechtsschutz in der EG und der WTO (Baden-Baden: Nomos 2002), at p. 119 Google Scholar; Purnhagen, Kai, “The Challenge of Globalization in Pharmaceutical Law – Is an International Harmonization of Drug Approval Procedures Modeled after the European System Worth Considering?”, 63 Food and Drug Law Journal (2008), 623 et sqq., at p. 635.Google Scholar

29 See especially Article 106 of Council Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311/67.

30 See especially Article 84 of Council Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311/67.

31 See on the impact of the ICH on European pharmaceutical law Krapohl, Sebastian, Risk Regulation in the Single Market – The Governance of Pharmaceuticals and Foodstuff in the European Union (Houndsmill: Palgrave 2008), pp. 83 et sqq. Google Scholar; Purnhagen, Kai, “Kann das europäische Arzneimittelzulassungsverfahren als Modell für eine internationale Harmonisierung dienen?”, 45 Europarecht (2010), pp. 438 et sqq., at p. 448.Google Scholar

32 See for a description of the REACH agency's objectives Heyvaert, Veerle, “The EU Chemicals Policy: Towards Inclusive Governance?”, LSE Law, Society and Economy Working Papers, No. 7 (2008), at pp. 89.Google Scholar

33 Council Directive 65/65/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products, see on this issue Vogel, David, “The Globalization of Pharmaceutical Regulation”, 11 Governance: A Journal of International Policy and Administration (1998), pp. 1 et sqq., at p. 3.CrossRefGoogle Scholar

34 Purnhagen, Kai, “The Challenge of Globalization in Pharmaceutical Law: Is an International Drug Approval System Modeled after the European System Worth Considering?”, 63 Food and Drug Law Journal (2008), pp. 623 et sqq., at pp. 634–627.Google Scholar

35 Wiktorowicz, Mary, “Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France”, 28 Journal of Health Politics, Policy and the Law (2003), pp. 615 et sqq., at p. 637.CrossRefGoogle Scholar

36 See on the interplay of private entities, the state and health care systems Ursula Weide, “Law and the German Universal Healthcare System: A Contemporary Overview”, 6 German Law Journal (2005), pp. 1141 et sqq.

37 Gödicke, Patrick and Purnhagen, Kai, “Haftungsgrundlagen für Schmerzensgeld bei der klinischen Prüfung von Arzneimitteln”, Medizinrecht (2007), pp. 139 et sqq., at p. 141.CrossRefGoogle Scholar

38 Melber, Thomas and Moelle, Henning, “Kausalitätsnachweis und Substantiierungslast im Arzneimittelhaftungsprozess”, Stoffrecht (2004), pp. 75 et. sqq. Google Scholar; Pflüger, Frank, “Kausalitätsvermutung und Beweislastumkehr in der novellierten Arzneimittelhaftung”, Pharmarecht (2003), pp. 363 et sqq.Google Scholar

39 To secure supply with drugs, pharmacists enjoy a lot privileges such as having a monopoly on drugs in their respective area of sale.

40 See Purnhagen, Kai, “Rabattgewährung für apothekenpflichtige Arzneimittel nach dem Gesetz zur Verbesserung der Wirtschaftlichkeit in der Arzneimittelversorgung (AVWG)”, Medizinrecht (2006), pp. 315 et sqq.CrossRefGoogle Scholar

41 On the French regulatory policy Mary Wiktorowicz, 28 Journal of Health Politics, Policy and the Law 615, 637 (2003).

42 Joined Cases C-468/06 to C-478/06 Sot. Lélos v. GlaxoSmithKline AEVE [2008] ECR I-7139.

43 See the dissenting Opinion of Advocate General Jacobs in Case C-53/03 Syfait and Others v. GlaxoSmithKline AEVE [2005] ECR I-4609; Turner-Kerr, Peter, “Finally a bit of clarity for pharmaceutical companies; but uncertainties remain: judgment of the ECJ in Sot Lelos kai Sia EE v GlaxoSmithKline AEVE”, 30 European Competition Law Review (2009), pp. 5760 Google Scholar; Desogus, Claudia, “Parallel trade and pharmaceutical R&D: the pitfalls of the rule of reason”, 29 European Competition Law Review (2008), pp. 645 et sqq Google Scholar. For an overview on the arguments before the judgment see Coscelli, Andrea, Edwards, Geoff and Overd, Alan, “Parallel trade in pharmaceuticals: more harm than good?”, 29 European Competition Law Review (2008), pp. 490492 Google Scholar; Robert, Gavin and Ridley, Stephanie, “Parallel Trade in the Pharmaceutical Sector: Scourge or benefit?”, 27 European Competition Law Review (2006), pp. 91 et sqq.Google Scholar

44 For matters of confidentiality and trade secrets at stake, the cases will not be disclosed here.

45 Krapohl therefore constitutes that risk regulation in Europe is pathdependant; see Krapohl, Sebastian, Risk Regulation in the Single Market – The Governance of Pharmaceuticals and Foodstuffs in the European Union (Houndmills: Palgrave 2008), esp. pp. 17 et sqq.Google Scholar

46 See, inter alia, Jacquè, Jean, “Artikel 3”, in von der Groeben, Hans and Schwarze, Jürgen (eds), Kommentar zum EU-/EG-Vertrag, 6th edition (Baden-Baden: Nomos 2003)Google Scholar; Curtin, Deirdre, “The Constitutional Structure of the Union: A Europe of Bits and Pieces”, 30 Common Market Law Review, 1993, pp. 22 et sqq., at pp. 27–30.Google Scholar

47 Deirdre Curtin, “The Constitutional Structure of the Union: A Europe of Bits and Pieces”, supra note 46, pp. 22 et sqq., at p. 28.

48 Hilf, Meinhard and Pache, Eckhard, “Article 3 EU”, in Grabitz, Eberhard and Hilf, Meinhard (eds), Das Recht der Europäischen Union, 38th delivery (München: CH Beck 2009), para. 13.Google Scholar

49 Id.

50 See the “Better Regulation” Website of the Commsion, available on the Internet at <http://ec.europa.eu/governance/better_regulation/index_en.htm>.

51 Majone, Giandomenico, “Europe's “Democratic Deficit: The Question of Standards”, 4 European Law Journal (1998), pp. 5 et sqq., at p. 13.CrossRefGoogle Scholar

52 Wiener, Jonathan B., “Better Regulation in Europe”, 59 Current Legal Problems (2006), pp. 447 et sqq., at pp. 449–458.CrossRefGoogle Scholar

53 This term refers to a gap between the EU's “increasing responsibility and the limited capacities available for fulfilling them” (Les Metcalfe, “Building Capacities for Integration: The Future Role of the Commission”, Lecture given at the Schuman-Seminar: “Maastricht in Maastricht, the Treaty Revisited”, held at the Provincial Government House, Maastricht (NL) on 13 May 1996, available on the Internet at <http://aei.pitt.edu/827/01/1.htm>). Or in other words: How to effectively govern an increasing number previously national regulation at European level. Making European policies work comprises the management of European authorities and Member States and their interaction. It furthermore “involves designing and constructing organizational networks capable of functioning across all existing Member States and flexible enough to incorporate (…) countries in the future” (Les Metcalfe, “Building Capacities for Integration: The Future Role of the Commission”, Lecture given at the Schuman-Seminar: “Maastricht in Maastricht, the Treaty Revisited”, held at the Provincial Government House, Maastricht (NL) on 13 May 1996, available on the Internet at <http://aei.pitt.edu/827/01/1.htm>). See on this management deficit in general Metcalfe, Les, “After 1992: Can the Commission Manage Europe?”, 51 Australian Journal of Public Administration (1992), pp. 117 et sqq.CrossRefGoogle Scholar

54 Wiener, Jonathan B., “Better Regulation in Europe”, supra note 52, pp. 447 et sqq., at p. 497.Google Scholar

55 Ibid., supra note 52, at p. 498.

56 Ibid., supra note 52, at p. 498.

57 See to this end Kai Purnhagen, “Systematisation in European Risk Regulation” (PhD thesis on file with the European University Institute in Florence, forthcoming 2011); Rengeling, H.-W., Europäisches Stoffrecht – Zur Harmonisierung, Systematisierung und Kodifizierung allgemeiner Regelungen (Köln: Carl Heymanns 2009)Google Scholar; id., Harmonisierung und Systematisierung im Europäischen Stoffrecht”, 124 Deutsches Verwaltungsblatt (2009), pp. 605 et sqq.Google Scholar

58 See Kai Purnhagen, “Systematisation in European Risk Regulation”, supra note 57, Chapter 4.

59 See in this respect on the ancestor of Article 114 FEU C-359/92, Germany v. Council [1994] ECR I-03681.

60 Hans-Wolfgang Micklitz, “Anmerkung” to C-359/92, Germany v. Council [1994] ECR I-03681, 5 Europäische Zeitschrift für Wirtschaftsrecht (1994), p. 631.

61 It thereby, however, opens up a competition for approvals, which ultimately may lead to harmonisation of Member State legislation as well, see on this issue Purnhagen, Kai, “Kann das europäische Arzneimittelzulassungsverfahren als Modell für eine internationale Harmonisierung dienen?”, 45 Europarecht (2010), pp. 438 et sqq., at p. 443.Google Scholar