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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

Kai P. Purnhagen
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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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Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 3 , September 2010 , pp. 227 - 238
Copyright
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.

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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.

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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.

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

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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

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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

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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. 57–60 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. 490–492 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

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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>.

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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

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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