Challenges to the legitimacy of international regulation: The case of pharmaceuticals standardisation

Multilevel Regulation and the EU: The Interplay between Global, European and National Normative Processes

Volumn , Issue , 2008, Pages 51-71

  Dorbeck Jung, Bärbel R ^a  

^a UNIVERSITY OF TWENTE   (Netherlands)

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[No Author keywords available]

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EID: 84882693140     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1163/ej.9789004164383.i-426     Document Type: Chapter

References (41)

1. This document defines the standards that application data and application documents have to satisfy.
2. T.K. Hervey and J.V. McHale, Health Law in the European Union, Cambridge: Cambridge University Press, 2004. The ICH Guidance on Good Clinical Practice (CPMP/ICH 135/95) replaced the respective EU Guidelines of 1991
3. L. Senden, Soft Law in European Community Law, Cambridge: Hart Publishing, 2004.
4. D. Vogel, "The Globalization of Pharmaceutical Regulation", Governance: An International Journal of Policy and Administration, Vol. 11 1998, pp. 1-22.
5. A.J. Hoekema, Legitimiteit door legaliteit, over het recht van de overheid, [Legitimacy through legality, over the law of the government] Nijmegen: Ars Aequi Libri, 1991, p. 9
6. E. Vos, Institutional Frameworks of Community Health and Safety Regulation - Committees, Agencies and Private Bodies, Oxford: Hart Publishing, 1999, p. 94.
7. Vos refers to Winter when she points out that "legitimus" means "following a law", or, interpreted more generally, "following a rule or a principles". She adds that these rules must find a degree of social acceptance.
8. G. Winter, "Drei Arten gemeinschaftlicher Rechtsetzung und ihre Legitimation", in: G. Brüggemeier, (ed.), Verfassungen für ein ziviles Europa, Baden-Baden: Nomos, 1994, p. 48.
9. B.R. Dorbeck-Jung and H.M. de Jong, "Legitimate Governance with the State", in: H. Wagenaar, (ed.), Government Institutions: Effects, Changes and Normative Foundations, Dordrecht: Kluwer Academic Publishers, 2000, pp. 109-127.
10. P. Schmitter, "What is There to Legitimize in the European Union . . . And How Might this be Accomplished?" Max Planck Projektgruppe Recht der Gemeinschaftsgüter, Bonn, 2001, p. 2.
11. M. Weber, Wirtschaft und Gesellschaft, 5th edn, Tübingen: Mohr, 1980, p. 122. Translation by Winkelmann.
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19. C. Hood and D. Heald, (eds), Transparency. The Key to Better Governance? Oxford: Oxford University Press, 2006.
20. M.A.P. Bovens, "Public Accountability" in: E. Ferlie, et al., (eds) The Oxford Handbook of Public Management, Oxford: Oxford University Press, 2005.
21. G. De Burca and J. Scott, Law and New Governance in the EU and the US, Oxford: Hart Publishing, 2006
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24. J. Griffiths, "The Social Working of Legal Rules", Journal of Legal Pluralism and Unofficial Law, Vol. 48 2003
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26. J. Griffiths, "Self-regulating by the Dutch medical profession of medical behaviour that potentially shortens life", in: H. Krabbendam and H.M. ten Napel, (eds), Regulating Morality, Antwerpen: Maklu, 2000.
27. C. Coglianese and D. Lazer, "Management-Based Regulation: Prescribing Private Management to Achieve Public Goals", Law & Society Review, Vol. 37 2003, pp. 691-728.
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30. The six parties nominate an ICH coordinator as the main point of contact with the ICH Secretariat.
31. The status depends on the degree of changes the document sets forth. In the event of substantial new interpretation of the guidelines, the document shall be published for further comments (see step 2 of the formal procedure). If the document sets forth existing practices or minor changes, it shall be published as final (see step 4 of the formal procedure).
32. This evaluation is mainly based on the analysis of policy documents (available via the relevant websites) and the literature. There is not much literature about the ICH. In the evaluation of the acceptance of the ICH regulatory activities I refer to interviews with two key representatives of the Dutch Medicines Evaluation Authority. The interviews were held in September 2006.
33. The legal status of the guidelines can be different in the three regions. For example, the Common Technical Document structure for registration dossiers is mandatory in Japan and in the EU for new drug registration, but is only highly recommended in the US.
34. A. Franken and E. Kroth, "ICH 2003", Pharm. Ind., Vol. 65 2003, pp. 93-98.
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