The challenge of globalization in pharmaceutical law - Is an international drug approval system modeled after the European system worth considering?

Food and Drug Law Journal

Volumn 63, Issue 3, 2008, Pages

  Purnhagen, Kai P ^a  

^a UNIVERSITY OF LUCERNE   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

COMPETITION; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; HEALTH CARE POLICY; HEALTH CARE QUALITY; INTERNATIONAL COOPERATION; LAW; REVIEW; ARTICLE; CULTURAL ANTHROPOLOGY; DRUG LEGISLATION; ECONOMIC ASPECT; ECONOMICS; EUROPE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HISTORY; HUMAN; LEGAL ASPECT; MEDICAL ETHICS; POSTMARKETING SURVEILLANCE; RISK; SOCIAL PSYCHOLOGY; UNITED STATES;

CULTURE; DRUG APPROVAL; DRUG INDUSTRY; ECONOMIC COMPETITION; ETHICS, MEDICAL; EUROPE; GOVERNMENT REGULATION; HISTORY, 20TH CENTURY; HUMANS; INTERNATIONAL COOPERATION; INTERNATIONALITY; LEGISLATION, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY ASSURANCE, HEALTH CARE; RISK; SOCIAL VALUES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 50949114198     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (109)

1. David Vogel, The Globalization of Pharmaceutical Regulation, 11 GOVERNANCE: AN INT'L J. POL'Y & ADMIN. 1, 1 (1998);
2. Heinrich Hanika, Europäisches Arzneimittelrecht (European Pharmaceutical Law), 18 MEDIZINRECHT (MEDR) 63, 63 (2000) (F.R.G.) (stating that in 1997 for example the total amount of sales on the German pharmaceutical market were 50.2 billion Marks, whereby 21.25 billion Marks of it resulted from the export trade). Nowadays, the total amount of sales and increased also in export trade. In 2006 they were estimated 29.4 billion Euros, whereby 16.2 billion Euros of it resulted from export trade. Worldwide the total amount of sales was 643 billion U.S. dollars in 2006, see Press Release, Verband forschender Arzneimittelhersteller e.V., Statistics Kompakt - Zahlen und Fakten (2007) 2, available at http://www.vfa.de/download/SAVE/ de/presse/publikationen/Statistics2007kompakt/Statistics2007-kompakt.pdf.
3. Bayer China homepage, http://www.bayerchina.com.cn/ (follow "About Bayer," then "Bayer Worldwide" hyperlink under "Europe is Bayer's Homemarket").
4. Lawrence J. White, International Regulation of Securities Markets: Harmonization or Competition? 20 (Draft, Nov. 1993) (On file with the Department of Economics Leonard N. Stern School of Business, NY Univ., Working Paper Series No. EC-93-26).
5. Clement Bezold & Jonathan Peck, Drug Regulation 2056, 60 FOOD & DRUG L. J., 127 (2005) (Bezold & Peck are investigating such a possibility).
6. Sebastian Krapohl, Risk Regulation in the Single Market 86 (Mar. 2007) (unpublished Ph.D. dissertation, Otto-Friedrich-University of Bamberg) (on file with the Otto-Friedrich-University of Bamberg) (F.R.G.); Vogel, supra note 1, at 1.
7. White, supra note 3, at 7.
8. David Kay, THE INTERNATIONAL REGULATION OF PHARMACEUTICAL DRUGS 4 (1976).
9. See id. at 5.
10. See id.
11. See id.
12. See for the pharmaceutical market Bezold & Peck, supra note 10, at 127; Jürgen Feick, Marktzugangsregulierung: Nationale Regulierung, europäische Integration und internationale Harmonisierung in der Arzneimittelzulassung (Regulation of Market Approval: National Regulations, European Integration and International Harmonization of Pharmaceutical Authorization), in DIE POLITISCHE KONSTITUTION VON MÄRKTEN 228, 230 (Roland Czada & Susanne Lütz ed., 2000) (F.R.G.).
13. Bezold & Peck, supra note 4, at 129-130.
14. Feick supra note 11, at 231.
15. White, supra note 3, at 9-10.
16. It is, however, a consequence of a misinterpretation of the doctrine of "informed consent" that the patient has to be completely informed about the risks involved. Law cannot demand such an achievement, because it is not practically possible. First there will be always a lack of knowledge about the compounds between the physician, the pharmacist and the patient. Second, even the longest-term studies and the most detailed package leaflet cannot cover all possible risks. Furthermore, it is questionable in general, whether the package leaflet is an efficient information instrument at all. In a representative poll in Germany with packet leaflets designed as the German law desires, 42 percent of the people polled found the package leaflets in general too long, 29 percent are even more uncertain about the ingredients and the risks of the drug after reading the package leaflet and 20 percent characterize it as incomprehensible. At the same time, however, 65 percent of the interviewees stated that the package leaflet is the most important source to get information about the drug. See for the poll and its results KATRIN NINK & HELMUT SCHRÖDER, ZU RISIKEN UND NEBENWIRKUNGEN: LESEN SIE DIE PACKUNGSBEILAGE? (FOR POSSIBLE RISKS AND SIDE-EFFECTS SEE THE PACKAGE LEAFTLET?) 76 (2005) (F.R.G.).
17. Feick supra note 11, at 231.
18. Id.
19. Jeffrey Levi, Unproven AIDS Therapies: The Food and Drug Administration and ddI, in BIOMEDICAL POLITICS 9, 11 (Kathi E. Hanna ed., 1991) (stating for the U.S. American policy, that "each significant federal initiative for closer regulation of the industry coincided with a major catastrophe with a drug").
20. Levi id.; James L. Zelenay Jr., The Prescription Drug User Fee Act: Is a Faster Food Administration Always a Better Food and Drug Administration?, 60 FOOD & DRUG L.J. 261, 264 (2005).
21. Levi id.; Zelenay Jr. id.
22. Jürgen Feick, Regulatory Europeanization, National Autonomy and Regulatory Effectiveness: Marketing Authorization for Pharmaceuticals, 9 n.7 (2006) (F.R.G.), http://www.mpi-fg-koeln.mpg.de/review/downloads/ 02%20November%20-%20MPIfG%20DP.pdf (pointing out that France and the United States already had a sophisticated approval procedure with the result that thalidomide was not marketed in these countries).
23. In Germany known as the "Contergan-Katastrophe," named after the brand of the drug.
24. See for a well-investigated description Arthur Daemmrich, PHARMACOPOLITICS - DRUG REGULATIONS IN THE UNITED STATES AND GERMANY 60 ff. (2004); Krapohl, supra note 5, at 88-93.
25. Feick, supra note 21, at 9; Erwin Deutsch & Andreas Spickhoff, MEDIZINRECHT (MEDICAL LAW) 533 (6th ed. 2007) (F.R.G.).
26. Daemmrich, supra note 24, at 26; Zelenay, Jr., supra note 18, at 265 (Both stating, that the number of effected children was approximately 10,000).
27. Daemmrich, id.; Deutsch & Spickhoff supra note 24, at 534.
28. Daemmrich, id.; Deutsch & Spickhoff, id.
29. UDO DI FABIO, RISIKOENTSCHEIDUNGEN IM RECHTSSTAAT (DECISIONS ON RISKS IN THE RECHTSSTAAT) 41-52 (1994) (F.R.G.).
30. For a comparative analysis of the precautionary principle in Europe and the United States, see David Vogel, Comparing Environmental Governance: Risk Regulation in the EU and in the US 3-25 (2003) (On file with the Center for Responsible Business, Univ. of CA, Berkeley, Working Paper Series Paper 2). In Europe this principle is laid down in para. 2 of Art. 174 EC, undepinning Community action in the field of environmental protection. It was however, widened to apply in many different areas of risk regulation, in EC Health and Environmental Law, 12 European Law Journal 139-172 (2006) (Italy)
31. White, supra note 3, at 20. Generally speaking, different legal systems might be either harmonized or unified. While harmonization identifies the difference of legal systems and seeks to find proper method for handling those within the frameworks of these systems, unification regularly results in the adoption of one of these formats, see Emanuela Carbonera & Francesco Parisi, The paradox of legal harmonization, 132 Public Choice 367-400 (2007) (Neth.) (providing economic analysis)
32. Id., at 8.
33. Id. at 37.
34. See for example Sec. 201 (p) (1) Food, Drug & Cosmetic Act (FDCA).
35. Jerome A. Halperin, International Harmonization in the Pharmaceutical Sector, 13 FOOD, DRUG, COSMETIC & MEDICAL DEVICE L. DIGEST 109, 110 (1996).
36. See Vogel, supra note 1, at 2.
37. See Halperin', supra note 33, at 110.
38. See id. (speak's of a "If we're going to harmonize, let's do it my way" position).
39. INGO SCHNEIDER, DAS KOOPERATIONSPRINZIP IM VORFELD DER ARZNEIMITTELZULASSUNG [THE PRINCIPLE OF COOPERATION IN THE PREFIELD OF PHARMACEUTICAL AUTHORIZATION] 29 (2003) (F.R.G).
40. See id. (who pointed out, that the difference of the traditions of medical schools in Europe was a reason for the member states to treat harmonization with reserve).
41. See Halperin, supra note 33, at 109 (discussing these expectations with a special remark on the demand of honoring of the sovereignty of every individual country).
42. See White, supra note 3, at 20.
43. Id.
44. Vogel, supra note 29, at 20.
45. See Fabrizio Cafaggi & Hans-W. Micklitz, Administrative and Judicial Collective Enforcement of Consumer Law in the U.S. and the European Communinty 37-38 (2007) (on file with the European Univ. Institute in Florence, EUI Working Papers LAW 2007/22) available at http://cadmus.eui.eu.
46. Id.
47. See NATIONAL BIOETHICS ADVISORY COMMISSION, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN BEINGS 1-17 (2001), available at www.georgetown.edu/research/nrcbl/nbac/pubs.html.
48. Sharon Frank, A NEW MODEL FOR EUROPEAN MEDICAL DEVICE REGULATION 8 (2003) (stating for the comparable issue of medical devices that "access to (...) and the promotion of the innovation of medical devices should not be at the expense of the health of the consumers (although...) both regulatory regimes aim to ensure safe medical devices for patients").
49. See Dan Kidd, The International Conference on Harmonization of Pharmaceutical Regulations, the European Medicines Evaluation Agency, and the FDA: Who's zooming who?, 4 IND. J. GLOBAL LEGAL STUD. 183, 185 (1996);
50. Joachim Spalcke, ARZNEIMITTELZULASSUNGSVERFAHREN IN DER EUROPÄISCHEN UNION UND DEN VEREINIGTEN STAATEN VON AMERIKA (PHARMACEUTICAL AUTHORIZATION ON THE EUROPEAN UNION AND THE UNITED STATES OF AMERICA) 112 (2004) (F.R.G.). Halperin supra note 33, at 109 (discusses, that there have been some earlier meetings concerning harmonization, one in 1902 in Brussels and one 1970 in Heidelberg, that have not been a great success, compared to the ICH). Preface to REPORT OF THE PROCEEDINGS OF THE FIFTH INTERNATIONAL PHARMACEUTICAL CONGRESS i, v (London 1881) (Gr. Brit.) (stating, that there have been so called International Pharmaceutical Congresses before that had the emphasis to harmonize standards. They started in 1865 in Brunswick and where organized several times in Paris (1867), Vienna (1869), St. Petersburg (1874), and London (1881)) Although they were named "International Congress," they focused only on the harmonization of European pharmaceutical standards. Therefore, they can hardly be counted "international."
51. P. Helboe, European Drug Master File Procedure for Active Ingredients (EC Note for Guidance), in DRUG MASTER FILES - GLOBAL HARMONIZATION OF QUALITY STANDARDS 21, 30 (Helga Möller & Walter Oeser ed., 1992) (F.R.G.).
52. C. P. Hoiberg, Guidelines for Drug Master Files (FDA/USA), in DRUG MASTER FILES - GLOBAL HARMONIZATION OF QUALITY STANDARDS 33, 46 (Helga Möller & Walter Oeser ed., 1992) (F.R.G.).
53. See Rosemary Kanusky, Pharmaceutical Harmonization: Standardizing Regulations Among the United States, the European Economic Community, and Japan, 16 HOUSTON J. OF INT'L L. 665, 682 (1994).
54. See Daniel Green, EU Body to Speed Up Approval of New Drugs, FIN. TIMES, (Jan. 22, 1995).
55. Martin Bangemann, Welcome Addresses by Mr. Martin Bangemann, Vice-President of the Commission of the European Communities, in Welcome and Introduction, in PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCES ON HARMONISATION BRUSSELS 1991 1, 4 (P.F. D'Arcy & D.W.G. Harron ed., 1992) (Gr.Brit.) (giving the money in the old ECU currency, converted by author).
56. Id.
57. Id.
58. Id.
59. Spalcke supra note 48, at 115; Halperin supra note 33, at 109 (both pointing that out especially on pharmaceutical law harmonization issues).
60. See Vogel, supra note 1, at 2.
61. Hanika supra note 1, at 63. Unfortunately, to the author's knowledge there are no recent statistics available.
62. Spalcke supra note 48, at 112, 116.
63. Id., at 113.
64. Richard. B. Arnold, Objectives and Preparation of the Conference and the Role of the Workshops, in Welcome and Introduction, in PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCES ON HARMONISATION BRUSSELS 1991 7, 8 (P.F. D'Arcy & D.W.G. Harron ed., 1992) (Gr.Brit.) (discussing that "today, concerns about health care costs, including drug and drug development costs, the emergence of new disease problems, ethical concerns about the use of experimental animals and possibly unnecessary procedures in humans provide a powerful incentive to rationalize technical requirements for drug registration").
65. See id.
66. Spalcke supra note 48, at 116; Guilio Poggolino, Europe: An Example of Harmonisation, in Welcome and Introduction, in PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCES ON HARMONISATION BRUSSELS 1991 17, 17 (P.F. D'Arcy & D.W.G. Harron ed., 1992) (Gr.Brit.); Kidd, supra note 48, at 184 (all stating that the EU System could be the model for future pharmaceutical approval harmonization).
67. Schneider supra note 38, at 31. Unfortunately there is no more recent data available. Unlike the national agencies, the EMEA does not publish statistics frequently. However, Krapohl showed that most of the stakeholders were generally satisfied with the centralized procedure. 68 percent of the interviewees from the group of authorization holders and 75 percent of the group of regulatory authorities were satisfied with the centralized procedure. Additionally, 40 percent from the group of physician associations and 57 percent of the patient associations preferred the centralized procedure to the decentralized, see Krapohl, supra note 5, at 139.
68. See Art. 4 (1) Regulation 2309/93/EEC.
69. See Art. 9 (1) Regulation 2309/93/EEC.
70. See Art. 11 (2, 3), 73 Regulation 2309/93/EEC.
71. See Art. 73 (4) Regulation 2309/93/EEC.
72. See Art. 73 (5) Regulation 2309/93/EEC.
73. Schneider supra note 38, at 30.
74. See id.
75. See id, at 34.
76. See id. Unfortunately, there is no more recent data available.
77. See Art. 28 (2) in connection with Art. 8, 10 (1) and 11 Directive 2001/83/EC.
78. See Art. 28 (2) 3 Council Directive 2001/83/EC.
79. See Art. 28 (1) a.E. in connection with Art. 21 (4) Directive 2001/83/EC.
80. See Art. 28 (4) Directive 2001/83/EC.
81. See Art. 29 ff. and Art. 32 f. Directive 2001/83/EC.
82. Spalcke supra note 48, at 49 (pointing out, that the Reference Member State always will defend its approval).
83. Art. 34, 121 (2) Directive 2000/83/EC.
84. ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "Structure of the ICH" hyperlink under "About ICH").
85. See id.
86. ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "ICH Previous Conferences" hyperlink under "Conferences").
87. Richard. B. Arnold, Annex 1 Co-Sponsors of the Conference, in PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCES ON HARMONISATION BRUSSELS 1991 xxi, xxi-xxiii (P.F. D'Arcy & D.W.G. Harron ed., 1992) (Gr.Brit.); Vogel, supra note 1, at 11.
88. See Schneider supra note 38, at 107-114 (summarizing the discussion about the legal categorization of the ICH-guidelines).
89. See Kai P. Purnhagen, From B2b and B2c Relationships to a Competition of Agencies (B2a): Switching the Perspective in International Economic Law as Shown on the Example of International Pharmaceutical Law - Consequences for Regulation and Possible Solutions" (unpublished draft, July 14, 2008), available at SSRN: http://ssrn.com/abstract=1159667.
90. ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "Structure of the ICH" hyperlink under "About ICH," then under "Structure of the ICH").
91. Id.
92. Id. (follow "Structure of the ICH" hyperlink under "About ICH," then under "ICH Observers").
93. Id. (follow "Structure of the ICH" hyperlink under "About ICH," then under "Structure of the ICH").
94. Arnold, supra note 85, at 9; ICH homepage, http://www.ich.org/ cache/compo/276-254-1.html (follow "Structure of the ICH" hyperlink under "About ICH," then under "ICH Steering Committee").
95. ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "ICH Previous Conferences" hyperlink under "Conferences").
96. Id.
97. See Schneider supra note 38, at 107-114 (2003) (summarizing the discussion about the legal categorization of the ICH-guidelines).
98. See ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "Process for Harmonisation" hyperlink under "About ICH," then under "Formal ICH Procedure" hyperlink).
99. Id. (follow "Process for Harmonisation" hyperlink under "About ICH").
100. Id.
101. See Vogel, supra note 1, at 4.
102. See id.
103. Bangemann, supra note 53, at 2; Poggolino, supra note 64, at 17.
104. The guidelines, available at the ICH homepage, http://www.ich.org/cache/compo/276-254-1.html (follow "Guidelines" hyperlink under "Publications").
105. Id. (follow "Guidelines" hyperlink under "Publications," then follow "Multidisciplinary Topics" hyperlink, then "Medical Terminology" hyperlink); see also the MedDRA Website, available at http://meddramsso.com/MSSOWeb/index.htm.
106. See the homepage of the FDA, http://www.fda.gov/cder/guidance/ 939fnl.pdf and the homepage of the EMEA, http://www.emea.europa.eu/pdfs/human/ ich/013595en.pdf.
107. Supra note 103 (follow "Guidelines" hyperlink under "Publications," then follow "Multidisciplinary Topics" hyperlink, then "Electronic Standards for the Transfer of Regulatory Information" hyperlink).
108. Id. (follow "Guidelines" hyperlink under "Publications," then follow "Multidisciplinary Topics" hyperlink, then "The Common Technical Document" hyperlink).
109. Id. (follow "Guidelines" hyperlink under "Publications," then follow "Multidisciplinary Topics" hyperlink, then "Data Elements and Standards for Drug Dictionaries" hyperlink).