Regulating medicines in Europe: competition, expertise and public health
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
London [u.a.]
Routledge
2000
|
| Ausgabe: | 1. publ. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XII, 243 S. graph. Darst. |
| ISBN: | 0415208777 0415208785 |
Internformat
MARC
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| 245 | 1 | 0 | |a Regulating medicines in Europe |b competition, expertise and public health |c John Abraham and Graham Lewis |
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| 264 | 1 | |a London [u.a.] |b Routledge |c 2000 | |
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| 650 | 4 | |a Drug Evaluation |z European Union | |
| 650 | 4 | |a Drug and Narcotic Control |z European Union | |
| 650 | 4 | |a Drugs |x Safety regulations |z European Union countries | |
| 650 | 4 | |a Drugs |x Testing |x Government policy |z European Union countries | |
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Datensatz im Suchindex
| _version_ | 1820128343205347328 |
|---|---|
| adam_text |
Contents
List of illustrations viii
Acknowledgements x
List of abbreviations and acronyms xi
Introduction 1
1 Science, technology and regulation 5
Political economy of regulation 5
Technical expertise, regulatory science and citizenship 18
Scientific uncertainty, drug development and public health 25
Conclusion 33
2 Opening the black box of European medicines regulation:
methodology and terminology 35
Research design 36
Research methods 37
Terminological matters 41
3 National regulation in Europe 43
The scale and structure of the pharmaceutical industry 44
Consumers and patients as organised interests 47
The establishment of modern drug regulation 49
'Independence' and 'conflict of interest' 57
Neo liberal politics and the minimal regulatory state 60
Conclusion 76
4 The Europeanisation of medicines regulation 80
The industry's transnational agenda 80
Legal instruments for harmonisation 83
Mutual recognition: the CPMP procedure 85
Mutual recognition: the multi state procedure 86
The industry's blueprint for Europe 87
Mutual recognition: the decentralised procedure 88
CPMP arbitration 93
The concertation procedure 96
The centralised procedure 97
The timetable for centralised evaluations 99
European regulators and industry consultation 101
The role and selection of CPMP rapporteurs 104
Mutual recognition: making it work 107
Pbarmacovigilance and harmonisation 108
The transposition of EU legislation into national law 111
Conclusion 113
5 The politics of scientific expertise 115
The background of failure for the multi state procedure 115
The new regime and the 'virtual' Euro agency 117
The CPMP: representing politics as science 119
Informality, efficiency and transparency 123
The internal market and scientific peer review 127
The viability of national agencies 131
The viability of national scientific advisory committees 132
'Independence' and conflicts of interest 136
The global context of European regulatory science 137
The neglect of pharmacovigilance 139
Conclusion 144
6 Competition, harmonisation and public health 147
Halcion, Viagra and other disharmonies 147
Safety standards 152
Approval times, inter agency competition and safety
evaluation 156
Industry regulator closeness and consultation 162
Secrecy and the impossibility of independent
social scientific verification 167
Conclusion 168
7 Democracy, technocracy and secrecy 172
Transparency and public participation in European
medicines licensing 175
The consumerist challenge to secrecy and technocracy 179
Industry and government perspectives on secrecy 183
Harmonisation towards greater openness:
rhetoric and reality 191
Conclusion 199
8 Conclusions and political implications 202
The European regulatory state 202
European harmonisation of regulatory science 207
Accountability and citizenship in Europe 212
Political implications 215
Appendix 219
Notes 220
Bibliography 225
Index 238
Illustrations
Tables
3.1 Industrial interests of expert scientific advisers
on medicines regulation in 1989 and 1996 59
4.1 Number of finalised mutual recognition
(decentralised) procedures (1995 to June 1999) 92
4.2 Total number of finalised mutual recognition
(decentralised) procedures by type
(1995 to June 1999) 92
4.3 Percentage of procedures per Reference Member
State (NASs) 1995 to June 1999 93
4.4 Number of centralised procedures 1995 to 1999 98
4.5 Centralised procedure: number of rapporteurs/
co rapporteurs in different EU Member States,
1996 and 1998 106
6.1 Industry and regulator views on potential levelling
down of safety standards 153
6.2 Industry and regulator views on competition
between Member States as a threat to public health 158
6.3 Industry and regulator views on closeness of
industry regulator relations as a threat to
public health 165
7.1 The information hierarchy 182
7.2 Industry and regulator views on greater public
access to information about new drugs in principle 184
7.3 Industry and regulator support for European Public
Assessment Reports (EPARs) 185
7.4 Industry and regulator views on policies affecting wider
public access to information on new drugs 187 |
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| spelling | Abraham, John Verfasser aut Regulating medicines in Europe competition, expertise and public health John Abraham and Graham Lewis 1. publ. London [u.a.] Routledge 2000 XII, 243 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Europäische Union Europäische Union (DE-588)5098525-5 gnd rswk-swf Concurrentie gtt EU-richtlijnen gtt Farmaceutische industrie gtt Geneesmiddelen gtt Regelgeving gtt Politik Drug Approval European Union Drug Evaluation European Union Drug and Narcotic Control European Union Drugs Safety regulations European Union countries Drugs Testing Government policy European Union countries Public Policy European Union Regulierung (DE-588)4201190-5 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Europäische Union. Mitgliedsstaaten Europäische Union (DE-588)5098525-5 b Arzneimittel (DE-588)4003115-9 s Regulierung (DE-588)4201190-5 s DE-604 Lewis, Graham Verfasser aut HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009693682&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Abraham, John Lewis, Graham Regulating medicines in Europe competition, expertise and public health Europäische Union Europäische Union (DE-588)5098525-5 gnd Concurrentie gtt EU-richtlijnen gtt Farmaceutische industrie gtt Geneesmiddelen gtt Regelgeving gtt Politik Drug Approval European Union Drug Evaluation European Union Drug and Narcotic Control European Union Drugs Safety regulations European Union countries Drugs Testing Government policy European Union countries Public Policy European Union Regulierung (DE-588)4201190-5 gnd Arzneimittel (DE-588)4003115-9 gnd |
| subject_GND | (DE-588)5098525-5 (DE-588)4201190-5 (DE-588)4003115-9 |
| title | Regulating medicines in Europe competition, expertise and public health |
| title_auth | Regulating medicines in Europe competition, expertise and public health |
| title_exact_search | Regulating medicines in Europe competition, expertise and public health |
| title_full | Regulating medicines in Europe competition, expertise and public health John Abraham and Graham Lewis |
| title_fullStr | Regulating medicines in Europe competition, expertise and public health John Abraham and Graham Lewis |
| title_full_unstemmed | Regulating medicines in Europe competition, expertise and public health John Abraham and Graham Lewis |
| title_short | Regulating medicines in Europe |
| title_sort | regulating medicines in europe competition expertise and public health |
| title_sub | competition, expertise and public health |
| topic | Europäische Union Europäische Union (DE-588)5098525-5 gnd Concurrentie gtt EU-richtlijnen gtt Farmaceutische industrie gtt Geneesmiddelen gtt Regelgeving gtt Politik Drug Approval European Union Drug Evaluation European Union Drug and Narcotic Control European Union Drugs Safety regulations European Union countries Drugs Testing Government policy European Union countries Public Policy European Union Regulierung (DE-588)4201190-5 gnd Arzneimittel (DE-588)4003115-9 gnd |
| topic_facet | Europäische Union Concurrentie EU-richtlijnen Farmaceutische industrie Geneesmiddelen Regelgeving Politik Drug Approval European Union Drug Evaluation European Union Drug and Narcotic Control European Union Drugs Safety regulations European Union countries Drugs Testing Government policy European Union countries Public Policy European Union Regulierung Arzneimittel Europäische Union. Mitgliedsstaaten |
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