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Regulating Medicines in Europe : Competition, Expertise and Public Health - John Abraham

Regulating Medicines in Europe

Competition, Expertise and Public Health

Paperback Published: 28th September 2000
ISBN: 9780415208789
Number Of Pages: 256

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This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

List of illustrationsp. viii
Acknowledgementsp. x
List of abbreviations and acronymsp. xi
Introductionp. 1
Science, technology and regulationp. 5
Political economy of regulationp. 5
Technical expertise, regulatory science and citizenshipp. 18
Scientific uncertainty, drug development and public healthp. 25
Conclusionp. 33
Opening the black box of European medicines regulation: methodology and terminologyp. 35
Research designp. 36
Research methodsp. 37
Terminological mattersp. 41
National regulation in Europep. 43
The scale and structure of the pharmaceutical industryp. 44
Consumers and patients as organised interestsp. 47
The establishment of modern drug regulationp. 49
'Independence' and 'conflict of interest'p. 57
Neo-liberal politics and the minimal regulatory statep. 60
Conclusionp. 76
The Europeanisation of medicines regulationp. 80
The industry's transnational agendap. 80
Legal instruments for harmonisationp. 83
Mutual recognition: the CPMP procedurep. 85
Mutual recognition: the multi-state procedurep. 86
The industry's blueprint for Europep. 87
Mutual recognition: the decentralised procedurep. 88
CPMP arbitrationp. 93
The concertation procedurep. 96
The centralised procedurep. 97
The timetable for centralised evaluationsp. 99
European regulators and industry consultationp. 101
The role and selection of CPMP rapporteursp. 104
Mutual recognition: making it workp. 107
Pharmacovigilance and harmonisationp. 108
The transposition of EU legislation into national lawp. 111
Conclusionp. 113
The politics of scientific expertisep. 115
The background of failure for the multi-state procedurep. 115
The new regime and the 'virtual' Euro-agencyp. 117
The CPMP: representing politics as sciencep. 119
Informality, efficiency and transparencyp. 123
The internal market and scientific peer reviewp. 127
The viability of national agenciesp. 131
The viability of national scientific advisory committeesp. 132
'Independence' and conflicts of interestp. 136
The global context of European regulatory sciencep. 137
The neglect of pharmacovigilancep. 139
Conclusionp. 144
Competition, harmonisation and public healthp. 147
Halcion, Viagra and other disharmoniesp. 147
Safety standardsp. 152
Approval times, inter-agency competition and safety evaluationp. 156
Industry-regulator closeness and consultationp. 162
Secrecy and the impossibility of independent social scientific verificationp. 167
Conclusionp. 168
Democracy, technocracy and secrecyp. 172
Transparency and public participation in European medicines licensingp. 175
The consumerist challenge to secrecy and technocracyp. 179
Industry and government perspectives on secrecyp. 183
Harmonisation towards greater openness: rhetoric and realityp. 191
Conclusionp. 199
Conclusions and political implicationsp. 202
The European regulatory statep. 202
European harmonisation of regulatory sciencep. 207
Accountability and citizenship in Europep. 212
Political implicationsp. 215
Appendixp. 219
Notesp. 220
Bibliographyp. 225
Indexp. 238
Table of Contents provided by Syndetics. All Rights Reserved.

ISBN: 9780415208789
ISBN-10: 0415208785
Audience: Tertiary; University or College
Format: Paperback
Language: English
Number Of Pages: 256
Published: 28th September 2000
Country of Publication: GB
Dimensions (cm): 20.96 x 13.34  x 1.27
Weight (kg): 0.36
Edition Number: 1

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