Regulating Medicines in Europe: Competition,

Drawing on detailed research undertaken over the last four years in Brussels, Germany, the Netherlands and the UK,Regulating Medicines in Europepresents a critical appraisal of medicines regulation policy and exposes the influence of the pharmaceutical industry in the acceleration of drug approvals.

John Abraham is Professor of Sociology and Co-director of the Centre for Research in Health and Medicine, University of Sussex.

List of illustrations

viii

Acknowledgments

x

List of abbreviations and acronyms

xi

Introduction

1

(4)

Science, technology and regulation

5

(30)

Political economy of regulation

5

(13)

Technical expertise, regulatory science and citizenship

18

(7)

Scientific uncertainty, drug development and public health

25

(8)

Conclusion

33

(2)

Opening the black box of European medicines regulation: methodology and terminology

35

(8)

Research design

36

(1)

Research methods

37

(4)

Terminological matters

41

(2)

National regulation in Europe

43

(37)

The scale and structure of the pharmaceutical industry

44

(3)

Consumers and patients as organised interests

47

(2)

The establishment of modern drug regulation

49

(8)

`Independence' and `conflict of interest'

57

(3)

Neo-liberal politics and the minimal regulatory state

60

(16)

Conclusion

76

(4)

The Europeanisation of medicines regulation

80

(35)

The industry's transnational agenda

80

(3)

Legal instruments for harmonisation

83

(2)

Mutual recognition: the CPMP procedure

85

(1)

Mutual recognition: the multi-state procedure

86

(1)

The industry's blueprint for Europe

87

(1)

Mutual recognition: the decentralised procedure

88

(5)

CPMP arbitration

93

(3)

The concertation procedure

96

(1)

The centralised procedure

97

(2)

The timetable for centralised evaluations

99

(2)

European regulators and industry consultation

101

(3)

The role and selection of CPMP rapporteurs

104

(3)

Mutual recognition: making it work

107

(1)

Pharmacovigilance and harmonisation

108

(3)

The transposition of EU legislation into national law

111

(2)

Conclusion

113

(2)

The politics of scientific expertise

115

(32)

The background of failure for the multi-state procedure

115

(2)

The new regime and the `virtual' Euro-agency

117

(2)

The CPMP: representing politics as science

119

(4)

Informality, efficiency and transparency

123

(4)

The internal market and scientific peer review

127

(4)

The viability of national agencies

131

(1)

The viability of national scientific advisory committees

132

(4)

`Independence' and conflicts of interest

136

(1)

The global context of European regulatory science

137

(2)

The neglect of pharmacovigilance

139

(5)

Conclusion

144

(3)

Competition, harmonisation and public health

147

(25)

Halcion, Viagra and other disharmonies

147

(5)

Safety standards

152

(4)

Approval times, inter-agency competition and safety evaluation

156

(6)

Industry-regulator closeness and consulation

162

(5)

Secrecy and the impossibility of independent social scientific verification

167

(1)

Conclusion

168

(4)

Democracy, technocracy and secrecy

172

(30)

Transparency and public participation in European medicines licensing

175

(4)

The consumerist challenge to secrecy and technocracy

179

(4)

Industry and government perspectives on secrecy

183

(8)

Harmonisation towards greate openness: rhetoric and reality

191

(8)

Conclusion

199

(3)

Conclusions and political implications

202

(17)

The European regulatory state

202

(5)

European harmonisation of regulatory science

207

(5)

Accountability and citizenship in Europe

212

(3)

Political implications

215

(4)

Appendix

219

(1)

Notes

220

(5)

Bibliography

225

(13)

Index

238

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Regulating Medicines in Europe: Competition, Expertise and Public Health

Summary

Author Biography

Table of Contents

Supplemental Materials