Regulating medicines in Europe : competition, expertise and public health / John Abraham and Graham Lewis.

Format:

• Book

Author/Creator:

• Abraham, John, 1961-

Contributor:

• Lewis, Graham, 1942-

Language:

English

Subjects (All):

• Drugs--Testing--Government policy--European Union countries.
• Drugs--Safety regulations--European Union countries.
• Drugs--Safety regulations.
• Drugs.
• Drugs--Testing--Government policy.
• Drugs--Testing.
• European Union countries.

Physical Description:

xii, 243 pages : illustrations ; 23 cm

Place of Publication:

London ; New York : Routledge, 2000.

Summary:

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

Contents:

• 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
• 2 Opening the black box of European medicines regulation: methodology and terminology 35
• Research design 36
• Research methods 37
• 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
• 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
• Pharmacovigilance and harmonisation 108
• The transposition of EU legislation into national law 111
• 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
• 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
• 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
• 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.

Notes:

Includes bibliographical references (pages [225]-237) and index.

ISBN:

• 0415208777
• 0415208785

OCLC:

43641303