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Book Cover
Author Abraham, John, 1961-

Title Regulating Medicines in Europe : Competition, Expertise and Public Health
Published Hoboken : Taylor and Francis, 2014
Online access available from:
ProQuest Ebook Central    View Resource Record  


Description 1 online resource (256 pages)
Contents Cover; Title Page; Copyright Page; Table of Contents; List of illustrations; Acknowledgements; List of abbreviations and acronyms; Introduction; 1 Science, technology and regulation; Political economy of regulation; Technical expertise, regulatory science and citizenship; Scientific uncertainty, drug development and public health; Conclusion; 2 Opening the black box of European medicines regulation: methodology and terminology; Research design; Research methods; Terminological matters; 3 National regulation in Europe; The scale and structure of the pharmaceutical industry
Consumers and patients as organised interestsThe establishment of modern drug regulation; 'Independence' and 'conflict of interest'; Neo-liberal politics and the minimal regulatory state; Conclusion; 4 The Europeanisation of medicines regulation; The industry's transnational agenda; Legal instruments for harmonisation; Mutual recognition: the CPMP procedure; Mutual recognition: the multi-state procedure; The industry's blueprint for Europe; Mutual recognition: the decentralised procedure; CPMP arbitration; The concertation procedure; The centralised procedure
The timetable for centralised evaluationsEuropean regulators and industry consultation; The role and selection of CPMP rapporteurs; Mutual recognition: making it work; Pharmacovigilance and harmonisation; The transposition of EU legislation into national law; Conclusion; 5 The politics of scientific expertise; The background of failure for the multi-state procedure; The new regime and the 'virtual' Euro-agency; The CPMP: representing politics as science; Informality, efficiency and transparency; The internal market and scientific peer review; The viability of national agencies
The viability of national scientific advisory committees'Independence' and conflicts of interest; The global context of European regulatory science; The neglect of pharmacovigilance; Conclusion; 6 Competition, harmonisation and public health; Halcion, Viagra and other disharmonies; Safety standards; Approval times, inter-agency competition and safety evaluation; Industry-regulator closeness and consultation; Secrecy and the impossibility of independent social scientific verification; Conclusion; 7 Democracy, technocracy and secrecy
Transparency and public participation in European medicines licensingThe consumerist challenge to secrecy and technocracy; Industry and government perspectives on secrecy; Harmonisation towards greater openness: rhetoric and reality; Conclusion; 8 Conclusions and political implications; The European regulatory state; European harmonisation of regulatory science; Accountability and citizenship in Europe; Political implications; Appendix; Notes; Bibliography; Index
Summary 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 interest
Notes Print version record
Subject Drugs -- Testing -- Government policy -- European Union countries
Drugs -- Testing -- Government policy.
MEDICAL -- Pharmacology.
European Union countries.
Form Electronic book
Author Lewis, Graham.
ISBN 1136295658