Regulating European Drug Problems


Book Description

Throughout Europe - from town halls and regional governments, through national Parliaments and ministries, to the high institutions of the European Union - there runs a vigorous debate on organised crime, municipal safety and private conduct. Drug problems and what to do about them often occupy center-stage at these debates. Throughout the 1990s the focus of legal attention has been primarily on the criminal law. New criminal offenses have been created, partly in response to influences 'from above' (from international and European agreements) and partly in response to pressure 'from below' (concerns of citizens at national and sub-national levels). But although criminal law certainly is important as far as the development of drug controls is concerned, it is by no means the whole story. There is a parallel history, a regulatory one, consisting of the increasing use of administrative measures, some of which are directly concerned with drugs while others are more general but equally applicable. These responses, together with civil law, variously function as adjuncts to criminal law or as alternatives to it, in relation to drug trafficking at European and national levels, drug-related public nuisance as it concerns citizens at municipal level, and drug users. After charting existing measures in the legal orders of Member states and of the Community, Regulating European Drug Problems looks at prospects for administrative drug controls after Amsterdam - in the context of the development of the Single Market, cooperation against crime and insecurity, subsidiarity, and human rights. At a practical level, the study offers provocative ideas to policy-makers and administrators working at the intersection of city-level, national, and European responses to drugs. For scholars and students, the book offers comparative legal research and European synthesis, and forges new links between fields of law, suppresion of organised crime, and economic and social regulation.




Regulating Medicines in Europe


Book Description

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.




Regulating European Drug Problems


Book Description

Throughout Europe - from town halls and regional governments, through national Parliaments and ministries, to the high institutions of the European Union - there runs a vigorous debate on organised crime, municipal safety and private conduct. Drug problems and what to do about them often occupy center-stage at these debates. Throughout the 1990s the focus of legal attention has been primarily on the criminal law. New criminal offenses have been created, partly in response to influences `from above' (from international and European agreements) and partly in response to pressure `from below' (concerns of citizens at national and sub-national levels). But although criminal law certainly is important as far as the development of drug controls is concerned, it is by no means the whole story. There is a parallel history, a regulatory one, consisting of the increasing use of administrative measures, some of which are directly concerned with drugs while others are more general but equally applicable. These responses, together with civil law, variously function as adjuncts to criminal law or as alternatives to it, in relation to drug trafficking at European and national levels, drug-related public nuisance as it concerns citizens at municipal level, and drug users. After charting existing measures in the legal orders of Member states and of the Community, Regulating European Drug Problems looks at prospects for administrative drug controls after Amsterdam - in the context of the development of the Single Market, cooperation against crime and insecurity, subsidiarity, and human rights. At a practical level, the study offers provocative ideas to policy-makers and administrators working at the intersection of city-level, national, and European responses to drugs. For scholars and students, the book offers comparative legal research and European synthesis, and forges new links between fields of law, suppresion of organised crime, and economic and social regulation.




Evaluating the impact of Laws Regulating Illicit Drugs on Health and Society


Book Description

Evaluating the impact of Laws Regulating Illicit Drugs on Health and Society serves as an informative reference for social science researchers and policymakers on the science behind drug regulation. The book presents contributions from many leading researchers in drug law and policy evaluation. The 12 chapters highlight scientific evidence from a diverse range of international projects on evaluation of different illicit drug laws. Each contribution takes policies into account while also using methodological tools and relevant data sets. For a priori evaluation, the modern leximetric approach is applied to compare different drug laws. For posterior evaluation the analysis of social and health outcomes, using standard and new indicators are presented, discussed and applied. Next, the book covers the use of drug market estimation methods in policy research. Specific new indicators allowing the evaluation of interventions such as harm reduction and prevention are presented and analysed using international research data. The book concludes with a summary of the links of illegal drug market gains with corruption, and its consequences. Evaluating the impact of Laws Regulating Illicit Drugs on Health and Society gives readers a unique, evidence-based perspective on the relationship between drugs, laws, policy and socioeconomic conditions. Key Features Features 12 contributions from international experts on drug legislation and social science Demonstrates evidence-based evaluation of drug laws and policies Highlights Leximetric and forecast methods applied to illicit drug laws with examples Highlights the use of standard and new socioeconomic indicators to evaluate drug laws and policies Informs readers about different policy approaches to drug regulation and their consequences Summarizes the links of illegal drug markets with corruption Provides detailed references for further reading




Treating Drug Problems:


Book Description

Treating Drug Problems, Volume 2 presents a wealth of incisive and accessible information on the issue of drug abuse and treatment in America. Several papers lay bare the relationship between drug treatment and other aspects of drug policy, including a powerful overview of twentieth century narcotics use in America and a unique account of how the federal government has built and managed the drug treatment system from the 1960s to the present. Two papers focus on the criminal justice system. The remaining papers focus on Employer policies and practices toward illegal drugs. Patterns and cycles of cocaine use in subcultures and the popular culture. Drug treatment from a marketing, supply-and-demand perspective, including an analysis of policy options. Treating Drug Problems, Volume 2 provides important information to policy makers and administrators, drug treatment specialists, and researchers.




European Drug Policies


Book Description

The drug control regime established by the international community has not succeeded in curbing either the demand for, or the offer of, narcotics. But, despite a series of developments in the Americas – including the legalisation of cannabis in Uruguay and in several states in the United States of America – there is still little support in Europe for repealing drug-prohibition laws. Nevertheless, a gradual policy convergence reveals the emergence of a European model favouring public-health strategies over a strictly penal approach to combatting drugs, while growing transnational support for legalisation indicates the persistence of an alternative paradigm for drug policy. This book examines the various influences on drug policies in Europe, as grassroots movements, NGO networks, private foundations and academic research centres increasingly confront the prevailing discourses of drug prohibition. Pursuing an interdisciplinary approach and bringing together legal scholars, social scientists and practitioners, it provides a comprehensive and critical assessment of drug policy reform in Europe.




EBOOK: Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality


Book Description

"This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors: Julia Abelson, Christa Altenstetter, Vittorio Bertele’, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.




The Effects of Drug Regulation


Book Description

Most national governments have created agencies with the responsibility for deciding which medicinal drugs should be imported or manufactured and made available through their health systems. Many of these agencies were set up some twenty years ago in the wake of the thalidomide disaster. Since that time they have developed in quite different ways in response to national, cultural and economic influences. Their direct cost is very small in comparison to overall health budgets but their indirect effects, both in terms of health and the economy, can be substantial. In 1980 the World Health Organization (WHO) Regional Office for Europe set up a series of studies of drug evaluation in the European region aimed at determining the effects of the work of regulatory agencies on the availability of drugs, on the pharmaceutical industry, and on the health of individuals in the countries concerned. This book sets that work in a historical context and describes the sources of the data used by the project team and the methods used by WHO and others in assessing the work of these agencies and its repercussions for the community. Finally, it presents an analysis of current knowledge and the plans and prospects for future research. The first draft of this book was presented to a meeting of experts in the field of drug regulation at Oslo in March 1984, and the present text embodies the views and conclusions of that meeting.




The Interplay of Global Standards and EU Pharmaceutical Regulation


Book Description

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.




Guide to EU and UK Pharmaceutical Regulatory Law


Book Description

In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.