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EU Pharmaceutical Regulation
This book provides an analysis of European Union pharmaceutical regulation from a policy-making perspective. The focus is on how the often conflicting agendas of the pharmaceutical industry, the EU member states, the European Commission, and consumer interests are reconciled within the context of regulatory outcomes having to serve public health, healthcare and industrial policy needs within the single market. In providing a unique perspective on how and why EU pharmaceutical policy is made, the book will be of interest to academics, students and policy-practitioners interested in EU policy-making, regulation and public policy analysis.
How the EU Really Works
The European Union is facing a profound crisis and is confronted with multiple challenges. Over the last two decades, it has experienced a series of dramatic changes to its powers, its institutional design, its constitutional framework and its borders. At the same time, the uneasy relationship between European citizens and elites has complicated both the reform and the function of the Union. While the Lisbon treaty provided some answers to crucial questions, it did not clarify the nature of the EU, which remains at the crossroads of federal and intergovernmental logic. The current economic and financial crisis puts the EU’s legitimacy further under pressure and creates the impression of a ...
How the EU Really Works
This book provides a concise analysis of the EU and its dynamics by paying particular attention to its day to day operation. It proposes to help students and scholars understand its evolution, its institutions, its decision-making and the interactions between the EU and various actors. Avoiding abstract theorizing, the authors propose an easy to read analysis of how the Union works while recognizing the complexity of the situation. Throughout the book, the key issues of European integration are addressed: democratic deficit, politicization, the role of member states, institutional crisis and citizen involvement.
Pharmaceuticals in the European Union
This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.
Three Bio-Realms
Biotechnology has become one of the most important issues in public policy and governance, altering the boundaries between the public and the private, the economic and the social, and further complicating the divide between what is scientifically possible and ethically preferred. Given the importance of biotechnology in shaping relations between the state, science, the economy, and the citizenry, a book that explores the Canadian biotechnology regime and its place in our democracy is timelier than ever. Three Bio-Realms provides the first integrated examination of the thirty-year story of the democratic governance of biotechnology in Canada. G. Bruce Doern and Michael J. Prince, two recognized specialists in governance innovation and social policy, look at particular ‘network-based’ factors that seek to promote and to regulate biotechnology inside the state as well as at broader levels. Unmatched by any other book in its historical scope and range, Three Bio-Realms is sure to be read for years to come.
Medical Law
Providing a clear and accessible guide to medical law, this work contains extracts from a wide variety of academic materials so that students can acquire a good understanding of a range of different perspectives.
Medical Devices
Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical proced...
Regulatory quality in Europe
The European Union and its member states are investing in ambitious programmes for ‘better regulation’ and targets of regulatory quality. This book, available in paperback for the first time, lifts the veil of excessively optimistic propositions covering the whole better regulation agenda. It provides an innovative conceptual framework to handle the political complexity of regulatory governance. It approaches better regulation as an emerging public policy, with its own political context, actors, problems, rules of interaction, instruments, activities and impacts. Focusing on the key tools of impact assessment, consultation, simplification, and access to legislation, the authors provide f...
Health Systems Governance in Europe
Health system governance in Europe : the role of European Union law and policy / Elias Mossialos ... [et al.] -- Health care and the EU : the law and policy patchwork / Tamara Hervey and Bart Vanhercke -- EU regulatory agencies and health protection / Govin Permanand and Ellen Vos -- The hard politics of soft law : the case of health / Scott L. Greer and Bart Vanhercke -- Public health policies / Martin McKee, Tamara Hervey and Anna Gilmore -- Fundamental rights and health care / Jean McHale -- EU competition law and public services / Tony Prosser -- EU competition law and health policy / Julia Lear, Elias Mossialos and Beatrix Karl -- Public procurement and state aid in national health care...
