Implications of Future EU Policy on the Provision of Medicines and on Actors in the European Pharmaceutical Sector PDF Download

Author: Ewout Johan Marius van Ginneken
Publisher: Univerlagtuberlin
ISBN: 379832235X
Category :
Languages : en
Pages : 210

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Author: Mossialos, Elias
Publisher: McGraw-Hill Education (UK)
ISBN: 0335214657
Category : Education
Languages : en
Pages : 390

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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.

Author: Pablo Figueroa
Publisher: Edward Elgar Publishing
ISBN: 1785362615
Category : Business & Economics
Languages : en
Pages : 758

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This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586035211
Category : Business & Economics
Languages : en
Pages : 154

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Book Description
In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.

Author: Govin Permanand
Publisher: Manchester University Press
ISBN: 9780719072727
Category : Medical
Languages : en
Pages : 272

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Book Description
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.

Author: Russell Graeme Hunter
Publisher:
ISBN: 9789172231221
Category : Antitrust law
Languages : en
Pages : 76

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Author: Giuditta Savonitto
Publisher: Cambridge Scholars Publishing
ISBN: 1527533603
Category : Political Science
Languages : en
Pages : 189

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Book Description
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.

Author: Monika Steffen
Publisher: Routledge
ISBN: 1134219555
Category : Political Science
Languages : en
Pages : 232

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Book Description
Health constitutes a core element of welfare states and a vital nerve in the trust relation between citizen and their governments. Focusing on the health sector, this book analyzes the closely interwoven relationship between the European Union and Member States. The authors explore the dynamic and multi-fold process of de-nationalizing health policies and illustrate how European policies develop in a sector that still appears to be under exclusively national competence. They describe the multiple forms and ways the Europeanization process takes, driven by market integration, public health crises and politics of consumer protection. The authors also provide a detailed analysis of key topics: the pharmaceutical sector, market regulation of medical goods and devices, food safety, the blood provision and plasma industry, European politics on bioethics, and risk reduction in the field of drug abuse. Providing a comprehensive and informed assessment of the Europeanization process in the field of health policies, this book will be of interest to students and scholars of health, European integration and policy-making.

Author: Arne Noack
Publisher: GRIN Verlag
ISBN: 3638726703
Category :
Languages : en
Pages : 54

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Book Description
Seminar paper from the year 2003 in the subject Business economics - Operations Research, grade: A, Vrije University Brussel (Vesalius College), course: Economics, language: English, abstract: The health of their population has always been a great concern for governments of Post-War Europe. In order to achieve their goals they had to work closely together with the pharmaceutical Industry. With the phenomenon of the aging population the importance of development of new drugs is increasing. The increasingly old population of Europe creates a big market for pharmaceutical companies. The pharmaceutical Industry is a very complex sector with close links to other Industries. The chemical Industry for example is an important supplier for materials needed in the process of creating new drugs. Furthermore is the market for pharmaceuticals characterized by extremely little concentration and a huge variety of products. Globally in 1998, the 300 best-selling products held a share of less than 45% of the worlds market. The top two products held 1.3% of the market each.1 This fact creates a necessity for the companies to research new, so called "Blockbuster drugs" to succeed on this market with a high competition. The data on the various methods of drug discovery is enormous and sophisticated. In this paper the structure of the Research & Development sector of the European pharmaceutical industry will be examined, which is of increasing importance for the success of the individual companies. The specific data on the R & D section will be given a general character. Furthermore it will give a brief overview of the different regions in Europe and their individual differences. In the end, the difficulties and challenges of R & D in the pharmaceutical industry will be described and compared to other pharma markets abroad. [1 Data taken from "Combining discovery with development" by Dr. Peter Eddershaw; World pharmaceutical frontiers 2003/2004 ]

Author: John Abraham
Publisher: Routledge
ISBN: 1136295658
Category : Medical
Languages : en
Pages : 256

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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.