Author: Claudia Desogus Publisher: ISBN: 9789400001473 Category : Drugs Languages : en Pages : 0
Book Description
This book deals with parallel trade of pharmaceuticals from a law and economics perspective. Traditionally, restrictions to parallel trade were regarded negatively because they ran against the rules of the EU internal market. However, in recent judgments (Bayer, Glaxo, and Syfait), EU courts questioned some of the legal principles underpinning the EU policy on parallel trade in the field of pharmaceuticals. This shift suggested that there might be scope for improvement of such policy. However, how and to what extent this change should be performed remained partially unclear. Through the analysis of the impact that parallel trade of pharmaceuticals has on consumer welfare, both in a static and in a dynamic sense, this book examines whether the current legal approach to parallel trade of pharmaceuticals reflects the findings of economic theory, whether it should change, and, if so, on what basis this adjustment should take place. The analysis not only provides a policy assessment, but also offers some insights on one of the issues debated within the process of modernization of EU competition law: how judges should integrate economic reasoning in the antitrust assessment of corporate practices. The book will be particularly useful both for practitioners and legal scholars who want deepen their understanding of the EU pharmaceutical market and of the most recent EU judicial developments in that field, as well as of their implications for EU competition law in a 'modernized' context.
Author: Wolf Sauter Publisher: Edward Elgar Publishing ISBN: 1802204415 Category : Law Languages : en Pages : 325
Book Description
This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Author: Josef Drexl Publisher: Edward Elgar Publishing ISBN: 0857932462 Category : Law Languages : en Pages : 347
Book Description
Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Author: Pablo Figueroa Publisher: Edward Elgar Publishing ISBN: 1785362615 Category : Business & Economics Languages : en Pages : 758
Book Description
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
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: Margherita Colangelo Publisher: Bloomsbury Publishing ISBN: 1509965521 Category : Law Languages : en Pages : 257
Book Description
This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030904491X Category : Medical Languages : en Pages : 225
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Ann-Kathrin Lehnhausen Publisher: Springer ISBN: 3658165510 Category : Business & Economics Languages : en Pages : 85
Book Description
This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Author: Claudia Desogus
Author: Wolf Sauter
Author: Josef Drexl
Author: Pablo Figueroa
Author: José Luis Valverde
Author: Margherita Colangelo
Author: Institute of Medicine
Author: Patrick Brennan
Author: Giovanni Pitruzzella
Author: Ann-Kathrin Lehnhausen