Competition And Innovation In The Eu Regulation Of Pharmaceuticals
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Competition And Innovation In The Eu Regulation Of Pharmaceuticals
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Author : Claudia Desogus
language : en
Publisher:
Release Date : 2011
Competition And Innovation In The Eu Regulation Of Pharmaceuticals written by Claudia Desogus and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Drugs categories.
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.
Eu Competition Law And Pharmaceuticals
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Author : Wolf Sauter
language : en
Publisher: Edward Elgar Publishing
Release Date : 2022-11-15
Eu Competition Law And Pharmaceuticals written by Wolf Sauter and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-15 with Law categories.
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.
Regulation Innovation And Competition In Pharmaceutical Markets
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Author : Margherita Colangelo
language : en
Publisher: Bloomsbury Publishing
Release Date : 2023-04-20
Regulation Innovation And Competition In Pharmaceutical Markets written by Margherita Colangelo and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-20 with Law categories.
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.
Pharmaceutical Innovation Competition And Patent Law
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Author : Josef Drexl
language : en
Publisher: Edward Elgar Publishing
Release Date : 2013-01-01
Pharmaceutical Innovation Competition And Patent Law written by Josef Drexl and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-01-01 with Law categories.
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.
The Challenges Of The New Eu Pharmaceutical Legislation
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Author : José Luis Valverde
language : en
Publisher: IOS Press
Release Date : 2005
The Challenges Of The New Eu Pharmaceutical Legislation written by José Luis Valverde and has been published by IOS Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Business & Economics categories.
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.
Eu Law Of Competition And Trade In The Pharmaceutical Sector
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Author : Pablo Figueroa
language : en
Publisher: Edward Elgar Publishing
Release Date : 2019
Eu Law Of Competition And Trade In The Pharmaceutical Sector written by Pablo Figueroa and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Business & Economics categories.
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.
European Pharmaceutical Regulation
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Author : Patrick Brennan
language : en
Publisher:
Release Date : 2004
European Pharmaceutical Regulation written by Patrick Brennan and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with categories.
The Changing Economics Of Medical Technology
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1991-02-01
The Changing Economics Of Medical Technology written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-02-01 with Medical categories.
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.
Health Data Pools Under European Data Protection And Competition Law
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Author : Giulia Schneider
language : en
Publisher: Springer Nature
Release Date : 2022-04-13
Health Data Pools Under European Data Protection And Competition Law written by Giulia Schneider and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-13 with Law categories.
This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.
The Roles Of Innovation In Competition Law Analysis
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Author : Paul Nihoul
language : en
Publisher: Edward Elgar Publishing
Release Date : 2018
The Roles Of Innovation In Competition Law Analysis written by Paul Nihoul and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.
Rapid technological innovations have challenged the conventional application of antitrust and competition law across the globe. Acknowledging these challenges, this original work analyses the roles of innovation in competition law analysis and reflects on how competition and antitrust law can be refined and tailored to innovation.