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Eu Competition Law And Pharmaceuticals
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Book Synopsis Competition Law of the European Union by : Van Bael & Bellis
Download or read book Competition Law of the European Union written by Van Bael & Bellis and published by Kluwer Law International B.V.. This book was released on 2021-03-01 with total page 1618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new Sixth Edition of a major work by the well-known competition law team at Van Bael & Bellis in Brussels brings the book up to date to take account of the many developments in the case law and relevant legislation that have occurred since the Fifth Edition in 2010. The authors have also taken the opportunity to write a much-extended chapter on private enforcement and a dedicated section on competition law in the pharmaceutical sector. As one would expect, the new edition continues to meet the challenge for businesses and their counsel, providing a thoroughly practical guide to the application of the EU competition rules. The critical commentary cuts through the theoretical underpinnings of EU competition law to expose its actual impact on business. In this comprehensive new edition, the authors examine such notable developments as the following: important rulings concerning the concept of a restriction by object under Article 101; the extensive case law in the field of cartels, including in relation to cartel facilitation and price signalling; important Article 102 rulings concerning pricing and exclusivity, including the Post Danmark and Intel judgments, as well as standard essential patents; the current block exemption and guidelines applicable to vertical agreements, including those applicable to the motor vehicle sector; developments concerning online distribution, including the Pierre Fabre and Coty rulings; the current guidelines and block exemptions in the field of horizontal cooperation, including the treatment of information exchange; the evolution of EU merger control, including court defeats suffered by the Commission and the case law on procedural infringements; the burgeoning case law related to pharmaceuticals, including concerning reverse payment settlements; the current technology transfer guidelines and block exemption; procedural developments, including in relation to the right to privacy, access to file, parental liability, fining methodology, inability to pay and hybrid settlements; the implementation of the Damages Directive and the first interpretative rulings. As a comprehensive, up-to-date and above all practical analysis of the EU competition rules as developed by the Commission and EU Courts, this authoritative new edition of a classic work stands alone. Like its predecessors, it will be of immeasurable value to both business persons and their legal advisers.
Book Synopsis Competition and Patent Law in the Pharmaceutical Sector by : Giovanni Pitruzzella
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Book Synopsis Pharmaceutical Innovation, Competition and Patent Law by : Josef Drexl
Download or read book Pharmaceutical Innovation, Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Competition Law of the EEC by : Ivo Van Bael
Download or read book Competition Law of the EEC written by Ivo Van Bael and published by . This book was released on 1990 with total page 1160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis EU Competition Law and Pharmaceuticals by : Wolf Sauter
Download or read book EU Competition Law and Pharmaceuticals written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2022-11-15 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Navigating European Pharmaceutical Law by : Maria Isabel Manley
Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by Oxford University Press, USA. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan
Book Synopsis The Goals of Competition Law by : Daniel Zimmer
Download or read book The Goals of Competition Law written by Daniel Zimmer and published by Edward Elgar Publishing. This book was released on 2012 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: What are the normative foundations of competition law? That is the question at the heart of this book. Leading scholars consider whether this branch of law serves just one or more than one goal, and if it serves to protect unfettered competition as such, how this goal relates to other objectives such as the promotion of economic welfare. The book brings together contributions on the relevance of different welfare standards, on the concept of 'freedom to compete' and on distributional fairness as a goal of competition law. Moreover, it discusses the relationship to other legal goals such as mar.
Book Synopsis Guide to EU Pharmaceutical Regulatory Law by : Sally Shorthose
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2017-02-17 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but 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. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives 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.
Book Synopsis The Interplay Between Competition Law and Intellectual Property by : Gabriella Muscolo
Download or read book The Interplay Between Competition Law and Intellectual Property written by Gabriella Muscolo and published by Kluwer Law International B.V.. This book was released on 2019-01-17 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis EU and US Antitrust Arbitration by : Gordon Blanke
Download or read book EU and US Antitrust Arbitration written by Gordon Blanke and published by Kluwer Law International B.V.. This book was released on 2011-01-01 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: EU and US Antitrust Arbitration is the first book that deals with how both of the world's leading antitrust systems, US and EU law, are treated in international arbitration. In forty-nine chapters written by renowned experts, this book provides an in-depth examination of all relevant topics, from drafting arbitration clauses, to arbitrability, provisional measures, the applicability of antitrust law in arbitrations, dealing with economic evidence and experts in relation to antitrust law, to relations with courts and regulators, remedies, and recognition and enforcement of arbitration awards dealing with antitrust issues. Both antitrust and merger control are covered. The perspectives of the arbitrator and the in-house andquot;userandquot; of arbitration are included. Two chapters outline and explain US antitrust law and EU antitrust law with special reference to matters particularly likely to arise in arbitration. One chapter is devoted to ICC antitrust arbitrations and another to the emerging area of EU State aids in arbitration. There are industry-specific chapters, such as on telecommunications and pharmaceuticals, and much else. In this substantial book, practitioners will find helpful and easy-to-understand guidance to their questions on antitrust arbitrations.
Book Synopsis Competition and Innovation in the EU Regulation of Pharmaceuticals by : Claudia Desogus
Download or read book Competition and Innovation in the EU Regulation of Pharmaceuticals written by Claudia Desogus and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Multi-dimensional Approaches Towards New Technology by : Ashish Bharadwaj
Download or read book Multi-dimensional Approaches Towards New Technology written by Ashish Bharadwaj and published by Springer. This book was released on 2018-07-23 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access edited book captures the complexities and conflicts arising at the interface of intellectual property rights (IPR) and competition law. To do so, it discusses four specific themes: (a) policies governing functioning of standard setting organizations (SSOs), transparency and incentivising future innovation; (b) issue of royalties for standard essential patents (SEPs) and related disputes; (c) due process principles, procedural fairness and best practices in competition law; and (d) coherence of patent policies and consonance with competition law to support innovation in new technologies. Many countries have formulated policies and re-oriented their economies to foster technological innovation as it is seen as a major source of economic growth. At the same time, there have been tensions between patent laws and competition laws, despite the fact that both are intended to enhance consumer welfare. In this regard, licensing of SEPs has been debated extensively, although in most instances, innovators and implementers successfully negotiate licensing of SEPs. However, there have been instances where disagreements on royalty base and royalty rates, terms of licensing, bundling of patents in licenses, pooling of licenses have arisen, and this has resulted in a surge of litigation in various jurisdictions and also drawn the attention of competition/anti-trust regulators. Further, a lingering lack of consensus among scholars, industry experts and regulators regarding solutions and techniques that are apposite in these matters across jurisdictions has added to the confusion. This book looks at the processes adopted by the competition/anti-trust regulators to apply the principles of due process and procedural fairness in investigating abuse of dominance cases against innovators.
Book Synopsis The Reform of EC Competition Law by : Ioannis Kokkoris
Download or read book The Reform of EC Competition Law written by Ioannis Kokkoris and published by Kluwer Law International B.V.. This book was released on 2010-01-01 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents a fresh approach to EC competition law - one that is of singular value in grappling with the huge economic challenges we face today. As a critical analysis of the law and options available to European competition authorities and legal practitioners in the field, it stands without peer. It will be greatly welcomed by lawyers, policymakers and other interested professionals in Europe and throughout the world.
Book Synopsis Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Book Synopsis An Introduction to EU Competition Law by : Moritz Lorenz
Download or read book An Introduction to EU Competition Law written by Moritz Lorenz and published by Cambridge University Press. This book was released on 2013-04-25 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Succinct and concise, this textbook covers all the procedural and substantive aspects of EU competition law. It explores primary and secondary law through the prism of ECJ case law. Abuse of a dominant position and merger control are discussed and a separate chapter on cartels ensures the student receives the broadest possible perspective on the subject. In addition, the book's consistent structure aids understanding: section summaries underline key principles, questions reinforce learning and essay discussion topics encourage further exploration. By setting out the economic principles which underpin the subject, the author allows the student to engage with the complexity of competition law with confidence. Integrated examples and an uncluttered writing style make this required reading for all students of the subject.
Download or read book Bellamy & Child written by David Bailey and published by Oxford University Press, USA. This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Competition Law and Policy in the EU --Article 101(1) --Article 101(3) --Market Definition --Cartels --Non-Covert Horizontal Cooperation --Vertical Agreements Affecting Distribution or Supply --Merger Control --Intellectual Property Rights --Article 102 --The Competition Rules and the Acts of Member States --Sectoral Regimes --Enforcement and Procedure --Fines for Substantive Infringements --The Enforcement of the Competition Rules by National Competition Authorities --Litigating Infringements in National Courts --State Aids.
