Eu Competition Law And Pharmaceuticals
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Author | : Van Bael & Bellis |
Publisher | : Kluwer Law International B.V. |
Total Pages | : 1618 |
Release | : 2021-03-01 |
Genre | : Law |
ISBN | : 9041154051 |
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.
Author | : Giovanni Pitruzzella |
Publisher | : Kluwer Law International |
Total Pages | : 0 |
Release | : 2016 |
Genre | : Antitrust law |
ISBN | : 9789041159274 |
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Author | : Josef Drexl |
Publisher | : Edward Elgar Publishing |
Total Pages | : 347 |
Release | : 2013-01-01 |
Genre | : Law |
ISBN | : 0857932462 |
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 | : Ivo Van Bael |
Publisher | : |
Total Pages | : 1160 |
Release | : 1990 |
Genre | : Antitrust law |
ISBN | : |
Author | : Maria Isabel Manley |
Publisher | : Oxford University Press, USA |
Total Pages | : 0 |
Release | : 2015 |
Genre | : Law |
ISBN | : 9780198717997 |
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
Author | : Wolf Sauter |
Publisher | : Edward Elgar Publishing |
Total Pages | : 325 |
Release | : 2022-11-15 |
Genre | : Law |
ISBN | : 1802204415 |
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 | : Sally Shorthose |
Publisher | : Kluwer Law International B.V. |
Total Pages | : 590 |
Release | : 2017-02-17 |
Genre | : Law |
ISBN | : 9041170022 |
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.
Author | : Daniel Zimmer |
Publisher | : Edward Elgar Publishing |
Total Pages | : 529 |
Release | : 2012 |
Genre | : Law |
ISBN | : 0857936611 |
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.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 225 |
Release | : 1991-02-01 |
Genre | : Medical |
ISBN | : 030904491X |
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 | : Gordon Blanke |
Publisher | : Kluwer Law International B.V. |
Total Pages | : 1052 |
Release | : 2011-01-01 |
Genre | : Law |
ISBN | : 9041127607 |
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.