Eu Law Of Competition And Trade In The Pharmaceutical Sector

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.

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.

This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of “What rules should govern claims by suppliers about the national or geographic origin of their goods or services?” This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues.

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.

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.

This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com

A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.