EU Competition Law and Pharmaceuticals

Edited by Wolf Sauter,Jotte Mulder,Marcel Canoy

ISBN13: 9781802204407

Imprint: Edward Elgar Publishing Ltd

Publisher: Edward Elgar Publishing Ltd

Format: Hardback

Published: 10/11/2022

Availability: Not yet available

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. The author team comprises academic experts and private practitioners who analyse recent case law at both EU (and UK) and Member State levels - in the context of current issues and future trends, including those related to COVID-19 - and examine the impact of competition law on the behaviour of the pharmaceutical industry. The book carefully considers the balance between competition and innovation, as well as between competition and regulation. It 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. Integrating an overview of competition law, IP law and pharmaceutical regulation, this book will be an ideal read for scholars and graduate students, as well as private and public practitioners interested in pharmaceutical and European law.
Contents: Foreword xiv PART I INTRODUCTION, LEGAL AND ECONOMIC CONTEXT 1 Introduction 2 Marcel Canoy, Jotte Mulder and Wolf Sauter 2 Excessive pricing doctrine in the pharmaceutical sector: the space for reform 16 Frederick M Abbott 3 Evergreening exclusive rights in pharmaceutical products: the case of SPCs, paediatric extensions and orphan drugs 33 Frantzeska Papadopoulou 4 The economics of patents and innovation in pharma 48 Marcel Canoy and Matthijs Versteegh PART II THE COMPETITION CASES SECTION IIA PAY FOR DELAY AND PATENT STRATEGIES 5 Settlement agreements acknowledging patent validity in the United Kingdom 62 Okeoghene Odudu 6 Anticompetitive pharmaceutical patent settlements: the EU cases on pay-for-delay 79 Jotte Mulder and Wolf Sauter SECTION IIB EXCESSIVE PRICING 7 The Aspen case of the Italian Competition Authority 98 Claudia Desogus 8 Unfair pricing: policy considerations and recent experience in the pharmaceutical sector 113 Andrew Groves and Lourenco Ventura 9 Temporary dominance and excessive pharmaceutical pricing - CD Pharma (Denmark) 124 Behrang Kianzad 10 Excessive pricing for pharmaceuticals in the Netherlands: the Leadiant case 138 Freek Bruggert and Clara Ceulemans 11 The EU Aspen decision: the European Commission's first excessive pricing decision in the pharmaceutical market 151 Harald Mische SECTION IIC DISPARAGEMENT AND MISLEADING INFORMATION 12 Disparagement: the European Union and France 175 Adrien Giraud, Juliette Raffaitin and Constance Dobelmann 13 The dissemination of misleading information in the pharmaceutical market: the Italian experience 199 Margherita Colangelo SECTION IID MERGERS AND PARALLEL TRADE 14 EU merger control in the pharmaceutical sector: an overview 213 Jan Truijens Martinez 15 Taking stock of the single market imperative in the Court's case law on parallel trade in pharmaceuticals: are matters as settled as they seem? 229 Jotte Mulder PART III FUTURE DIRECTIONS 16 Towards responsive enforcement of EU antitrust in pharmaceuticals 248 Wolf Sauter 17 Excessive pricing in pharmaceuticals: perspectives from EU antitrust and regulation 264 Giorgio Monti and Leigh Hancher 18 Tackling grand challenges with competition law: lessons from the pandemic 281 Ioannis Lianos, Timo Minssen and Christy Kollmar Index
  • Competition law / Antitrust law
  • Regulation of medicines & medical devices
  • Professional & Vocational
List Price: £110.00