EU Competition Law and Pharmaceuticals

Edited by Wolf Sauter, Full Professor of Law, Markets and Behavior, Vrije Universiteit Amsterdam and Coordinating Specialist Enforcement Official, Dutch Authority for Consumers and Markets (ACM), Marcel Canoy, Endowed Professor of Health Economics, Vrije Universiteit Amsterdam and Economic Adviser to Dutch Authority for Consumers and Markets (ACM) and Jotte Mulder, Antitrust attorney, Pels Rijcken, The Hague and Assistant Professor, Utrecht University, the Netherlands

• Contents:Foreword xivPART I INTRODUCTION, LEGAL ANDECONOMIC CONTEXT1 Introduction 2Marcel Canoy, Jotte Mulder and Wolf Sauter2 Excessive pricing doctrine in the pharmaceutical sector:the space for reform 16Frederick M Abbott3 Evergreening exclusive rights in pharmaceutical products:the case of SPCs, paediatric extensions and orphan drugs 33Frantzeska Papadopoulou4 The economics of patents and innovation in pharma 48Marcel Canoy and Matthijs VersteeghPART II THE COMPETITION CASESSECTION IIA PAY FOR DELAY AND PATENT STRATEGIES5 Settlement agreements acknowledging patent validity inthe United Kingdom 62Okeoghene Odudu6 Anticompetitive pharmaceutical patent settlements: the EUcases on pay-for-delay 79Jotte Mulder and Wolf SauterSECTION IIB EXCESSIVE PRICING7 The Aspen case of the Italian Competition Authority 98Claudia Desogus8 Unfair pricing: policy considerations and recent experiencein the pharmaceutical sector 113Andrew Groves and Lourenço Ventura9 Temporary dominance and excessive pharmaceuticalpricing – CD Pharma (Denmark) 124Behrang Kianzad10 Excessive pricing for pharmaceuticals in the Netherlands:the Leadiant case 138Freek Bruggert and Clara Ceulemans11 The EU Aspen decision: the European Commission’s firstexcessive pricing decision in the pharmaceutical market 151Harald MischeSECTION IIC DISPARAGEMENT AND MISLEADINGINFORMATION12 Disparagement: the European Union and France 175Adrien Giraud, Juliette Raffaitin and Constance Dobelmann13 The dissemination of misleading information in thepharmaceutical market: the Italian experience 199Margherita ColangeloSECTION IID MERGERS AND PARALLEL TRADE14 EU merger control in the pharmaceutical sector: an overview 213Jan Truijens Martinez15 Taking stock of the single market imperative in the Court’scase law on parallel trade in pharmaceuticals: are mattersas settled as they seem? 229Jotte MulderPART III FUTURE DIRECTIONS16 Towards responsive enforcement of EU antitrust inpharmaceuticals 248Wolf Sauter17 Excessive pricing in pharmaceuticals: perspectives fromEU antitrust and regulation 264Giorgio Monti and Leigh Hancher18 Tackling grand challenges with competition law: lessonsfrom the pandemic 281Ioannis Lianos, Timo Minssen and Christy KollmarIndex

‘Pharmaceutical and vaccine markets are highly complex. In European healthcare systems, the state is the major purchaser, and so ordinary rules of competition law are insufficient in themselves to respond to the various dynamics at play: cost-effective innovation; access to medicines; burden on the public purse. But competition law is one of the aspects of the relevant regulatory toolkit, so it’s crucial to understand how it applies. This cross-disciplinary and timely book goes well beyond the superficial, in its analysis and critique of contemporary developments and the direction of travel of European competition law as it applies to pharmaceuticals.’