Hardback

EU Competition Law and Pharmaceuticals

9781802204407 Edward Elgar Publishing

New Horizons in Competition Law and Economics series

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

Publication Date: 2022 ISBN: 978 1 80220 440 7 Extent: 324 pp

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.

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Critical Acclaim

Contributors

Contents

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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.

Critical Acclaim

‘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.’
– Tamara Hervey, City, University of London, UK

Contributors

Contributors: Frederick Abbott, Freek Bruggert, Marcel Canoy, Clara Ceulemans, Margherita Colangelo, Claudia Desogus, Constance Dobelmann, Adrien Giraud, Andrew Groves, Leigh Hancher, Behrang Kianzad, Christy Kollmar, Ioannis Lianos, Timo Minssen, Harald Mische, Giorgio Monti, Jotte Mulder, Okeoghene Odudu, Frantzeska Papadopoulou, Juliette Raffaitin, Wolf Sauter, Jan Truijens Martinez, Lourenço Ventura, Matthijs Versteegh

Contents

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 Lourenço 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