EU Law and Life Sciences Peter BOGAERT Damien GERADIN Editors Robin BLANEY Jennifer BOUDET Miranda COLE Michael CLANCY Sarah FOREST Laurie-Anne GRELIER Christos MALAMATARIS John RUPP Jennifer SAPERSTEIN Henriette (Jetty) TIELEMANS Nicoleta TUOMINEN Kristof VAN QUATHEM John WILEUR GO TO TABLE OF CONTENTS EU LAW AND LIFE SCIENCES Editors Peter Bogaert Damien Geradin © Institute of Competition Law, 2014 GO TO TABLE OF CONTENTS EU Law and LifE SciEncES All rights reserved. No photocopying: copyright licenses do not apply. situation. Legal advice should always be sought before taking any legal action based on the information provided. The publisher accepts no responsibility for any acts or omissions contained herein. Enquiries concerning reproduction should be sent to the Institute of Competition Law, at the address below. Copyright © 2014 by Institute of Competition Law 60 Broad Street, Suite 3502, NY 10004 www.concurrences.com [email protected] Printed in the United States of America First Printing, 2014 ISBN 978-1-939007-421 Publisher’s Cataloging-in-Publication (Provided by Quality Books, Inc.) EU law and life sciences / editors, Peter Bogaert, Damien Geradin. pages cm Includes bibliographical references and index. LCCN 2013956306 ISBN 9781939007421 ISBN 9781939007445 1. Life sciences--Law and legislation--European Economic Community countries. I. Bogaert, Peter. II. Geradin, Damien. KJE6172.E9 2014 349.24 QBI13-600305 Cover and book design by Yves Buliard, www.ybgraphic.fr GO TO TABLE OF CONTENTS PREFACE Everyone with an interest in the life sciences sector must have at least a basic knowledge of the European Union legal and regulatory system. The EU is the single largest market for medicines and authorities in the member states still play a major role in regulating pharmaceuticals and medical devices, many of the most important issues are now decided at the EU level, by the European Medi- cines Agency, the European Commission, Parliament and Council, the courts of the European Union and other EU institutions. This book provides a detailed description of the principles of EU law, regulation and policy that most directly affect the pharmaceutical and medical device sectors. It describes systems for control of market entry; periods of regulatory and patent protection; regulation of advertising and promotion; - tion, parallel trade, life cycle management and pricing and merger control; protection of personal data; which combines experts in all relevant areas of law and regulation in major jurisdictions around the world. suggestions for additional topics that might be covered in future editions. Richard Kingham Covington & Burling LLP GO TO TABLE OF CONTENTS III INSTITUTE OF COMPETITION LAW PUBLICATIONS WILLIAM E. KOVACIC: AN ANTITRUST TRIBUTE LIBER AMICORUM (Vol. I) Nicolas Charbit - Elisa Ramundo - Anna Chehtova - Abigail Slater (Eds.) January 2013 431 pages (Hardcover and e-Book) WILLIAM E. KOVACIC: AN ANTITRUST TRIBUTE LIBER AMICORUM (Vol. II) Nicolas Charbit - Elisa Ramundo (Eds.) Anna M. Pavlik - Jessica Rebarber (Asst. Eds.) March 2014 (Hardcover and e-Book) 2013 COMPETITION DIGEST A SYNTHESIS OF EU AND NATIONAL LEADING CASES Foreword by Frédéric Jenny Nicolas Charbit - Elisa Ramundo - Maly Op-Courtaigne (Eds.) January 2013 672 pages (Paperback and e-Book) 2014 COMPETITION DIGEST A SYNTHESIS OF EU AND NATIONAL LEADING CASES Foreword by Frédéric Jenny Nicolas Charbit - Elisa Ramundo - Maly Op-Courtaigne (Eds.) September 2014 (Paperback and e-Book) COMPETITION LAW ON THE GLOBAL STAGE: DAVID GERBER’S GLOBAL COMPETITION LAW IN PERSPECTIVE Nicolas Charbit - Elisa Ramundo (Eds.) January 2014 173 pages (Hardcover and e-Book) EU LAW AND LIFE SCIENCES Peter Bogaert - Damien Geradin (Eds.) January 2014 274 pages (Hardcover and e-Book) GO TO TABLE OF CONTENTS IV EU Law and LifE SciEncES CONTRIBUTORS Robin Blaney Jennifer Boudet Miranda Cole Michael Clancy Sarah Forest Laurie-Anne Grelier Christos Malamataris John Rupp Jennifer Saperstein Henriette (Jetty) Tielemans Nicoleta Tuominen Kristof Van Quathem John Wileur GO TO TABLE OF CONTENTS EU Law and LifE SciEncES EU Law and LifE SciEncES V TABLE OF CONTENTS 1 OVERVIEW OF THE REGULATORY CATEGORIES AND REGIMES FOR LIFE SCIENCES PRODUCTS 5 A. INTRODUCTION ...................................................................... 5 B. HISTORICAL OVERVIEW .............................................................. 6 C. KEY ASPECTS OF THE MAIN EU REGULATORY REGIMES. 10 D. PRODUCTS FOR ANIMAL USE ........................................................ 20 E. BORDERLINE DETERMINATIONS ..................................................... 21 F. GEOGRAPHICAL SCOPE OF THE EU RULES ............................................ 22 2 THE MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS AND THE REGULATORY OBLIGATIONS OF COMPANIES 25 A. INTRODUCTION ..................................................................... 26 B. MARKETING AUTHORISATION PROCEDURES ......................................... 26 C. TYPES OF MARKETING AUTHORISATION APPLICATIONS ............................... 34 D. OTHER AUTHORISATION PROCEDURES AND EXEMPTIONS ............................. 39 E. OBLIGATIONS OF THE MARKETING AUTHORISATION HOLDER .......................... 42 3 THE PROTECTION OF MEDICINAL PRODUCTS 47 A. PATENT PROTECTION ................................................................ 47 B. REGULATORY EXCLUSIVITY ......................................................... 51 4 ADVERTISING AND INFORMATION – EU RULES GOVERNING MEDICINAL PRODUCTS AND MEDICAL DEVICES 63 A. INTRODUCTION .................................................................... 64 B. MEDICINAL PRODUCTS .............................................................. 65 C. MEDICAL DEVICES .................................................................. 82 D. TRANSPARENCY RULES ............................................................. 83 GO TO TABLE OF CONTENTS EU Law and LifE SciEncES 1 5 PHARMACOVIGILANCE 85 A. INTRODUCTION ..................................................................... 85 B. KEY REGULATORY AUTHORITIES ..................................................... 87 C. PHARMACOVIGILANCE QUALITY SYSTEM ............................................ 88 D. EXPEDITED REPORTING REQUIREMENTS ............................................. 90 E. PERIODIC REPORTING REQUIREMENTS ............................................... 95 F. RISK MANAGEMENT PLAN ........................................................... 97 G. POST-AUTHORISATION SAFETY STUDIES .............................................. 98 H. OTHER SOURCES OF REPORTING OBLIGATIONS ....................................... 99 I. OTHER CONSIDERATIONS. 101 J. ENFORCEMENT AND PENALTIES .................................................... 103 6 MARKET DEFINITIONS IN THE LIFE SCIENCES SECTOR 107 A. INTRODUCTION: BASIC CONCEPTS .................................................. 107 B. HUMAN PHARMACEUTICALS ....................................................... 109 C. OTHER PRODUCT GROUPS .......................................................... 115 D. CONCLUSION ...................................................................... 119 7 PARALLEL TRADE OF LIFE SCIENCE PRODUCTS 121 A. INTRODUCTION .................................................................... 121 B. KEY STAKEHOLDERS ............................................................... 122 C. APPLICABLE LAWS AND CASES ..................................................... 124 D. APPLICATION OF THE LAWS AND CASES TO SPECIFIC STRATEGIES ..................... 136 8 LIFE-CYCLE MANAGEMENT STRATEGIES AND EU COMPETITION LAW 139 A. INTRODUCTION .................................................................... 139 B. PHARMACEUTICAL SECTOR INQUIRY ............................................... 140 C. REGULATORY ABUSE ............................................................... 142 D. PATENT SETTLEMENTS BETWEEN ORIGINATORS AND GENERIC COMPANIES . 156 E. CONCLUSION ...................................................................... 159 GO TO TABLE OF CONTENTS 2 EU Law and LifE SciEncES 9 PRICING OF PHARMACEUTICAL PRODUCTS AND COMPETITION LAW 161 A. ABUSIVE PRICING PRACTICES ...................................................... 162 B. EXCLUSIONARY PRICING PRACTICES ................................................ 162 C. EXPLOITATIVE PRICING PRACTICES ................................................. 184 D. DISCRIMINATORY PRICING PRACTICES .............................................. 188 E. CONCLUSION ...................................................................... 192 10 EU MERGER CONTROL IN THE LIFE SCIENCES SECTOR 193 A. INTRODUCTION .................................................................... 193 B. PROCEDURAL RULES ............................................................... 194 ..................................... 198 ............................... 206 E. REMEDIES ......................................................................... 209 F. CONCLUSION ...................................................................... 213 11 DATA PROTECTION IN THE LIFE SCIENCES INDUSTRY 215 A. EU DATA PROTECTION LAW ........................................................ 215 B. DATA PROTECTION IN THE PHARMACEUTICAL SECTOR ............................... 222 C. DATA PROTECTION LAW IN THE PHARMACEUTICAL SECTOR IN PRACTICE . 226 12 BRIBERY RELATED RISK AND MITIGATION MEASURES FOR LIFE SCIENCES COMPANIES 235 A. OVERVIEW OF BRIBERY ACT .......................................................