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.