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284 Pages·1997·10.421 MB·English
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Interdisciplinary Approaches to Gene Therapy Legal, Ethical and Scientific Aspects Springer Berlin Heidelberg New York Barcelona Budapest Hong Kong London Milan Paris Santa Clara Singapore Tokyo Stefan MOiler . JUrgen W. Simon Jan W. Vesting (Eds.) Interdisciplinary Approaches to Gene Therapy Legal, Ethical and Scientific Aspects i Springer Dr. rer. nat. Stefan Muller AltmannstraBe 23 0-28209 Bremen Prof. Dr. jur. JOrgen W. Simon LinzerstraBe 3 0-30519 Hannover Jan W. Vesting FundstraBe 1( 0-30161 Hannover ISBN-13: 978-3-540-63056-2 e-ISBN-13: 978-3-642-60829-2 DOl: 10.1007/978-3-642-60829-2 ISBN 978-3-540-63056-2 Springer-Verlag Berlin Heidelberg New York Cataloging-in-Publication Data applied for Die Deutsche Bibliothek - CIP-Einheitsaufnahme Interdisciplinary approaches to gene therapy: legal, ethical and scientific aspects / Stefan Muller; Jurgen W. Simon; Jan W. Vesting. - Berlin; Heidelberg; New York; Barcelona; Budapest; Hong Kong; London; Milan; Paris; Santa Clara; Singapore; Tokyo: Springer, 1997 ISBN 978-3-540-{j3056-2 This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting. reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provi sions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law. © Springer-Verlag Berlin . Heidelberg 1997 Reprint orthe original edition 1997 The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and there fore free for general use. Cover-Design: Erich Kirchner, Heidelberg SPIN 10630019 64/2202-5 4 3 2 1 0 - Printed on acid-free paper Preface The present volume is a collection of the papers. and even some more, read during the workshop "Luneburg Symposium on Interdisciplinary Approaches to Gene Therapy", which took place at the University of Uineburg, Germany. from March 25-27. 1996. More than 150 persons coming from 16 different countries participated in it. While we were working on two different studies conceming the legal. ethical and scientific aspects of gene therapy we realised that there was a lack of interdisciplinary approaches "ithin the field of gene therapy. So we decided to bring together in a Symposium researchers of different professions and backgrounds involved with gene therapy. The symposium was intended to stress the legal, ethical and scientific aspects of gene therapy considered in different contexts, to bring together different intemational perspectives, to offer the opportunity to get acquainted with the work of the different institutes and researchers in the world. and to stimulate further research and co-operation. It is a great honour for us to publish this volume to present some different interdisciplinary aspects in the field of gene therapy by well known authors. It was our intention that the symposium should be a fonun for different or even opposing opinions. Therefore. the papers collected in this volume do not necessarily express the opinions of the editors. One clear result of our highly controversial symposium is. that much more basic work has to be done on gene therapy in general. We would be glad if this volume could both contribute to and stimulate the works on such an urgent task. VI Preface Acknowledgements We would like to thank all the following institutions for their generous grants which made both the symposium and this publication possible: Deutsche Forschungsgemeinschafi, Niedersachsisches Ministerium fur Wissenschaft und Kultur, European Comission DG XIL Universitit Liineburg, Sandoz AG, Zeneca GmbH, Bayer AG, SmithKline-Beecham Stiftung, Qiagen GmbH, Hoechst AG. For organisational help with the manuscript of this volume we would like to thank Angelika Willkommen and Frank Lilie. Liineburg, January 1997 Stefan Miiller Jiirgen W. Simon Jan W. Vesting Table of Contents Part I: Scientific Aspects of Gene Therapy Introduction to Principles and Examples of Somatic Gene Therapy U. KLEEBERG, A. G. HILDEBRANDT ................................................. 3 Gene Therapy with Non-Viral Vector Systems C. COUTELLE.............. ......... .. .. ..................... 17 Gene Therapy of Human Melanoma -from Animal Experiments to the Clinical Trial J. NOWAK, D. JANUSZKIEWICZ. 1. MAZUREK. M. ZACIAK. J. MALICKI. P. MURA WA. M. WIZNEROWICZ. P. C. HEINRICH. S. ROSE-JOHN, A. MACKIE\VICz......... . ....................................... 27 Development of a Gene Therapy for Arthritis P. D. ROBBINS. S. C. GHIVIZZANI. R. KANG. C. H. EVANS ................... .t I The Industrial Perspective of Somatic Gene Therapy U. GOTTSCHALK ........................................... '" .................................... 51 Industrial Aspects of Gene Transfer Systems D.R. SCHIWEK, R. MATTES .................................................................. 55 Safety Considerations in Constmction of Viral Vectors for Gene Therapy G. HOBOM................. . ......................................... 63 Safety Aspects During Manufacturing of Gene Therapeutic Material H. WEHLMANN.................... ................................. . .......... 73 Gene Therapy and Medical Genetic Service: Biological Safety and Ethical Aspects V. I. IVANOV............... .. ............................... .. ........................ 85 vm Table of Content Part II: Legal Aspects of Gene Therapy Legal Aspects of Genetic Therapies in Gennany 1. W. VESTING ............................................................................................. 91 The Regulation of Genetic Teclmology in the United Kingdom: Hard or Soft Options? T. McGLEENAN ........................................................................................... 99 Legal Aspects of Gene Therapy -The Austrian Regulation Model N. ZACfIER ................................................................................................. 117 Survey About Regulation on Gene Therapy in Some European Countries 1. W. SIMON ............................................................................................... 129 Development of Agents for Somatic Gene Therapy - Role of European Drug Agencies U. KLEEBERG, A. G. HILDEBRANDT ...................................................... 137 Regulation of Gene Therapy from the EU's Point of View E. BLEIBAUM ............................................................................................. 149 Regulation of Genetic Therapy -The American Experience A. 1. GRANT ............................................................................................... 157 "Is there a Demand for the Worldwide Regulation of Gene Therapy" H. CHOI ....................................................................................................... 161 Patents and Gene Therapy C.M.ROMEO-CASABONA ......................................................................... 179 Table of Content IX Part III: Ethical Aspects of Gene Therapy Free Access to Gene Therapy and Dictates of Application T. SCHROEDER-KURTH ............................................................................ 191 A Survey of Ethical Questions Concerning Gene Therapy D. MIETH .................................................................................................... 197 Ethical Assessment of Gene Therapy in Asia D. R. 1. MACER ......................................................................................... 213 Gene Therapy from the Viewpoint of Parent and Patient Organisations Y. S. POORTMAN ................... . ................................................. 237 The Genome, Artificial E\'olution. and Human Rights - A New Way to Post-Modem Global COllllllunty H. SAKAMOTO ..................................................................................... 253 Germ Line Risks of Somatic Gene Therapy -an Ethical Issue C. REIDvIANN-SUTTER......... ................... ............... .. ............ 259 Ethics and Gene Therapy from UNESCO'S Viewpoint G. B. KUTUKDIJAN ................................................................................ 269 A Project on Medical Ethics Accompanying the Gene Therapy Symposiulll in Uineburg (in March 1996) C. WEWETZER U. SCHLAUDRAFF. K. H. WEHKAMP ......................... 275 Part I: Scientific Aspects of Gene Therapy

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