Interdisciplinary Approaches to Gene Therapy: Legal, Ethical and Scientific Aspects

284 Pages·1997·10.421 MB·English

by  U. Kleeberg, A. G. Hildebrandt (auth.), Dr. rer. nat. Stefan Müller, Prof. Dr. jur. Jürgen W. Simon, Jan W. Vesting (eds.)

Interdisciplinary Approaches
to Gene Therapy
Legal, Ethical and Scientific Aspects
Springer
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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
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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
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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
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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