Overview
- Identifies pros and cons so as to provide advice to lawmakers and regulators
- Analysis of the legal frameworks which provides insight into regulatory concepts
- Scientific introduction into iPS cell technology and genome editing of iPS cells
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About this book
The book provides a concise overview of currently applicable regulatory frameworks of states which are among the world leaders in research and development (R&D) of cell and gene therapies. Developments in genome editing are expected to lead to new possibilities for the treatment of hereditary diseases in humans. The treatment of such often severe but hitherto uncurable diseases can be based on genome-edited induced pluripotent stem cells (iPS cells). Such treatments constitute combined cell/gene therapies. These therapies need to be governed by a regulatory framework which ensures quality, safety, and efficacy of the relevant therapeutic products. On the other hand, such regulations may retard product approval and impede R&D. Accordingly, national regulations for therapies based on genome-edited iPS cells are an important and, as the case may be, decisive factor for both researchers and industry regarding their decision where to locate their R&D activities. Therefore, regulatory frameworks impact significantly on the competitiveness of states and their economies. This is why a comparative analysis of laws and regulations of different countries matters. Such a comparative legal analysis provides an important insight into regulatory concepts which, in turn, may inspire adjustments of, or amendments to, domestic legal regimes. For this purpose, experts present country reports on France, Germany, Japan, South Korea, Switzerland, and the USA. The reports on France and Germany also refer to the parameters and implications arising from pertinent EU law. This contributed volume is aimed at researchers, but also at, e.g., legal scholars, lawmakers, regulators, and political decision makers.
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Keywords
Table of contents (9 chapters)
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Front Matter
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Back Matter
Editors and Affiliations
About the editors
Hans-Georg Dederer is a full professor and holder of the Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law at the University of Passau (Germany). His fields of research include biotechnology law. He is also a member of the Permanent Senate Commission on Genetic Research of the German Research Foundation (Deutsche Forschungsgemeinschaft – DFG).
Gregor Frenken is a teaching and research assistant in the Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law at the University of Passau (Germany).
Bibliographic Information
Book Title: Regulation of Genome Editing in Human iPS Cells
Book Subtitle: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies
Editors: Hans-Georg Dederer, Gregor Frenken
DOI: https://doi.org/10.1007/978-3-030-93023-3
Publisher: Springer Cham
eBook Packages: Law and Criminology, Law and Criminology (R0)
Copyright Information: The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022
Hardcover ISBN: 978-3-030-93022-6Published: 24 May 2022
Softcover ISBN: 978-3-030-93025-7Published: 25 May 2023
eBook ISBN: 978-3-030-93023-3Published: 23 May 2022
Edition Number: 1
Number of Pages: X, 334
Number of Illustrations: 3 b/w illustrations, 10 illustrations in colour
Topics: Private International Law, International & Foreign Law, Comparative Law , European Law, Human Genetics