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Legal Basis of Global Tissue Banking: A Proactive Clinical Perspective PDF

305 Pages·2015·3.656 MB·English
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Legal Basis of Global Tissue Banking A Proactive Clinical Perspective 9525_9789814663434_tp.indd 1 23/6/15 6:24 pm b1816 MR SIA: FLY PAST b1816_FM TTTThhhhiiiissss ppppaaaaggggeeee iiiinnnntttteeeennnnttttiiiioooonnnnaaaallllllllyyyy lllleeeefffftttt bbbbllllaaaannnnkkkk bb11881166__FFMM..iinndddd vvii 1100//1100//22001144 11::1122::3399 PPMM Legal Basis of Global Tissue Banking A Proactive Clinical Perspective Editor Glyn O Phillips Research Transfer Ltd, UK Phillips Hydrocolloids Research Ltd, UK World Scientific NEW JERSEY • LONDON • SINGAPORE • BEIJING • SHANGHAI • HONG KONG • TAIPEI • CHENNAI 9525_9789814663434_tp.indd 2 23/6/15 6:24 pm Published by World Scientific Publishing Co. Pte. Ltd. 5 Toh Tuck Link, Singapore 596224 USA office: 27 Warren Street, Suite 401-402, Hackensack, NJ 07601 UK office: 57 Shelton Street, Covent Garden, London WC2H 9HE Library of Congress Cataloging-in-Publication Data Legal basis of global tissue banking : a proactive clinical perspective / edited by Glyn O. Phillips. p. ; cm. Includes bibliographical references and index. ISBN 978-9814663434 (hardcover : alk. paper) -- ISBN 978-9814663441 (electronic) I. Phillips, Glyn O., editor. [DNLM: 1. Tissue Banks--legislation & jurisprudence. 2. Internationality. QS 523] RD127 362.17'83--dc23 2014048337 British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library. Copyright © 2016 by World Scientific Publishing Co. Pte. Ltd. All rights reserved. This book, or parts thereof, may not be reproduced in any form or by any means, electronic or mechanical, including photocopying, recording or any information storage and retrieval system now known or to be invented, without written permission from the publisher. For photocopying of material in this volume, please pay a copying fee through the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, USA. In this case permission to photocopy is not required from the publisher. Typeset by Stallion Press Email: [email protected] Printed in Singapore JQuek - Legal Basis of Global Tissue Banking.indd 1 26/6/2015 2:33:44 PM b2069 Legal Basis of Global Tissue Banking 9x6 CONTENTS About the Editor xi About the Authors xiii Preface xxv 1. Introduction: From a Cottage Industry to a Global Business 1 Glyn O. Phillips The Development of Tissue Banking 2 The Early Pioneers 4 Legislation 7 References 8 2. Legal Framework for International Operation of Tissue Banks 13 Peter Myint Introduction 13 Europe 14 United Kingdom 14 United States 17 International Atomic Energy Agency (IAEA) Code of Practice for Radiation Sterilisation of Tissue Allografts 21 References 28 v bb22006699__FFMM..iinndddd vv 66//2244//22001155 11::0011::3355 PPMM b2069 Legal Basis of Global Tissue Banking 9x6 vi | Contents 3. The Legal and Regulatory Framework for Tissues and Cells in the European Union 31 Deborah R. Hutchison Establishment of a European Union (EU) Regulatory Framework for Tissues and Cells 31 The European Tissue and Cells Directives (EUTCD) 32 Transposition of EUTCD in the EU Member States 37 What is Next? 53 References 54 4. Litigation Risks Facing Tissue Banks in the United States 65 Daniel D. Harshman Phase 1: The Pleading Stage 66 Phase 2: Fact Discovery 66 Phase 3: Expert Discovery 68 Phase 4: Dispositive Motions (Summary Judgment) 68 Phase 5: Pretrial Preparations 70 Phase 6: The Jury Trial 71 How do Lawyers Determine Who to Sue and What Claims to Assert? 72 Common Lawsuits Filed Against Tissue Banks 74 How to Prepare for Litigation in US Courts 78 References 83 5. The Importance of a Code of Ethics and a Code of Practice for Tissue Establishments 85 Jorge Morales Pedraza Main Ethical Issues 87 The Adoption of a Code of Ethics and a Code of Practice 88 Main Ethical Principles 93 Code of Practice 95 References 99 6. Ethical, Religious, Legal, and Cultural Issues for Tissue Banking, with Special Reference to the Asia-Pacific Region 101 Aziz Nather and Wee Lin Introduction 101 Ethical Considerations 101 bb22006699__FFMM..iinndddd vvii 66//2244//22001155 11::0011::3355 PPMM b2069 Legal Basis of Global Tissue Banking 9x6 Contents | vii Religious Considerations 103 Legal Considerations 108 Cultural Issues Pertaining to Organ Donation and Transplantation 117 References 118 7. Challenges for Tissue Banking in the Asia-Pacific Region and Recent Progress in Malaysia 121 Norimah Yusof Introduction 121 Regional Programmes 122 Regulatory System 123 Challenges for Tissue Banking in Malaysia 132 Conclusion 145 Acknowledgements 145 References 146 8. Legal System for Tissue Banking in Latin America 149 Eulogia Kairiyama Introduction 149 History of Tissue Banking snd Transplantation in Latin America 151 Scope of Regional Integration 152 Current Tissue Banking Activity 155 Overview of Legislation and the Current Situation Regarding Tissue Banking in Latin America 157 Conclusion 190 Acknowledgements 190 References 191 9. Establishing a Legal System for Tissue Banking in China 197 Li Bao Xing, Zhao Yaping and Glyn O. Phillips Historical Development 197 Development of Formal Regulatory and Legal Systems 198 Other Tissue Banks Developing Legal Systems to Gain National Approval Throughout China 202 References 203 bb22006699__FFMM..iinndddd vviiii 66//2244//22001155 11::0011::3366 PPMM b2069 Legal Basis of Global Tissue Banking 9x6 viii | Contents 10. Independence for Wales from the Remainder of the United Kingdom: A Change from Informed Consent to Presumed Consent 205 Glyn O. Phillips Introduction 205 The Scope of the Human Transplantation (Wales) Bill 206 Motivation and Response 209 11. Germany: Regulation of Tissues and Tissue Banking — A Special Case 211 Peter Hergert and Ralf R. Tönjes Introduction 211 Legal Framework 213 Final Remarks 223 References 224 12. Legal Issues Associated with Producing and Marketing Tissues Internationally 227 Caroline A. Hartill Overview of Key Challenges 227 Development of Advanced Technologies for Tissue Processing 229 References 233 13. A Retrospective Look at the Largest Recall of Processed Bone Tissue in History 235 Helena Lazares and John T. Salvucci Introduction 235 The Criminal Scheme that Initiated the Recall 236 Federal and Legal Intervention 239 Disease Transfers by Bone 242 Transmission of Viral Disease in BTS Litigation 246 Conclusions 249 References 250 bb22006699__FFMM..iinndddd vviiiiii 66//2244//22001155 11::0011::3366 PPMM b2069 Legal Basis of Global Tissue Banking 9x6 Contents | ix 14. Polymethyl Methacrylate: An Acceptable Material for Tissue Augmentation and Reconstruction 253 Mario Cabraja, Jack Klecan and Glyn O. Phillips History and Material Development 253 PMMA: Preparation and Composition 256 Standards and Testing for Stability and Strength 258 General Clinical Utilisation 262 References 268 Index 275 bb22006699__FFMM..iinndddd iixx 66//2244//22001155 11::0011::3366 PPMM

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