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May 10 , 2009

Legal Basis of Global Tissue Banking

A Proactive Clinical Perspective
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Overview

The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis.

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Essentials of Tissue Banking

This book provides a coherent and up-to-date review of the scientific and technical principles in routine tissue banking practices, incorporating a plethora of new guidance and regulatory documents produced in response to recent regulation.

This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system.


Contents:
  • Introduction: From a Cottage Industry to a Global Business (G O Phillips)
  • Current Legal Framework for International Operation of Tissue Banks (P Myint)
  • The Legal and Regulatory Framework for Tissues and Cells in the Europe Union (D R Hutchison)
  • Litigation Risks Facing Tissue Banks in the United States (D D Harshman)
  • The Importance of a Code of Ethics and a Code of Practice for Tissue Banking Establishment (J M Pedraza)
  • Religious, Legal and Cultural Issues for Tissue Banking, with Special Reference to the Asia Pacific Region (ANather & W Lin)
  • Challenges for Tissue Bankers in Asia Pacific Region and Recent Progress in Malaysia (N Yusof)
  • Legal System for Tissue Banking in Latin America (E Kairiyama)
  • Establishing a Legal System for Tissue Banking in China (B XLi et al.)
  • Independence for Wales from the Remainder of the United Kingdom: A Change from Informed Consent to Presumed Consent (G O Phillips)
  • Germany — Tissuea Special Case and Regarded as a Pharmaceutical for Legislation (R R Tönjes & P Hergert)
  • Legal Issues Associated with Producing and Marketing Tissues Internationally (C Hartill)
  • A Retrospective Look at the Largest Recall of Processed Bone Tissue in History (H Lazares & J T Salvucci)
  • Polymethyl Methacrylate and Acceptable Material for Tissue Augmentation and Reconstruction (M Cabraja et al.)

Readership: Ethicists, lawyers, policymakers, clinicians, healthcare professionals, stem cell scientists, researchers and academics in bioethics, and general public.
Key Features:
  • China practices are opened up for the first time to the West
  • The European highly complex systems are described clearly and succinctly which may make the system understandable even to the European Commission
  • Wales will change its legal system of tissue procurement and its difference from the remainder of the UK is described
  • Germany is a special case in Europe and isauthoritatively covered
  • There is a description of probably the most notable tissue banking litigation in the USA
  • The pioneeringglobal work of the International Atomic Agency in setting basic systems in place is described
  • The influence of religious belief on tissue andlegal practices is also covered
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