Legal Basis of Global Tissue Banking

A Proactive Clinical Perspective

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.

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 (Glyn O Phillips)
• Legal Framework for International Operation of Tissue Banks (Peter Myint)
• The Legal and Regulatory Framework for Tissues and Cells in the European Union (Deborah R Hutchison)
• Litigation Risks Facing Tissue Banks in the United States (Daniel D Harshman)
• The Importance of a Code of Ethics and a Code of Practice for Tissue Establishments (Jorge Morales Pedraza)
• Ethical, Religious, Legal, and Cultural Issues for Tissue Banking, with Special Reference to the Asia-Pacific Region (Aziz Nather and Wee Lin)
• Challenges for Tissue Banking in the Asia-Pacific Region and Recent Progress in Malaysia (Norimah Yusof)
• Legal System for Tissue Banking in Latin America (Eulogia Kairiyama)
• Establishing a Legal System for Tissue Banking in China (Li Bao Xing, Zhao Yaping and Glyn O Phillips)
• Independence for Wales from the Remainder of the United Kingdom: A Change from Informed Consent to Presumed Consent (Glyn O Phillips)
• Germany: Regulation of Tissues and Tissue Banking — A Special Case (Peter Hergert and Ralf R Tönjes)
• Legal Issues Associated with Producing and Marketing Tissues Internationally (Caroline A Hartill)
• A Retrospective Look at the Largest Recall of Processed Bone Tissue in History (Helena Lazares and John T Salvucci)
• Polymethyl Methacrylate: An Acceptable Material for Tissue Augmentation and Reconstruction (Mario Cabraja, Jack Klecan and Glyn O Phillips)

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 is authoritatively covered
• There is a description of probably the most notable tissue banking litigation in the USA
• The pioneering global work of the International Atomic Agency in setting basic systems in place is described
• The influence of religious belief on tissue and legal practices is also covered