Legal basis of global tissue banking : a proactive clinical perspective / editor Glyn O. Phillips, Research Transfer LTD, UK, Phillips Hydrocolloids Research Ltd, UK.

Format:

Book

Contributor:

Phillips, Glyn O.

Language:

English

Subjects (All):

Tissue banks--Law and legislation.

Tissue banks.

Physical Description:

1 online resource (305 p.)

Place of Publication:

Singapore ; Hackensack, New Jersey : World Scientific Publishing Company, 2016.

Language Note:

English

Summary:

"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."-- Provided by publisher.

Contents:

""CONTENTS""; ""About the Editor""; ""About the Authors""; ""Preface""; ""1. Introduction: From a Cottage Industry to a Global Business""; ""The Development of Tissue Banking""; ""The Early Pioneers""; ""Legislation""; ""References""; ""2. Legal Framework for International Operation of Tissue Banks""; ""Introduction""; ""Europe""; ""United Kingdom""; ""Reporting Requirements""; ""United States""; ""Reporting Requirements""; ""International Atomic Energy Agency (IAEA) Code of Practice for Radiation Sterilisation of Tissue Allografts""; ""Pre-Sterilisation Validation Requirements""

""Sterilisation Process Validation Requirements""""Establishing a Sterilisation Dose""; ""References""; ""3. The Legal and Regulatory Framework for Tissues and Cells in the European Union""; ""Establishment of a European Union (EU) Regulatory Framework for Tissues and Cells""; ""The European Tissue and Cells Directives (EUTCD)""; ""Directive 2004/23/EC9""; ""Directive 2006/17/EC10""; ""Directive 2006/86/EC11""; ""Implementation of the EU Directives""; ""Transposition of EUTCD in the EU Member States""; ""Austria""; ""Belgium""; ""Bulgaria""; ""Croatia""; ""Cyprus""; ""Czech Republic""

""Denmark""""Estonia""; ""Finland""; ""France""; ""Germany""; ""Greece""; ""Hungary""; ""Ireland""; ""Italy""; ""Latvia""; ""Lithuania""; ""Luxembourg""; ""Malta""; ""The Netherlands""; ""Poland""; ""Portugal""; ""Romania""; ""Slovakia""; ""Slovenia""; ""Spain""; ""Sweden""; ""The United Kingdom""; ""What is Next?""; ""References""; ""4. Litigation Risks Facing Tissue Banks in the United States""; ""Phase 1: The Pleading Stage""; ""Phase 2: Fact Discovery""; ""Phase 3: Expert Discovery""; ""Phase 4: Dispositive Motions (Summary Judgment)""; ""Phase 5: Pretrial Preparations""

""Phase 6: The Jury Trial""""How do Lawyers Determine Who to Sue and What Claims to Assert?""; ""Common Lawsuits Filed Against Tissue Banks""; ""How to Prepare for Litigation in US Courts""; ""References""; ""5. The Importance of a Code of Ethics and a Code of Practice for Tissue Establishments""; ""Main Ethical Issues""; ""The Adoption of a Code of Ethics and a Code of Practice""; ""Main Ethical Principles""; ""Code of Practice""; ""References""; ""6. Ethical, Religious, Legal, and Cultural Issues for Tissue Banking, with Special Reference to the Asia-Pacific Region""; ""Introduction""

""Ethical Considerations""""Religious Considerations""; ""Buddhist View on Tissue Donation""; ""Islamic View on Tissue Donation""; ""Christian View on Tissue Donation""; ""Hindu View on Tissue Donation""; ""Legal Considerations""; ""Singapore""; ""Australia""; ""India""; ""Malaysia""; ""Sri Lanka""; ""Philippines""; ""Vietnam""; ""Indonesia""; ""Japan""; ""Korea""; ""Wales""; ""Bangladesh""; ""Countries in the Asia-Pacifi c Region with No Laws on Tissue Donation""; ""Cultural Issues Pertaining to Organ Donation and Transplantation""; ""References""

""7. Challenges for Tissue Banking in the Asia-Pacific Region and Recent Progress in Malaysia""

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

981-4663-44-1