Medicines, Medical Devices and the Law

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  • Format: Paperback
  • Copyright: 2011-06-16
  • Publisher: Cambridge University Press
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Supplemental Materials

What is included with this book?


In recent years the need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors including the changing structure of healthcare in the UK and Europe, the increasing specialisation in litigation relating to medicines' control and provision and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. Until now the information resources available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book is designed to address this situation by bringing together the knowledge of the laws governing the regulation of medicines of the most experienced and qualified experts in one volume ranging across all aspects of the field. All areas of the law relating to the research, development, manufacture, distribution and dispensation of medicines and medical devices in the UK are covered as well as various topics within the law governing responsibilities, procedures and compensation in cases of malpractice and injury.

Table of Contents

European regulation of medical
Medicines regulation
The supply of unlicenced medicines for particular patient use
The pharmacist and supply of medicines
The supply and reimbursement of medicines under NHS
The doctor, professional responsibility and legal duties
Drug induced injury
Principles of civil liability for manufacturers and suppliers
Responsibilities and liabilities of regulatory agencies
Causation issues in civil proceeding
Adjudication and funding of claims
Plaintiff support groups
No fault compensation schemes
Medical ethics in treatment and research
The criminal law and the prescriber
Enforcement and criminal liability for medicines and medical devices
Drug induced automatism as a defence in criminal action
The medical expert
Medicines in the coroner's inquest
References and selected bibliography
Table of Contents provided by Publisher. All Rights Reserved.

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