Medicines, Medical Devices and the Law

by Edited by John O'Grady , Ian Dobbs-Smith , Nigel Walsh , Michael Spencer

• ISBN13: 9780521292511
• ISBN10: 0521292514
• Format: Paperback
• Copyright: 2011-06-16
• Publisher: Cambridge University Press

Summary

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

Foreword

Preface

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

Index

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