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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.
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.
Foreword William Asscher; Preface; 1. European regulation of medical devices C. Hodges; 2. Medicines regulation A. Cartwright; 3. The supply of unlicenced medicines for particular patient use J. O'Grady and A. Wearing; 4. The pharmacist and supply of medicines S. Sharpe; 5. The supply and reimbursement of medicines under NHS I. Dodds-Smith; 6. The doctor, professional responsibility and legal duties R. G. Forrester; 7. Drug induced injury J. O'Grady; 8. Principles of civil liability for manufacturers and suppliers S. Pearl; 9. Responsibilities and liabilities of regulatory agencies M. Mildred; 10. Causation issues in civil proceedings A. Barton; 11. Adjudication and funding of claims G. Hickinbottom; 12. Plaintiff support groups A. Simanowitz; 13. No fault compensation schemes M. Mildred; 14. Medical ethics in treatment and research F. Wells; 15. The criminal law and the prescriber M. Spencer; 16. Enforcement and criminal liability for medicines and medical devices M. Tyler; 17. Drug induced automatism as a defence in criminal action M. C. Powers; 18. The medical expert M. Bloom; 19. Medicines in the coroner's inquest A. Barton; References and selected bibliography; Index.
This book provides information on the complex interrelations between medicines, medical devices and the law.
"This is a book that has been needed for the last decade. The need has been filled with this excellent book written and edited by people who are highly competent in their specialist fields. For those who had not realized that they needed this book it should, perhaps, be spelt out clearly who should have a copy on their shelves - pharmaceutical physicians, registration managers, pharmaceutical company lawyers, lawyers practising in the field of medical malpractice and negligence and managers of National Health Service (NHS) trusts." - Reviewed by J P Griffin Review published in Adverse Drug Reactions and Toxicological Reviews Volume 19, Number 1, 2000
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