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Medicines, Medical Devices and the Law

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

ISBN13: 9781900151078
ISBN: 1900151073
Published: January 1999
Publisher: Greenwich Medical Media Ltd
Country of Publication: UK
Format: Hardback
Price: £126.00

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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.

Medical Law and Bioethics
1. European regulation of medical devices
2. Medicines regulation
3. The supply of unlicenced medicines for particular patient use
4. The pharmacist and supply of medicines
5. The supply and reimbursement of medicines under NHS
6. The doctor, professional responsibility and legal duties
7. Drug induced injury
8. Principles of civil liability for manufacturers and suppliers
9. Responsibilities and liabilities of regulatory agencies
10. Causation issues in civil proceedings
11. Adjudication and funding of claims
12. Plaintiff support groups
13. No fault compensation schemes
14. Medical ethics in treatment and research
15. The criminal law and the prescriber
16. Enforcement and criminal liability for medicines and medical devices
17. Drug induced automatism as a defence in criminal action
18. The medical expert
19. Medicines in the coroner's inquest.