Medicines, Medical Devices and the Law

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 and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. However, the information available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book aims to address this situation by bringing together the knowledge of the laws governing the regulation of medicines ranging across the field from the ethics of the use of medicines in treatment and research, through to drug-induced injury, civil liability and no-fault compensation schemes.

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 1999 book aims to address the lack of information available to those involved in the complex interrelations between medicines, medical devices and the law by bringing together the knowledge of the laws governing the regulation of medicines, ranging across the field.