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 1999 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. Table of Contents 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.