作者/科法所 秋元奈穗子 老師
This book describes the evolution of a whole legal system for the safety of drugs in the United States through 20th century up to the latest regulatory reforms from the perspective how laws evolved to regulate “information.” Then it compares the system evolved in Japan.This book describes the evolution of a whole legal system for the safety of drugs in the United States through 20th century up to the latest regulatory reforms from the perspective how laws evolved to regulate “information.” Then it compares the system evolved in Japan.
As we usually say that a drug becomes a drug by the information accompanying with the substance, acquisition and communication of information on safety and effectiveness is essential throughout the development and use of drugs. At the same time, since this information necessarily involves uncertainty as information on medicine and biotechnology, ensuring the appropriateness of information becomes the key to the legal system on drugs.
In the United States, by facing with couple of barriers against the safe use of drugs which could not be solved under the traditional administrative and common laws, such as medication errors by outpatients, emerging safety information revealed after approval of new drugs, and distortion of information through promotional activities of drug companies, each areas of laws evolved to enhance the communication and appropriateness of safety information. This book analysis the developments of laws including administrative regulations on labeling and promotion, civil laws of product liability law (duty to warn doctrine) and tort law (informed consent doctrine), federal criminal laws and how they interact each other to control the flow of information of drugs. As a conclusion, it demonstrates that we could find a newly established legal system on drugs– legal system creating informational network where multiple laws differently facilitates each of the actors involved in the field of medication, that is, physicians, patients, pharmaceutical companies pharmacists, and regulators to communicate each other properly for the purpose of drug safety.