Discussion On The Legislation Of Super Drug Specification

About the problem of off-label use medicines, fewer domestic research attention, academic foundation is weak, the lack of systematic theoretical basis and regulation system. This paper attempts to explore the specification of off-label use medicines legislation, research and legislation to promote domestic system to build off-label use medicines, medical institutions and their employees to resolve conflicts off-label use behaviors and patient package insert of the right to life, the right to health, to ease the current slightly nervous doctor-patient relationship.This paper on legislative issues were discussed over off-label use medicines, through the school library, Internet electronic databases, Chinese legal retrieval systems and other ways to collect journals, newspapers, academic dissertation, clinical medical record, laws and regulations and other information theoretic analysis of the problem, research is divided into three part.The first part," The necessity of off-label use medicines legislation to explore." The part of the author using the method of literature research and case studies, legal issues raised from the super- drug instructions starting medication, because medication conflicts over drug instructions produced a detailed analysis of key issues and proposed legislation to solve the doctor-patient relationship is balanced.The second part, " domestic and abroad legal system of regulation over the package insert medication." This part of the analysis by comparing the author to clarify the status of domestic off-label regulation of drugs medication instructions, introduce some foreign experience and practice, provide a reference for our legislation.Part 3," Legal Regulation build super package insert medication." The relevant part of the author based on the theoretical basis of law, medicine, pharmacy, ethics, expand interdisciplinary research from a multidisciplinary point of view, the legal effect of the level select, established legal principles, the specific content to build a clear Liability, legal disputes, legislative idea deficiencies six aspects to analyze and discuss in detail.I believe that should first National Health and Family Planning Commission to develop departmental regulations for ultra manual medication issues, and establish a set of security mechanisms. The mechanism should cover risk grading super package insert medication, grading informed consent process improvement, operation and supervision of the program, the establishment of standards development organizations, medical institutions and their employees to reduce or waive the liability conditions, drug instructions to modify the program, contents of promotional materials for its pharmaceutical sales companies should bear the legal responsibility and so on. Then gradually involve changes to improve timely constantly adjusted according to changes in social conditions and medical services, and when conditions are ripe and then drew formulate administrative regulations of the State Council.Through legislative package insert for super-medication management and restraint, can effectively prevent abuse of drugs, constraints commercial factors leading ultra package insert medication, to promote the development of new indications for drugs, so that patients can get cheaper more effective medical costs services, both medical institutions and their employees to protect the legitimate rights of rational drug use, and protection of the right to health and the right to know the patient, the doctor-patient relationship balanced and harmonious society.