Limitations And Solutions Of The Off-label Drug Use Under The Threshold Of The Physician Law

With the continuous development of medical technology,off-label drug use has been applied in clinical diagnosis and treatment.China has changed from no legal provisions to legalization after the promulgation of the People’s Republic of China(PRC)Medical Law,but the relevant provisions are not clear.The basic problems of off-label drug use are the basis of this paper,including the concept of off-label drug use,the historical evolution of off-label drug use at home and abroad and the positive significance of legalization of off-label drug use,which shows that under the background of global medical health,legalization of off-label drug use is an inevitable trend promoted by history.The lack of standardization of legalization of off-label drug use is the analysis part of the paper.Because of the medical and legal nature of it,there are some defects in Article 29 of the Physician Law,such as vague provisions of "special circumstances",difficult operation of "clear and informed consent" of patients,and unclear proof standards of evidence-based medicine.The overseas investigation of the legal regulation of off-label drug use is the in-depth research part of the paper,learning from the supervision system of the United States,the risk management system of the United Kingdom,and the data sharing system of France.The core of this paper is to improve the legal regulation of over-the-counter drugs.In view of the existing problems in China,the advantages of foreign mature institutional systems are combined with China’s practice to form two solutions: first,the applicable rules of off-label drug use are further clarified by refining the legal provisions of the Physician Law,explaining the meaning and purpose of Article 29;Secondly,it is necessary to improve the construction of pharmaceutical system matching with the over-the-counter drugs in the Physician Law,and build a legal rule network of over-the-counter drugs in Socialism with Chinese characteristics’ s legal system through the formulation of the system.