Study on the Legal Realistic Dilemmas and Countermeasures of the Clinical Application of the Off-label Drug Use

OBJECTIVE To sort out and analyze the legal provisions concerning the off-label drug use in the newly revised Law on Doctors of the People’s Republic of China, and to provides reference for the construction of the legal mechanism of the off-label drug use which is suitable for China’s national conditions.METHODS Analyzed the current situation of the legislation on the off-label drug use, analyzed the difficulties of legal governance in the clinical application of off-label drug use in China, and drawn lessons from the legal system on the off-label drug use in the United States, and put forward the corresponding measures to solve the problem. RESULTS Relevant legislation needed to be improved urgently, evidence-based medicine system research was insufficient, patients’ informed consent right was not fully implemented, risk control measures for ultra manual drugs were not complete, and clinical drug management was not strict. These were the legal and practical difficulties that China faces in the clinical application of ultra manual drugs. CONCLUSION To address the legal dilemma of off-label drug use in clinical application in China, multiple approaches need to be taken to build up related legal governance mechanism. Including the completion of legislation, construction of evidence-based medical evidence system, insurance of patients’ right to informed consent, completion of the risk prevention mechanism of off-label drug use, and the improvement of the supervision mechanism of off-label drug use, etc.