[Research on the legal regulation of experimental medicine in China]

Zhonghua Yi Xue Za Zhi. 2023 May 16;103(18):1367-1372. doi: 10.3760/cma.j.cn112137-20221210-02612.
[Article in Chinese]

Abstract

The increasing number of clinical trials of new drugs in China has brought huge benefits to the society, but also implied huge risks. This is particularly evident in experimental medicine. Germany has achieved good results in regulating experimental medical behaviors through the model of legislative norms. China should learn from Germany's beneficial experience to promote the orderly development of experimental medical behavior in China. Specifically, the crime of illegal human experiment should be added to the criminal law; Adopt special legislation model to regulate experimental medical behavior; Establish a no fault medical liability system to share experimental medical risks;Absorb and learn from the relevant norms of the international community on human experiment.

我国新药临床试验数量不断增长,在带来巨大社会效益的同时也隐含着巨大风险。这一点,在实验性医疗中体现得尤为明显。德国通过立法规范实验性医疗行为,取得了良好成效。我国应当借鉴德国的有益经验,促进实验性医疗有序发展。具体而言,应当在刑法中增设非法人体试验罪;采取专门立法模式规制实验性医疗行为;建立无过错医疗责任制度分担实验性医疗风险;吸收借鉴国际社会关于人体试验的相关规范。.

Publication types

  • English Abstract

MeSH terms

  • Biomedical Research*
  • China
  • Germany
  • Humans
  • Liability, Legal*