Legal and Ethical Challenges in the Construction of China's Biobanks

Abstract

China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China's biobanks have collected a large number of biological samples. The law gives many institutions the right to store and use biological samples; however, due to the absence of government regulation, lack of ethical norms, and unclear legal provisions, the risks related to biosafety are rising. In terms of informed consent, China's current legislation clearly defines the scope and standard of “informed consent,” but the corresponding boundaries are still vague, and there are loopholes in practical operation. In terms of privacy and confidentiality, Chinese laws do not specify the ownership of genetic information. In the event of genetic risk, Chinese doctors often tell the family members of patients about genetic information. In terms of cross-border supervision of biological samples, the Chinese government not only regulates the entry of biological samples, but also controls the exit of biological samples. In recent years, the corresponding law enforcement and punishment efforts have increased. In terms of trust, China's biobanks often rely on hospitals. Against the background of tense doctor-patient relationships, biological sample donors do not trust hospitals, which is unfortunate because biological sample donors often donate out of their trust in doctors. In terms of benefit sharing, China's legal system still lacks clear provisions, and there are disputes about the mode and subject of benefit sharing. In China's future legislative revision(s), the above aspects should be improved, the ethical traditions of China's “patriarchal system” should be considered, and a biobanking system in line with China's national conditions should be formulated.