When West Meets East: Investigating the Law and Practice of the Informed Consent Rule in China

Abstract

Informed consent, as an ethical term and a moral requirement for medicines, means that the patients are entitled to be informed about their state of health and all relevant information concerning any proposed physically invasive intervention, and may consent to or reject the intervention based on the sufficient information they receive from the medical professionals. The informed consent rule is usually considered to be based on liberal individualism, especially the concept of respect for autonomy in Western countries. Many ethical questions, therefore, can be answered by asking foremost what the patient wants, rather than what the family, society or even the state believes to be in the best interest of the patient.

As a non-Western culture represented by Confucianism, Chinese culture and moral traditions are customarily considered as communitarian-oriented, i.e., instead of individual, it emphasizes the importance of the family, community, and the state. Given that the legal doctrine is still in its early and experimental phase, the introduction of informed consent into China, a culture distinct from the West, poses inevitable challenges due to its association with liberalism and individualism. For instance, although the newly enacted Civil Code reconfirmed the patient’s exclusive right to be informed with medical information, family members are actively involved in the process of medical decision-making and may even make decisions on behalf of the patient in clinical practice. Additionally, the legal provisions concerning the informed consent rule are dispersed across various legal documents and have been criticized for contradictory clauses and lack of clarity, which led to challenges in the application of the informed consent rule within the judicial and medical practice, including the excessive reliance on Medical Authentication Report and mistrust between medical professionals and patients.

The existence of the above findings implies that there are discrepancies between the law in books and the law in practice. This thesis, therefore, intends to examine the application of informed consent doctrine under legal, judicial and medical contexts, especially what are the gaps between the legal framework, judicial application and clinical practice and the underlying socio-legal reasons that led to such gaps. Detailed analysis of the application of the informed consent rule is provided in this thesis through the statutory interpretation, questionnaire and interviews, case study, and other research methodologies.

It is discovered that the original legislative intent of the right to informed consent has not been fully realized in judicial and medical practice. Courts appear to rely excessively on appraisal reports when determining violations of informed consent and neglect to provide clear statements in their decisions when the law is unclear. The patient's autonomy is not genuinely protected, and the doctor-patient relationship is not facilitated by the provisions of the right to informed consent in medical practice, which has become a mere formality. The underlying reasons behind the above gaps are multi-dimensional, including the influence of traditional familism culture, the ambiguity of the current legal provisions and the complex nature of medical negligence cases. Therefore, in order to guarantee the legality and reasonableness of the informed consent rule, the last part of this thesis has made several suggestions for the future legal reform, thereby providing legislators and policy makers with valuable insights into potential future legal reforms.

The informed consent rule in China has achieved initial success due to the establishment of the preliminary mechanism. But in the long run, further efforts should be made to deepen the relevant legal reform. Reform is a demanding and prolonged endeavor that, like the construction of Rome, cannot be completed hastily. It necessitates qualities such as patience, perseverance, and the ability to endure setbacks and initial failure.

Date of Award	25 Apr 2025
Original language	English
Awarding Institution	City University of Hong Kong
Supervisor	Chunyan DING (Supervisor)