The Tort Law of P.R. China and the Implementation of Informed Consent

Informed consent, a norm denominated formally in the 1950s, has become accepted as a very important principle in bioethics, and it is now looked upon as an effective tool in the medical practice and research for the protection of patients. However, for a long time, opinions have differed as regards the nature of informed consent and how it may be applied effectively in real practice. This is reflected in the way informed consent has been defined and redefined in laws of the past. This, too, is the situation in China. Now, with the new Tort Law of P.R. China,¹ which came into force on 1 July 2010, the issue of informed consent, its significance, its implementation and its feasibility again trigger a new wave of heated discussion among scholars in the medical, legal as well as ethical fields.

This article, revolving around how informed consent is described in the Tort Law, will first seek to point out the new characteristics in the treatment of informed consent in this law as compared with those in other laws before, and try to grasp the realistic meaning of such change. In the meantime, I will, taking the perspective of the connotation, purpose and significance of informed consent, further discuss the limitations of the adoption of informed consent in the Tort Law, and the possible difficulties that may arise in both theory and practice in the implementation of the law. Finally, I will show that much still remains to be done in China to push forward the work involving the implementation of informed consent and the protection of patient/subject benefits and rights.

I. The status of Informed Consent in Laws Before and Why the Tort Law is Promulgated

Informed consent, as a key principle in bioethics, has its essence in autonomous decision-making and choice by the agent of action. In medical practice and research, the process of autonomous decision-making and choice is the process of informing patients or subjects about diagnosis, treatment or research plans, risks and benefits, alternative treatment plans, etc. The patients or subjects, having acquired and fully understood the information, then make the decision to accept or refuse treatment or research participation. This is to say that informed consent does not merely seek to inform and obtain consent from the patients or subjects; what matters here is the fact that such consent must be voluntarily given under no coercion or any other undue influences.

In other words, autonomy is the core of informed consent, and unless the patient has no full capacity for civil conduct, such consent must be given by the patient or subject himself. However, scholars in China have long expressed doubts over whether informed consent, which emphasises individual autonomous consent, could actually fit in well with the Chinese cultural environment, and such doubts are reflected in the way informed consent has been treated in Chinese laws and regulations of the past.

The earliest law containing informed consent in China may be traced back to 16 April 1929, when the Ministry of Health of the Republic of China issued Regulations on Hospital Management.² According to the "Regulations": "In case of major operations, hospitals must obtain written consent from the patient himself and his representative before such operations may be conducted." Then, in 1982, the Ministry of Health of the People’s Republic of China issued Working Regulations on Hospitals. In the Appendix of Article 40 of this document, it was stipulated that: "Written consent from the patient’s family or work unit is required before operations, but minor operations may be excluded".³ In this case, consent from the patient’s family alone will suffice, and consent from the patient is not required. And these were applied in the clinical context for a long time.

Things are a bit different with Regulations on Medical Institutions,⁴ promulgated by Chinese central government (State Council) in 1994. According to Article 62 of this law: "For any medical institution to perform operations, special medical check-ups and treatments, it has to make sure to obtain written consent...