Understanding and Application of the Medical Malpractice Handling Regulations

Author: Tang Huade (Editor) / Country:
Publisher:
Publish Date: 2002-05-01
Features:
(II) Medical accidents occurring during medical activities
From the discussion in the previous text, we have learned that the "Medical Accident Handling Regulations" improved upon the provisions of the "Medical Accident Handling Measures" by no longer limiting the occurrence of medical accidents to the "process of diagnosis and treatment care," but instead expanding it to "medical activities." This is a very clear advancement. However, determining what constitutes "medical activities" is not an easy task. China's laws, regulations, and rules have not defined the connotation and extension of medical activities. Currently, the only reference available is the Ministry of Health's "Explanation on Several Issues."
(III) The act must violate medical health management laws, administrative regulations, departmental rules, and diagnosis and treatment norms and conventions
Due to the debate in China's tort law theory regarding whether the constitutive elements of tort civil liability should include "illegality," the provision in the "Medical Accident Handling Regulations" that "the act violates medical health management laws, administrative regulations, departmental rules, and diagnosis and treatment norms and conventions" may either indicate the illegality required for constituting a medical accident or merely serve as a standard for judging the negligence of the actor. The views of some renowned tort law scholars in China may influence the courts' handling of medical dispute cases regarding this issue. For example, Professor Wang Liming and others argue that the illegality of tortious acts does not have independent connotations. On one hand, tort disputes are diverse, and tort law cannot list all types of tortious acts, making it difficult to determine the independent connotations of illegality. On the other hand, most tortious acts are negligent, and it is hard to judge whether such acts are illegal—only whether the actor is negligent. Therefore, the illegality of an act is merely an important basis for determining whether the actor is negligent and does not have independent space as a constitutive element of tort liability distinct from negligence.
Conversely, scholars such as Professor Yang Lixin and Professor Zhang Xingbao argue that illegality should be affirmed and recognized as an independent element in the constitutive requirements of tort liability. Otherwise, it would lead to an inappropriate expansion of tort law and make it impossible to explain issues of illegality as an excuse for tort liability.
Regarding this issue, we believe that setting aside the mere discussion of whether tort liability should include illegality as one of its constitutive elements and focusing solely on medical accidents, we can find that the illegality of an act and the negligence of the actor are actually in an intertwined state, with both connections and distinctions. The connection lies in the fact that due to the increasing closeness of human society, more and more laws and regulations require certain professionals to fulfill statutory duties of care, and many industries also have their own rules. This has led to the rule of negligence presumption, which holds that if a person's act violates statutory duties of care or industry rules, it is deemed negligent, and illegality is presumed as negligence. The rule of negligence presumption is one manifestation of the trend toward the objectification of negligence in the development of modern tort law. The function of negligence objectification is to refine traditional individualistic negligence liability, no longer emphasizing the moral blameworthiness of the actor but focusing more on objective normative criteria in social activities.
In the context of medical accidents, in most cases, if the behavior of medical institutions or medical staff "violates medical health management laws, administrative regulations, departmental rules, and diagnosis and treatment norms and conventions," it is sufficient to indicate that the act is negligent. This point was already proven in the "Explanation on Several Issues" issued by the Ministry of Health, which stated when discussing the negligence of medical accident actors, "Constituting a negligent act in a medical accident must have dual characteristics of illegality and harm. Illegality: In medical accidents, it mainly refers to violating diagnosis and treatment rules and technical operation procedures. These can be written or tacitly accepted rules followed by everyone in practice."
The distinction between illegality and negligence lies in the fact that the medical activities conducted by medical institutions and medical staff, from minor injections and extractions to major amputations, organ transplants, and heart surgery, are all infringements on patients' rights, particularly their right to bodily integrity. Yet, such acts are not considered unlawful because they are consented to by the patient, thus creating an illegality excuse. This requires medical institutions and medical staff to fulfill their duty of informing patients during medical activities. In fact, the "medical health management laws, administrative regulations, departmental rules, and diagnosis and treatment norms and conventions" include numerous provisions requiring doctors to obtain patient consent during medical activities. For example, Article 26 of the "Practice of Chinese Medical Practitioners Law" states, "Physicians shall truthfully inform patients or their families about the condition of the illness but should avoid adverse consequences. When conducting experimental clinical medical treatment, approval from the hospital and consent from the patient or their family are required."
Article 11 of the "Medical Accident Handling Regulations" states, "During medical activities, medical institutions and medical staff shall truthfully inform patients about their condition, treatment measures, and risks, and promptly answer their inquiries, but should avoid adverse consequences."
Article 62 of the "Implementation Rules of the Medical Institution Management Regulations" states, "Medical institutions shall respect patients' right to know about their condition, diagnosis, and treatment. When performing surgery, special examinations, or special treatments, they shall provide necessary explanations. If it is not appropriate to inform the patient due to protective medical measures, the relevant situation shall be notified to the patient's family."
If medical institutions and medical staff violate these statutory duties of informing, such as conducting experimental clinical treatment without informing the patient, and the treatment fails, causing harm to the patient, even if the medical institution and medical staff have no negligence themselves (e.g., due to abnormal patient conditions, special patient physique resulting in medical accidents, or unforeseeable or unavoidable adverse consequences under current medical technology), they shall still bear liability for damages.