New legislation in China balancing the rights of both doctors and patients

The Tort Law of the People's Republic of China, which was implemented on 1 July 2010, is another important basic civil law following the Contract Law and the Property Law. This law was put into the legislation process in 2001, and was finally adopted at the 12th session of the Standing Committee of the Eleventh National People's Congress on 26 December 2009. It represents the collective wisdom of the legislative, theoretical and law practical circles. Separating the Tort Law from the Debt Law as a separate part of the Chinese Civil Laws is a great breakthrough in the traditional civil law system. It is the first time worldwide that a separate category has been used to define medical malpractice liability, and it provides references for legislation of medical malpractice liability in other countries.

Present situation of medical disputes in China

In recent years, medical disputes in China have been gradually increasing. According to the survey conducted by the China Hospital Management Association during June–July 2005 in 270 hospitals, the issues of patients abusing, threatening or even beating medical staff occurred in 73.33% of the 270 hospitals, and the issues of patients threatening or assaulting hospital administrators due to discontentment with treatment outcomes occurred in 59.63% of the hospitals. ¹ The total number of lawsuits in medical disputes accepted by the courts in China increased from 9600 in 2005 to 10,200 in 2006, 11,000 in 2007 and 13,800 in 2008. ^2,3

While the contradiction between doctors and patients has become an outstanding problem and medical disputes have increased, the settlement of medical disputes in China has sunk into an embarrassing position of judicial dualization in recent years. On 4 April 2002, the State Council of China promulgated the Regulation on Handling Medical Malpractices, which was implemented on 1 September 2002. Therefore, the Notice of the Supreme People's Court on Trying Civil Cases on Medical Disputes by referring to the Regulation on Handling Medical Malpractices was promulgated on 6 January 2003.

According to the Notice, ‘If any lawsuit is brought to the court regarding a dispute over medical compensation resulting from a medical malpractice which occurred after the enforcement of the Regulation, it shall be handled by referring to the relevant provisions in the Regulation; for other disputes over medical compensation resulting from reasons other than medical malpractices, the provisions in the General Principles of Civil Law shall apply.’ After the enforcement of the Regulation, the people's court, when trying a civil case on a dispute over medical compensation resulting from a medical malpractice, may determine the compensation liability for the medical malpractice by referring to the Regulation. The compensation liability of the civil cases resulting from causes other than medical malpractices should be determined by referring to the General Civil Law, the Contract Law and so on. Therefore, the above regulations caused the judicial dualization in law application, judicial expertise and compensation standard, counting against the protection of the rights of doctors and patients as well as against the mutual trust between doctors and patients.

Introduction of the medical malpractice liability defined in the Tort Law

Emphasizing the protection of patients' rights and respecting the specificity of medicine

Appropriately handling disputes between doctors and patients includes protecting the rights of patients, protecting the rights of hospitals and medical staff and benefiting the progression of medical sciences and the development of the health-care system. This is the basic principle of the medical malpractice liability legislation by the legislative department in China. The Tort Law contains 92 clauses. Except for the general regulations on tort liability, the Tort Law also sets regulations on product liability, vehicle traffic accident liability, medical malpractice liability, environmental pollution liability, highly dangerous activity liability, animal breeding damage liability and object damage liability. Among these liabilities, the medical malpractice liability is stipulated by 11 clauses, more than those for any other liability, indicating the discretion and highly conscientious attitude of legislators while legislating regulations on the medical malpractice liability. Of the 11 clauses for the medical malpractice liability, nine stipulate the rights of patients and the liability of medical institutions and medical staff and two stipulate the right protection and exoneration of hospitals and medical staff. Hence, the regulations of the Tort Law on the medical malpractice liability not only emphasize the protection of patients' rights but also respect the specificity of medicine.

Establishing the imputation principle system with the fault liability as the basic principle, and fault presumption and non-fault liability as supplementary principles

The 54th clause of the Tort Law stipulates that the medical institutions bear the liability when their medical malpractices cause damage to patients. This clause determines the fault liability as the basic imputation principle for medical malpractice liability. ⁴ The 58th clause stipulates the medical institution as the fault party when the damage to patients is caused by the following situations: the medical staff offend laws, administrative regulations, local regulations and other diagnosis- and treatment-related regulations; the medical staff hide or refuse to provide the clinical records related to the dispute; and the medical staff falsify, distort or destroy the clinical records. ⁴ The 59th clause stipulates that when the damage to patients is caused by the defects of drugs, disinfectants or medical instruments or by the infusion of unqualified blood products, the patients can appeal for compensation either from the manufacturer or blood provider or from the medical institution, ⁴ which is a typical non-fault liability clause. It shows that Chinese legislators borrowed the legislative and judicial experience widely from other countries while determining the imputation principle for the medical malpractice liability. Different types of medical malpractice liability should not be handled by only referring to the fault liability principle or fault presumption principle. In fact, they should be handled by referring to the principles of the fault liability, fault presumption and non-fault liability, accordingly establishing an imputation principle system with the fault liability as the basic principle, and fault presumption and non-fault liability as supplementary principles.

Stipulating in detail the obligation of the medical staff to disclose to patients, and defining the patients' right to know

The 55th clause of the Tort Law stipulates that the medical staff should inform the patients about the disease conditions and medical practices while diagnosing and treating the patients. If a surgical operation, specific examination or specific treatment is necessary, the medical staff should inform the patient about the risks and alternatives, and obtain informed consent from the patient; while it is inappropriate to inform the patient directly, the medical staff should inform the close relatives of the patient and obtain informed consent from them. When the medical staff offend this clause and cause damage to the patient, the medical institution bears the compensation liability. ⁴ Although some current laws, administrative regulations and local regulations in China have already defined the obligation of the medical staff to disclose to patients and the content of the patients' right to know, adopting a basic civil law to stipulate the patients' right to know from the aspect of tort liability will further protect patients' rights.

Prohibiting unnecessary and excessive examinations in medical institutions

The 63rd clause of the Tort Law stipulates that the medical institutions and medical staff should not offend the diagnosis and treatment standards, and perform unnecessary examinations. ⁴ To better protect patients' rights, this clause aims to prohibit the widely concerned situation of abusive examinations by the medical staff, which causes additional financial burden to the patients and even causes adverse effects on patients' health. However, the unnecessary examinations are relatively difficult to define, and can only be judged by the compliance with the diagnosis and treatment standards.

Enforcing the protection of the rights of medical institutions and medical staff, and balancing the rights between doctors and patients

At present, the contradiction between doctors and patients is an outstanding problem in China. Especially, the disturbance in hospitals by hired medical violators severely interrupts normal medical orders, and affects the work and life of the medical staff. In China, ‘hired medical violators’ is a new word used in news reports in recent years. It was first used by Mr Qun-An Mao, the press spokesman of the Ministry of Health, China, on 10 July 2006 when reporting medical disputes. ‘Hired medical violators’ are hired by the party of patients and patients' relatives in the cases of medical disputes, and interrupt medical orders and benefit from medical disputes by setting obstacles in hospitals to impede other patients, breaking down furniture and instruments in hospitals, following and assaulting medical staff and so on. The 64th clause of the Tort Law stipulates that the lawful rights and interests of medical institutions and medical staff are under the protection of laws, and that the one who disturbs medical orders and interrupts the work and lives of the medical staff bears the tort liability. ⁴ This clause reflects that Chinese legislators have considered both the protection of the rights of patients as the vulnerable group in medical activities and the specificity of the medical industry while legislating the medical malpractice liability. The laws should not only protect the rights of patients who suffer from damage caused by medical malpractices, but also protect the lawful rights of medical institutions and medical staff to ensure the healthy and ordered development of the health-care system.

Germany, France, Japan, the Netherlands and Russia are some classic countries that are adopting the Corpus of Civil Law. According to the Medical Tort Law legislation in the Corpus of Civil Law of the five countries, neither specific regulation of medical malpractice liability nor standard application rules are included. In Germany, France, Japan and Russia, medical compensation is decided on the basis of personal injury and healthy injury regulation, whereas in the Netherlands, the acts of medical treatment are defined as contractual acts and medical compensation is decided according to the liabilities for breach of contract by referring to the specific Medical Service Contract Law. The experience of medical compensation legislation in China can lend the above countries some reference values. The UK and the USA do not have the Corpus of Civil Law and specific legislation on medical malpractice liability. In these two countries, cases of medical disputes are mainly judged according to previous precedents. However, in China, the cases should be judged according to relevant provisions of medical malpractice liability in current Tort Law, not according to previous precedents. Although the judicial system in China differs from those in England, the USA and other countries that adopt the Common Law, the principles of Medical Tort Law legislation established in China can also be used as references for the judges in those countries while judging lawsuits of medical malpractice.