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Medical Malpractice in the People's Republic of China: The 2002 Regulation on the Handling of Medical Accidents

Published online by Cambridge University Press:  01 January 2021

Extract

In China, there have been numerous reports that doctors or other health care workers have been attacked by patients or members of patient’s families. From 2000 to 2003, there were 502 reports of violence against health care workers in the city of Beijing, in which 90 health care workers were wounded or disabled. From January 1991 to July 2001, in Hubei Province, 568 attacks on health care facilities and workers were reported, and some health care workers were even killed. In Jiangsu Province, from 2000 to 2002, violent events against health care facilities and workers increased by 35% every year, with an average of 177 such events occurring each year. Those acts of violence have been attributed, in part, to the inadequacy of the legal system for handling medical disputes that was in effect prior to 2002.

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Symposium
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Copyright © American Society of Law, Medicine and Ethics 2005

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References

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See October 10, 1989 Supreme People's Court's reply to Sichuan High People's Court, id. Many lay people may feel that they fall in the cleft between the administrative and the judicial systems; see Gao, Z. Zhao, J., “Preliminary Comment on the Question of Law Application in the Management of Medical Disputes,” (qian tan yi liao jiu fen chu li zhong de fa lu shi yong wen ti) Modern Law Science (dang dai fa xue) 5 (1999): 4648, at 46; Lu, Y. Huang, Y. Zhang, B., “Exploring the Reform of Legal System of Managing Medical Accident Disputes,” (dui chu li yi liao shi gu jiu fen fa lu zhi du gai ge de tan tao) The Chinese Health Service Management (zhong guo wei sheng shi ye guan li) 6 (1998): 301–304, at 303.Google Scholar
Basically there have been three groups of arguments. The first group, represented by health care professionals, argued against the application of Consumer Protection Law to medical practices because: (1) healthcare facilities are enterprises of social welfare, not managers; (2) the results of treatment could not be guaranteed; (3) patients are not general consumers since the price of health care service is still below its cost due to government control; and (4) the application will make health care workers overcautious and in the long run stifle the innovation of medicine. The second group argued for the application because patients (consumers) still pay for health care service and drugs (products) they receive from health care facilities (managers). The third group argued for further differentiation of the characteristics of health care facilities such that only welfare-oriented health care facilities should not be covered by Consumer Protection Law. See Wang, L., supra note 72, at 9–10; Guo and Chen, see supra note 57, at 183.Google Scholar
In 1999, Si Chuan Province Lu Zhou City Middle People's Court stipulated that medical disputes should be covered by Consumer Protection Law; in 2000, Zhe Jiang Province People's Congress covered medical disputes in its implementation regulation of Consumer Protection Law in 2000. See Qing Wen, G. Xin Shan, C., id., at 182–83. As far as we know in July, 2004, Chong King City, Guang Dong Province, Tibet, Ji Lin Province, Shan Dong Province, Jiang Su Province, Hu Nan Province, Yun Nan Province, Liao Ning Province, and Gan Su Province also have regulations covering medical practices in the implementation of Consumer Rights and Interests Protection Law. However, it is unclear to us whether and how local people's courts and local health departments apply these regulations in handling medical accidents. Further interpretation is needed with regard to what liability health care facilities should bear for medical harm caused by their service to consumers. Both the 1987 Regulation and GPCL adopt rules of negligence in determining liability for medical accidents. The plausible interpretation is that health care facilities do not bear strict or no-fault liability for medical harms caused by their health care service. See Li, Y., “Mistake in the Question Asked by Conventional Legal Study: Comment on the Debate Regarding Whether Consumer Rights and Interests Protection Should be Applied in Medical Disputes,” (chuan tong fa xue wen ti shi zhi wu: Ping yo guan yi liao jiu fen shi fo shi yong xiao fei zhe chuan yi bao hu fa de too lun) Hunan Social Science (hu nan she hui ke xue) 2 (2003): 160163, at 161.Google Scholar
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For example, in 1998 the PRC Practicing Doctors Law was adopted; in 1994, both Regulations on the Management of Nurses and Regulations on the Management of Health Care Facilities were adopted.Google Scholar
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Although we do not have nation-wide statistics on the trend of medical malpractice litigation, some local statistical figures did give us a hint about this. See First Civil Branch of Jiang Su High People's Court, see supra note 63, at 21; Zhang, K. Chen, T., “The Specificity, Difficulty and Adjudication Policy of Current Cases of Medical Disputes (I),” (dang qian yi liao jiu fen an jian de te dian ji sheng pan dui ce [shang]) Judicature of China (lu shi sha long) (2003): 28–30, at 29; Wang, H., “Analysis of Accepted Cases of Medical Dispute,” (liao jiu fen shou li an jian fen xi) The Chinese Health Service Management (zhong guo wei sheng shi ye guan li) 6 (1999): 306309, at 309–10.Google Scholar
Wang, , id. at 309; Xiao, , supra note 82, at 22.Google Scholar
In its March 24, 1992 reply to Tian Jin High People's Court (guan yu li xin rong su tian jin shi di er yi xue yuan fu shu yi yuan yi liao shi gu pei chang yi an ru he shi yong fa lu wen ti de fu han), it confirmed that the GPCL should be applied in the calculation of compensation in civil litigation of medical malpractice. In SPC's Law Interpretation No. 7 (2001) regarding interpretations for several questions of liability for spiritual injury in tort cases (zui gao ren min fa yuan guan yu que ding min shi qin quan jing shen sun hai pei chang ze ren ruo gan wen ti de jie shi, fa shi [2001] 7 hao), the SPC has allowed awarding damages for pain and suffering when infringement of rights to life or health is the basis of claims. Finally, in SPC's Law Interpretation No. 33 (2001) regarding the application of Civil Procedure Law (zui gao ren min fa yuan guan yu min shi su song zheng ju de ruo gan gui ding, fa shi [2001] 33 hao), health care facilities have been required to bear the burden of proof in showing the lack of fault on their side as well as the lack of causal relationship between the health care services and the patient's injury.Google Scholar
See Zhu, W., “Medical Accidents: Ten Years of Law Revision,” (yi liao shi gu: Shi nian xiu fa), available at <http://cul.sina.com.cn/s/2002-04-02/11422.html> (last visited on June 7, 2005); Zhu, Y., “Ten Years to Revise One Law: The Process of Drafting the ‘Regulation of Handling Medical Accidents’” (shi niam xiu yi fa: Yi liao shi gu chu li tiao li de qi cao guo cheng), available at <http://health.enorth.com.cn/sytem/2002/04/16/000313358.shtml> (last visited on June 7, 2005).+(last+visited+on+June+7,+2005);+Zhu,+Y.,+“Ten+Years+to+Revise+One+Law:+The+Process+of+Drafting+the+‘Regulation+of+Handling+Medical+Accidents’”+(shi+niam+xiu+yi+fa:+Yi+liao+shi+gu+chu+li+tiao+li+de+qi+cao+guo+cheng),+available+at++(last+visited+on+June+7,+2005).>Google Scholar
See generally, Ko, S., “Chinese Anti-Monopoly Law: An Introduction to Chinese Legislation,” Washington University Global Studies Law Review 3, no. 2 (2004): 267275, at 270–71 (describing the procedure for developing regulations.)Google Scholar
See Song, R., “Thoughtway on the Lawmaking of ‘the Bylaw of Medical Accident Management,’” (yi liao shi gu chu li tiao li li fa si lu) Chinese Hospitals (zhong guo yi yuan) 6, no. 6 (2002): 1719, at 17.Google Scholar
Tian, K., “A Try to Comment on the Management of Medical Accident Disputes,” (shi lun yi liao shi gu jiu fen de chu li fang shi) Journal of Nanjing Medical University (Social Science) (nan jing yi ke da xue xue bao [she hui ke xue ban]) 2 (2002): 8588, at 8; Zhu, see supra note 96. The legislation process was criticized for its lack of public participation and hearing; see Huang, K. Sun, H., “Comment on the Legislation Deficits of the Regulation on Handling Medical Accidents,” (lun yi liao shi gu tiao li de li fa que xian), available at <http://article.chinalawinfo.com/article/user/article_display.asp?ArticleID=22023> (last visited on June 7, 2005).Google Scholar
See generally, Lo, , supra note 23, at 126, 155–156 (regarding alternative mechanisms of dispute resolution.) According to Article 46 of the 2002 regulation, negotiation, administrative handling (chu li) and mediation (tiao jie), and civil litigation are all available procedures of dispute resolution. Moreover, requests for administrative handling and administrative mediation may be separated. Administrative handling (chu li) is focused primarily on the administrative management of health care staff and facilities, as indicated by Article 35 and the title of Chapter 4. According to Article 42, the results of a technical authentication can provide the basis for administrative punishment of health care providers and for mediation between the parties. Although administrative handling could be construed broadly to include administrative mediation, administrative handling under Article 37 is not necessarily the same as administrative mediation under Articles 46 and 48. See Shi, M. Zhao, T. Wu, M. eds., “One Hundred Questions on the Regulation on the Handling of Medical Accidents,” (yi liao shi gu chu li tiao li bai wen) Beijing: Fa Lu Chu Ban She, 2002, at 75–76. Either party to the dispute may apply for administrative handling under Article 37, but an application under Article 48 for administrative mediation on the issue of compensation may only be filed if both parties agree to the application. Thus, it is possible that the two parties might agree to conduct authentication under the direction of the health department, but refuse to agree on an application for administrative mediation.Google Scholar
As referenced in Article 44, mediation may also be conducted in the people's court.Google Scholar
Also note that Art 39 allows for a second technical authentication if requested by a party.Google Scholar
This may impose incentives that are similar to the British system of attorney's fees in which the “loser pays.” See, generally, Rowe, T., “Shift Happens: Pressure on Foreign Attorney-Fee Paradigms from Class Actions,” Duke Journal of Comparative & International Law 13 (2003) 125149, at 128 and n. 16.Google Scholar
The 2002 regulation does not address the type of procedure for technical authentication that the court should adopt. Instead, it is the Law (fa) 2003 No. 20 Notice from the Supreme People's Court that requires courts to adopt the procedure of technical authentication as stipulated in the 2002 regulation when they deal with medical accidents. For cases other than medical accidents, the courts have discretion to use procedures in accordance with the Civil Procedure Law or Criminal Procedure Law. The wording of this notice as regards forensic examination is as follow: “In adjudication of civil cases … when it comes to forensic examination of medical accidents, the conduct of those examinations shall be handed over to medical societies as stipulated in the 2002 regulation. When it comes to non-medical-accident cases, forensic examination shall be conducted according to the Regulation on the Management of Forensic Examinations Entrusted by People's Courts to External Entities.”Google Scholar
According to William Sage, the system that is “usually but oddly called ‘no-fault’” is really a system of strict liability. Sage, , supra note 43, at 19. In China, the GPCL recognizes liability without fault, but only if that liability is authorized by another law. GPCL, supra note 47, at Art. 106. See also Wang, Mo, , supra note 8, at 167–168.Google Scholar
Art. 2. Although the regulatory definition of “medical accident” incorporates the tort law concept of negligence, plaintiffs in China apparently have the option to assert claims against hospitals for breach of contract as well. As Wang and Mo have explained, Article 106 of the GPCL “appears to have imposed a tortious liability partially by way of a contractual obligation.” Wang, Mo, , supra note 8, at 168. This appears to be distinguishable from the U.S. system, in which liability for medical malpractice is based on tort rather than contract. In U.S. jurisdictions, the establishment of a physician-patient relationship is based on contract, and it is the creation of that relationship which imposes a duty to the patient. However, a patient's claim that the physician has breached that duty is based on negligence, which is part of the law of torts. Under common law, damages for breach of contract are limited to losses that were within the contemplation of the parties at the time of contracting, whereas damages for negligence include all losses that were proximately caused by the tortious act. In China, however, Article 112 of the GPCL apparently authorizes recovery of consequential damages for breach of contract. GPCL, supra note 47, at Art. 112.Google Scholar
Article 131 of the GPCL provides that, if the victim also bears fault in causing the harm, the tortfeasor's liability may be decreased. With regard to medical accidents, Article 49 of the 2002 regulation provides that the amount of compensation shall be based in part on the level of responsibility (ze ren) of the negligent conduct in causing harm to the patient. According to Shi, Min, et al., the level of ze ren refers to the proportion of the medical harm that can be attributed to the negligent medical conduct. Shi, Zhao, Wu, , eds., supra note 101, at 77–78. In addition, according to Article 36 of the Temporary Regulation of Medical Accident Technical Authentication, there are four levels of responsibility: Complete responsibility, major responsibility, minor responsibility and mild responsibility. The definitions of responsibility in the temporary regulation on technical authentication are as follow: Complete responsibility (medical harm was caused completely by medical negligent behavior), major responsibility (medical harm was caused mainly by medical negligent behavior), minor responsibility (medical harm was caused mainly by factors other than medical negligent behavior), mild responsibility (almost all medical harm was caused by factors other than medical negligent behavior). Thus, the proportion of liability is determined by the proportion of medical harm that was caused by negligent medical practice. If a patient bears fault which contributed to the medical injury, then health care facilities and workers may not bear complete responsibility for the injury.Google Scholar
See also Chen, , supra note 7, at 147 and 166 (questioning whether 4 years in prison is really an administrative penalty).Google Scholar
Specifically, article 335 of the Criminal Law provides that “[a]ny medical worker who, grossly neglecting his duty, causes death or severe harm to the health of the person seeking medical service shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention.” Criminal Law of the P.R.C., Art. 335, (Law Press China, 2002).Google Scholar
Wang, Y., “The Sameness and Difference between the Regulation of Handling Medical Accidents and the Regulation on Dealing with Medical Incidents,” (yi liao shi gu chu li tiao li yu yi liao shi gu chu li ban fa de zhu yao yi tong dian) Chinese Hospitals (zhong guo yi yuan) 6, no. 6 (2002): 1017, at 13. Of course, how these articles work needs empirical evidence. If these reports are accessible to the public, it is unclear whether Chinese doctors or health care facilities will report their medical errors more honestly than their U.S. counterparts.Google Scholar
See The notice regarding good preparation for practicing the Regulation of Handling Medical Accidents, which was delivered jointly by Ministry of Health and National Bureau of Managing Chinese Medicine and Drugs (wei sheng bu guo jia zhong yi yao guan li ju guan yu zuo hao shi shi yi liao shi gu chu li tiao li yo guan gong zuo de tong zhi), available at <http://news.xinhuanet.com/zhengfu/2002–08/07/content_513996.htm> (last visited on June 7, 2005).+(last+visited+on+June+7,+2005).>Google Scholar
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See id., at 411 (“Even more importantly, such a shift to EML would target the component of the health care system that possesses the greatest capacity for continuously improving the quality of care”) See also Sage, et al., supra note 113, at 11 (“Hospitals and other advanced facilities are usually well equipped to monitor staff physicians and to create environments that improve the total quality of care.”Google Scholar
Pei, et al., supra note 36, at 1722–1723; Hsiao, , supra note 28, at 1051. In the U.S., some proponents of enterprise liability rely on the existing authority of hospitals to limit or terminate the clinical privileges of physicians who fail to provide quality medical care. See, e.g., Abraham, Weiler, , supra note 113, at 414.Google Scholar
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Shi, Zhao, Wu, eds., supra note 101, at 76. Thus, administrative mediation is not a basis for judicial enforcement, but merely increases the likelihood of success in subsequent litigation.Google Scholar
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At Hai Ding District of Beijing City, within seven months after the 2002 Regulation came into force, only one out of 40 cases was found by technical authentication groups to be a liability accident. However, in Shanghai City, 80% of more than 300 non-liability conclusions of technical authentications were later challenged by conclusions of forensic medical examinations. This may explain why most plaintiffs in Hai Ding District of Beijing City preferred forensic medical examinations for their cases. See Ma, J., “Comment on the finalization of compensating for harm in medical disputes-challenging Article 49 of the Regulation on Handling Medical Accidents,” (lun yi huan jiu fen sun hai pei chang de que ding- dui yi liao shi gu chu li tiao li di 49 tiao de zhi yi) Journal of Law & Medicine (fa lu yu yi xue za zhi) 11, no. 1 (2004): 15, at 4.Google Scholar
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According to Supreme People's Court Law (fa) No. 20 (2003) notice, the 2002 Regulation shall pre-empt GPCL as applied to the handling of all medical accidents. However, even though some scholars support this restricted scheme out of cost concerns, they still argue for equitable adjustment of the compensation according to the conditions of patients and their dependents. See Zhang, J., “Preliminary Analysis of Several Problems with the Regulation on Handling Medical Accidents,” (yi laio shi gu chu li tiao li de ji ge wen ti qian xi), Journal of Law & Medicine (fa lu yu yi xue za zhi) 10, no. 1 (2003): 913, at 12; Yang, L., “New Development and Adjudication Policy in the Regulation on Handling Medical Accidents (II),” (yi liao shi gu chu li tiao li de xin fin zhan ji sheng pan dui ce [er]), available at <http://www.civillaw.com.cn/weizhang/default.asp?id=7823> (last visited on June 7, 2005).Google Scholar
See Supreme People's Court's notice, Law 20 (2003), regarding the application of the 2002 regulation in adjudicating civil cases of medical disputes (zui gao ren min fa yuan guan yu can zhao yi liao shi gu chu li tiao li sheng li yi liao jiu fen min shi an jian tong zhi, fa (2003) 20 hao), available at <http://www.jincao.com/fa/law10.s33.htm> (last visited on June 7, 2005). (last visited on June 7, 2005).' href=https://scholar.google.com/scholar?q=129See+Supreme+People's+Court's+notice,+Law+20+(2003),+regarding+the+application+of+the+2002+regulation+in+adjudicating+civil+cases+of+medical+disputes+(zui+gao+ren+min+fa+yuan+guan+yu+can+zhao+yi+liao+shi+gu+chu+li+tiao+li+sheng+li+yi+liao+jiu+fen+min+shi+an+jian+tong+zhi,+fa+(2003)+20+hao),+available+at++(last+visited+on+June+7,+2005).>Google Scholar
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Some confusion resulted when the SPC issued a separate document entitled Law Interpretation (fa shi) No. 20, (2003) which is different from the Law No. 20 (2003) Notice discussed above. In its 2003 Law Interpretation, the SPC adopted a position with regard to the way in which courts should apply laws to determine compensation for personal injury. The SPC's Interpretation Regarding Questions in Applying Law in Adjudicating Personal Injury Cases (zui gao ren min fa yuan guan yu sheng li ren sheng sun hai pei chang an jian shi yong fa lu ruo gan wen ti de jie shi), Law Interpretation No. 20 (2003). It is important to note that Law Interpretation No. 20 (2003) is different from Law No. 20 (2003). The 2003 Law Interpretation by the SPC aroused suspicion about whether it preempts the 2002 regulation on medical accidents. On the basis of that 2003 Law Interpretation from the SPC, patients and their families might be awarded higher amounts of damages than they could receive under the 2002 regulation. Eventually, this issue was clarified by means of a newsletter on the SPC's website, which re-emphasized the message of the Law No. 20 (2003) Notice. Basically, this newsletter is a collection of answers given to reporters' questions by the chief official of the First Civil Court of the SPC (zui gao ren min fa yuan min yi ting fu ze ren jiu sheng li yi liao jiu fen an jian de fa lu shi yong wen ti da ji zhe wen), available at <http://www.court.gov.cn/news/bulletin/activity/200404120015.htm> (last visited on June 7, 2005). The newsletter on the SPC's website basically directs the courts to apply the Law No. 20 (2003) Notice in dealing with cases of medical accidents, instead of applying the 2003 Law Interpretation which addresses interpretation and implementation of laws in cases of personal injury. Thus, for cases of medical accidents, the 2002 regulation shall be applied; for other cases the 2003 Law Interpretation shall be applied. (last visited on June 7, 2005). The newsletter on the SPC's website basically directs the courts to apply the Law No. 20 (2003) Notice in dealing with cases of medical accidents, instead of applying the 2003 Law Interpretation which addresses interpretation and implementation of laws in cases of personal injury. Thus, for cases of medical accidents, the 2002 regulation shall be applied; for other cases the 2003 Law Interpretation shall be applied.' href=https://scholar.google.com/scholar?q=131Some+confusion+resulted+when+the+SPC+issued+a+separate+document+entitled+Law+Interpretation+(fa+shi)+No.+20,+(2003)+which+is+different+from+the+Law+No.+20+(2003)+Notice+discussed+above.+In+its+2003+Law+Interpretation,+the+SPC+adopted+a+position+with+regard+to+the+way+in+which+courts+should+apply+laws+to+determine+compensation+for+personal+injury.+The+SPC's+Interpretation+Regarding+Questions+in+Applying+Law+in+Adjudicating+Personal+Injury+Cases+(zui+gao+ren+min+fa+yuan+guan+yu+sheng+li+ren+sheng+sun+hai+pei+chang+an+jian+shi+yong+fa+lu+ruo+gan+wen+ti+de+jie+shi),+Law+Interpretation+No.+20+(2003).+It+is+important+to+note+that+Law+Interpretation+No.+20+(2003)+is+different+from+Law+No.+20+(2003).+The+2003+Law+Interpretation+by+the+SPC+aroused+suspicion+about+whether+it+preempts+the+2002+regulation+on+medical+accidents.+On+the+basis+of+that+2003+Law+Interpretation+from+the+SPC,+patients+and+their+families+might+be+awarded+higher+amounts+of+damages+than+they+could+receive+under+the+2002+regulation.+Eventually,+this+issue+was+clarified+by+means+of+a+newsletter+on+the+SPC's+website,+which+re-emphasized+the+message+of+the+Law+No.+20+(2003)+Notice.+Basically,+this+newsletter+is+a+collection+of+answers+given+to+reporters'+questions+by+the+chief+official+of+the+First+Civil+Court+of+the+SPC+(zui+gao+ren+min+fa+yuan+min+yi+ting+fu+ze+ren+jiu+sheng+li+yi+liao+jiu+fen+an+jian+de+fa+lu+shi+yong+wen+ti+da+ji+zhe+wen),+available+at++(last+visited+on+June+7,+2005).+The+newsletter+on+the+SPC's+website+basically+directs+the+courts+to+apply+the+Law+No.+20+(2003)+Notice+in+dealing+with+cases+of+medical+accidents,+instead+of+applying+the+2003+Law+Interpretation+which+addresses+interpretation+and+implementation+of+laws+in+cases+of+personal+injury.+Thus,+for+cases+of+medical+accidents,+the+2002+regulation+shall+be+applied;+for+other+cases+the+2003+Law+Interpretation+shall+be+applied.>Google Scholar
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For example, Article 385 of the Revised Criminal Law stipulates that the act of officials receiving others’ property to benefit others through their duties comprises the crime of bribery; no severe outcome is needed. However, in Article 53 and 57 of the 2002 regulation, severe outcomes are stipulated as the conditions that comprise the crimes. In addition, Article 53 and 57 of the 2002 Regulation add “receiving interests” as one of the conditions that comprise the crime of bribery. However, this is beyond the projection of “receiving property” in Article 385 of the revised Criminal Law. See Shi, X. Xu, D., “The Conflict between the Regulation on Handling Medical Accident and Criminal Law,” (yi liao shi gu chu li tiao li yu xing fa gui ding de chong tu) People's Procuratorial Monthly (ren min jian cha) 6 (2002): 54–55, at 55. Also see Huang, Sun, , supra note 100; Guo, F. W., supra note 123.Google Scholar
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