Skip to main content
  • 417 Accesses

Abstract

This chapter examines China’s legal context, medical context and law relating to TCM. In the legal context, China demonstrates that a jurisdiction can, through statutory intervention or legislation, expand the scope of a doctor’s duty to inform to cover the disclosure of alternatives. It also further illustrates that the Tort approach is not always the best way to honour a patient’s right to be informed. In the medical context, China presents an “integrative” medical culture. Behind the facade of TCM’s flourishing and equal status to Western medicine, TCM’s uniqueness has actually been diluted by the Western-medicine-oriented approach of integration. Although it may not be wise to accord practitioners freedom to practise both TCM and Western medicine, because of the irreconcilability of the two medical cultures, the “integrative” approach is consistent with the thesis that health care practitioners would better possess and present patients with contextualised information that transcends the boundaries of the different “schools of thought”.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    In China, that includes Western medicine practitioners and Traditional Chinese Medicine practitioners.

  2. 2.

    Regulation on Medical Institutions (1994, State Council)(医疗机构管理条例, 1994年,国务院).

  3. 3.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) (中华人民共和国药品管理法,2001年,全国人大常委会).

  4. 4.

    Law of the People’s Republic of China on Prevention and Treatment of Infectious Diseases (1989, revised 2004, The Standing Committee of the National People’s Congress) (中华人民共和国传染病防治法, 1989年,2004年修订,全国人大常委会).

  5. 5.

    China is still waiting for its national Mental Health Law. It has been subjected to more than 25 years’ discussion and debate and more than ten revisions since it was drafted in 1985. However, there are some local regulations in this area, for example, Shanghai Mental Health Regulation (2001, The Standing Committee of Shanghai People’s Congress) (上海市精神卫生条例, 2001年, 上海市人民代表大会常务委员会).

  6. 6.

    I will explore this in the part “Traditional Chinese Medicine and the Law” of this Chapter.

  7. 7.

    Such as Regulation on Human Organ Transplantation (2007, State Council) (人体器官移植条例, 2007年, 国务院).

  8. 8.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) (中华人民共和国执业医师法, 1998年,全国人大常委会).

  9. 9.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 2 (中华人民共和国执业医师法, 1998年, 第2条).

  10. 10.

    Law on Practising Doctors of the People’s Republic of China (1998), Articles 8–20 (中华人民共和国执业医师法, 1998年, 第8-20条).

  11. 11.

    Law on Practising Doctors of the People’s Republic of China (1998), Articles 4 and 7(中华人民共和国执业医师法, 1998年, 第4, 7条).

  12. 12.

    For example, according to Article 3, doctors should “have sound professional ethics and high levels of competence for medical practice, demonstrate humanitarianism and fulfill the sacred responsibility for preventing and treating diseases, healing the wounded and rescuing the dying and safeguarding the health of people.”

  13. 13.

    One of the doctors’ rights is the right “to conduct medical diagnosis, disease investigation and medical disposal, issue corresponding medical certificate and choose appropriate plans for medical treatment, disease prevention and healthcare” (emphasis added). See, Article 21 (1) of the Law. Doctors have the following duties in practising medicine: (1) to abide by laws, regulations and the technical and operating rules;(2) to foster the spirit of dedication, follow professional ethics, fulfill the responsibilities as a doctor and serve the patients conscientiously; (3) to care for and respect the patients and guard patients’ privacy; (4) to work hard for professional proficiency, update one’s knowledge and raise professional and technical competence; (5) to disseminate hygienic and health care knowledge and educate the patients on health issues. See, Article 22 of the Law.

  14. 14.

    In addition to the “informed consent” requirement which I will elaborate later, the six other “practising rules” are: (1) When implementing medical treatment, disease prevention and healthcare measures and signing relevant medical certificates, doctors shall conduct diagnosis and investigations themselves (in person) and timely fill in medical documents according to stipulations, and shall not conceal, forge or destroy medical documents and relevant materials. Doctors shall not issue medical certificates that are not related to their own practising scope or not in line with the practising categories. (2) For emergency and critical cases, doctors shall adopt emergency treatment measures and shall not refuse to give emergency treatment. (3) Doctors shall use medicines, sterilizing drugs and medical equipment approved for use by relevant state departments. Except for proper diagnosis and treatment, doctors shall not use narcotic drugs, toxic drugs for medical use, medicines for mental disease or radioactive medicines. (4) Doctors shall not solicit or illegally accept money or articles from patients or seek other illegitimate gains by taking advantage of one’s position. (5) In case of natural disasters, outbreaks of contagious diseases, sudden accidents with heavy casualties and other emergencies that pose a serious threat to people’s life and health, doctors shall follow the orders of the health administrative departments of the people’s governments at or above the county level. (6) In case of a malpractice or when an epidemic situation is found, doctors shall report in a timely manner to the employer institution or the health administrative departments in accordance with relevant stipulations. When a doctor finds that the patient is suspected of being involved in an injury case or dies of abnormal cause, the doctor shall report to relevant departments in accordance with relevant stipulations. See, Articles 23–29 of the Law.

  15. 15.

    See also, Xiju Zhao, Chinese Medical Negligence Law: How to Distinguish and Accommodate Common Law Principles? in Chen Lei & C.H. van Rhee (eds). Towards a Chinese Civil Code: Historical and Comparative Perspectives Brill 2012. I have done a lot of updating and rewriting about the topic in this part.

  16. 16.

    General Principles of the Civil Law of the People’s Republic of China (1986, NPC) (中华人民共和国民法通则, 1986年,全国人大).

  17. 17.

    Regulation on the Handling of Medical Accidents (2002, State Council) (医疗事故处理条例, 2002年, 国务院).

  18. 18.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC) (中华人民共和国侵权责任法, 2009年, 全国人大常委会).

  19. 19.

    General Principles of the Civil Law of the People’s Republic of China (1986, NPC), Article 98 (“Citizens shall enjoy the rights of life and health.”) (中华人民共和国民法通则, 1986年,全国人大, 第98条).

  20. 20.

    Regulation on Dealing with Medical Accidents (1987, State Council) (医疗事故处理办法, 1987年, 国务院); Regulation on the Handling of Medical Accidents (2002, State Council) (医疗事故处理条例, 2002年, 国务院).

  21. 21.

    Supreme People’s Court’s Reply to Tian Jin High People’s Court Regarding How to Apply Laws in Adjudicating the Medical Incident Compensation Case of Li Xin-rong v. The Affiliated Hospital of Tian Jin No. 2 Medical College (1992, SPC) (最高人民法院关于李荣诉天津市第二医学院附属医院医疗事故赔偿一案如何适用法律问题的复函, 1992年, 最高人民法院); Notice of the Supreme People’s Court on Trying Civil Cases on Medical Disputes by Referring to the “Regulation on Handling Medical Accidents” (No. 20 [2003] of the Supreme People’s Court) (最高人民法院关于参照《医疗事故处理条例》审理医疗纠纷民事案件的通知, 2003年, 最高人民法院); The Interpretation of the Supreme People’s Court Concerning Some Issues on the Application of Law for the Trial of Cases on Compensation for Personal Injury (2003, SPC) (最高人民法院关于审理人身损害赔偿案件适用法律若干问题的解释, 2003年, 最高人民法院); Answers by the Chief Official of the First Civil Court of the SPC to Reporters’ Questions on How to Apply Laws in Adjudicating Medical Lawsuits (最高人民法院民一庭负责人就审理医疗纠纷案件的法律适用问题答记者问). The Supreme People’s Court has the power to give general interpretation on the application of laws in judicial proceedings (“judicial interpretation”(“司法解释”(“Si Fa Jie Shi”))).

  22. 22.

    Notice of the Supreme People’s Court on Trying Civil Cases on Medical Disputes by Referring to the “Regulation on Handling Medical Accidents” (No. 20 [2003] of the Supreme People’s Court) (最高人民法院关于参照《医疗事故处理条例》审理医疗纠纷民事案件的通知, 2003年, 最高人民法院).

  23. 23.

    The Interpretation of the Supreme People’s Court Concerning Some Issues on the Application of Law for the Trial of Cases on Compensation for Personal Injury (2003, SPC) (最高人民法院关于审理人身损害赔偿案件适用法律若干问题的解释, 2003年, 最高人民法院).

  24. 24.

    Academically “medical damage liability” is defined as a tort liability where medical institutions and healthcare professionals in the therapeutic activities, due to negligence or, under the expressly defined circumstances, no matter whether there is negligence or not, caused personal injuries or other injuries to patients, and therefore shall bear damage compensation liability and other liabilities. See, Yang Li Xin “Study on the Concept of Medical Damage Liability” (2009) No. 3 Politics and Law 75, 79 (杨立新: “医疗损害责任概念研究”, 载《政治与法律》2009 年第3 期, 第79页).

  25. 25.

    The Supreme People’s Court of China Interpretation on How to Apply Laws in Adjudicating Cases of Liability for Medical Damage (Discussion Paper) http://www.ahyllaw.com/display.asp?id=1238 (last accessed 20 April, 2012) (最高院关于审理医疗损害责任纠纷案件适用法律若干问题的解释(征求意见稿)). The Interpretation has 38 articles.

  26. 26.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 6 (1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第6(1)条).

  27. 27.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 6 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第6(2)条).

  28. 28.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 7 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第7条). For example, product liability (Chapter 5), liability for environmental pollution (Chapter 8) and inherently hazardous or dangerous activities (Chapter 9).

  29. 29.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 54 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第54条).

  30. 30.

    Chinese new law about civil liability for medical damage is deemed as a substitute for Chinese “medical accident” law. According to Article 2 of the Regulation on the Handling of Medical Accidents (2002, State Council), “medical accidents” (医疗事故 (“Yi Liao Shi Gu”)) is defined as “accidents that have caused personal injury to the patients negligently by the medical institutions or the staff members thereof in the activities of medical treatment by violating the laws, regulations, ministerial rules concerning medical treatment and health or the standards or conventions of medical treatment and nursing” (emphasis added).

  31. 31.

    Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health), Article 88 (医疗机构管理条例实施细则, 1994年, 卫生部, 第88条).

  32. 32.

    Compare, Yang Li Xin “On the Principle and System of Imputation for Medical Damage Liability” (2009) 10 Journal of China University of Political Science and Law 62, 62–72 (杨立新: “论医疗损害责任的归责原则及体系”, 载《中国政法大学学报》2009 年第2 期, 第62-72页) (suggesting three principles for three different contexts: (1) the principle of fault liability for cases of medical technology liability; (2) the principle of presumption of fault for cases of medical ethics liability(including the case of failing to disclose information); (3) the principle of no-fault liability for cases of medical products liability).

  33. 33.

    For example, Natanson v. Kline, 350 P.2d 1093 (Kan. 1960).

  34. 34.

    That is witnessed by leading informed consent cases in common law, such as Sidaway v Bethlehem Royal Hospital Governors [1985] 1 All ER 643, (1985) AC 871 (UK); Reibl v. Hughes [1980] 2 SCR 880, (1980) 114 D.L.R . (3d) 1 (S.C .C.) (Canada); Rogers v Whitaker (1992) 175 C.L.R. 479 (HCA) (Australia); Smith v. Auckland Hospital Board, [1964] NZLR 241; revd [1965] NZLR 191 (New Zealand).

  35. 35.

    See, Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Articles 54, 55, 57, 58, 59, 60, 62 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第54, 55, 57, 58, 59, 60, 62条).

  36. 36.

    See, Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 34(1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第34(1)条).

  37. 37.

    Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 97.

  38. 38.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 57 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第57条) (“In diagnosis and treatment activities, health professionals fail to exercise the duty of diagnosis and treatment corresponding to the then-prevailing medical level, and cause injuries to the patient, the medical institution concerned shall be liable for compensation.”).

  39. 39.

    Tort Liability Law of People’s Republic of China (2d official discussion draft, December. 21, 2), Article 57 (中华人民共和国侵权责任法(二次审议稿), 第57条) (emphasis added).

  40. 40.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 60 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第60(2)条).

  41. 41.

    Yang Li Xin “Proof and Burden of Proof of Medical Negligence” (2009) No. 6 Journal of Law 1, 3 (杨立新: “论医疗过失的证明及举证责任”, 载《法学杂志》2009年第6期, 第3页).

  42. 42.

    Notice of the Supreme People’s Court on Trying Civil Cases on Medical Disputes by Referring to the “Regulation on Handling Medical Accidents” (No. 20 [2003] of the Supreme People’s Court), Article 2 (2) (最高人民法院关于参照《医疗事故处理条例》审理医疗纠纷民事案件的通知, 2003年, 最高人民法院, 第2 (2)条). See also, The Supreme People’s Court of China 2012, Article 20 (affirming that courts shall not admit the conclusions of authentication made by medical experts as evidence if judges have “reasonable doubt” about them).

  43. 43.

    For example, according to the Queensland (Australia) Civil Liability Act (2003), the general principles for general standard of care are: (1) A person does not breach a duty to take precautions against a risk of harm unless – (a) the risk was foreseeable (that is, it is a risk of which the person knew or ought reasonably to have known); and (b) the risk was not insignificant; and (c) in the circumstances, a reasonable person in the position of the person would have taken the precautions. (2) In deciding whether a reasonable person would have taken precautions against a risk of harm, the court is to consider the following (among other relevant things) – (a) the probability that the harm would occur if care were not taken; (b) the likely seriousness of the harm; (c) the burden of taking precautions to avoid the risk of harm; (d) the social utility of the activity that creates the risk of harm. See, Civil Liability Act 2003 (Qld), s 9 (1) (2). The risk-benefit analysis is applicable in medical negligence law.

  44. 44.

    For example, in Australia, the standard of care for professionals (including but not limited to medical professionals) are: (1) A professional does not breach a duty arising from the provision of a professional service if it is established that the professional acted in a way that (at the time the service was provided) was widely accepted by peer professional opinion by a significant number of respected practitioners in the field as competent professional practice. This serves as a defense for professionals to a claim of negligence. (2) To benefit from this defense, a professional needs to introduce evidence in support of his or her conduct that satisfies four criteria: (a) The conduct was widely accepted. The conduct was not only accepted by one particular regional group, but by various groups. This may mean that the practice may need to be accepted nationally, or internationally, dependent upon the professional concerned. Peer professional opinion does not have to be universally accepted to be considered widely accepted. (b) The conduct was accepted by a significant number of practitioners. Having regard to the number of practitioners in practice, a large proportion accepted the behaviour. It does not mean that over half of practitioners need to accept the conduct. It is possible for a number of “schools of thought” to exist in relation to the practices within a profession. (c) The practitioners providing evidence in support must be “in the field’ of practice under review, and “respected” in that field. Accordingly, in areas of specialty medicine and research, there will be exist a limited number of professionals who will be able to provide the evidence necessary. (d) The evidence must support that the conduct in question was “competent”. (3) The fact that there are differing peer professional opinions widely accepted by a significant number of respected practitioners in the field concerning a matter does not prevent any 1 or more (or all) of the opinions being relied on for the purposes of this section. (4) However, peer professional opinion can not be relied on if the court considers that the opinion is irrational or contrary to a written law. See, Civil Liability Act 2003 (Qld), s 22 (1) (2) (3) (4); J. A. Devereux 2007, 650–651.

  45. 45.

    See, Sect. 3.5.2.

  46. 46.

    Lachlan McMurtrie 2006, 224 (highlighting that widely accepted medical practice may not concur with what has been scientifically and clinically proven to an appropriate treatment regime; arguing that the law should recognise clinical practice guidelines using principles of evidence-based medicine as the prima facie standard of care for treatment, rather than allowing customary practice to define standard of care and requiring little or no objective proof of efficacy or safety).

  47. 47.

    Those stories, reported by Chinese media, are mainly concerned with patients’ complaints about doctors’ lack of skill and responsibility in providing health care, doctors’ over-prescribing expensive medication, doctors’ subjecting patients to needless examination and treatment, and doctors’ taking bribes and kickbacks from patients and pharmaceutical companies.

  48. 48.

    A survey showed that the medical profession is more pessimistic about the doctor-patient relationship than patients. The impression of bad doctor-patient relations may be created by media exposure of extreme cases. See, Fu Zi Tang et al. 2006, 11.

  49. 49.

    See, The Lancet 2; Yi Yang et al. 2 (responding to the first Editorial); The Lancet 2012.

  50. 50.

    A survey showed that patients and the medical profession hold divergent opinions towards the media’s involvement in medical disputes. While 73.3% of the patients surveyed commented positively towards the media and think that the media contributed to disputes-resolution, almost all hospitals and medical professionals oppose the media being involved in medical disputes and think that the media are destructive to dispute-resolution. See, Fu Zi Tang et al. 2006, 38. See also, The Lancet 2, 657; Yi Yang et al. 2, 1823–1824 (saying the media to “provoke[] tension between doctors and patients”, “mislead[]” the public, and “demonise[]” Chinese doctors)).

  51. 51.

    See, Xu Xin and Lu Rong Rong (2), 82–101. See also, Dean M. Harris and Chien-Chang Wu (2005), 456. A survey showed that 56.1% of medical professionals surveyed had experienced the patient’s physical threat. See, Fu Zi Tang et al. 2006, 14. Violence against doctors, including murder, is commonplace and reportedly increasing. In 2006, the last year for which detailed records on patient-doctor violence was reported publicly (including violence perpetrated by patient family members and friends), the Chinese Ministry of Health stated that 5,519 medical personnel had been “injured” in disputes. And on March 29, the China Daily cited an “official source” who said that in 2, 17,000 violent incidents took place, affecting roughly 70% of all public hospitals in China. See, Adam Minter Violent Crimes in China’s Hospitals Spread Happiness http://www.bloomberg.com/news/2012-03-29/violent-crimes-in-china-s-hospitals-spread-happiness.html (last accessed April 28, 2012). Two recent examples of violence against health professionals are: (1) In September, 2011, Xu Wen, a 43-year-old otolaryngologist at Beijing Tongren Hospital, had been stabbed 17 times in her arms, head and back by a dissatisfied patient, Wang Baoming. (2) In March, 2012, Wang Hao, a young internist at the First Affiliated Hospital of Harbin Medical University in northeast China, was stabbed to death by a disgruntled patient. Three other doctors were seriously injured in the attack.

  52. 52.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 64 (“Lawful interests and rights of medical institutions and its health professionals shall be protected by law. Those who interfere with the order of medical treatment and obstruct the work and life of medical professionals shall assume legal liability according to law.”) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第64条).

  53. 53.

    Two phenomena do destroy the reputation of Chinese medical profession. Some Chinese doctors accept or even seek red envelopes (“Hong Bao” (红包)) (a monetary gift in exchange for favourable service) from patients against the rules. Second, some doctors receive or even ask for financial kickbacks (“Hui Kou” (回扣)) from drug companies. Even doctors acknowledge that “lack of professional ethics” or “deterioration of professional ethics” is one of the main reasons for medical disputes. See, Yi Yang et al. 2.

  54. 54.

    A survey done by Ding Xiang Yuan (丁香园), a popular biomedical website in China, in 2, reveals that when asked about the main reasons for the increased tension between doctors and patients, 78% of 14,577 survey participants (including 5,710 residents, 5,132 attending physicians, 2,256 associate chief physicians, and 609 chief physicians) blamed it on a lack of government funding to hospitals and 70% accused the public media for negative reports. See, Yi Yang et al. 2, 1823–1824.

  55. 55.

    A study showed that almost 90% of doctors surveyed must see 10–40 patients in their 8-h office time. 14.7% of them will see 40 patients in their 8-h office time. See, Fu Zi Tang et al. 2006, 16.

  56. 56.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 58 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第58条).

  57. 57.

    Liang Hui Xing 2, 38–39; Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 101. See also, The Supreme People’s Court of China 2012, Article 8. Compare, Lin Wen Xue 2, 21 (interpreting “presumption of fault” as giving the defendant an opportunity to rebut the presumption); Wang Yue 2, 36 (reading “presumption of fault” as meaning that judges can directly presume fault, without the need to organize authentication); Liao Huan Guo 2, 24 (reading Article 58 as “shifting burden of proof”).

  58. 58.

    For example, in English law, departure from a protocol is not automatically negligent. It raise a prima-facie case of negligence and, unless the circumstances indicate that there were good reasons for departing from the usual practice, the professional will be found liable. See, Jonathan Montgomery Health Care Law (2 ed, Oxford University Press, New York, 2003) 183–184.

  59. 59.

    See, The Legislative Affairs Commission of the Standing Committee of the National People’s Congress 2, 252 (emphasising that the “fault” that is presumed in Article 58 is the “fault” that caused the patient’s damage).

  60. 60.

    For example, under the Regulation on the Handling of Medical Accidents (2002), the notion of “medical accidents” (医疗事故 (“Yi Liao Shi Gu”)) means “accidents that have caused personal injury to the patients negligently by the medical institutions or the staff members thereof in the activities of medical treatment by violating the laws, regulations, ministerial rules concerning health care, and norms of diagnosis, treatment and nursing” (emphasis added). Although “negligence” and “a violation of statutory provisions and medical norms” are two different elements of the notion, when establishing “medical accidents”, the authentication committee and the courts seldom consider whether the defendant-doctor is “negligent”. The law does not require them to do that. Their focus is simply on whether there is “a violation of statutory provisions and medical norms”. “Negligence” is equated and confused with “a violation of statutory provisions and medical norms”.

  61. 61.

    This is also evidenced by Chinese product liability law. According to Article 46 of Product Quality Law (2000), there are two tests for the “defect” of a product: (1) “unreasonable risk”; (2) national and industrial standards. It turns out that, in establishing the “defect” of a product, Chinese judges are busy with looking at whether the product conforms to “national and industrial standards”, rather than judging whether or not the product has an “unreasonable risk”.

  62. 62.

    The Legislative Affairs Commission of the Standing Committee of the National People’s Congress 2, 235 (citing the example of “emergency” to illustrate how to rebut the presumption).

  63. 63.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 59 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第59条).

  64. 64.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 59 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第59条).

  65. 65.

    There were many reports about the case. For example, see, Fraudulent dealer forges licenses to sell fatal fake chemical, http://english.peopledaily.com.cn/200605/24/eng20060524_268115.html; Dealer Sells Fake Chemical to Pharmaceutical Company, http://www.china.org.cn/english/2006/May/169289.htm; Fake Medicine Firm Fined, Banned After 11 Deaths, http://www.china.org.cn/english/2006/Jul/173341.htm; Five suspects questioned for fake drug case, http://english.gov.cn/2006-05/21/content_287035.htm; Death toll from contaminated drug rises to 14 in S China, http://english.people.com.cn/90001/90776/90882/6344024.html (last accessed May 1, 2012). Chinese Premier Wen Jiabao chaired a State Council executive meeting, ordering government departments to launch a thorough investigation into the case and intensify supervision and regulation of the pharmaceutical market.

  66. 66.

    The chemical dealer was arrested by Jiangsu police. The Qiqihar No. 2 Pharmaceutical was fined 19 million yuan (US$2.3 million). The production licence of the company was revoked by the Heilongjiang provincial food and drug administration and the sale of the firm’s drugs banned. Five company employees, two deputy factory directors in charge of technology and supply, one material buyer, one general manager, and one testing office director, went on trial in Guangzhou Intermediate People’s Court. They were sent to jail for their involvement in the counterfeit drug operation.

  67. 67.

    See, the judgments of the Qi Er Yao Armillarisni A case: Guangzhou Tianhe District People’s Court (2007) Tian Fa Min Yi Chu Zi NO. 905 (June 26, 2); Guangzhou Intermediate People’s Court (2) Sui Zhong Fa Min Yi Zhong Zi No. 3082 (December 10, 2, Appeal) (齐二药亮菌甲素注射液产品质量损害赔偿纠纷案,广州市天河区人民法院(2007)天法民一初字第905号(2年6月26日,一审);广州市中级人民法院(2)穗中法民一终字第3082号(2年12月10日,二审)).

  68. 68.

    Yang Li Xin “On the Principle and System of Imputation for Medical Damage Liability” (2009) 10 Journal of China University of Political Science and Law 62, 62–72 (杨立新: “论医疗损害责任的归责原则及体系”, 载《中国政法大学学报》2009 年第2 期, 第62-72页) (suggesting the principle of no-fault liability for cases of medical product liability).

  69. 69.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 41 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第41条).

  70. 70.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 42 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第42条).

  71. 71.

    If this happens, Chinese practice is to order the medical institution and the blood-supplying institution concerned to give the patients a sum of fee, based on the principle of “fairness”. This has been confirmed by Beijing High Court in its interpretation on how to apply Chinese Tort Liability Law. See, Beijing High Court 2, Rule 34.

  72. 72.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 43 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第43条).

  73. 73.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 43 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第43条) (“If damages are caused by defects existing in the products, the infringee may claim for compensation either from the producer or from the seller of the products. If defects in the products are caused by the producer, the seller shall have the recourse against the producer after it has paid the compensation. If defects existing in the products are due to the fault of the seller, the producer shall have the recourse against from the seller after it has paid the compensation.”).

  74. 74.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 61 (1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第61(1)条).

  75. 75.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 61 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第61(2)条).

  76. 76.

    The Supreme People’s Court of China 2012, Article 11; Beijing High Court 2, Rule 12.

  77. 77.

    Beijing High Court 2, Rule 13.

  78. 78.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 62 (1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第62(1)条).

  79. 79.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 62 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第62(2)条).

  80. 80.

    See, Opinions of the Supreme People’s Court on Several Issues concerning the Implementation of the General Principles of the Civil Law of the People’s Republic of China (For Trial Implementation) (1988, SPC, Fa (Ban) Fa [1988] No. 6), Article 140 (最高人民法院关于贯彻执行《中华人民共和国民法通则》若干问题的意见(试行) (1988年,最高人民法院,法(办)发[1988]6号), 第140条); Interpretation of the Supreme People’s Court on Several Issues about the Trial of Cases concerning the Right of Reputation (1998, SPC, Judicial Interpretation No.26 [1998]), Question and Answer 7 (最高人民法院关于审理名誉权案件若干问题的解答(1998年,最高人民法院,回答七)).

  81. 81.

    Interpretation of the Supreme People’s Court on Problems regarding the Ascertainment of Compensation Liability for Emotional Damages in Civil Torts (2001, SPC, Fa Shi [2001] No.7), Article 1 (最高人民法院关于确定民事侵权精神损害赔偿责任若干问题的解释(2001年,最高人民法院,法释[2001] 7号),第1条).

  82. 82.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 2 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第2条).

  83. 83.

    The clauses in the Tort Law that relate to the protection of a patient’s right of privacy include Article 15 (the infringee may demand the infringer to stop the infringement, compensate for damage, and make an apology, etc.), and Article 22 (“If the infringement on any personal right and interest results in serious mental injury, the infringee shall have the right to demand compensation for mental distress.”).

  84. 84.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 63 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第63条).

  85. 85.

    The Supreme People’s Court of China 2012, Article 36. See also, Beijing High Court 2, Rule 6.

  86. 86.

    According to a survey, 70% of the doctors surveyed think that over-examination helps to produce evidence that can be used in the doctor-patient lawsuits. See, Ding Xiang Yuan: It Is Difficult to Change: What Are the Doctors’ Opinions about the Difficulty in Seeing Doctors and Costliness in Having Illness Treated? http://6d.dxy.cn/article/2012/02/23/19186 (last accessed April 25, 2012) (丁香园: “难言改观:医生眼中的看病难与看病贵”, 载 http://6d.dxy.cn/article/2012/02/23/19186,2012年4月25日访问).

  87. 87.

    See, Yang Li Xin “On the Principle and System of Imputation for Medical Damage Liability” (2009) 10 Journal of China University of Political Science and Law 62, 62–72 (杨立新: “论医疗损害责任的归责原则及体系”, 载《中国政法大学学报》2009 年第2 期, 第62-72页) (suggesting three categories of medical liability: (1) medical technology liability; (2) medical ethics liability; (3) medical products liability).

  88. 88.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 56 (“In case any of the medical institutions violates the provisions of the present Regulation by doing any of the following, it shall be ordered by the administrative department of health to make corrections; if the circumstances are serious, the person-in-charge and other people that are held to be responsible shall be given administrative punishments or disciplinary punishments: …(2) Refusing to photocopy or reproduce medical records for the patients without good reasons; (3) Failing to write or properly keep medical records in accordance with the requirements of the administrative department of health under the State Council; (4) Failing to make up medical records of rescue within the prescribed time limit; (5) Failing to seal up, keep and open the medical records or material objects according to the requirements of the present Regulation;…”) (医疗事故处理条例, 2002年, 国务院, 第56条).

  89. 89.

    According to the statistics of Ministry of Health, in 2 there are 17,243 cases of violence or disturbance in hospitals. In 5 years, there is an increase of 7,000 cases.

  90. 90.

    In doctors’ eyes, the possible causes of violence against Chinese health professionals are: (1) Because of China’s one-child policy, parents and grandparents pay great attention to the health of their child and demand higher-quality health services for their children. (2) Because a high proportion of health care payments is out-of-pocket, and, starved of funds from the government, Chinese hospitals resort to prescribing expensive, and often unnecessary, drugs, diagnostics, and procedures, poor workers and their dependants (children, spouses, and parents) have high expectations of the therapeutic efficacy of such expensive treatments. (3) There is a common lack of reasonable understanding about medicine among the general public. (4) The quality of medical services in some Chinese hospitals is low. See, Sheng-Li Huang and Xiao-Yan Ding (2011).

  91. 91.

    In April, 2012, Ministry of Health and Ministry of Public Security even released to the public a notice, restating their stance against Yi Nao and subjecting some kinds of violence and disturbance in hospitals to administrative punishment and criminal responsibility. See, Ministry of Health and Ministry of Public Security of People’s Republic of China, Notice to the Public about Maintaining Order in Medical Institutions (April 30, 2012, Wen Tong [2012] No. 7) (中华人民共和国卫生部 中华人民共和国剬安部: “关于维护医疗机构秩序的通告”(2012年4月30日, 卫通〔2012〕7号)).

  92. 92.

    Ding Xiang Yuan Chinese Version of Guidelines on How to Prevent Violence in Health Care Workplace http://www.cmda.gov.cn/xinwen/redianxinwen/2011-11-03/10059.html (last accessed May 1, 2012) (丁香园:《医疗工作场所防止暴力行为中国版指南(2011–2012)》, 载 http://www.cmda.gov.cn/xinwen/redianxinwen/2011-11-03/10059.html, 2012年5月1日访问).

  93. 93.

    State Council 2012 (trying to revoke the link between the income of health professionals and the profits gained through selling drugs and undergoing examinations).

  94. 94.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 26 (“Where the infringee is also attributable to the damage, the liability of the infringer may be mitigated.”) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第26条).

  95. 95.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 27 (“If the damage is caused by the victim intentionally, the person who commits the act shall assume no liability”) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第27条).

  96. 96.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 28 (“If the damage is caused by a third party, the third party shall assume the tort liability.”) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第28条).

  97. 97.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 29 (“If any damage is caused to other people for the reason of force majeure, no liability shall be assumed. Where there are otherwise different provisions, such provision shall govern.”) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第29条).

  98. 98.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 60 (1) (“A medical institution shall not be liable for compensation if injuries are caused to a patient under any of the following circumstances: (1) the patient or his close family members fail(s) to cooperate with the medical institution in performing diagnosis and medical treatment that conforms to diagnosis and treatment standards; …. The medical institution and its medical staff members who have fault under the circumstance as mentioned in Item (1) of the preceding paragraph shall bear corresponding compensation liability.”)(中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第60 (1)条).

  99. 99.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 60 (3) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第60 (3)条).

  100. 100.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 49 (医疗事故处理条例, 2002年, 国务院, 第49条).

  101. 101.

    For example, the victims of the negligence may themselves be responsible for breaking the chain of causation. If the patient’s conduct contributed to the original injury, the injury would be attributable only partly to the professionals. Contributory negligence theory not only can serve as a defence to liability, but also can be raised in the context of causation. Finally, the patient’s injury may be the result of natural causes, such as underlying medical problems or an unavoidable accident, rather than the doctor’s negligent conduct. According to New Zealand legislation, “Treatment Injury” is personal injury that is caused by treatment. It is “not a necessary part, or ordinary consequence, of the treatment, taking into account all the circumstances of the treatment, including (i) the person’s underlying health condition at the time of the treatment; and (ii) the clinical knowledge at the time of the treatment”. Treatment injury does not include personal injury that is wholly or substantially caused by a person’s underlying health condition. It also excludes personal injury that is a result of a person unreasonably withholding or delaying their consent to undergo treatment. The fact that the treatment did not achieve a desired result does not, of itself, constitute treatment injury. See, Injury Prevention, Rehabilitation, and Compensation Act 2001 (NZ), s 32.

  102. 102.

    The Commonwealth countries have drawn clear distinctions between law and science and between fact-finders and medical experts. In the realm of proving causation in medical malpractice lawsuits, Australian common law has distinguished legal causation from scientific causation. Unlike the scientific causation, the purpose of legal causation is to ascertain or apportion legal responsibility. It has shown readiness and willingness to embrace common sense, value judgments and policy considerations in determining causation. See, Chappel v Hart (1998) 195 CLR 232, 242–243.

  103. 103.

    Liao Tian Ming et al. 2, 2 (revealing that Chinese judges have high dependence on the conclusions of authentication).

  104. 104.

    Chappel v Hart (1998) 195 CLR 232, 243, per McHugh J.; 255 per Gummow J.; 269 per Kirby J.; 282 per Hayne J..

  105. 105.

    Bonnington Castings Ltd v Wardlaw [1956] AC 613.

  106. 106.

    McGhee v National Coal Board [1973] 1 WLR 1; Fairchild v Glenhaven Funeral Services Ltd [2002] 3 WLR 89.

  107. 107.

    Accident Compensation Corp v Ambros [2] 1 NZLR 340, 351 (CA). The distinction drawn between these two categories of cases is that, in cases involving product liability, industrial pollution and industrial diseases, the creator of the risk is also the beneficiary of the risk which has generally been created for commercial profit, while, in medical cases, there are usually pre-existing conditions of the claimant, and uncertainty is an inherent part of medical practice, and medicine is of high social utility. See, Accident Compensation Corp v Ambros [2] 1 NZLR 340, 351 (CA), para. [36].

  108. 108.

    Chaplin v. Hicks [1911] 2 KB 786, [1911–13] All ER Rep 224; Allied Maples v Simmons & Simmons [1995] 1 WLR 1602; Sellars v Adelaide Petroleum NL (1994) 179 CLR 332.

  109. 109.

    Hotson v East Berkshire Area Health Authority [1987] AC 750; Gregg v Scott [2005] UKHL 2; 2 AC 176; Lawson v Laferrière (1991) 78 DLR (4th) 609; Accident Compensation Corp v Ambros [2] 1 NZLR 340, 353 (CA), para. [46]. Compare, Rufo v. Hosking, 2004 NSWCA 391.

  110. 110.

    Gregg v Scott [2005] 2 AC 176, para. [90], per Lord Hoffmann.

  111. 111.

    Stipulations of the Supreme People’s Court on Evidence in Civil Litigation (2001, No. 33, SPC), Article 4 (8) (“In tort litigation caused by medical acts, medical institutions shall bear the burden of proving that there is no causation between medical acts and harms, and there is no medical fault.”) (最高人民法院关于民事诉讼证据的若干规定, 法释〔2001〕33号, 最高人民法院, 第4 (8)条).

  112. 112.

    The Chief Official of the First Civil Court of the SPC 2004.

  113. 113.

    However, arguably, that also can be interpreted as leaving the exceptional approach of shifting burden of proof intact. Chinese law needs to clarify this.

  114. 114.

    The Supreme People’s Court of China 2012, Article 6; Beijing High Court 2, Rule 8.

  115. 115.

    The Supreme People’s Court of China 2012, Article 7; Beijing High Court 2, Rule 8 (both of them saying nothing about the burden of proof of causation in informed consent cases).

  116. 116.

    The Supreme People’s Court of China 2012, Article 10 (shifting the burden of proving that there is no defect and there is no causation between the defect and the damage to the medical institution and the product manufacturer; shifting the burden of proving that the blood is not substandard and there is no causation between the blood transfusion and the damage the patient suffered to the medical institution and the blood-supplying institution); Beijing High Court 2, Rule 10 (the plaintiff-patient bearing the burden of proving the defect of the product, the damage suffered and the causation between the defect and the damage; the plaintiff-patient bearing the burden of proving the blood is substandard, he has suffered damage and there is causation between the blood transfusion and the damage).

  117. 117.

    Wilsher v Essex AHA [1988] 1 All ER 871, [1988] AC 1074 (HL).

  118. 118.

    Snell v Farrell (1990) 72 DLR (4th) 289; Accident Compensation Corp v Ambros [2] 1 NZLR 340 (CA). On the one hand, the approach allows the court to draw robust inferences of causation in some cases of uncertainty. A court may draw an inference of causation even if there is no positive scientific evidence, or expert evidences are not conclusive or even conflicting. On the other hand, a court may only draw a valid inference based on facts supported by the evidence and not on the basis of supposition or conjecture. See, Accident Compensation Corp v Ambros [2] 1 NZLR 340, 358 (CA), para. [67].

  119. 119.

    Accident Compensation Corp v Ambros [2] 1 NZLR 340, 358 (CA), para. [67].

  120. 120.

    Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 102. Compare, Yang Li Xin 2, 14–15 (arguing for loosening the burden of proof for both medical negligence and causation).

  121. 121.

    See also, Xiju Zhao The new Tort Liability Law and the journey towards informed consent in China in Medical Law International Vol. 12, No. 2. I have done some updating and rewriting in this part.

  122. 122.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 26 (中华人民共和国执业医师法, 1998年, 第26条) (emphasis added).

  123. 123.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 26 (中华人民共和国执业医师法, 1998年, 第26条).

  124. 124.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 26 (中华人民共和国执业医师法, 1998年, 第26条).

  125. 125.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 37 (8) (中华人民共和国执业医师法, 1998年, 第37 (8)条). According to the Article 37, a doctor’s breach of the “practising rules” may be subjected to the following responsibilities: (1) being warned or having their medical practice suspended for a period between 6 months and 1 year by the administration departments of health; (2) for serious cases, their practising certificates being revoked; (3) for criminal offenses, criminal liabilities being investigated.

  126. 126.

    Regulation on Medical Institutions (1994, State Council) (医疗机构管理条例, 1994年, 国务院).

  127. 127.

    Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health) (医疗机构管理条例实施细则, 1994年, 卫生部).

  128. 128.

    Chapter 6 of Regulation on Medical Institutions (1994, State Council); Chapter 7 of Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health).

  129. 129.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 11 (医疗事故处理条例, 2002年, 国务院, 第11条).

  130. 130.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 11 (医疗事故处理条例, 2002年, 国务院, 第11条).

  131. 131.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 11 (医疗事故处理条例, 2002年, 国务院, 第11条).

  132. 132.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 56 (1) (“In case any of the medical institutions violates the provisions of the present Regulation by doing any of the following, it shall be ordered by the administrative department of health to make corrections; if the circumstances are serious, the person-in-charge and other people that are held to be responsible shall be given administrative punishments or disciplinary punishments: (1) Failing to truthfully inform the patient of his condition, the measures of medical treatment or medical risks…”) (医疗事故处理条例, 2002年, 国务院, 第56 (1)条).

  133. 133.

    Zheng Xue-feng, Chen Guo-qing v. Jiang Su Province People’s Hospital (Medical Service Contract) (published in Supreme People’s Court Report [2004] No. 8) (郑雪峰、陈国青诉江苏省人民医院医疗服务合同纠纷案(2004年8月10日中华人民共和国最高人民法院剬报[2004]第8期出版)).

  134. 134.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55(1)条).

  135. 135.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55(2)条).

  136. 136.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 56 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第56条). According to Chinese Family Law and Inheritance Law, “close family members” include spouses, parents, children, siblings, grandparents, and grandchildren.

  137. 137.

    It answers several concerns that raised and highlighted in a high-profile tragedy (the Xiao Zhijun (肖志军) episode). In November 2007, a pregnant woman Li Liyun (李丽云) and her baby died because a medical institution in Beijing cannot obtain the consent to operation from Xiao Zhijun, who was assumed to be Li’s husband, but later turned out to be Li’s boyfriend. It is not very clear why Xiao refused to sign the consent form. Li’s parents sued the hospital, claiming that the hospital failed to take measures to rescue the life of Li and her baby. In 2009, Beijing High People’s Court ruled in favour of the hospital, mainly on the basis that, according to the conclusion of forensic examination, there is no causation between Li’s death and the conduct of the hospital.

  138. 138.

    The Legislative Affairs Commission of the Standing Committee of the National People’s Congress 2, 231. See also, Liang Hui Xing 2, 37 (favouring to protect a patient’s right of self-determination).

  139. 139.

    See, The Supreme People’s Court of China 2012, Article 23 (clarifying that Article 56 shall apply to the following circumstances: (1) the patient is in critical condition and cannot express opinions, and the explicit opinions of the patient’s close family member cannot be obtained; (2) the patient’s condition is rapidly deteriorating, if immediate medical intervention is not taken, that will result in irreparable consequences; (3) the patient cannot express opinions, but the opinions of his close family members are not in the patient’s interest). The first (1) and (2) circumstances are “emergent”, but the third is not.

  140. 140.

    For detailed discussion, see, Ji Tao 2, 10–13.

  141. 141.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 26 (中华人民共和国执业医师法, 1998年, 第26条).

  142. 142.

    Regulation on Medical Institutions (1994, State Council), Article 33 (医疗机构管理条例, 1994年, 国务院, 第33条).

  143. 143.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 11 (医疗事故处理条例, 2002年, 国务院, 第11条).

  144. 144.

    As far as the burden of proof is concerned, I have a concern whether there are convincing reasons for distinguishing the cases of informed consent from the cases of ordinary medical negligence. See, The Supreme People’s Court of China 2012, Articles 6–7; Beijing High Court 2, Rule 8 (Both of them opine that, in medical negligence cases, the plaintiff-patient must prove the fault of the medical institution and/or professionals, the causation between the fault and the damages suffered by the patient. However, in their view, the defendant-medical institution has the burden of proving that it has exercised the duty to disclose information to the patient. But they say nothing about the burden of proof of causation in informed consent cases).

  145. 145.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 60(1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第60(1)条) (“A medical institution shall not be liable for compensation if injuries are caused to a patient under any of the following circumstances: (1) the patient or his close family members fail(s) to cooperate with the medical institution in performing diagnosis and medical treatment that conforms to diagnosis and treatment standards; (2) the medical staff have exercised reasonable duty of diagnosis and medical treatment under emergency situations such as rescuing the life of the patient who is in critical condition; (3) effective diagnosis and medical treatment is impossible at the current medical treatment level. …” (emphasis added)).

  146. 146.

    See, Chaps. 2 and 3.

  147. 147.

    See, Liang Hui Xing 2, 37–38 (interpreting that “the duty of diagnosis and treatment” is a type of “the duty of care”).

  148. 148.

    Chen Rui Xue v. China People’s Armed Police Hospital of Shanghai, People’s Court of Changning District of Shanghai (2000) Chang Min Chu Zi No. 3174; The No. 1 Intermediate People’s Court of Shanghai (2000) Hu Yi Zhong Min Zhong Zi No. 900 (Appeal) (陈瑞雪诉中国人民武装警察部队上海总队医院案 一审判决书:上海市长宁区人民法院(2000)长民初字第3174号;二审判决书:上海市第一中级人民法院(2000)沪一中民终字第900号). The case involves a doctor’s failure to inform a patient of a complication of an operation. Although the intermediate court acknowledged that the doctor was not negligent in performing the operation, the doctor was found negligent in failing to disclose the risk of the operation. The appellant court changed the trial court’s opinion that the doctor is not liable because the harm the patient suffered is an unavoidable complication of the operation and the doctor is not negligent in diagnosing and treating the patient. In the appellant court’s opinion, medical activities have two separate stages, i.e. the stage of informing a patient of a risk before operation and that of performing the operation. The appellant court relied significantly on the authentication report (medical expert opinion) in determining whether a doctor is negligent in providing services, but found the doctor in breach of the duty to inform even if the report did not touch on the issue.

  149. 149.

    The Legislative Affairs Commission of the Standing Committee of the National People’s Congress 2, 229 (introducing the Japanese notion of “medical level” as the standard of care in the context of information disclosure).

  150. 150.

    New Zealand’s Code of Patients’ Rights offers an example. See, Right 6 (1) of the Code (“Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including –

    1. (a)

      An explanation of [consumer’s] condition; and

    2. (b)

      An explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and

    3. (c)

      Advice of the estimated time within which the services will be provided; and

    4. (d)

      Notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and

    5. (e)

      Any other information required by legal, professional, ethical, and other relevant standards; and

    6. (f)

      The results of tests; and

    7. (g)

      The results of procedures.”).

  151. 151.

    Sidaway v Bethlehem Royal Hospital Governors [1985] 1 All ER 643, (1985) AC 871.

  152. 152.

    Dr Khoo James and Another v Gunapathy d/o Muniandy and another appeal [2002] 2 SLR 414; [2002] SGCA 25.

  153. 153.

    Reibl v. Hughes [1980] 2 SCR 880, (1980) 114 D.L.R . (3d) 1 (S.C .C.).

  154. 154.

    Rogers v Whitaker (1992) 175 C.L.R. 479 (HCA).

  155. 155.

    Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulation 1996, Schedule, Right 6 (2).

  156. 156.

    Foo Fio Na v Dr Soo Fook Mun and Anor [2007] 1 MLJ 593.

  157. 157.

    Tort Liability Law of People’s Republic of China (2d official discussion draft, December. 21, 2), Article 54 (中华人民共和国侵权责任法(二次审议稿), 第54条) (emphasis added).

  158. 158.

    Tort Liability Law of People’s Republic of China (2d official discussion draft, December. 21, 2), Article 54 (中华人民共和国侵权责任法(二次审议稿), 第54条).

  159. 159.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55条).

  160. 160.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55条).

  161. 161.

    The concept of “diagnosis and treatment activities” is wide-ranging. It means “any activity that, through different methods, such as examination, using medicines and medical devices, and operations, aims to diagnose illness, cure illness, alleviate illness, alleviate pain, improve functions, prolong life and help patients to restore health”. See, Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health), Article 88 (医疗机构管理条例实施细则, 1994年, 卫生部, 第88条). For definitions in other jurisdictions, See, Health Care Consent Act (Canada), 1996 S.O., c. 2, Sched. A, s. 2 (1) (“‘treatment’ means anything that is done for a therapeutic, preventive, palliative, diagnostic, cosmetic or other health-related purpose, and includes a course of treatment, plan of treatment or community treatment plan, but does not include, (a) the assessment for the purpose of this Act of a person’s capacity with respect to a treatment, admission to a care facility or a personal assistance service, the assessment for the purpose of the Substitute Decisions Act, 1992 of a person’s capacity to manage property or a person’s capacity for personal care, or the assessment of a person’s capacity for any other purpose, (b) the assessment or examination of a person to determine the general nature of the person’s condition, (c) the taking of a person’s health history, (d) the communication of an assessment or diagnosis, (e) the admission of a person to a hospital or other facility, (f) a personal assistance service, (g) a treatment that in the circumstances poses little or no risk of harm to the person, (h) anything prescribed by the regulations as not constituting treatment.”).

  162. 162.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55条).

  163. 163.

    Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health), Article 88 (医疗机构管理条例实施细则, 1994年, 卫生部, 第88条).

  164. 164.

    Beijing High Court 2, Rule 38.

  165. 165.

    The Supreme People’s Court of China 2012, Article 33 (anticipating that there are “other” circumstances where informed consent is needed for diagnosis and treatment); Beijing High Court 2, Rule 38 (envisaging that the rule of informed consent may apply to “other” diagnosis and treatment activities that may cause serious adverse consequences to patients).

  166. 166.

    See, Health Care Consent Act, 1996 S.O., c. 2, Sched. A, s. 2 (1) (“‘plan of treatment’ means a plan that, (a) is developed by one or more health practitioners, (b) deals with one or more of the health problems that a person has and may, in addition, deal with one or more of the health problems that the person is likely to have in the future given the person’s current health condition, and (c) provides for the administration to the person of various treatments or courses of treatment and may, in addition, provide for the withholding or withdrawal of treatment in light of the person’s current health condition”; “‘course of treatment’ means a series or sequence of similar treatments administered to a person over a period of time for a particular health problem”.).

  167. 167.

    Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health), Article 88 (医疗机构管理条例实施细则, 1994年, 卫生部, 第88条).

  168. 168.

    See, An Wen Jun v. The People’s Hospital of Xinjiang Uygur Autonomous Region, etc., The Urumqi Intermediate Court of Xinjiang Uygur Autonomous Region (2) Wu Zhong Min Yi Zhong Zi No. 840 (安文君诉新疆维吾尔自治区人民医院分院等医疗损害赔偿纠纷上诉案,新疆维吾尔自治区乌鲁木齐市中级人民法院民事判决书(2)乌中民一终字840号) (finding that the doctor is negligent in both selecting the proposed surgery and informing the patient of alternatives to the proposed surgery).

  169. 169.

    See, Xu Gui Shen, etc. v. Guangdong Province People’s Hospital, The Guangzhou Intermediate Court (2004) Sui Zhong Fa Min Yi Zhong Zi No. 1352 (许桂燊等与广东省人民医院医疗损害赔偿纠纷上诉案,广东省广州市中级人民法院民事判决书(2004)穗中法民一终字第1352号) (finding the defendant not negligent in selecting the mode of surgery, but negligent in failing to properly inform the patient of the economic burden of the surgery).

  170. 170.

    The Lancet 2 (admitting that Chinese doctors have a financial incentive to over-investigate and over-treat).

  171. 171.

    Code of Ethics for Human Assisted Reproductive Technologies (2001, Ministry of Health), Principle 2(2) (人类辅助生殖技术伦理原则, 2001年, 卫生部, 原则(二)(2)).

  172. 172.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (2) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55 (2)条).

  173. 173.

    In Australian context, injury means personal injury. Personal injury includes – (a) fatal injury; and (b) pre-natal injury; and (c) psychological or psychiatric injury; and (d) disease. Damages includes any form of monetary compensation. General damages means damages for – (a) pain and suffering; or (b) loss of amenities of life; or (c) loss of expectation of life; or (d) disfigurement. Personal injury damages means damages that relate to the death of or injury to a person. Harm means harm of any kind, including the following – (a) personal injury; (b) damage to property; (c) economic loss. See, Civil Liability Act 2003 (Qld), ss 51, 69, Schedule 2 Dictionary.

  174. 174.

    Beijing High Court 2, Rule 39.

  175. 175.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 2 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第2条).

  176. 176.

    Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 98 (1). Compare, Lin Wen Xue 2, 22 (arguing that the damage in the context of informed consent include physical and mental damage, but does not include the damage to the right to know).

  177. 177.

    Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 98 (2).

  178. 178.

    Project Group of “Study on Judicial Interpretation of Tort Liability Law” 2, Article 98 (3). For cases, see, Yuan Tian v. Yunnan Province No. 1 People’s Hospital, Kunming Intermediate People’s Court (2004) Kun Min Yi Chu Zi No. 80; The High People’s Court of Yunnan Province (2005) Yun Gao Min Yi Zhong Zi No. 134 (袁田诉云南省第一人民医院医疗损害赔偿案,昆明市中级人民法院(2004)昆民一初字第80号; 二审:云南省高级人民法院(2005)云高民一终字第134号) (protecting the patient’s right of being informed even though the harm the patient suffered is not the cause of the surgery concerned).

  179. 179.

    People’s Hospital of Peking University 2, 1 (emphasis added).

  180. 180.

    The Supreme Court, 3rd petty bench, 2001.11.27, 55 Minshu 1154, 1769 Hanji 56, 1079 Hanta 198.

  181. 181.

    In the USA context, the period between the 1950s and the 1970s witnessed the emergence of newer and less disfiguring alternatives to radical mastectomies. Those alternatives (such as lumpectomy and radiation therapy) were equally effective for many patients as the radical mastectomy. However, in the 1970s many surgeons routinely continued to perform radical mastectomy, often without informing their patients of the newer, less disfiguring alternatives. To break this “self-righteous silence”, laws guaranteeing breast cancer patients access to complete information about treatment alternatives had been enacted in many states of USA. See, Joan H. Krause 1999, 379.

  182. 182.

    Xia Yun 2007, 376, footnote 2.

  183. 183.

    Xia Yun 2007, 376, footnote 2.

  184. 184.

    Xia Yun 2007, 375, footnote 2.

  185. 185.

    Medical malpractice legal proceedings are costly and time-consuming. A Chinese survey showed that 73.3% hospitals surveyed attach importance to the hospital reputation. 9.5% care a lot about their energy and time involved in dealing with medical accident lawsuits. Only 4.8% of them attach value to economic compensation. See, Fu Zi Tang et al. 2006, 12.

  186. 186.

    The New Rural Co-operative Medical Care System (NRCMCS) is a new 2005 initiative to overhaul the healthcare system, particularly intended to make it more affordable for the rural poor.

  187. 187.

    In 2000, rural residents made up two-thirds of the population, but their health expenditures accounted for only 22.5% of the nation’s total. In 2000, the life expectancy for a person living in Shanghai compared to a person living in Guizhou was 13.5 years higher, equivalent to the life expectancy gap between individuals in the developed nations and the most underdeveloped countries in the world. See, Ho 2, 38–39.

  188. 188.

    In 2007, the average visits per annum that every Western medicine practitioner and TCM practitioner received is 1,508.48 and 1,623.11 respectively.

  189. 189.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 63 (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第63条).

  190. 190.

    WHO (2001), Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review, p 2.

  191. 191.

    In TCM, there is a fine balance between the two opposing but interrelated and inseparable forces of nature, Yin and Yang. Yin has been described as those aspects of cold, slow, passive, dark, and female, whereas Yang is hot, excited, active, light, and male. Health is maintained by achieving and then maintaining the balance between these opposing forces. Disease is the result of imbalance, and imbalance results from a blockage of vital energy (Qi) that flows throughout the body along well-defined channels called meridians.

  192. 192.

    Yu Yunxiu, a senior officer in the Nationalist government, was a leading advocate for abolishing TCM in China. In his eyes, traditional Chinese medicine is nothing more than accumulation of experiences, without explicit, solid and convincible laboratory evidence. See, He Xian Zhong 2004, 72–76.

  193. 193.

    Soon after the establishment of the People’s Republic of China in 1949, Mao Zedong, the charismatic leader of the government, called for solidarity between traditional Chinese medical physicians and modern scientific medical physicians. In 1953, noticing that many intellectuals and local officials disregarded traditional Chinese medicine, Mao commented that both traditional Chinese medicine and modern scientific medicine included good and bad parts and that what had to be done was to inherit the good parts from each. In 1954, Mao emphasized that “it is more important for the modern Western medical physician to learn from the traditional Chinese medical physician than the other way around” because traditional Chinese medicine had accumulated enormous effective experiences in the thousands of years of its practice. In 1955, the Ministry of Health arranged a special delegation of 76 Western medical physicians to learn traditional Chinese medicine from a group of experts in Beijing for two and a half years. Many local cities followed this example and organized similar reeducation programs for the modern Western medical physicians. See, Fan Ruiping “Modern Western Science as A Standard for Traditional Chinese Medicine: A Critical Appraisal” (2003) 31 Journal of Law, Medicine & Ethics 213, 217. These people (Western medicine doctors who systematically learned TCM) are called “Xi Xue Zhong” (“西学中”) and many of them have become leading integrative medicine doctors. This idea has been diluted since Mao’s death. Western medicine doctors are no longer pushed to learn and practice traditional Chinese medicine.

  194. 194.

    Art. 21, Constitution of People’s Republic of China 1982, as amended (stipulating that “the state develops both modern medicine and traditional Chinese medicine”).

  195. 195.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 3 (中华人民共和国中医药条例, 2003年, 第3条).

  196. 196.

    World Health Organization WHO Traditional Medicine Strategy 2002–2005 (Geneva: WHO, 2002): at 8–9, http://www.who.int/medicines/library/trm/trm_strat_eng.pdf (accessed 20 July 2006).

  197. 197.

    World Health Organization Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review 2001.

  198. 198.

    Actually they are required by law to administer “double diagnosis”, although “double diagnosis” is not easy to be done for every patient. See, Stipulations on Many Issues Surrounding Running Traditional Chinese Medicine Hospitals (1980, Ministry of Health), Article 5 (中医医院工作若干问题的规定(试行), 1980年, 卫生部,第5条).

  199. 199.

    One is to attempt to discover effective chemical ingredients in Chinese medicinal herbs in order to explain their clinical effects. The other is to disclose anatomically observable “lines” behind the channel (jing-luo) system of Chinese medicine so as to offer a scientific explanation for the function of acupuncture. See, Ruiping 2003, 218.

  200. 200.

    For example, the herb qing hao su (青蒿素) has been used in China for treating fever for over 2,000 years. In 1971 it was found to have specific antimalarial activity and the active compound artemesin was isolated. In clinical trials, parasite clearance times were shorter than with chloroquine, symptoms responded more rapidly, and there was no serious toxicity. Qing hao su has now become a first line drug for malaria in many parts of Asia. See, Hesketh and Wei Xing Zhu 1997, 117.

  201. 201.

    Fan Ruiping 2003, 218 (revealing that, although much labor and energy were invested in the hope of finding a physical basis for “jing-luo” (channel) system in Chinese medicine, all was done in vain).

  202. 202.

    Fan Ruiping 2003, 218–219 (proposing a dual standard medical integration).

  203. 203.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) (中华人民共和国执业医师法, 1998年,全国人大常委会).

  204. 204.

    Regulation on Medical Institutions (1994, State Council)(医疗机构管理条例, 1994年, 国务院).

  205. 205.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) (中华人民共和国药品管理法,2001年,全国人大常委会).

  206. 206.

    The Regulation on the Handling of Medical Accidents (2002, State Council) (医疗事故处理条例, 2002年, 国务院).

  207. 207.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC) (中华人民共和国侵权责任法, 2009年, 全国人大常委会).

  208. 208.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) Article 8 (中华人民共和国执业医师法, 1998年,全国人大常委会, 第8条).

  209. 209.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) Article 9 (1) (中华人民共和国执业医师法, 1998年,全国人大常委会, 第9 (1)条). Two other circumstances under which a person can take the examination are: (1) after obtaining the certificate for assistant practising doctors and degrees from 3-year colleges, he has worked for 2 years or more at a health care institution; (2) he has a medical degree from a technical secondary school and has worked for 5 or more years at a health care institution.

  210. 210.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) Article 10 (中华人民共和国执业医师法, 1998年,全国人大常委会, 第10条) (“Those who have medical degrees from 3-year medical colleges or technical secondary schools can take examination of assistant practising doctors’ qualifications after a probation period of 1 year or more under guidance from practising doctors at institutions for medical treatment, disease prevention or health care.”).

  211. 211.

    Law on Practising Doctors of the People’s Republic of China (1998, Standing Committee of the National People’s Congress) Article 11 (中华人民共和国执业医师法, 1998年,全国人大常委会, 第11条).

  212. 212.

    Regulation on Medical Institutions (1994, State Council)(医疗机构管理条例, 1994年, 国务院).

  213. 213.

    Implementing Measures for Regulation on Medical Institutions (1994, Ministry of Health) Article 3 (医疗机构管理条例实施细则, 1994年, 卫生部, 第3条).

  214. 214.

    Regulation on Medical Institutions (1994, State Council) Articles 24–39(医疗机构管理条例, 1994年, 国务院, 第24-39条); Implementing Measures for Regulation on Medical Institutions (1994, Ministry of Health) Articles 51–65 (医疗机构管理条例实施细则, 1994年, 卫生部, 第51-65条).

  215. 215.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) (中华人民共和国药品管理法,2001年,全国人大常委会).

  216. 216.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 102 (中华人民共和国药品管理法,2001年,全国人大常委会, 第102条).

  217. 217.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 102 (中华人民共和国药品管理法,2001年,全国人大常委会, 第102条).

  218. 218.

    Good Laboratory Practice for Pharmaceuticals (2003, State Food and Drug Administration) (药物非临床研究质量管理规范, 2003年, 国家食品药品监督管理局).

  219. 219.

    Good Clinical Practice for Pharmaceuticals (2003, State Food and Drug Administration) (药物临床试验质量管理规范, 2003年, 国家食品药品监督管理局).

  220. 220.

    Good Manufacture Practice for Pharmaceuticals (l999, State Food and Drug Administration) (药品生产质量管理规范, 1999年, 国家食品药品监督管理局).

  221. 221.

    Good Supply Practice for Pharmaceuticals (2000, State Food and Drug Administration) (药品经营质量管理规范, 2000年, 国家食品药品监督管理局).

  222. 222.

    Good Manufacture Practice for Chinese traditional medicinal materials (2002, State Food and Drug Administration) (中药材生产质量管理规范(试行)(GAP), 2002年, 国家食品药品监督管理局).

  223. 223.

    Management Measures on Prescription Drug and OTC Drug Classification (1999, State Food and Drug Administration) (处方药与非处方药分类管理办法(试行), 1999年, 国家药品监督管理局).

  224. 224.

    Management Measures on Reporting and Surveillance of Drug Adverse Reactions (2004, State Food and Drug Administration) (药品不良反应报告和监测管理办法, 2004年, 卫生部、国家食品药品监督管理局).

  225. 225.

    Stipulations on Drug Information Disclosure Booklet and Leaflet (2006, State Food and Drug Administration) (药品说明书和标签管理规定, 2006年, 国家食品药品监督管理局).

  226. 226.

    Measures on Approving New Pharmaceuticals (1999, State Drug Administration) Article 6 (新药审批办法, 1999年, 国家药品监督管理局, 第6条).

  227. 227.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 3 (中华人民共和国药品管理法,2001年,全国人大常委会, 第3条). Also see, Regulations on the Management of Protection of Resources of Wild Medicinal Materials (1987, State Drug Administration) (野生药材资源保护管理条例, 1987年, 国家医药管理局).

  228. 228.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 103 (中华人民共和国药品管理法,2001年,全国人大常委会, 第103条).

  229. 229.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 10 (中华人民共和国药品管理法,2001年,全国人大常委会, 第10条).

  230. 230.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 19 (中华人民共和国药品管理法,2001年,全国人大常委会, 第19条).

  231. 231.

    Law of the People’s Republic of China on Pharmaceutical Administration (2001, The Standing Committee of the National People’s Congress) Article 36 (中华人民共和国药品管理法,2001年,全国人大常委会, 第36条); Regulations on the Protection of Varieties of the Traditional Chinese Medicines (1992, State Council) (中药品种保护条例, 1992年, 国务院).

  232. 232.

    Stipulations on Many Issues Surrounding Running Traditional Chinese Medicine Hospitals (1980, Ministry of Health), Article 5 (中医医院工作若干问题的规定(试行), 1980年, 卫生部,第5条).

  233. 233.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 11 (中华人民共和国中医药条例, 2003年, 第11条).

  234. 234.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Articles 16–19 (中华人民共和国中医药条例, 2003年, 第16-19条).

  235. 235.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 12 (中华人民共和国中医药条例, 2003年, 第12条).

  236. 236.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 30 (中华人民共和国中医药条例, 2003年, 第30条). However, complaints have been made by TCM orthopaedists and osteopaths, claiming that experts who authenticate “medical accident” in their field are dominated by Western medicine experts. That will place them in disadvantage because TCM and Western medicine differ on theories and practices of orthopaedics and osteopathy. See, Zhang Yong Chao 2005, 36–41.

  237. 237.

    Beijing TCM Regulation (2001, Beijing), Article 30 (北京市发展中医条例, 2001年, 第30条).

  238. 238.

    Shandong Province TCM Regulation (1999, Shandong Province), Article 33 (山东省中医条例, 1999年, 第33条).

  239. 239.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 4, 9 and 22 (中华人民共和国中医药条例, 2003年, 第4, 9, 22条).

  240. 240.

    Law on Practising Doctors of the People’s Republic of China (1998), Article 26 (中华人民共和国执业医师法, 1998年, 第26条).

  241. 241.

    Rules for Implementing the Regulation on Medical Institutions (1994, Ministry of Health) Article 62 (医疗机构管理条例实施细则, 1994年, 卫生部, 第62条).

  242. 242.

    The Regulation on the Handling of Medical Accidents (2002, State Council), Article 11 (医疗事故处理条例, 2002年, 国务院, 第11条).

  243. 243.

    Tort Liability Law of People’s Republic of China (2009, Standing Committee of NPC), Article 55 (1) (中华人民共和国侵权责任法, 2009年, 全国人大常委会, 第55(1)条).

  244. 244.

    Chinese law is committed to protect “business secrets”. “Business secrets” is defined as “the technical information and operational information which is not known to the public, which is capable of bringing economic benefits to the owners of the rights, which has practical applicability and which the owners of the rights have taken measures to keep secret”. See, Law of the People’s Republic of China for Countering Unfair Competition (1993, Standing Committee of NPC), Article 10 (中华人民共和国反不正当竞争法, 1993年, 全国人大常委会, 第10条).

  245. 245.

    Regulation on Traditional Chinese Medicine of People’s Republic of China (2003, State Council), Article 12 (中华人民共和国中医药条例, 2003年, 第12条).

References

  • Beijing High Court. 2. The guiding rules about how to adjudicate cases of liability for medical damage (November 18, 2, Jing Gao Fa Fa [2] No. 400). http://lawyer.fabao365.com/21692/article_101666. Accessed 20 Apr 2012 (北京市高级人民法院关于审理医疗损害赔偿纠纷案件若干问题的指导意见(试行)(2年11月18日,京高法发[2]第400号).

  • Chen, Hua. 2009. A reflection on informed consent from the different perspectives of Chinese and western cultures. Medicine and Philosophy (Humanistic & Social Medicine Edition) 30: 17–19 (陈化: “从中西文化差异审视知情同意”, 载《医学与哲学(人文社会医学版)》2009 年第7 期, 第17-19页).

    Google Scholar 

  • Chen, Zhihua. 2. Liability for medical damage: Comments and cases. Beijing: Law Press (陈志华:《医疗损害责任深度释解与实务指南》,法律出版社2年版).

    Google Scholar 

  • Chen, Ke Ji, and Yue Rong Jiang. 2009. Current status and problems in developing clinical guidelines for Chinese medicine and integrative medicine. Journal of Chinese Integrative Medicine 7: 301–305 (陈可冀, 蒋跃绒: “中医和中西医结合临床指南制定的现状与问题”, 载《中西医结合学报》第7卷2009年第4期,第302-305页).

    Article  Google Scholar 

  • Dai, Qingkang. 2003. Informed consent in China: Status Quo and its future. Medical Law International 6: 53–71.

    Article  Google Scholar 

  • Devereux, J.A. 2007. Australian medical Law, 3rd ed. London/New York: Routledge-Cavendish.

    Google Scholar 

  • Fan, Ruiping. 2003. Modern western science as a standard for traditional Chinese medicine: A critical appraisal. The Journal of Law, Medicine & Ethics 31: 213–221.

    Article  Google Scholar 

  • Fu, Zi Tang, et al. 2006. Empirical analysis on adjudication of medical lawsuits. Beijing: People’s Court Press (付子堂 等著:《医疗纠纷案件审理之实证分析》, 人民法院出版社2006年版).

    Google Scholar 

  • Gao, Shengping. 2. China’s Tort Liability Law: Issues, statutory provisions in other jurisdictions and leading cases. Beijing: Peking University Press (高圣平:《〈中华人民共和国侵权责任法〉立法争点、立法例及经典案例》,北京大学出版社2年版).

    Google Scholar 

  • Harris, Dean M., and Wu Chien-Chang. 2005. Medical malpractice in the People’s Republic of China: The 2002 regulation on the handling of medical accidents. The Journal of Law, Medicine & Ethics 33: 456–477.

    Article  Google Scholar 

  • He, Xian Zhong. 2004. Leader of abolishing TCM: Yu Yun Xiu and his conducts. Nature Dialectics 26: 72–76 (郝先中: “废止中医派的领袖——余云岫其人其事”,载《自然辩证法通讯》第26卷2004年第6期,第72-76页).

    Google Scholar 

  • Hesketh, Therese, and Wei Xing Zhu. 1997. Health in China: Traditional Chinese medicine: One country, two systems. British Medical Journal 315: 115–117.

    Article  Google Scholar 

  • Ho, Christina S. 2. Health reform and de facto federalism in China. China: An International Journal 8: 33–62.

    Google Scholar 

  • Huang, Sheng-Li, and Xiao-Yan Ding. 2011. Violence against Chinese health-care workers. The Lancet 377: 1747.

    Article  Google Scholar 

  • Ji, Tao. 2. Who exercises the right of informed consent in the therapeutic context? Zhe Jiang Social Science 2: 10–13 (季涛: “谁是医疗关系中知情同意权的主体?”, 载《浙江社会科学》2年第2期, 第10-13页).

    Google Scholar 

  • Jiang, Chun Ling. 2006. On the patient’s right to informed consent: Cases survey and thinking. Nanjing University Law Review (Autumn) 113 (姜春玲: “论患者的知情同意权 ——判例调查基础上的理论与立法检讨”, 载《南京大学法律评论》2006年秋季号, 第113页).

    Google Scholar 

  • Krause, Joan H. 1999. Reconceptualizing informed consent in an era of health care cost containment. Iowa Law Review 85: 261–386.

    Google Scholar 

  • Lachlan, Mc.Murtrie. 2006. Setting the legal standard of care for treatment and evidence-based medicine: A case study of antenatal corticosteroids. Journal of Law and Medicine 14: 220–227.

    Google Scholar 

  • Lei, Yi, and Ming Wu. 2. Survey on medical staffs’ perception of the doctor-patient relationship: A case study of a public hospital in Beijing. Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease 18: 1055–1057 (雷祎,吴明: “北京市某三甲医院医务人员对医患关系的认知及其影响因素研究”,载《实用心脑肺血管病杂志》2年第8期,第1055-1057页).

    Google Scholar 

  • Li, Xiao Yun. 2. Analysis of reasons for choosing caesarean section and responding measures. Contemporary Medicine 16: 103–104 (李晓芸: “社会性因素剖宫产术原因分析及预防对策”, 载《当代医学》2年第9期, 第103-104页).

    Google Scholar 

  • Li, Jian Sheng, and Xue Qing Yu. 2. Current situation and thinking on the development of TCM clinical treatment guidelines. CJTCMP 25: 647–650 (李建生,余学庆: “中医临床治疗指南制定的现状与思考”, 载《中华中医药杂志》第25卷2年第5期, 第647-650页).

    Google Scholar 

  • Liang, Hui Xing. 2. On the “medical damage liability” of the Tort Liability Law. Studies in Law and Business 6: 35–37 (梁慧星: “论《侵权责任法》中的医疗损害责任”, 载《法商研究》2年第6期, 第35-37页).

    Google Scholar 

  • Liao, Huan Guo. 2. How to establish medical fault: Understanding and applying medical damage liability law. Politics and Law 5: 18–27 (廖焕国: “论医疗过错的认定———以医疗损害侵权责任的理解与适用为视点”, 载《政治与法律》2年第5期, 第18-27页).

    Google Scholar 

  • Liao, Tian Ming, et al. 2. Survey and reflections on medical authentication in medical malpractice cases. Journal of He Tian Normal College 2: 2–3 (廖天明等: “医疗损害赔偿案件中医疗鉴定问题的调研思考”, 载《和田师范专科学校学报》(汉文综合版)2年第2期, 第2-3页).

    Google Scholar 

  • Lin, Wen Xue. 2. Exploration of some issues regarding medical damage liability of ‘Tort Liability Law’. Journal of Law Application 7: 21–24 (林文学:“《侵权责任法》医疗损害责任规定若干问题探析”,载《法律适用》2年第7期,第21-24页).

    Google Scholar 

  • Liu, Xue Ying, Yue Ning Deng, and Zhong Jian Li. 2. Investigation and analysis of violation of doctors’ rights in five cities and An-san, Tie-ling of Liao Xi. Chinese Medical Ethics 21: 87–89 (刘雪莹,邓悦宁,李中建: “辽西五市和鞍山铁岭两市医生遭遇侵权现状的调查与分析”, 载《中国医学伦理学》2年第4期,第87-89页).

    Google Scholar 

  • Ministry of Health (People’s Republic of China). 2. Letter regarding recommended “medical informed consent forms”. http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3586/203/46248.htm. Accessed 2 Oct 2 (卫生部医政司: “关于推荐使用《医疗知情同意书》的函(卫医政疗便函〔2〕42号)”).

  • Montgomery, Jonathan. 2003. Health care law, 2nd ed. New York: Oxford University Press.

    Google Scholar 

  • Nie, Jing Bao. 2002. Is informed consent not applicable in China? Intellectual flaws of the “cultural difference argument”. Medicine and Philosophy 23: 18–22 (聂精保: “知情同意在中国不适用吗———“文化差异论”的认知错误”, 载《医学与哲学》2002年第6期,第18-22页).

    Google Scholar 

  • People’s Hospital of Peking University. 2. Compilation of medical informed consent forms. http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3586/203/46248.htm. Accessed 2 Oct 2 (北京大学人民医院: “医疗知情同意书汇编”).

  • Project Group of “Study on Judicial Interpretation of Tort Liability Law”. 2. Suggestion and discussion draft of judicial interpretation of Tort Liability Law of People’s Republic of China. http://www.civillaw.com.cn/article/default.asp?id=49876. Accessed 12 July 2 (中国人民大学民商事法律科学研究中心“侵权责任法司法解释研究”课题组:“中华人民共和国侵权责任法司法解释草案建议稿(草案)”).

  • Qian, Hua. 2. The difficulty of combining TCM and Western medicine and solutions. Chinese Journal of Information on TCM 15: 1–2 (钱 华: “中西医结合的难点和方法思考”, 载《中国中医药信息杂志》第15卷2年第2期, 第1-2页).

    Google Scholar 

  • State Council. 2012. Plans and implementing measures on deepening the health care system reform in the period of “twelve five year” (Guo Fa (2012) No. 11, March 14, 2012). http://www.gov.cn/zwgk/2012-03/21/content_2096671.htm. Accessed 4 May 2012 (“十二五”期间深化医药卫生体制改革规划暨实施方案 (国务院, 国发〔2012〕11号, 2012年3月14日)).

  • Su, Yin Li, and Le Zhi Li. 2. Progress research on attitudes to the patient’s right of informed consent among the patients, their relatives and medical staffs. Medicine and Philosophy (Humanistic & Social Medicine Edition) 29: 28–29 (苏银利,李乐之:“医患不同角色群体对患者知情同意权的态度研究进展”,载《医学与哲学(人文社会医学版)》2年第29卷第3期, 第28-29页).

    Google Scholar 

  • Sun, Ze Ting, et al. 2006. The present situation of and thinking on combining traditional Chinese medicine and western medicine. Medicine and Philosophy 27: 77–79 (孙泽庭,聂正怀,邓崇平: “中西医结合的现状与思考”, 载《医学与哲学》第27 卷2006年第3期, 第77-79页).

    Google Scholar 

  • Tai, Michael Cheng-tek, and Tsung-po Tsai. 2003. Who makes the decision? Patient’s autonomy vs paternalism in a confucian society. Croatian Medical Journal 44: 558–561.

    Google Scholar 

  • The Chief Official of the First Civil Court of the SPC. 2004. Answers by to Reporters’ questions on how to apply laws in adjudicating medical lawsuits. http://www.cmda.gov.cn/yishiweiquan/weiquanzhishi/2009-02-25/5311.html. Accessed 19 Sept 2. (最高人民法院民一庭负责人就审理医疗纠纷案件的法律适用问题答记者问).

  • The Lancet. 2. Chinese doctors are under threat. The Lancet 376: 657.

    Article  Google Scholar 

  • The Lancet. 2012. Ending violence against doctors in China. The Lancet 379: 1764.

    Google Scholar 

  • The Legislative Affairs Commission of the Standing Committee of the National People’s Congress. 2. Explanations about the Tort Liability Law of People’s Republic of China. Beijing: Peking University Press (全国人大常委会法制工作委员会民法室:《〈中华人民共和国侵权责任法〉条文说明、立法理由及相关规定》,北京大学出版社2年版).

    Google Scholar 

  • The Supreme People’s Court of China. 2012. Interpretation on how to apply laws in adjudicating cases of liability for medical damage (Discussion Paper). http://www.ahyllaw.com/display.asp?id=1238. Accessed 20 Apr 2012 (最高院关于审理医疗损害责任纠纷案件适用法律若干问题的解释(征求意见稿)).

  • Wang, Yue. 2. Exploration on issues regarding medical damage compensation. Chinese Journal of Forensic Sciences 2: 34–37 (王岳: “对医疗损害责任相关问题的探讨”, 载《中国司法鉴定》2 年第2 期, 第34-37页).

    Google Scholar 

  • Wang, Yi Feng, and Yi Ping Xu. 2009. Survey on implementation of the informed consent rule in hospitals. Hospital Administration Journal of Chinese People’s Liberation Army 16: 52–54 (王译锋,徐懿萍: “医院实施知情同意调查”, 载《解放军医院管理杂志》2009年第1期,第52-54页).

    Google Scholar 

  • Wen, Xiang. 2004. The traditional Chinese medicine regulation by Nanjing Guo Min Government. Min Guo Dang An 4: 82–86 (文 庠: “南京国民政府《中医条例》述评”, 载《民国档案》2004年第4期, 第82-86页).

    Google Scholar 

  • Wen, Chao Ying, Xiu Hua Pi, and Wen Zhong Dong. 2007. The reasons for disharmony of doctor – patient relationship. Medicine and Philosophy (Humanistic & Social Medicine Edition) 28: 24–26 (温超英、皮秀华、董文忠:“医患关系不和谐的原因”,载《医学与哲学》2007年第5期,第24-26页).

    Google Scholar 

  • Wu, Xi, et al. 2. Characteristics of “acupuncture clinical practice guidelines” and their implementing principles and methods. Guiding Journal of Traditional Chinese Medicine and Pharmacy 16: 1–4 (吴曦 等: “‘针灸临床实践指南’的特点及制定的原则与方法探讨”, 载《中医药导报》2年第16卷第6期, 第1-4页).

    Google Scholar 

  • Xia, Yun. 2007. Medical malpractice law: Reflections on Japanese law. Beijing: Law Press (夏芸著:《医疗事故赔偿法——来自日本法的启示》,法律出版社2007年版).

    Google Scholar 

  • Xia, Yun. 2009. Japanese reform of medical malpractice lawsuits and evaluation of appraisal conclusions. Evidence Science 17: 261–282 (夏芸:“日本医疗诉讼改革及对鉴定结论的评价”,载《证据科学》2009年第17卷第3期,第261-282页).

    Google Scholar 

  • Xia, Yun. 2011. Rethinking the theory of “medical level” and the test for medical negligence. Oriental Law 5: 29–40 (夏芸:“再考 ‘医疗水平论’及医疗过失判断标准”,载《东方法学》2011年第5期,第29-40页).

    Google Scholar 

  • Xu, Xin, and Rong Rong Lu. 2. Violence and mistrust: Research on violence in medical treatment in transforming China (2000∼2006). Law and Social Development 1: 82–101 (徐昕、卢荣荣: “暴力与不信任———转型中国的医疗暴力研究: 2000∼2006”, 载《法制与社会发展》2年第1期,第82-101页).

    Google Scholar 

  • Yang, Li Xin. 2009a. Study on the concept of medical damage liability. Politics and Law 3: 75–82 (杨立新: “医疗损害责任概念研究”, 载《政治与法律》2009 年第3 期, 第 75-82页).

    Google Scholar 

  • Yang, Li Xin. 2009b. On the principle and system of imputation for medical damage liability. Journal of China University of Political Science and Law 10: 62–72 (杨立新: “论医疗损害责任的归责原则及体系”, 载《中国政法大学学报》2009 年第2 期, 第62-72页).

    Google Scholar 

  • Yang, Li Xin. 2009c. Proof and burden of proof of medical negligence. Journal of Law 6: 1–6 (杨立新: “论医疗过失的证明及举证责任”, 载《法学杂志》2009年第6期, 第1-6页).

    Google Scholar 

  • Yang, Li Xin. 2. The reform of liability for damages caused by medical treatment in the Tort Liability Law: Its success and shortage. Journal of Renmin University of China 4: 9–16 (杨立新: “《侵权责任法》改革医疗损害责任制度的成功与不足”, 载《中国人民大学学报》 2年第4期, 第9-16页).

    Google Scholar 

  • Yang, Li Xin, and Ling Fang Wang. 2007. TCM practitioners’ duty to inform and liability for breach of the duty. Journal of Gansu Institute of Political Science and Law 95: 13–16 (杨立新,王玲芳: “试论中医师的告知义务及违反告知义务的责任”, 载《甘肃政法学院学报》总第95期, 第13-16页).

    Google Scholar 

  • Yang, Hui, et al. 2003. Why are doctors not happy? Hospital Management Forum 2: 18–20 (杨辉 等:“医生为什么不满意?”,载《医院管理论坛》2003年第2期,第18-20页).

    Google Scholar 

  • Yang, Yi, et al. 2. Facing up to the threat in China. The Lancet 376: 1823–1824.

    Article  Google Scholar 

  • Yu, Lei. 2. Thought on the application of informed consent in traditional Chinese medicine clinical diagnosis and treatment. Medicine and Philosophy (Humanistic & Social Medicine Edition) 29: 30–31 (俞蕾: “知情同意在中医药临床诊疗中的应用思考”,载《医学与哲学(人文社会医学版)》 2年第29卷第3期,第30-31页).

    Google Scholar 

  • Yu, Mingshui. 2. Litigation for compensation for medical damage. Beijing: Law Press (余明永:《医疗损害赔偿纠纷》,法律出版社2年版).

    Google Scholar 

  • Zhang, Yong Chao. 2005. Embarrassment in authenticating TCM orthopaedics and osteopathy medical accidents. Ji Yuan Ling Dao Jue Ce Can Kao 6: 36–41 (张永超: “中医正骨医疗事故鉴定的尴尬”, 载《医院领导决策参考》2005年第6期, 第36-41页).

    Google Scholar 

  • Zhang, Ao Hui, and Yu Zheng Dong. 2. Analysis on the reasons for difficulties in enforcing informed consent. Chinese Medical Ethics 23: 30–31 (张奥会,董玉整: “患者知情同意落实难问题之原因分析”, 载《中国医学伦理学》2年第2期, 第30-31页).

    Google Scholar 

  • Zhang, Gui Qing, and Jin Li Han. 2. Comparison of the preoperative psychological condition of the patients who made informed consent themselves and those whose family members did instead. Chinese Mental Health Journal 22: 383–386 (张桂青,韩金丽: “本人知情同意与家属知情同意情况下患者术前心理状况的比较”, 载《中国心理卫生杂志》2年第5期, 第383-386页).

    Google Scholar 

  • Zhang, Ying Tao, and Fu Chuan Sun. 2004. Localization of informed consent in China: The trend of informed consent in the context of Chinese culture. Medicine and Philosophy 25: 12–15 (张英涛,孙福川: “论知情同意的中国本土化———中国文化视野中的知情同意走向”,载《医学与哲学》2004年第25卷第9期, 第12-15页).

    Google Scholar 

  • Zhao, Xiju. 2. Study on medical law. Beijing: Law Press (赵西巨著:《医事法研究》,法律出版社2年版).

    Google Scholar 

  • Zhao, Xiju. 2009. Adoption and disclosure of emerging therapies. Oriental Law 6: 119–133 (赵西巨: “医生对新疗法的使用与告知”,载《东方法学》2009年第6期,第119-133页).

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2012 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Zhao, X. (2012). Chinese Context. In: The Duty of Medical Practitioners and CAM/TCM Practitioners to Inform Competent Adult Patients about Alternatives. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-31647-0_10

Download citation

Publish with us

Policies and ethics