Otago Law Review
|
|
Home
| Databases
| WorldLII
| Search
| Feedback
Otago Law Review |
|
Last Updated: 16 November 2022
No-Fault Compensation for Medical Injuries: The Case of China
77
No-Fault Compensation for Medical Injuries: The Case of China
Ding Chunyan*
A global debate about the merits of a no-fault system alternative to tort law for compensating victims of medical injuries started in the early 1970s.1 Since then, a number of jurisdictions have established no-fault schemes and developed three major no-fault scheme models for medical injuries. The first model is a stand-alone, comprehensive no-fault compensation scheme that acts as an alternative to civil litigation, which is exemplified by New Zealand’s no-fault scheme (1974).2 The second model is a no-fault scheme for medical injuries that co-exists with civil litigation, such as the Nordic no-fault compensation schemes for medical injury in operation in Sweden (1975), Finland (1987), Denmark (1988) and Norway (1992).3 When the Scottish government recently considered the potential benefits of a no-fault compensation scheme for clinical negligence, its working group proposed a no-fault scheme along the lines of this second model for public consultation.4 The third model is a more limited no-fault scheme for compensating a certain type of medical injury. For example, in the United States of America, Virginia (1987) and Florida (1988) have adopted no-fault compensation schemes for birth- related neurological injuries.5There are great controversies about the costs and benefits of a no- fault scheme (and in particular the first model).6 Despite this, many
* Associate Professor, School of Law, City University of Hong Kong.
LR 1169.
Compensation in Scotland for injuries resulting from clinical treatment Consultation Report, 4 April 2014) www.gov.scot/publications/ consultation-report-consultation-recommendations-fault-compensation- scotland-injuries-resulting-clinical-treatment/>.
jurisdictions have chosen to introduce the third model of a no-fault scheme for medical injuries due to its flexibility and reduced impact on tort law and civil litigation.7 Little academic attention has been paid to the situation in China on this issue, namely whether any no-fault schemes exist, if so, how they operate, and their unique features and problems. This article aims to fill the gap by focusing on two no-fault schemes for compensating medical injuries currently operating in China: one compensates for no-fault clinical injuries, and the other compensates for no-fault adverse events attributed to vaccination (vaccination adverse events). Although these two schemes sound like the second model and the third model of no-fault scheme as described above, this article finds that neither of them is a genuine no-fault scheme because they have not removed the requirement of fault. Instead, the two schemes require victims to prove that their medical injury was “not caused by fault”. This requirement substantially reduces the merits of the no-fault system, causes additional obstacles to victims in seeking no-fault compensation, and limits accessibility to the no-fault system. The article suggests that the Chinese Government should establish a genuine no-fault scheme for compensating victims of vaccination adverse events to replace the existing one, although it remains open for discussion whether the current no-fault scheme for medical injuries should continue or be extended.
This article is divided into six parts. Part II briefly reviews tort liability for medical injuries under Chinese law in order to provide a backdrop for the discussion on no-fault compensation for medical injuries. Part III examines the compensation scheme for no-fault clinical injuries and Part IV examines no-fault vaccination adverse events in terms of the managing body and sources of funds, the eligibility criteria and the compensation criteria. Part V analyses the unique features and the practical problems of Chinese no-fault schemes for compensating medical injuries in the light of the no-fault system adopted in other jurisdictions. Part VI concludes with a summary and suggestions.
II Tort Liability for Medical Injuries under Chinese Law
The Chinese Tort Liability Law (“TLL”)8 establishes a basic legal framework of tort law. Article 6 of the TLL sets out a general fault principle for tort liability, with an exception of statutory strict liability recognised by art 7 of the TLL. Regarding tort liability for medical injuries, two provisions are most relevant: Articles 54 and 59, both being in Chapter Seven of the TLL (titled “Liability for medical injuries”):
Article 54 Where a patient sustains any harm during diagnosis and treatment due to the fault of the medical institution or any of its medical staff, the medical institution shall incur compensatory liability.
Article 59 Where any harm to a patient is caused by a defect in any drug, medical disinfectant or medical device or by the transfusion of substandard blood, the patient may seek compensation from the manufacturer or the institution providing the blood, or seek compensation from the medical institution. If the patient seeks compensation from the medical institution, the medical institution that has paid the compensation shall have recourse
against the liable manufacturer or institution providing the blood.
Specifically, art 54 of the TLL establishes fault-based institutional tort liability for clinical injuries. It is supplemented by art 58 of the TLL, which recognises “presumed fault” where the medical institution is proved to have: violated a law, administrative regulation or rule or any other provision on the procedures and standards for diagnosis and treatment; or concealed or refused to provide the medical history data related to a dispute; or forged, tampered with or destroyed any medical history data. Article 59 of the TLL lays down joint and several strict liability for medical product-related injuries (eg caused by drug, vaccine, medical disinfectant, medical device and blood products). The manufacturer and the medical institution using the medical products are jointly liable for such medical injuries.9 Moreover, as art 23 of the Interpretation of the Supreme People’s Court on Issues concerning the Application of Law in Determining Liability for Medical Injury Cases10 provides, the victim is entitled to punitive damages twice the amount of awarded compensatory damages, when the manufacturer knowingly manufactures defective medical products that cause the victim to die or suffer serious personal injuries.11To sum up, victims of clinical injuries must prove the fault of the medical institution, the injury and the causation between the fault and the injury in order to successfully claim compensation under tort law. Despite a strict liability for medical product-related injuries, victims still need to prove the defect of the medical product, the injury and the causation between the defect and the injury. Once tort liability for medical injury is established, victims are able to claim compensation according to the criteria set out in the Interpretations of the Supreme People’s Court
concerning Issues in Determining Compensation for Personal Injury Cases.12 Both pecuniary and non-pecuniary damages are recoverable.
III Compensation Scheme for No-Fault Medical Injuries
National law only provides victims of clinical injuries with tortious remedies based upon the fault principle. However, the government of Zhenjiang City of Jiangsu Province, which was selected as a “law reform test unit” by the Central Government, established a compensation scheme for no-fault medical injuries (“Zhenjiang Scheme”) based upon a local piece of legislation titled the Measures of Zhenjiang City on the Relief for No-Fault Medical Injuries (“Zhenjiang Measures”)13 in 2014. It is the first and only no-fault compensation scheme for clinical injuries to co-exist with tort law remedies in China. Given its nature as a legal experiment, it was only set to operate for five years from 1 June 2014. Although the experiment period expired in June 2019, the Zhenjiang Scheme has been extended in Zhenjiang City.14 This part of the article reviews the Zhenjiang Scheme from three perspectives: its managing body and sources of funds, the eligibility criteria, and the compensation criteria.
A Managing Body and Sources of Funds
The Zhenjiang Scheme is not a mandatory scheme but allows the local medical institutions to freely choose whether or not to participate.15 It is managed directly by the Zhenjiang Society of Research on Patient Rights and Interests (“the Zhenjiang Society”),16 which is a non-governmental social association (NGO). Although the Zhenjiang Scheme was initiated by the government, the local government decided to delegate the running of the scheme to an NGO, presumably for two major reasons. First, the scheme may seem more independent and trustworthy when it is administered by a NGO, given that the majority of medical institutions involved in medical disputes are public hospitals backed by
the Government or its health bureau.17 Second, by stepping back from the direct management of the scheme, the local government may avoid any political repercussions from public dissatisfaction with the scheme, as well as avoiding the legal risk of a judicial review.18 The NGO thus serves as a firewall for the government. However, the operation and management of the scheme remains under the supervision of the local health bureau,19 which has authority and power to intervene if necessary. At first glance, it seems odd for the government to choose the Zhenjiang Society as a standing body to run and administer the scheme because it is a relatively new association – founded in June 2013 and based in Jiangsu University – and its mission focuses on patient rights protection research. However, it is indeed a quasi-governmental organisation embedded in the local political and bureaucratic processes because its establishment was proposed and supported by the local government.20 Therefore, it can be regarded as a genuine delegate of the latter.
The Zhenjiang Scheme relies on multiple sources of funds, which are mainly from fees paid by the participant medical institutions and private donations.21 Each participant medical institution makes an annual payment to the fund according to certain criteria, including the number of beds in the hospital, the specialised departments of the hospital and so on. The Zhenjiang Society has been granted the power to annually review and adjust the fee criteria according to the balance sheet, subject to the approval of the local health bureau.22 The Zhenjiang Scheme is thus not funded by the public treasury or special tax revenue.
B Eligibility Criteria
The scheme is not available to all victims of clinical injuries. Article 9 of the Zhenjiang Measures provides three eligibility criteria: (1) there is causation between the injury and the clinical activities; (2) the medical institution or its staff bears no fault in relation to the clinical injury; and(3) the clinical injury must be death, or personal injury of no less than the
fifth level of injury according to the Classification Criteria for Medical Malpractice Cases (for Trial Implementation).23 The applicant needs to prove all three criteria to establish eligibility.
Moreover, art 10 of the Zhenjiang Measures excludes victims from resorting to the Zhenjiang Scheme in the following seven situations: (1) the injury is caused by the disease of the patient; (2) the injury is caused by the fault of the medical institution, which should be held liable for compensation according to the law; (3) the injury should be compensated by a third party according to the law; (4) the injury is caused by non- collaboration or delayed treatment of the patient or the next of kin; (5) the patient or the next of kin engages in activities that disrupt medical care practice, the work and the life of medical staff; (6) the patient, the next of kin, or the medical institution provides false facts, hinders the truth or commits other fraudulent activities; and (7) the patient or the next of kin commit other activities violating laws, regulations or rules.
The above seven situations can be divided into three groups. First, if there is no causation between the injury and the clinical activity, compensation is unavailable (situations 1 and 4), which is merely a reiteration of the first eligibility criterion. Second, if there is any other party legally liable for the injury, no compensation is available (situations 2 and 3). This not only repeats the second eligibility criterion (that is, only unexpected or unavoidable clinical injuries are compensable under the scheme)24 but also supplements it by providing that victims of clinical injuries are ineligible where they can claim compensation from a third party (eg the manufacturer or the seller of medical products). However, it is unclear whether private insurers are seen as such a third party. Third, victims of clinical injuries become ineligible to access the scheme if they or their next of kin have committed illegal or unlawful activities (situations 5, 6 and 7). In particular, situation 5 is intended to address the frequent commission in China of “medical chaos”,25 where, in the event of adverse medical incidents, disgruntled patients or their relatives along with their friends or entrepreneurial agitators, physically attack medical staff and violently create chaos at the site of the medical institution to express their anger and claim compensation.26 Although the Chinese Government has recently made great efforts to control and
reduce medical chaos events by taking multiple countermeasures,27 this has not improved the strained relationship between doctors and patients. The reason why art 10 of the Zhenjiang Measures bars the victims or their next of kin who make medical chaos from claiming compensation is two-fold: the exclusion aims to punish those victims that commit medical chaos, and also benefit the victims that seek remedies in a non- violent manner by providing compensation that tort law does not offer. A further aspect of this is that victims of clinical injuries must return the full amount of compensation received to the scheme if they later commit any medical chaos.28
To determine whether eligibility criteria are satisfied in individual cases, as provided by arts 14 and 15 of the Zhenjiang Measures, the Zhenjiang Society delegates the “medical authentication” 29 to Zhenjiang Medical Association according to the procedural rules set out in the Regulations for Handling Medical Malpractice Cases30 and the Interim Measures on Medical Malpractice Technical Authentication.31 In order to control the costs of medical authentication, the Zhenjiang Medical Association routinely organises medical experts to collectively conduct medical authentication of clinical injury cases once every three months.32 It provides a conclusion to Zhenjiang Society within three working days33 and it is then the task of the Zhenjiang Society to decide whether the victim is eligible for compensation under the scheme (and the amount of compensation when the conclusion is positive). They must inform the victim of their decision within seven working days from receiving the conclusion of medical authentication. Additionally, the applicant can submit to the Zhenjiang Society a judicial decision, medical malpractice technical authentication report, forensic medical authentication report34 or a settlement agreement reached through the
27 At 159.
people’s medical mediation.35 These are all admissible for determining the issue of eligibility.36
However, a number of procedural ambiguities may arise from the practice of determining the eligibility issue. First, it is unclear how to solve conflicting medical expert opinions, for example, between those made by the medical association and by the forensic authentication institution, or between different forensic authentication institutions. Second, it is unclear whether the victim of a clinical injury is entitled to appeal against the conclusion of medical authentication made by Zhenjiang Medical Association or the decision made by Zhenjiang Society. Third, although access to the Zhenjiang Scheme does not mean the victim loses the right to litigate, the procedure will automatically terminate when the victim initiates an action or engages in mediation regarding the same clinical injury after lodging an application to the scheme,37 and it is unclear whether the victim will lose the right to litigate after receiving compensation under the scheme. Moreover, if the victim successfully claims compensation through medical litigation or mediation thereafter, it remains unclear whether he or she should return the compensation received to the scheme.
C Compensation Criteria
Victims of clinical injuries are entitled to a lump sum compensation under the Zhenjiang Scheme. Article 21 of the Zhenjiang Measures sets out the maximum amounts of compensation according to the degree of severity of clinical injuries (see Table 1). In exceptional cases, should Zhenjiang Society take into account the medical expenses and financial status of the victim, the figures can be increased by 50 per cent. The medical institution makes the payment of compensation to the victim. It must then request reimbursement from the scheme at the end of each quarter. The scheme thus has a limited ability to compensate the victims of serious clinical injuries, who are normally in great financial need. Therefore, as a supplementary measure, the Zhenjiang Society can refer victims with serious financial difficulties to the Zhenjiang Charity Federation for further financial support.38
Table 1: Maximum Compensation Scale under the Zhenjiang Scheme
|
Clinical injuries
|
Maximum amount of compensation (RMB)
|
|
Death/First-level injury
|
30,000
|
|
Second-level injury
|
25,000
|
|
Third-level injury
|
20,000
|
|
Fourth-level injury
|
15,000
|
|
Fifth-level injury
|
10,000
|
IV Compensation Scheme for No-Fault Adverse Events Attributed to Vaccination
China’s tort law, product liability law and drug law generally provide victims of adverse events attributed to vaccination (vaccination adverse events) with compensation, based upon strict liability against the manufacturer and the seller and fault liability against the administering medical institution. In addition to tort law remedies, since 2005, chapter five (titled “Handling of Adverse Events Attributed to Vaccination”) of the Regulations on the Administration of Circulation and Immunization of Vaccine (“Vaccine Regulations”)39 has provided a compensation scheme for no-fault vaccination adverse events (“Vaccination Scheme”). Meanwhile, since 2008 the provincial governments have issued local regulations on vaccination40 or local rules on compensation for no-fault vaccination adverse events.41 Recently, the Vaccine Administration Law,42 made by the Chinese national legislature in June 2019, has reiterated the Vaccination Scheme.43 Similar to the Zhenjiang Scheme discussed above, this part of the article will introduce the Vaccination Scheme in terms of three aspects: the managing body and the sources of funds, the eligibility criteria and the compensation criteria.
of the National People’s Congress on 29 June 2019; effective on 1 December 2019). In response to a string of vaccine scandals over faulty shots, fake data, and fraudulent labelling, the law was made to tighten control and supervision of the vaccine industry as well as increase the penalties for violations, see Wang Xiaodong “Law on Vaccine Supervision Includes Tough Penalties for Producing Fakes” China Daily (online ed, China, 1 July 2019). www.chinadaily.com.cn/a/201907/01/ WS5d195893a3103dbf1432b18e.html>.
A Managing Body and Sources of Funds
The Vaccination Scheme has been established nationwide and is managed by the local health bureau at various levels. Specifically, when an inoculated person has had, or been suspected to have had, an adverse reaction to vaccination, or when there is a dispute over an adverse reaction to a vaccination, both the inoculated person and the medical institution administering the vaccination can request the county-level health bureau at the locality of the medical institution to handle the case.44 If an inoculated person dies or suffers serious disability, or if there is a suspected mass adverse reaction to a vaccination, the county-level health bureau must report the case to its municipal government and it is for the municipal-level health bureau to handle it.45The source of funds under the Vaccination Scheme differs according to the type of vaccine. The Vaccine Regulations divide vaccines into two types: Type 1 vaccines refer to compulsory vaccines provided to citizens by the government free of charge; Type 2 vaccines refer to voluntary vaccines that citizens choose to have and pay for themselves.46 The funds for compensating no-fault adverse events attributed to Type 1 vaccines (Type 1 adverse events) come from the provincial government’s treasury while for Type 2 vaccines, the funds for compensating no-fault adverse events come from the relevant manufacturer.47
B Eligibility Criteria
Article 40 of the Vaccine Regulations defines an “adverse event attributed to vaccination” as an adverse reaction to medicine that causes damage to the inoculated person’s tissue, organs and function during or after the standard vaccination of qualified vaccine and for which no relevant party has fault.48 It can be read that there are two eligibility criteria for the Vaccination Scheme: (1) there is causation between the inoculated person’s personal injury and the vaccination; and (2) no relevant party has fault. Despite the lack of statutory explanation, it is generally agreed that “the relevant party” may include the manufacturer of the vaccine, the medical institution administering vaccination as well as the inoculated person.Article 41 of the Vaccine Regulations provides a number of situations that are not regarded as vaccination adverse events: (1) when post vaccination the inoculated person suffers a common reaction due to the vaccine’s feature; (2) the inoculated person suffers personal injury caused by a defective vaccine; (3) the inoculated person suffers personal
injury caused by the medical institution’s negligent administration of vaccination; (4) the inoculated person who was in delitescence or an unnoticed prodromal phase of a certain disease at the time of the vaccination and then, following vaccination, co-incidentally suffers from that disease; (5) the inoculated person who had a contraindication unknown to the medical institution due to that person’s or his or her guardian’s non-disclosure, suffers recrudescence or deterioration associated with the original disease following vaccination; and (6) the inoculated person suffers an individual or mass psychogenic reaction due to psychological factors. Specifically, situation 1 is excluded because this is not an adverse reaction but a common reaction to the vaccination. Situations 2, 3 and 5 are excluded because the adverse events are caused by a defective vaccine, negligent administration of the vaccination and the failure of the inoculated person or his or her guardian to disclose the contraindication. Finally, in situations 4 and 6, the cause of injury is not the vaccine but the unnoticed original disease or psychological factors, and on this basis can be excluded from the scheme.
The issue whether eligibility criteria are satisfied in individual cases is determined through a special procedure, consisting of administrative investigation and medical authentication that is set out in the Measures on the Authentication of Adverse Reaction to Vaccination (“Authentication Measures”).49 First, the county-level centre of disease control and prevention (“CDC”) processes and investigates a potential case of a vaccination adverse event and makes a decision on the eligibility issue. When the case involves death or serious disability of the inoculated person, involves mass victims or has social significance, it must be submitted to the municipal-level or provincial-level CDC for investigation.50 The CDC’s decision should be reported to the health bureau and the drug administration at the same level.51 Second, when any relevant party (including the manufacturer, the medical institution administering the vaccination and the inoculated person) disputes the CDC’s decision, that party is entitled to apply for authentication to the municipal-level medical association at the locality of the medical institution within 60 days from receiving the decision.52 Normally, an authentication conclusion is made within 45 days of the medical association receiving the application materials.53 Third, any relevant party that disagrees with the authentication conclusion can apply for re-authentication to the provincial-level medical association within 15 days of receiving the conclusion.54 The re-authentication conclusion is considered final under the scheme.
C Compensation Criteria
Victims of vaccination adverse events are entitled to a lump sum compensation under the Vaccination Scheme.55 The Central Government has authorised each provincial government to decide the compensation criteria applicable within its jurisdiction. The CDC’s undisputed decision or the (final) authentication conclusion is taken as the basis to assess compensation.56 In general, medical injuries resulting from vaccination adverse events are grouped into four categories according to the degree of severity: (1) first-grade injury including death and severe disabilities;(2) second-grade injury referring to moderate disabilities with injury to organs and tissue resulting in serious functional impairment (further divided into four sub-categories); (3) third-grade injury referring to mild disabilities with damage to the organs and tissue resulting in ordinary functional impairment (further divided into five sub-categories); and (4) fourth-grade injury meaning obvious personal injuries.57
However, the details of the compensation criteria vary from province to province. There are by and large three approaches that Chinese provincial governments have adopted to assess compensation for the above four categories of injuries. First, a fixed maximum amount of compensation for different (sub)categories of personal injuries. The compensation for first-grade injury is normally set as 20, 25 or 30 times the previous year’s average annual disposable income of urban residents in the province (“the Amount”); the maximum amount of compensation for other (sub)categories of personal injuries is set based upon the Amount by multiplying the disability coefficient.58 The disability coefficients for the four categories of injury are 1.0, 0.6-0.9, 0.1-0.5, and less than
0.1 respectively. The second approach to determine the compensation amount is to assess various items of compensable loss suffered by the inoculated person. For example, the government of Guangxi Zhuang Minority Autonomous Region decides the compensation amount by assessing medical expenses, lost income, nursing fee, authentication fee, transportation fee, disability appliance fee and disability compensation or death compensation, funeral expenses and autopsy fee. Different cases therefore attract different amounts of compensation.59 This is similar to the compensation criteria under tort law, although compensation for pain and suffering is generally unavailable under the Vaccination Scheme.60 The third approach is a hybrid of the first two approaches:
the compensation amount is calculated based upon various items of compensable damages but each (sub)category of personal injuries is subject to a cap. For example, Shanghai sets the maximum amount for first-grade injury as follows: 25 times the previous year’s average annual disposable income of urban residents in Shanghai. In terms of the cap for other less severe (sub)categories of personal injuries, the multiple decreases with the decreasing degree of severity of injury until it becomes one time for fourth-grade injury.61 Other provinces have adopted one of the above three approaches and also applied a fixed amount of compensation to death cases by taking into account the age of the deceased victim.62
V Features and Problems of Chinese No-Fault Schemes for Compensating Medical Injuries
The experimental Zhenjiang Scheme and the national Vaccination Scheme are two illustrations of no-fault compensation for medical injuries currently operating in China. Based on these, is it possible to identify any unique features of the Chinese no-fault schemes? How different are they from the equivalent schemes of other jurisdictions? Do they achieve the expected functions of a no-fault system? What are the practical problems arising from their implementation? This part of the article analyses these questions in relation to no-fault systems operating in other jurisdictions.
A Has China Adopted a Genuine No-Fault System for Medical Injuries?
The gist of a no-fault system is the removal of the requirement to prove fault,63 which generates a number of fundamental advantages over fault- based tort law. First, a much larger group of victims are able to receive compensation under a no-fault system than is the case under tort law because compensation under a no-fault system is extended to those medical injury cases where there is no suggestion that fault has occurred or fault can be proved. Second, victims are able to obtain compensation more easily and quickly under a no-fault system because they do not need to prove fault despite the requirement to prove causation. Third, a less defensive and better relationship between doctors and patients is likely to be established under a no-fault system because its focus is not on finding fault and attributing blame to individual doctors or medical institutions.64 Although product liability under tort law is based on strict liability, which also does not require fault, a no-fault system has advantages over the former because it does not need to prove the “defect” of the product.
However, both the Zhenjiang Scheme and the Vaccination Scheme require, among their eligibility criteria, that victims of medical injuries prove their injuries are free of fault, that is, neither caused by the fault of the medical institution or its staff under the Zhenjiang Scheme, nor caused by a defective vaccine or the negligent administration of the vaccination under the Vaccination Scheme. In other words, the term “no- fault” is understood as “no requirement of fault” in other jurisdictions which adopt a no-fault system, while in China, the same term is understood as “without fault”. Therefore, to claim compensation for no- fault medical injuries, Chinese victims must prove a negative requirement of “without fault”, which is sometimes more difficult to establish than a positive requirement of fault under tort law. Because a finding of fault under tort law is replaced with a finding of “without fault” under the Zhenjiang Scheme and the Vaccination Scheme, the above advantages that a no-fault system has in relation to the removal of the requirement of fault do not exist in the Chinese case. Even worse, victims of medical injuries in many cases have to bear a much heavier burden to prove the negative requirement of “without fault” than they do under tort law. For example, victims of vaccination adverse events need to prove not only that the vaccine made by the manufacturer was not defective but also that the medical institution had no fault in administering the vaccination.
As a consequence, the Chinese no-fault schemes only cover a relatively limited scope of victims of medical injuries, that is, those who are able to prove that their medical injuries do not involve the fault of the potential defendants under tort law, including the medical institution, the manufacturer of medical products. Victims of medical injuries cannot obtain compensation under the no-fault schemes easily and quickly; sometimes it is more difficult and lengthier for them to get compensation than doing so through tort law remedies. Although victims of medical injuries attempt to prove “without fault” on the part of doctors, which doctors are supposed to be happy to accept, a rejection of their application due to a failure to prove the absence of fault will be followed by allocating and attributing blame to individual doctors. Therefore, the Chinese no-fault schemes have few of the fundamental advantages of a no-fault system operating in other jurisdictions.
Moreover, related to the requirement of “without fault”, is the controversial question of how victims of medical injuries can prove this requirement. Should they resort to the court for an answer? Can they present a forensic medical authentication report to prove this requirement? When several medical authentication reports yield conflicting conclusions, which one should prevail over the other? The Zhenjiang Scheme has failed to solve these issues because art 18 of the Zhenjiang Measures simply lists judicial decisions, medical malpractice technology authentication reports, forensic medical authentication reports and settlement agreements reached through the people’s medical mediation, and generally recognises their admissibility for determining the eligibility issue (ie, that there is a no-fault medical injury). There is hardly any certainty about how they will be assessed
and weighed in the case of conflict. Under the Vaccination Scheme, the Vaccination Regulations are also silent on these issues. Although the local CDC’s administrative investigation and the local medical associations’ authentication of an adverse reaction to the vaccination are utilised to determine the issue of eligibility, it is unclear whether and to what extent judicial decisions, medical malpractice technology authentication reports and forensic medical authentication reports presented by the relevant parties may be helpful and used to establish the requirement of “without fault” in practice. The evidentiary ambiguities and difficulties that victims of medical injuries face will further reduce the utility of the Chinese no-fault schemes.
B What is the Relationship between Chinese No-Fault Schemes and Tort Litigation?
Whether the right to litigate is retained under a no-fault system is one distinct feature of different models of no-fault scheme for medical injuries operating in other jurisdictions. The New Zealand no-fault scheme provides compensation for personal injuries from various types of accidents including work accidents, road accidents and medical accidents; the victims who are entitled to access the scheme are barred from filing a tort action.65 By contrast, the Swedish no-fault scheme provides compensation only for medical injuries and the victims covered by the scheme retain their right to litigate.66 Despite opposite treatments of the victim’s right to litigate, both models share the similarity that the jurisdiction of tort law and that of the no-fault system overlap in terms of compensation for preventable or avoidable medical injuries.The Chinese case differs from these two models in that it lacks an overlap between the jurisdiction of tort law and that of no-fault schemes. Chinese tort law governs fault-caused medical injuries and medical product liability while its no-fault schemes compensate residual medical injuries: those not caused by the fault of the medical institution or its staff under the Zhenjiang Scheme, and those neither caused by the defective vaccine nor by the negligent administration of the vaccination under the Vaccination Scheme. Due to the absence of jurisdiction overlap, the no- fault schemes are unable to cure the deficiencies of the tort system as its alternative. In theory, whether the victims covered by the Chinese no-fault schemes retain the right to litigate is not an issue in China. However, the practice does present a more complicated picture.
Because no law stipulates the order of access between the no-fault system and the tort law system, victims of medical injuries can freely decide which system to start with. If a victim of medical injury files a
tort action in the first place67 and does not get tortious compensation because of the failure to prove fault, he or she may seek compensation from an appropriate no-fault scheme, which exactly aims to provide compensation for “without-fault” medical injuries. Although whether, or how, the managing body of the no-fault scheme should take judicial opinions into account remains unclear, it is likely that judicial opinions will carry weight in the decision of the issue of eligibility under the no-fault scheme. However, if a victim claims compensation under the no-fault scheme in the first place and is rejected because of the failure to prove the requirement of “without fault”, he or she will turn to the court for remedies.68 If the court does not support his or her claim because of the failure to prove fault, can the victim resort to the no-fault system for a second time? If no, is it fair that the victim is left without remedy merely because the managing body of the no-fault scheme and the court disagree on the issue of fault? In another situation where a victim successfully claims compensation under the no-fault scheme in the first place and later finds the compensation cannot satisfy his actual damages, can he or she file a tort action to try his luck in the court? If the court supports his or her claim under tort law, should the victim return the compensation received under the no-fault scheme? All these questions await clarifications and answers by the law.
It is certainly true that the victim’s right to litigate has been restricted in reality. For example, it is common for local rules on compensation for no- fault vaccination adverse events to require the victim to sign a standard compensation agreement before making the payment of compensation.69 The agreement often includes a clause that the victim cannot dispute in any way the same facts after receiving the compensation under the scheme,70 or that the relevant parties cannot file an action based upon the same facts in the future.71 Although the legal basis of such restriction
and Xin’anxian Caocunxiang Tianlingcun Weishengsuo and Xin’anxian Caochunxiang Weishengsuo（ 2014）洛民终字第2343号 awarded compensation of RMB 720,000 to the plaintiff victim although it did not find defendant at fault (except for some misconduct).
on the right to litigate is dubious, in practice most victims of medical injuries comply with the restriction and abandon their right to litigate.72 In law, courts are not barred from accepting medical injury disputes
when the victim has already successfully claimed compensation under the Vaccination Scheme, which renders the relation between the no-fault schemes and tort litigation more complex. Moreover, a few courts will support the victim’s claim under tort law with different legal bases, even if the victim has already obtained compensation under the Vaccination Scheme.73 It may do so by awarding so-called “humanity relief” to victims of medical injuries. For example, in Zhang v Shandong Jiaotong Yiyuan,74 the plaintiff received a lump sum compensation of RMB 100,285 under the Vaccination Scheme and started a tort action because the compensation was insufficient to afford the subsequent medical treatments and care. The Basic People’s Court of Tianqiao District of Jinan City of Shandong Province accepted the case and awarded RMB 10,000 to the plaintiff as “humanity relief” – despite no fault being found on the part of the defendant medical institution. Another possibility is that the court may disagree with the finding of no fault by the managing body of the Vaccination Scheme and then award tort law compensation based upon the fault of the relevant parties. For example, in Sun v Lintaoxian Jibing Yufang Kongzhi Zhongxin,75 the plaintiff victim sued the defendants after receiving a lump sum compensation of RMB 70,000 under the Vaccination Scheme. The Intermediate People’s Court of Dingxi City of Gansu Province found that the defendants had been negligent and this had resulted in the plaintiff’s personal injury. The first two defendants were held liable for 80 per cent of the plaintiff’s damages and required to pay compensation of RMB 654,246. A final possibility is that the court may award damages to the victim of medical injury according
to “the principle of equitable liability” provided by art 24 of the TLL.76 For example, in Wang v Wuhanshi Hongshanqu Guanshanjie Diyi Shequ Weisheng Fuwu Zhongxin,77 the Intermediate People’s Court of Wuhan City of Hubei Province held that the plaintiff’s receipt of compensation under the Vaccination Scheme did not exclude his right to litigate under tort law. Furthermore, the forensic medical authentication report could be admitted and used in determining tort liability. The court decided that the three dependents were jointly liable for compensation of RMB 117,626 on the ground of the principle of equitable liability.
To sum up, due to the absence of jurisdictional overlap between the no-fault system and the tort law system in China, victims of medical injuries whose claim fails in one system must go through the other system in order to acquire compensation. Moreover, the relationship between the no-fault schemes and tort litigation has not been clearly defined. Some victims have resorted to both systems, which sometimes produce conflicting findings and reach different conclusions. As a result, some victims are left without remedy under both systems, and others obtain remedies from both systems in the same case. This indicates the unfairness of the compensation system for medical injuries.
C Do Chinese No-Fault Schemes Provide Accessible, Efficient and Fair Compensation for Medical Injuries?
A no-fault system is expected to provide more accessible, efficient and fair compensation to victims of medical injuries than a tort law system even if causation is still required under the no-fault system.78 However, it is doubtful that the Chinese no-fault systems are able to achieve these advantages in reality. First of all, the accessibility of the compensation schemes for no-fault medical injuries in China is largely limited by the strict eligibility criteria. Specifically, under the Zhenjiang Scheme, the victims whose medical injuries are caused by the fault of the medical institution or its staff, whose medical injuries can be compensated by a third party, and whose medical injuries are less severe than the fifth level of injury are denied access to the scheme. By March 2016, Zhenjiang Scheme had received 14 applications, among which 12 cases met its eligibility criteria. In total, the scheme paid RMB 420,000 in these cases, with the average amount of compensation at RMB 35,000 per case.79 As
the average number of medical mishaps in Zhenjiang is estimated to be 120 cases per year,80 it can be calculated that only 3.33 per cent of potential victims had resorted to the scheme up to that date.
Under the Vaccination Scheme, the victims whose medical injuries are caused by a defect in the vaccine or the negligence of the medical institution in administering the vaccination, and whose medical injuries are attributed to an unnoticed original disease or psychological factors, are excluded from the scheme. A large number of victims of vaccination adverse events cannot access the no-fault schemes as a result of failure to satisfy the eligibility criteria. As the data from Jiangxi Province show, there were 948 cases of confirmed vaccination adverse events in the province between 2008 and 2012. Of these 255 cases (26.9 per cent) were compensated through the scheme, which implies a low degree of accessibility. Among the 255 compensated cases, 222 cases (87.06 per cent) involved Type 1 vaccines and 33 cases (12.94 per cent) involved Type 2 vaccines; 195 cases (76.47 per cent) involved victims aged six or under, 51 cases (20 per cent) involved victims aged seven to fourteen, and only nine cases (3.53 per cent) involved victims aged 15 or above. The total amount of compensation for the 255 cases was RMB 6 million, the average amount of compensation per case was RMB 23,529.81
Moreover, some local rules on the Vaccination Scheme impose a one- year time limitation on an application for compensation. For example, art 16 of the Interim Measures of Inner Mongolia Autonomous Region on the Compensation for Adverse Events Attributed to Vaccination, provides that victims of vaccination adverse events must apply to the medical association of the Inner Mongolia Autonomous Region for the authentication of the severity degree of injury within one year of sustaining their injury, otherwise their application will be rejected.82
Because it may be difficult for the layman victim to notice the occurrence of medical injury attributed to vaccination, such a short time limitation severely limits the accessibility of the scheme.
Second, the efficiency of the compensation schemes for no-fault medical injuries in China is questionable. Under the Zhenjiang Scheme, medical experts of the local medical association conduct medical authentication of clinical injuries cases once every three months to save on administrative costs.83 Under the Vaccination Scheme, compensation to the victims of Type 1 adverse events may be delayed because of the bureaucratic approval system. For example, according to arts 24-27 of the Interim Measures of Henan Province on the Compensation for Adverse Events Attributed to Vaccination, after receiving an application for compensation from the victim of a confirmed vaccination adverse event, the county- level health bureau first reviews the case, then proposes an amount of compensation, and then passes all application materials to the municipal- level health bureau. The latter reviews the reported cases and collectively submits all applications to the provincial-level health bureau for approval twice a year: once at the end of May and once at the end of November. The provincial-level health bureau makes a final decision at the end of June and December respectively and passes its decision down level by level to the county-level health bureau, which then informs the victim of the decision and arranges the signing of a compensation agreement. The victim then waits for another two months to get the payment of compensation from the provincial treasury, after the signed compensation agreement is sent to and received by the provincial-level health bureau. Such lengthy bureaucratic arrangements aim to reduce administrative costs, but it seriously delays the payment of compensation to victims of medical injuries who are in urgent financial need. It was reported that the shortest time a victim spent waiting before receiving compensation in Zhejiang Province was 14 months, and a victim in Fujian Province even waited 15 years for compensation under the Vaccination Scheme.84
Unfortunately, the victims of Type 2 adverse events may have to overcome more difficulties and spend even longer waiting before successfully claiming and receiving compensation under the Vaccination Scheme because they have to make a claim against the manufacturer rather than the local health bureau, even if the latter or the medical institution that administered the vaccination provides some assistance for them to do so.85 If the manufacturer is located outside the locality of the victim, it is more difficult and time-consuming for the victim to claim under the scheme. Indeed, many victims choose to file a tort
action against the manufacturer (but do not resort to the administrative procedure under the scheme) when claiming compensation for no-fault vaccination adverse events.86 Courts help award no-fault compensation to victims if they can establish a good case under the Vaccination Scheme. However, given the complexity of such litigation and the possibility of appeal, it is extremely difficult, if not impossible, for the victims of Type 2 adverse events to get compensation awarded efficiently under the scheme.
Third, the fairness of the compensation schemes for no-fault medical injuries in China is in doubt, which is particularly evident under the Vaccination Scheme. As noted above, compensation criteria under the scheme vary from province to province, causing large disparities in terms of compensation. Victims in similar cases of vaccination adverse events are likely to receive significantly different amounts of compensation under the same scheme. Taking an infant who died due to an Type 1 adverse event as an example, the infant is entitled to compensation of RBM 114,108 (three times the average annual disposable income of urban residents in Jiangsu Province in the year of 2018)87 while the same infant is entitled to compensation of RMB 1,247,220 (20 times the average annual disposable income of urban residents in Beijing in the year of 2018) as well as funeral expenses, autopsy expenses, medical expenses and caring expenses if any.88 The compensation amount in Beijing is about 11 times that in Jiangsu Province in this example, even though both localities are categorised as developed areas in China. Such a huge disparity illustrates the lack of fairness of the Vaccination Scheme.
In addition, the application procedure and administrative procedure of the Vaccination Scheme (as stated in all local rules) focus on, and apply to, the victims of Type 1 adverse events. This is because the compensation fund for Type 1 vaccination cases comes from provincial treasuries. However, the application procedure for the victims of Type 2 adverse events, who must claim compensation against the manufacturer of the vaccine, is either unaddressed89 or ambiguous90 under the local rules. Therefore, due to the procedural unfairness between the victims inoculated with different types of vaccines, the victims of Type 2 adverse events have to make use of tort action to claim no-fault compensation under the scheme. The high costs of litigation for seeking no-fault compensation inevitably discourages them from resorting to the scheme, thus further limiting the accessibility of the scheme.
VI Conclusion
In China, the experimental Zhenjiang Scheme has operated for more than five years and the Vaccination Scheme has operated nationwide for more than a decade. As two compensation schemes for compensating no-fault medical injuries in the country, they demonstrate both the features and deficiencies of the developing no-fault system in China. There are practical difficulties with the causation requirement under the Vaccination Scheme. Causation is not at all easy to prove because of the scientific indeterminacy about the biological causation of adverse events. As an element of good practice, the local centres of disease control and prevention and the local medical associations, in determining whether the requirement of causation is satisfied, have relaxed this requirement by asking whether a causal link between the vaccine and the adverse event can be excluded: if the answer is negative, causation is established.91 This approach reduces the burden of proof of causation and helps many victims of vaccination adverse events establish the requirement of causation; otherwise they would be excluded from compensation under the scheme.On the other hand, the two compensation schemes for compensating no-fault medical injuries have revealed some fundamental deficiencies of Chinese no-fault schemes. In addition to the problematic requirement to prove “without fault”, the chaotic relationship between the no-fault schemes and tort litigation and the failure to provide accessible, efficient and fair compensation for medical injuries as analysed above, the issues of adequacy of compensation, affordability of the no-fault system and limited responsibilities of the government are also noteworthy. Under the Zhenjiang Scheme, compensation for victims of clinical injuries are extremely low and are insufficient, especially considering the inadequate social welfare system and the undeveloped private insurance system in the country. The maximum compensation for a victim who died from a clinical injury is RMB 30,000 under the scheme while the tortious compensation awarded by a court of Zhenjiang in the same case would at least reach RMB 817,660 in 2018.92 It is understandable that low compensation amounts have been set to maintain the affordability of the Zhenjiang Scheme because it is not state-funded and the fund relies on annual fees paid by the participant medical institutions and private donations. However, because more than 80 per cent of health care services
are provided by public medical institutions in China,93 it is necessary and important that the government engages in and funds the no-fault system for compensating clinical injuries. Otherwise, the goals of no-fault compensation for clinical injuries are unlikely to be achieved. In terms of the Vaccination Scheme, the victims of Type 2 adverse events can only claim no-fault compensation against the individual manufacturer, not the local health bureau. The adequacy and affordability of compensation in these cases entirely depends on the financial ability of the individual companies. Because Type 2 vaccines also have significant implications for public health and community benefits, it is justifiable for the government to engage in and ensure an effective implementation of the no-fault system for compensating victims of Type 2 adverse events.
To improve the Chinese no-fault schemes for compensating medical injuries, the most important step is to remove the “without fault” requirement, otherwise it is not a genuinely no-fault system and cannot serve as an alternative to tort law. The removal will not only increase the accessibility and efficiency of the no-fault schemes but will also help establish a healthy relationship between the no-fault system and the tort law system: avoiding the phenomena of no remedy and double remedy. Second, it is a matter of urgency to eliminate the huge disparities in compensation among various provinces under the Vaccination Scheme by adopting uniform and fair compensation criteria nationwide. Since 30 provincial governments have worked out three approaches to assess compensation for the four categories of personal injuries under the scheme, the Central Government may select one of the approaches as the benchmark for the purpose of establishing commonly accepted compensation criteria to be uniformly applied throughout the country. Third, to improve the efficiency of China’s no-fault system, it is necessary to refine the application procedure and streamline the administrative procedure of the Vaccination Scheme to reduce bureaucratic costs and facilitate timely compensation to victims in great financial need. A professional managing body of the Vaccination Scheme, separate from the local health bureau, may be established within the local government. Last but not least, it is important for the government (especially the Central Government) to bear responsibilities to establish, fund and manage the no-fault schemes for compensating medical injuries, especially those including an element of community responsibility, such as vaccination injury and hospital-acquired infection. Although the Central Government designed and established the Vaccination Scheme, it is the local governments that fund and operate it. Given the unbalanced economic development and fiscal resources between provincial governments, the Central Government needs to bear its responsibility to subsidise and
assist some local governments who are in fiscal difficulty to ensure the fairness and sustainability of the national no-fault system. As the new Vaccine Administration Law articulates that the Vaccination Scheme should provide victims of vaccination adverse events with timely, convenient and reasonable compensation,94 this article presents the above suggestions to achieve it.
NZLII:
Copyright Policy
|
Disclaimers
|
Privacy Policy
|
Feedback
URL: http://www.nzlii.org/nz/journals/OtaLawRw/2019/6.html