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The new Tort Liability Law and the journey towards informed consent in China

Identifieur interne : 003380 ( Istex/Corpus ); précédent : 003379; suivant : 003381

The new Tort Liability Law and the journey towards informed consent in China

Auteurs : Xiju Zhao

Source :

RBID : ISTEX:68B6597B5326C4F1931BE05CF1EAAC4FB946D21A

English descriptors

Abstract

Chinese informed consent law is in a period of fundamental transition. The recently enacted Tort Liability Law offers a new way of thinking about Chinese informed consent law in the therapeutic setting. It includes distinctive provisions relevant to informed consent, thereby creating a generous duty to inform, including a duty to inform about alternative treatment options. However, the rule as presently cast suffers from a lack of detail and clarity, fails to clearly identify the distinctiveness of the duty to disclose, and may be criticised for being all-embracing and overambitious. Nevertheless, one has reason to be optimistic about the future of Chinese informed consent law. This article offers a detailed tour through the new Tort Liability Law in the specific context of disclosure to patients and sets out certain suggestions for future development. These suggestions include that Chinese law should clearly distinguish the task of information disclosure from diagnosis and treatment, should introduce the ‘materiality’ test of information disclosure, and should also acknowledge the role of professional regulation in honouring and promoting the doctrine of informed consent. In the course of this examination, the author draws comparisons with the laws of Japan and also Commonwealth countries, including Asian common law jurisdictions, such as Singapore and Malaysia.

Url:
DOI: 10.1177/0968533212458430

Links to Exploration step

ISTEX:68B6597B5326C4F1931BE05CF1EAAC4FB946D21A

Le document en format XML

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<div type="abstract" xml:lang="en">Chinese informed consent law is in a period of fundamental transition. The recently enacted Tort Liability Law offers a new way of thinking about Chinese informed consent law in the therapeutic setting. It includes distinctive provisions relevant to informed consent, thereby creating a generous duty to inform, including a duty to inform about alternative treatment options. However, the rule as presently cast suffers from a lack of detail and clarity, fails to clearly identify the distinctiveness of the duty to disclose, and may be criticised for being all-embracing and overambitious. Nevertheless, one has reason to be optimistic about the future of Chinese informed consent law. This article offers a detailed tour through the new Tort Liability Law in the specific context of disclosure to patients and sets out certain suggestions for future development. These suggestions include that Chinese law should clearly distinguish the task of information disclosure from diagnosis and treatment, should introduce the ‘materiality’ test of information disclosure, and should also acknowledge the role of professional regulation in honouring and promoting the doctrine of informed consent. In the course of this examination, the author draws comparisons with the laws of Japan and also Commonwealth countries, including Asian common law jurisdictions, such as Singapore and Malaysia.</div>
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<p>Chinese informed consent law is in a period of fundamental transition. The recently enacted Tort Liability Law offers a new way of thinking about Chinese informed consent law in the therapeutic setting. It includes distinctive provisions relevant to informed consent, thereby creating a generous duty to inform, including a duty to inform about alternative treatment options. However, the rule as presently cast suffers from a lack of detail and clarity, fails to clearly identify the distinctiveness of the duty to disclose, and may be criticised for being all-embracing and overambitious. Nevertheless, one has reason to be optimistic about the future of Chinese informed consent law. This article offers a detailed tour through the new Tort Liability Law in the specific context of disclosure to patients and sets out certain suggestions for future development. These suggestions include that Chinese law should clearly distinguish the task of information disclosure from diagnosis and treatment, should introduce the ‘materiality’ test of information disclosure, and should also acknowledge the role of professional regulation in honouring and promoting the doctrine of informed consent. In the course of this examination, the author draws comparisons with the laws of Japan and also Commonwealth countries, including Asian common law jurisdictions, such as Singapore and Malaysia.</p>
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<title>Introduction</title>
<p>There is significant academic debate on whether the doctrine of informed consent is compatible with Chinese culture. Differences of opinion on this issue originate from different interpretations of Chinese medical culture, rather than the culture itself. Some scholars interpret informed consent as promoting an individual-centred culture and as ‘alien’ to the traditional family-dominated culture of China.
<sup>
<xref ref-type="fn" rid="fn1-0968533212458430">1</xref>
</sup>
Others contend that Confucianism, ‘family culture’ and traditional Chinese medical culture result in paternalism in Chinese health care and that this consequently poses great difficulties for translating informed consent into clinical care.
<sup>
<xref ref-type="fn" rid="fn2-0968533212458430">2</xref>
</sup>
Other scholars are reluctant to see Chinese and Western culture as dichotomous, rejecting the
<italic>individualism vs. communitarianism</italic>
,
<italic>individual autonomy vs. family decisions</italic>
, and
<italic> individual liberty vs. social/common good</italic>
dichotomies and arguing for diversity, plurality, and complexity of culture.
<sup>
<xref ref-type="fn" rid="fn3-0968533212458430">3</xref>
</sup>
Informed consent is deemed by many to be ‘not only … compatible with some spirits of Confucian moral tradition and traditional Chinese medical ethics, but also as justified by indigenous ethical terms, such as ‘‘
<italic>ren</italic>
’’ (humanity or humaneness), ‘‘
<italic>yi nai renshu</italic>
’’ (medicine as an art of humanity and humaneness) and ‘‘
<italic>chen</italic>
’’ (sincerity and truthfulness)’.
<sup>
<xref ref-type="fn" rid="fn4-0968533212458430">4</xref>
</sup>
</p>
<p>Whatever be the level of compatibility between Chinese culture and informed consent, it should be acknowledged that there are certain sociocultural obstacles to realising the informed consent ideal in modern China. A survey conducted in 2002 in Taiwan showed that in a Confucian society, the family element often determined the course of decision, and the patient’s autonomy was overlooked.
<sup>
<xref ref-type="fn" rid="fn5-0968533212458430">5</xref>
</sup>
A more recent survey in Mainland China revealed that 72.4% of patients surveyed acknowledged the legitimacy of family members being involved in decision making.
<sup>
<xref ref-type="fn" rid="fn6-0968533212458430">6</xref>
</sup>
Patients, family members and doctors were happy with involving family members, and sometimes giving them priority, when medical decisions-needed to be made.
<sup>
<xref ref-type="fn" rid="fn7-0968533212458430">7</xref>
</sup>
Many patients have a close relationship with their family and trust family members to make medical decisions on their behalf, and the impact on decision-making is further compounded by the fact that some patients need family contributions when paying medical bills.</p>
<p>Of course, there are likely to be discrepancies between the wishes of patients and those of family members regarding information disclosure. A study targeting cancer patients revealed that 77.6% of respondents wanted to know the true diagnosis, and most of them preferred to be fully informed.
<sup>
<xref ref-type="fn" rid="fn8-0968533212458430">8</xref>
</sup>
A survey of patients with very severe conditions also showed that 92.5% of respondents wanted to be informed of the severe nature of their conditions.
<sup>
<xref ref-type="fn" rid="fn9-0968533212458430">9</xref>
</sup>
A study comparing a group of patients who chose to make medical decisions themselves with a group of patients who opted for their family members to make decisions on their behalf suggested that the former group did not have increased psychological burdens, even if they knew their conditions, and the risks involved in medical intervention.
<sup>
<xref ref-type="fn" rid="fn10-0968533212458430">10</xref>
</sup>
This is in contrast with the attitudes of patients’ family members towards disclosure. One study showed that only 27.8% of family members preferred full information disclosure, with 66.8% of them preferring patients to be informed of only the diagnosis and 42% of them adopting ‘the less, the better’ attitude.
<sup>
<xref ref-type="fn" rid="fn11-0968533212458430">11</xref>
</sup>
As to patients who are terminally ill, only 2.5% of their family members preferred disclosure of true conditions, with 28.4% of them opposing patients being fully informed and 69.1% of them preferring the diagnosis to be concealed for some time.
<sup>
<xref ref-type="fn" rid="fn12-0968533212458430">12</xref>
</sup>
</p>
<p>Whatever this research tells us about the preferences of relatives, honouring individual autonomy has become important in Chinese legal culture. Since the 1990s, Chinese law has been committed to informed consent and the new Chinese
<italic>Tort Liability Law</italic>
accords the right of informed consent to competent patients rather than to their family members. In a society like China, it is preferable to involve family members when medical decisions are to be made. However, under the current law, that can only be done with the consent of the patient. The individual consent model not only reinforces patients’ rights but also enhances the doctor–patient relationship. Currently, the doctor–patient relationship suffers from lack of mutual trust and even hostility
<sup>
<xref ref-type="fn" rid="fn13-0968533212458430">13</xref>
</sup>
; a matter that has attracted international attention.
<sup>
<xref ref-type="fn" rid="fn14-0968533212458430">14</xref>
</sup>
Lack of communication is a major factor in the deterioration of this relationship.
<sup>
<xref ref-type="fn" rid="fn15-0968533212458430">15</xref>
</sup>
Health care professionals, who value information disclosure as a factor in helping to preempt medical lawsuits,
<sup>
<xref ref-type="fn" rid="fn16-0968533212458430">16</xref>
</sup>
view informed consent positively, believing that it is beneficial to both patients and practitioners.</p>
<p>This article offers a detailed analysis of the law of informed consent in China. Part II addresses both the historical application of consent and the questions surrounding it and the demands of consent in the modern context (that is, after passage of the 2009 Tort Law). In doing so, this section of the article offers some comparative observations from a range of commonwealth jurisdictions. The article then moves to predicting the future for Chinese informed consent law, drawing from developments in Japan and the United Kingdom (Part III) before offering some conclusions (Part IV). Finally there is a note. When I mention a patient or a doctor in a general sense, I simply use ?he?. It means ?he or she?. In the same way, ?his? means ?his or her?. They should be read as neutral.</p>
<sec id="section2-0968533212458430">
<title>The evolution of consent in the chinese medical context</title>
<p>Chinese medical negligence law is mainly attributable to the emergence, application and interpretation of three pieces of legislation: the
<italic>General Principles of Civil Law</italic>
(1986) (GPCL),
<sup>
<xref ref-type="fn" rid="fn17-0968533212458430">17</xref>
</sup>
the
<italic>Regulation on the Handling of Medical Accidents </italic>
(2002) (2002 Medical Accidents Regulation),
<sup>
<xref ref-type="fn" rid="fn18-0968533212458430">18</xref>
</sup>
and now the
<italic>Tort Liability Law</italic>
(2009) (2009 Tort Law).
<sup>
<xref ref-type="fn" rid="fn19-0968533212458430">19</xref>
</sup>
The three pieces of legislation that embraced the doctrine of informed consent within the pre-2009 framework were the
<italic>Regulation on Medical Institutions</italic>
(1994) (1994 Institutions Regulation), the
<italic>Law on Practising Doctors</italic>
(1998) (1998 Doctors Law), and the 2002 Medical Accidents Regulation. In this section, the operation of these instruments is reviewed before focusing on the impact of the 2009 Tort Law.</p>
</sec>
<sec id="section3-0968533212458430">
<title>Medical negligence and consent prior to the 2009 tort law</title>
<p>The GPCL provides general guidance on civil liability and applies to medical negligence. A doctor’s negligent conduct may cause personal injury and infringe a patient’s ‘rights of life and health’,
<sup>
<xref ref-type="fn" rid="fn20-0968533212458430">20</xref>
</sup>
therefore falling within the scope of GPCL. However, the Regulations on Medical Accidents (1987 and 2002)
<sup>
<xref ref-type="fn" rid="fn21-0968533212458430">21</xref>
</sup>
complicated the situation. The 2002 Medical Accidents Regulation had two components: one being a professional regulation and disputes’ resolution scheme and another being a medical accident compensation law. Both the GPCL and the 2002 Medical Accidents Regulation cover personal injury compensation. The problem is that the two pieces of legislation have different thresholds for compensation and different rules regarding the amount of compensation. There have been continuing concerns about the 2002 Medical Accidents Regulation’s inconsistency with the GPCL’s principles.</p>
<p>The Supreme People’s Court (SPC) of China then released several Judicial Interpretations, which created a two-layer, parallel approach.
<sup>
<xref ref-type="fn" rid="fn22-0968533212458430">22</xref>
</sup>
It drew a distinction between cases of medical accidents and nonmedical accidents and subjected them to different legal rules. Two other dichotomies or distinctions are (1) the distinction between two groups of applicable laws (the 2002 Medical Accidents Regulation and 2003 Notice
<sup>
<xref ref-type="fn" rid="fn23-0968533212458430">23</xref>
</sup>
<italic>v.</italic>
GPCL and the 2003 Interpretation
<sup>
<xref ref-type="fn" rid="fn24-0968533212458430">24</xref>
</sup>
) and (2) two systems of authentication (medical accident
<italic>technical</italic>
authentication
<italic>v.</italic>
<italic>forensic </italic>
authentication). The SPC’s approach entrenched rather than resolved these inconsistencies.</p>
<p>With respect to consent more specifically, the 1998 Doctors Law set out seven practising rules for medical practitioners, one of which was that ‘doctors should truthfully explain the patients’
<italic>condition</italic>
to the patients
<italic>or </italic>
their family members’.
<sup>
<xref ref-type="fn" rid="fn25-0968533212458430">25</xref>
</sup>
This was followed by a warning that ‘care shall be taken to avoid adverse impact on the patients’,
<sup>
<xref ref-type="fn" rid="fn26-0968533212458430">26</xref>
</sup>
which embodies the notion of ‘therapeutic privilege’.
<sup>
<xref ref-type="fn" rid="fn27-0968533212458430">27</xref>
</sup>
Doctors shall obtain approval from the hospital and the consent of the patient or family members before conducting clinical treatment on an
<italic>experimental </italic>
basis.
<sup>
<xref ref-type="fn" rid="fn28-0968533212458430">28</xref>
</sup>
Under this law, it seemed that the ambit of a doctor’s duty to disclose was very narrow, encompassing only information about a patient’s ‘condition’. Moreover, breach of this duty did not trigger any legal liability; only breach of the duty to obtain the consent of the patients or their family members in the context of
<italic>experimental</italic>
clinical treatments resulted in potential disciplinary and criminal responsibilities.
<sup>
<xref ref-type="fn" rid="fn29-0968533212458430">29</xref>
</sup>
</p>
<p>The insufficiency of disclosure under the 1998 Doctors Law could be offset, to some extent, by the 1994 Institutions Regulation
<sup>
<xref ref-type="fn" rid="fn30-0968533212458430">30</xref>
</sup>
under which a broader duty to disclose existed. Article 33 of the 1994 Institutions Regulation stipulated that, when administering ‘surgery, special examination or special treatment’, medical institutions should obtain the consent of the patient
<italic>and</italic>
his or her family members or relatives. Pursuant to Article 62 of the
<italic>Rules for</italic>
<italic>Implementing the Regulation on Medical Institutions</italic>
,
<sup>
<xref ref-type="fn" rid="fn31-0968533212458430">31</xref>
</sup>
medical institutions should respect the patient’s right to be informed of
<italic>conditions, diagnosis, and treatment, </italic>
and, before performing surgery, special examination, and special treatment, the medical institution should give the patient ‘necessary explanation’. On one hand, these provisions broadened the scope of disclosure by recognising that patients have the right to be informed of their condition, diagnosis and treatment. On the other hand, it seemed that the duty to disclose remained narrow, targeting only ‘surgery, special examination, and special treatment’ and lacked clarity by failing to specify what was to be disclosed. The provisions were also weakened by the fact that the 1994 Institutions Regulation and the Rules for Implementing the Regulation
<sup>
<xref ref-type="fn" rid="fn32-0968533212458430">32</xref>
</sup>
attached no liability to medical institutions for their employees’ failure to disclose.</p>
<p>Both the 1998 Doctors Law and the 1994 Institutions Regulation regulated the main ‘role players’ – in health care delivery; health care professionals and medical institutions. However, the doctrine of informed consent they articulated was almost toothless. Breach of the duty to inform did not even attract disciplinary sanctions. There was low awareness that breach of the duty to inform may result in
<italic>civil</italic>
liability. The 2002 Medical Accidents Regulation contained a separate provision regarding informed consent, but the provision appeared in the Chapter ‘Prevention and Handling of Medical Accidents’.</p>
<p>Of the three pieces of Chinese health care legislation which touched on the informed consent rule prior to the new Tort Law, the 2002 Medical Accidents Regulation offered the strongest formulation of the rule. It expressly stipulated that ‘in the activities of medical treatment, medical institutions and medical practitioners should truthfully inform patients of their conditions, treatment measures, medical risks and others’.
<sup>
<xref ref-type="fn" rid="fn33-0968533212458430">33</xref>
</sup>
This was more comprehensive than previous formulations and did not confine the duty to inform to specified categories of treatment. The range of information that fell within the duty to disclose was wider and nonexhaustive. In addition, it asked doctors to respond to a patient’s inquiries in a timely manner.
<sup>
<xref ref-type="fn" rid="fn34-0968533212458430">34</xref>
</sup>
Like the 1998 Doctors Law, it created a potential exception to the duty to warn: to ‘avoid an adverse impact on the patients’.
<sup>
<xref ref-type="fn" rid="fn35-0968533212458430">35</xref>
</sup>
However, the 2002 Medical Accidents Regulation only contemplated making corrections, and, in serious cases,
<italic>administrative or disciplinary</italic>
sanction could follow breach of the informed consent provision.
<sup>
<xref ref-type="fn" rid="fn36-0968533212458430">36</xref>
</sup>
It was very unlikely that breach of the duty to inform would fall within the concept of ‘medical accident’, and therefore attract compensation and civil liability. Apparently, when creating the notion of ‘medical accident’, legislators only envisaged the traditional context of diagnosis and treatment.</p>
<p>China is not a common law country. Before 2000 Chinese courts did not recognise a cause of action formulated in terms of breach of the ‘informed consent’ rule.
<sup>
<xref ref-type="fn" rid="fn37-0968533212458430">37</xref>
</sup>
Since 2000, informed consent cases have gradually emerged in the Chinese judicial arena. A case survey revealed that, in the opinions of Chinese courts, information that may fall within the duty to disclose included the qualifications and limitations of medical institutions, the purpose, risks and success rate of the proposed treatment, alternative treatment options, and the side effects of medicines.
<sup>
<xref ref-type="fn" rid="fn38-0968533212458430">38</xref>
</sup>
Some courts allowed compensation for mental distress even when they found that there was no causal link between the failure to disclose and the patient’s injury.
<sup>
<xref ref-type="fn" rid="fn39-0968533212458430">39</xref>
</sup>
It seems that the Chinese judiciary will not always follow the legislation and may adopt a proactive and liberal approach to the issue of information disclosure and compensation.</p>
</sec>
<sec id="section4-0968533212458430">
<title>Medical negligence and consent after the 2009 tort law</title>
<p>On 26 December 2009, after nearly 8 years of consultation, debate and revision, the standing committee of the National People’s Congress (NPC) adopted the 2009 Tort Law’.
<sup>
<xref ref-type="fn" rid="fn40-0968533212458430">40</xref>
</sup>
This law, together with the Chinese Contract Law (1999), the Chinese Property Law (2007), and several other branches of civil law, became part of the Chinese Civil Code. One of the objectives of the new Tort Law was to consolidate the provisions and principles of Tort Law scattered throughout more than 40 different pieces of legislation.
<sup>
<xref ref-type="fn" rid="fn41-0968533212458430">41</xref>
</sup>
Its 12 chapters and 92 provisions protect a nonexhaustive list of 18 categories of ‘civil rights and interests’.
<sup>
<xref ref-type="fn" rid="fn42-0968533212458430">42</xref>
</sup>
The remainder of this article is concerned with the implications of chapter 7 on informed consent.
<sup>
<xref ref-type="fn" rid="fn43-0968533212458430">43</xref>
</sup>
</p>
<p>Chapter 7 contains 11 articles (Articles 54–64). In addition to the context of diagnosis, treatment, and information disclosure, this chapter also encompasses liability for defective medical products.
<sup>
<xref ref-type="fn" rid="fn44-0968533212458430">44</xref>
</sup>
It provides new guidance on medical negligence law. The Tort law does not echo the concept of ‘medical accident’. It follows the GPCL’s principle that liability should be fault-based. If a patient is injured during diagnosis and medical treatment and such injury is caused by the fault of a medical institution and its staff, the institution shall be liable for compensation.
<sup>
<xref ref-type="fn" rid="fn45-0968533212458430">45</xref>
</sup>
</p>
<p>Before the new Tort Law, conflict and confusion existed over the issue of who (e.g. the patient or his family members) had the right to consent and therefore to be informed.
<sup>
<xref ref-type="fn" rid="fn46-0968533212458430">46</xref>
</sup>
There were three different theories. First, the 1998 Doctors Law adopted a ‘patient
<italic>or </italic>
family members’ approach.
<sup>
<xref ref-type="fn" rid="fn47-0968533212458430">47</xref>
</sup>
This gave patients and family members equal priority and status. More importantly, it regarded the patients’ consent as an alternative to the consent of family members. The second approach, ‘patient
<italic>and</italic>
family members’, was endorsed in the 1994 Institutions Regulation
<sup>
<xref ref-type="fn" rid="fn48-0968533212458430">48</xref>
</sup>
It formulated the ‘patients’ consent’ and ‘consent of family members or next of kin’ cumulatively rather than alternatively. Under this approach, the patients’ will could not be contravened or ignored and, comparatively speaking, it strengthened the importance of the patient’s autonomy and self-determination. But the patient’s exercise of this right was constrained by the involvement of family members. The 2002 Medical Accidents Regulation however, favoured a ‘patient’s consent’ approach.
<sup>
<xref ref-type="fn" rid="fn49-0968533212458430">49</xref>
</sup>
This third approach boldly accorded the right to know and decide to the patients themselves rather than their family members, and thereby moved closer to the spirit of the informed consent ideal. The new Tort Law has confirmed this third approach, reinforcing the notion that it is ‘the patients’ rather than ‘their family members’ who should exercise the right of self-determination. The following sections consider in detail the disclosure that must accompany, or rather precede, that consent.</p>
<sec id="section5-0968533212458430">
<title>What must be disclosed?</title>
<p>The 2009 Tort Law devotes two articles to the subject of information disclosure. Article 55 (1) provides that:
<disp-quote>
<p>Medical professionals shall, during diagnosis and treatment, inform patients about their conditions and treatment measures. If surgery, special examination, or special treatment is required, medical professionals shall disclose to patients about medical risks, alternative treatment plans and other information in a timely manner, and obtain their consent in writing. If it is not advisable to disclose information to the patient, information disclosure shall be served to his close family members whose written consent shall be obtained (emphasis added).
<sup>
<xref ref-type="fn" rid="fn50-0968533212458430">50</xref>
</sup>
</p>
</disp-quote>
Compared with previous legislation, the significant and very welcome step that the new Tort Law has taken is to expose a medical professional’s breach of the duty of disclosure to potential
<italic>civil (tort) liability</italic>
.
<sup>
<xref ref-type="fn" rid="fn51-0968533212458430">51</xref>
</sup>
Article 55 embraces the idea that in some circumstances, honest disclosure to the patient may not be desirable. This leaves room for application of ‘therapeutic privilege’. The law needs to clarify the circumstances which warrant applying this exception. Exceptions to the general duty to inform need to be interpreted narrowly and cautiously.</p>
<p>Article 56 creates a further exception based on emergency. If there is an imminent threat to the life of the patient and the opinion of the patient or his
<italic>close</italic>
family members cannot be obtained, corresponding medical measures may be performed immediately with the approval of the person in charge of the medical institution.
<sup>
<xref ref-type="fn" rid="fn52-0968533212458430">52</xref>
,
<xref ref-type="fn" rid="fn53-0968533212458430">53</xref>
</sup>
It is suggested that the situation where ‘the opinion of the patient or his close family members
<italic>cannot be obtained</italic>
’ should not be regarded as including one where the patient or his close family members
<italic>refuse</italic>
the treatment.
<sup>
<xref ref-type="fn" rid="fn54-0968533212458430">54</xref>
</sup>
</p>
</sec>
<sec id="section6-0968533212458430">
<title>Distinctiveness of the task of disclosure?</title>
<p>Chapter 7 of the Tort Law (Medical Damage Liability) has a
<italic>general</italic>
fault-based rule of medical liability (Article 54),
<sup>
<xref ref-type="fn" rid="fn55-0968533212458430">55</xref>
</sup>
standard of care provision (Article 57),
<sup>
<xref ref-type="fn" rid="fn56-0968533212458430">56</xref>
</sup>
presumption of fault provision (Article 58),
<sup>
<xref ref-type="fn" rid="fn57-0968533212458430">57</xref>
</sup>
and provision regarding defences to medical liability (Article 60).
<sup>
<xref ref-type="fn" rid="fn58-0968533212458430">58</xref>
</sup>
In addition to that, the Tort Law
<italic>separately</italic>
stipulates the doctor’s duty of disclosure (Articles 55 and 56). At this stage, it is still unclear
<italic>how distinctive</italic>
these informed consent provisions are or what the relationship is between those general medical liability provisions and the informed consent provisions. Should the general provisions govern and universally apply to the contexts of both diagnosis/treatment
<italic>and</italic>
information disclosure?</p>
<p>On one hand, embracing disclosure in the 2009 Tort Law indicates that the doctor’s duty to inform is being explored in the framework of Tort Liability and Medical Negligence Law. This means that some general medical negligence rules would unavoidably apply to both contexts, including information disclosure. Those rules may include the fault-based nature of liability, the general components of medical negligence liability (a duty of care, breach of duty, damage and causation), and the rules on burden of proof. On the other hand, devoting two separate provisions to the doctrine of informed consent may indicate that the context of information disclosure has some distinctiveness.</p>
<p>In the author’s view, the general provisions regarding medical damage liability cannot be applied uncritically and unthinkingly to the context of disclosure. For example, the key focus of Article 60 (defences to medical liability) is ‘diagnosis and treatment’ (诊疗(
<italic>zhen liao</italic>
)),
<sup>
<xref ref-type="fn" rid="fn59-0968533212458430">59</xref>
</sup>
rather than disclosure. Another example that supports the author’s view is that Article 58 presumes that medical professionals’ and medical institutions’ violation of laws, administrative regulations, rules and other diagnosis and treatment specifications involve being ‘at fault’. The laws and professional guidance are influential factors when the courts are engaged in the tasks of establishing the standard of care and finding negligence. But do those ‘external standards’ provide guidance and criteria on the issue of what kinds of information should be disclosed to patients? Even if the laws and professional guidelines can specify the medical risks and treatment options associated with a specified illness, it is doubtful that they can identify whether or not a particular patient would attach relevance and importance to those medical risks and treatment options. A further observation is that expert authentications and their conclusions would play a highly influential, if not decisive, role in establishing fault and causation. Does that mean that the persons who decide what information they need and, if the information had been disclosed, whether or not they would have chosen to undergo treatments should be the
<italic>experts</italic>
rather than the patients? To show loyalty to the rationale of the doctrine of informed consent, the author suggests that Chinese law might learn from other jurisdictions in recognising the distinctiveness of the task of disclosure from the tasks of diagnosis and treatment.</p>
<p>Most Commonwealth jurisdictions are familiar with the doctor-oriented ‘
<italic>Bolam </italic>
test’ used for determining the standard of care in medical negligence cases (so-called because it was adopted from the direction of the trial judge in the 1957 case of
<italic>Bolam v. Friern Hospital Management Committee)</italic>
.
<sup>
<xref ref-type="fn" rid="fn60-0968533212458430">60</xref>
</sup>
According to the
<italic>Bolam </italic>
test, the defendant doctor avoided liability in the tort of negligence provided he or she acted in accordance with an ‘accepted medical practice’, which must be regarded as proper by ‘a responsible body of medical men’ in that art. It is widely accepted that the Australian case of
<italic> Rogers v Whitaker</italic>
<sup>
<xref ref-type="fn" rid="fn61-0968533212458430">61</xref>
</sup>
marked a real departure from
<italic>Bolam</italic>
in the context of disclosure. The
<italic>Rogers </italic>
case involved an
<italic>inquisitive</italic>
patient and the High Court of Australia followed the landmark Canadian case of
<italic>Reibl v Hughes</italic>
,
<sup>
<xref ref-type="fn" rid="fn62-0968533212458430">62</xref>
</sup>
making it more explicit that medical opinions should not be conclusive in setting standards. That effect was achieved and vividly demonstrated by the court, highlighting the distinctiveness of the context of information disclosure. The dichotomy suggested in
<italic>Rogers</italic>
between the context of giving warnings or providing information and the context of diagnosis and treatment was maintained in some states’ statutory provisions in Australia. Consequently, most recent Australian civil liability statutes expressly deny the application of the reformulated
<italic>Bolam</italic>
test in the context of giving information.
<sup>
<xref ref-type="fn" rid="fn63-0968533212458430">63</xref>
</sup>
In the United States, especially in jurisdictions adopting the patient-oriented standard of information disclosure, the distinctiveness of information disclosure mainly comes from two aspects: (1) respect for the patient’s right of self-determination, and (2) more involvement of nonmedical judgement. Information disclosure is essentially a matter of practical and ethical considerations rather than one requiring exclusively medical judgement/technical skills.
<sup>
<xref ref-type="fn" rid="fn64-0968533212458430">64</xref>
</sup>
</p>
<p>China has already had a case in which the court explicitly pointed out that the duty to inform is distinct from the duty to provide service.
<sup>
<xref ref-type="fn" rid="fn65-0968533212458430">65</xref>
</sup>
The case involved 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. In the appeal court’s opinion, medical activities have two separate stages; the stage of informing a patient of a risk before operation and that of performing the operation. The appeal court relied significantly on the authentication report (medical expert opinion) in determining whether the doctor was negligent in
<italic>providing services</italic>
, but found the doctor in breach of the
<italic>duty to inform</italic>
even though the expert’s report did not touch on the issue.</p>
</sec>
<sec id="section7-0968533212458430">
<title>The doctor-oriented or the patient-oriented standard of disclosure?</title>
<p>As far as the scope of information disclosure is concerned, the patient-centred standard is not universally accepted. There are still jurisdictions which favour the doctor-oriented standard.
<sup>
<xref ref-type="fn" rid="fn66-0968533212458430">66</xref>
</sup>
The doctor-oriented standard stems from a misconceived perception that medical judgement and expert testimony are just as necessary to establish negligence in failing adequately to disclose as they are to proving negligence in diagnosis or treatment. The patient-oriented standard of information disclosure honours the patient’s right of self-determination and the distinctions drawn between ‘medical judgement’ and ‘layperson knowledge’, and between knowledge of ‘information’ and ‘materiality’ of information.</p>
<p>The 2009 Tort Law envisages three criteria as having value in determining whether conduct equates to medical negligence. The first is the ‘medical level’ criterion. According to Article 57, in determining ‘fault’ or ‘medical negligence’, the Tort Law asks whether a health-care professional failed to exercise care comparable with the then-prevailing medical standards or ‘the then-prevailing medical level’ (当时的医疗水平(
<italic>Dang Shi de Yi Liao Shui Ping</italic>
)).
<sup>
<xref ref-type="fn" rid="fn67-0968533212458430">67</xref>
</sup>
The ‘medical level’ (borrowed from the Japanese legal context) means a clinical level, not a scientific level, and is determined by the courts with reference to well-established and well-recognised medical practices.
<sup>
<xref ref-type="fn" rid="fn68-0968533212458430">68</xref>
</sup>
It does not embrace innovative, emerging, developing, and experimental treatments. The second criterion is ‘medical custom’ which is determined by the medical profession. Violating ‘laws, administrative regulations, rules, or other
<italic>stipulations regarding diagnostic and treatment practices</italic>
’ will result in the defendant-medical institution being presumed to be at fault.
<sup>
<xref ref-type="fn" rid="fn69-0968533212458430">69</xref>
</sup>
Medical custom plays a determinative role in establishing medical negligence because some scholars and legislators suggest that this
<italic>presumption of fault</italic>
should
<italic>not</italic>
be
<italic>rebuttable</italic>
.
<sup>
<xref ref-type="fn" rid="fn70-0968533212458430">70</xref>
</sup>
The third potential criterion relevant to establishing negligence in the context of Chinese Tort Law is the objective ‘reasonable doctor’ standard. The presence of this standard is evidenced by Article 60, which stipulates that, in a situation of emergency (such as rescuing the life of the patient who is critically ill) if health professionals have exercised
<italic>reasonable</italic>
care in their diagnosis and treatment, the medical institution does not bear liability for injuries suffered by the patient.
<sup>
<xref ref-type="fn" rid="fn71-0968533212458430">71</xref>
</sup>
Attempting to distinguish between these three doctor-oriented standards of care is beyond the scope of this article. However, whether those provisions, especially Article 57 (the standard of care/negligence provision), govern disclosure is an issue that is highly relevant to this article. To put it another way, in determining the scope of the doctor’s duty to inform, does the new Tort Law follow medical practice (the doctor-oriented standard) or patients’ informational needs (the patient-oriented standard)?</p>
<p>The Second Discussion Draft of the Tort Law formulated the first part of Article 57 in the following way: ‘Medical professionals shall fulfil the
<italic>duty of care</italic>
corresponding to the then-prevailing medical level.’
<sup>
<xref ref-type="fn" rid="fn72-0968533212458430">72</xref>
</sup>
However, the final version of the Tort Law provided that medical professionals shall fulfil ‘the
<italic>duty of diagnosis and treatment</italic>
corresponding to the then-prevailing medical level.’
<sup>
<xref ref-type="fn" rid="fn73-0968533212458430">73</xref>
</sup>
It is not clear why legislators replaced the term ‘the duty of care’ (注意义务(
<italic>Zhu Yi Yi Wu</italic>
)) with ‘the duty of diagnosis and treatment’ (诊疗义务 (
<italic>Zhen Liao Yi Wu</italic>
)), but clearly ‘the duty of diagnosis and treatment’ is less comprehensive than ‘the duty of care’.
<sup>
<xref ref-type="fn" rid="fn74-0968533212458430">74</xref>
</sup>
</p>
<p>Reading the new formulation of the provision regarding the standard of care, it is arguable that Article 57 is not intended to govern disclosure. That would leave some scope for reshaping the distinctive dimensions of disclosure. Article 57 endorses a ‘medical-practice-oriented’ standard of care. We cannot say that there is no relationship between medical practices and information disclosure. However, keeping some distance from Article 57, when formulating the scope of the duty to disclose, would give legal rules more flexibility to depart from the medical-practice-oriented standard and move to a more ‘patient-needs-oriented’ standard.</p>
</sec>
<sec id="section8-0968533212458430">
<title>Standards of disclosure in commonwealth jurisdictions</title>
<p>In Commonwealth jurisdictions, the scope of information disclosure often depends on whether the
<italic>Bolam</italic>
test applies or not. As detailed above, the
<italic>Bolam</italic>
test is a doctor-oriented test.
<sup>
<xref ref-type="fn" rid="fn75-0968533212458430">75</xref>
</sup>
In England, the landmark cases of
<italic> Bolam</italic>
and
<italic>Sidaway v Bethlem Royal Hospital Governors</italic>
, by according greater deference to the medical profession, established a doctor-oriented approach to the standard of information disclosure.
<sup>
<xref ref-type="fn" rid="fn76-0968533212458430">76</xref>
</sup>
However, it may be argued that English informed consent law no longer falls within the domain of
<italic>Bolam</italic>
.
<italic>Sidaway</italic>
did not unequivocally endorse the
<italic>Bolam</italic>
approach; Lord Scarman, for example, warmly embraced the patient-oriented standard of information disclosure and the notion of ‘materiality’ of risks. In
<italic>Pearce v United Bristol Healthcare NHS Trust</italic>
, Lord Woolf MR concluded that ‘if there is a significant risk which would affect the judgement of the reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.’
<sup>
<xref ref-type="fn" rid="fn77-0968533212458430">77</xref>
</sup>
Some commentators see Lord Woolf MR’s formulation of ‘a significant risk’ as a move closer to the prudent/reasonable patient standard. In any case, in English law the
<italic>Bolam</italic>
test is now subject to the
<italic>Bolitho</italic>
qualification. The
<italic> Bolitho</italic>
caveat is that, in order for a body of professional opinion to be held as ‘reasonable or responsible’, it should be ‘capable of withstanding logical analysis’.
<sup>
<xref ref-type="fn" rid="fn78-0968533212458430">78</xref>
</sup>
Therefore, if the
<italic>Bolam</italic>
test applies, a doctor’s failure to disclose must be supported by a body of medical opinion and the court must be convinced that the view supporting nondisclosure can withstand logical analysis. However, even if the
<italic>Bolam</italic>
test applies, a doctor is obliged to honestly respond to a patient’s information inquiry. The majority opinion in
<italic>Sidaway</italic>
distinguished the situation of ‘volunteering unsought information’ from the scenario of ‘responding to patient’s specific questions’, confining their pro-
<italic>Bolam </italic>
stance only to the former situation.
<sup>
<xref ref-type="fn" rid="fn79-0968533212458430">79</xref>
</sup>
A patient asking a specific question will expose the doctor to ‘a duty to give a reasonably adequate answer’.
<sup>
<xref ref-type="fn" rid="fn80-0968533212458430">80</xref>
</sup>
</p>
<p>As discussed above, the Australian case of
<italic> Rogers v Whitaker</italic>
<sup>
<xref ref-type="fn" rid="fn81-0968533212458430">81</xref>
</sup>
also departed from the
<italic>Bolam</italic>
test, offering a patient-oriented standard of disclosure.
<italic>Rogers</italic>
formulates the doctor’s duty as being a duty to warn patients of ‘material’ risks. Materiality has two limbs:
<disp-quote>
<p>a risk is material if, in the circumstances of the particular case,
<italic>a reasonable person in the patient’s position</italic>
, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that
<italic>the particular patient</italic>
, if warned of the risk, would be likely to attach significance to it. (emphasis added).
<sup>
<xref ref-type="fn" rid="fn82-0968533212458430">82</xref>
</sup>
</p>
</disp-quote>
The objective limb (the proactive duty to inform) explores whether ‘in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it’. It requires a medical practitioner to give information regardless of whether the practitioner knows or ought to know that the patient wants to be given the information. The word ‘a reasonable person in the patient’s position’ has both an objective element (a reasonable person) and a subjective element (in the patient’s position). The objective limb is actually a mixture of objectivity and subjectivity.</p>
<p>More prominently, the
<italic>Rogers</italic>
test has a specific subjective component. The second, or subjective, limb (the reactive duty to inform) recognises that
<italic>a particular patient</italic>
may not be a ‘reasonable’ one.
<sup>
<xref ref-type="fn" rid="fn83-0968533212458430">83</xref>
</sup>
The patient may have a number of ‘unreasonable’ concerns peculiar to them, they may ask questions or communicate in other ways concerns that ‘should have enlivened an appreciation’ on the part of doctors of the requirement to communicate
<italic>particular</italic>
information.
<sup>
<xref ref-type="fn" rid="fn84-0968533212458430">84</xref>
</sup>
These particular concerns should be given full weight if the medical practitioner was or should have been aware of them.
<sup>
<xref ref-type="fn" rid="fn85-0968533212458430">85</xref>
</sup>
This means that ‘the more inquisitive, or demanding, or less or more sophisticated perhaps, or obsessive, or suspicious, or hypochondriacal the patient may be, the greater the need for identification of and elaboration upon the slightest risks because such a patient may be likely to attach significance to them.’
<sup>
<xref ref-type="fn" rid="fn86-0968533212458430">86</xref>
</sup>
</p>
<p>One way of satisfying the subjective limb, thus triggering the doctor’s awareness, is by a patient asking questions, but that is not the only means of indicating or revealing particular concerns.
<sup>
<xref ref-type="fn" rid="fn87-0968533212458430">87</xref>
</sup>
There are ‘a multitude of potential circumstances’ in which a court might find that a medical practitioner should have known of a particular concern.
<sup>
<xref ref-type="fn" rid="fn88-0968533212458430">88</xref>
</sup>
In other words, under the
<italic>Rogers</italic>
test, the duty to disclose does not depend on a patient asking questions.</p>
<p>The Australian law indicates that, in determining whether a reasonable patient or the particular patient would be ‘likely to attach significance to’ a risk, the nature of the matter to be disclosed and the nature of the treatment may need to be considered.
<sup>
<xref ref-type="fn" rid="fn89-0968533212458430">89</xref>
</sup>
In particular, ‘the extent or severity of the potential injury’ and ‘the likelihood of the injury actually occurring’ are of great importance in cases of failure to warn.
<sup>
<xref ref-type="fn" rid="fn90-0968533212458430">90</xref>
</sup>
They should be considered together.
<sup>
<xref ref-type="fn" rid="fn91-0968533212458430">91</xref>
</sup>
They need to be weighed against the circumstances of the patient. These circumstances may include (a) the patient’s need for the operation
<sup>
<xref ref-type="fn" rid="fn92-0968533212458430">92</xref>
</sup>
; (b) the existence of reasonably available and satisfactory alternative treatments
<sup>
<xref ref-type="fn" rid="fn93-0968533212458430">93</xref>
</sup>
; and (c) whether the procedure is elective rather than lifesaving.
<sup>
<xref ref-type="fn" rid="fn94-0968533212458430">94</xref>
</sup>
</p>
<p>As far as the standard for disclosure is concerned, the
<italic>Bolam</italic>
and
<italic>Rogers</italic>
tests form a dichotomy. In Asian common law jurisdictions, Singapore shows continued loyalty to
<italic>Bolam</italic>
, even in the area of information disclosure. In the Singaporean case of
<italic>Gunapathy</italic>
,
<sup>
<xref ref-type="fn" rid="fn95-0968533212458430">95</xref>
</sup>
the Court of Appeal conducted ‘a comprehensive review of the
<italic>Bolam</italic>
jurisprudence’, especially ‘its meaning and ambit’,
<sup>
<xref ref-type="fn" rid="fn96-0968533212458430">96</xref>
</sup>
and finally confirmed that the
<italic>Bolam</italic>
test, as supplemented by
<italic>Bolitho</italic>
, is applicable to the issue of ‘advice’.
<sup>
<xref ref-type="fn" rid="fn97-0968533212458430">97</xref>
</sup>
That means that the law in Singapore chooses not to distinguish the issue of ‘advice’ or information disclosure from that of diagnosis and treatment. That stance was followed by subsequent cases.
<sup>
<xref ref-type="fn" rid="fn98-0968533212458430">98</xref>
</sup>
In a recent case involving claims of a doctor failing to inform a patient of both the risks associated with a treatment and alternative treatment options, the High Court endorsed the
<italic>Bolam/Bolitho/Gunapathy</italic>
approach, emphasising that ‘the doctor’s duty of care is comprehensive’.
<sup>
<xref ref-type="fn" rid="fn99-0968533212458430">99</xref>
</sup>
Following this approach, the
<italic>Bolam</italic>
test simply requires that a doctor’s practice relating to advice be affirmed by a body of responsible medical men skilled in his particular art.
<sup>
<xref ref-type="fn" rid="fn100-0968533212458430">100</xref>
</sup>
The question of the adequacy of medical advice is still largely within the scope of medical judgement as long as it is not illogical.
<sup>
<xref ref-type="fn" rid="fn101-0968533212458430">101</xref>
</sup>
</p>
<p>However, the
<italic>Rogers</italic>
test has found favour with the Malaysian courts. In
<italic> Foo Fio Na</italic>
,
<sup>
<xref ref-type="fn" rid="fn102-0968533212458430">102</xref>
</sup>
the Federal Court of Malaysia endorsed the
<italic>Rogers </italic>
approach in preference to the
<italic>Bolam </italic>
test, regarding the
<italic>Rogers</italic>
test as ‘a more appropriate and a viable test of this millennium’ than the
<italic>Bolam</italic>
test.
<sup>
<xref ref-type="fn" rid="fn103-0968533212458430">103</xref>
</sup>
In that case, the Court faced a question of whether the
<italic>Bolam</italic>
test should apply in relation to ‘all aspects of medical negligence’. The Court answered in the negative, opining that ‘the
<italic>Bolam</italic>
test has no relevance to the duty and standard of care of a medical practitioner in providing advice to a patient on the inherent and material risks of the proposed treatment’.
<sup>
<xref ref-type="fn" rid="fn104-0968533212458430">104</xref>
</sup>
The practitioner is ‘duty bound by law’ to inform the patient of the risks involved in any proposed treatment, provided the patient is capable of understanding and appreciating such information.
<sup>
<xref ref-type="fn" rid="fn105-0968533212458430">105</xref>
</sup>
</p>
<p>China’s Tort Law is not clear on which standard of disclosure (the doctor-oriented or the patient-oriented) it adopts. Its silence on this issue is regrettable because the task of choosing the standard of disclosure is unavoidable. At least in the common law world, the patient-oriented standard of disclosure has become a majority. I would suggest Chinese law follow that trend and adopt, at least, the objective limb of the ‘materiality’ test.</p>
</sec>
<sec id="section9-0968533212458430">
<title>What information?</title>
<p>The final version of Article 55 envisages a general context and a special context for the duty of disclosure. Generally, information about ‘conditions and treatment measures’ falls within a doctor’s duty to disclose. The general provision targets all diagnosis and treatment activities, including ‘surgery, special examination, and special treatment’. 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, cure or alleviate illness or pain, improve functions, prolong life and help patients to restore health’.
<sup>
<xref ref-type="fn" rid="fn106-0968533212458430">106</xref>
</sup>
However, when ‘surgery, special examination, or special treatment’ is involved, medical professionals shall,
<italic>additionally</italic>
, inform patients of ‘medical risks, alternative treatment plans and other information’.
<sup>
<xref ref-type="fn" rid="fn107-0968533212458430">107</xref>
</sup>
Furthermore, when the
<italic>special</italic>
context is engaged, the patient’s consent should be in writing.</p>
<p>‘Special examination’ and ‘special treatment’ mean (1) examination and treatment that entail some risks and possible negative consequences; (2) examination and treatment that may expose the patient to negative consequences and risks because of the patient’s idiosyncrasies or critical condition; (3) experimental clinical examination and treatment; and (4) examination and treatment that involve charges that may place large financial burden on the patient.
<sup>
<xref ref-type="fn" rid="fn108-0968533212458430">108</xref>
</sup>
It contemplates both the medical and the financial aspects of diagnosis and treatment.</p>
<p>Therefore, for invasive treatments, a doctor may need to disclose to patients their conditions, medical measures, medical risks, and alternative treatment plans and other information. The duty of disclosure in Chinese law therefore includes both disclosure of
<italic>risks</italic>
and disclosure of
<italic>alternatives</italic>
. Not all common law jurisdictions have embraced the disclosure of alternatives in the
<italic>legal</italic>
duty of information disclosure. This is partly attributable to the fact that the development of common law is reactive and piecemeal. By passing legislation on the matter, China has proactively expanded the scope of information disclosure to encompass information about both medical risks
<italic>and </italic>
alternative treatment options.</p>
<p>However, even in case law, Commonwealth jurisdictions have witnessed some developments that have overcome the piecemeal nature of common law. In the Canadian case of
<italic>Haughian v Paine</italic>
,
<sup>
<xref ref-type="fn" rid="fn109-0968533212458430">109</xref>
</sup>
the Saskatchewan Court of Appeal followed the Canadian line of authorities that focused on disclosure of
<italic>risks</italic>
<italic>Hopp v Lepp</italic>
,
<italic>Reibl v Hughes</italic>
and
<italic>Videto v Kennedy</italic>
.
<sup>
<xref ref-type="fn" rid="fn110-0968533212458430">110</xref>
</sup>
However, after quoting these cases and Lord Scarman’s opinion in
<italic>Sidaway</italic>
with approval, Sherstobitoff J.A., who delivered the judgment of the court, creatively observed that:
<disp-quote>
<p>I would
<italic>add</italic>
to the principles outlined above
<italic>a matter which was not under direct consideration</italic>
in the forgoing cases: In order to enable a patient to give informed consent, a surgeon must
<italic>also</italic>
, where the circumstances require it, explain to the patient
<italic>the consequences of leaving the ailment untreated, and alternative means of treatment and their risks</italic>
(emphasis added).
<sup>
<xref ref-type="fn" rid="fn111-0968533212458430">111</xref>
</sup>
</p>
</disp-quote>
The court found support for this observation from
<italic>Reibl v Hughes</italic>
, where a
<italic>commentator</italic>
quoted
<italic>Canterbury v Spence</italic>
and noted that expert testimony is necessary to establish not only the risks inherent in a given procedure but also ‘the consequences of leaving the ailment untreated, and alternative means of treatment and their risks’.
<sup>
<xref ref-type="fn" rid="fn112-0968533212458430">112</xref>
</sup>
</p>
<p>Singaporean case law provides another example of extending the duty to disclosure of alternatives – elevating a professional duty to a common law duty. In a case involving the issue of disclosure of treatment options, when applying the
<italic>Bolam</italic>
test to the context of information disclosure, the High Court cited the Ethical Code and Ethical Guidelines of Singapore Medical Council. The guidelines clearly set out a doctor’s responsibility to inform a patient about available alternatives, and the court viewed this as providing evidence as to the position taken by
<italic>a reasonable body of medical opinion</italic>
.
<italic>
<sup>
<xref ref-type="fn" rid="fn113-0968533212458430">113</xref>
</sup>
</italic>
</p>
</sec>
<sec id="section10-0968533212458430">
<title>What alternatives?</title>
<p>The 2009 Tort Law uses two terms – ‘treatment measures’ (医疗措施(
<italic>Yi Liao Cuo Shi</italic>
)) and ‘alternative treatment plans’ (替代医疗方案(
<italic>Ti Dai Yi Liao Fang An</italic>
)) – to describe treatment options. As they are used together in the same context, it is fair to construe the term ‘treatment measures’ as meaning ‘treatment options proposed or recommended by treating doctors’ and to interpret the term alternative treatment plans as covering ‘alternative treatment options to the proposed or recommended treatments’. The literal meaning of ‘plan’ is, arguably, broader than ‘treatment option’.
<sup>
<xref ref-type="fn" rid="fn114-0968533212458430">114</xref>
</sup>
</p>
<p>Reading Article 55 narrowly, the duty to disclose alternatives only applies to ‘surgery, special examination, or special treatment’. This mainly includes ‘invasive’, ‘risky’, ‘experimental’, and ‘expensive’ diagnostic and therapeutic activities.
<sup>
<xref ref-type="fn" rid="fn115-0968533212458430">115</xref>
</sup>
Therefore, when a doctor recommends or proposes a
<italic>surgical</italic>
or
<italic>invasive</italic>
treatment, the doctor should also inform patients of nonsurgical, noninvasive, or less invasive treatment options.
<sup>
<xref ref-type="fn" rid="fn116-0968533212458430">116</xref>
</sup>
Faced with
<italic>risky</italic>
treatments, a doctor needs to disclose alternatives that have better risk–benefit profiles or, at least, less risky alternative treatments. Where an
<italic>experimental</italic>
treatment is proposed, conventional or well-established treatment options need to be disclosed. Finally, a doctor needs to mention cheaper alternatives to
<italic>expensive</italic>
treatments.
<sup>
<xref ref-type="fn" rid="fn117-0968533212458430">117</xref>
</sup>
This is very important in China where a fee-for-service model of health care prevails and doctors have a strong financial incentive to propose and recommend expensive rather than cost-effective treatments.
<sup>
<xref ref-type="fn" rid="fn118-0968533212458430">118</xref>
</sup>
</p>
<p>In the context of diagnosis and treatment, Article 57 applies, which means that the law will determine negligence by considering ‘the then-prevailing medical level’. This level is in turn determined by well-established and widely recognised medical practices. Therefore, in the context of diagnosis and treatment, it is much safer for doctors to follow more conventional practices or treatments. However, arguably when the context shifts to disclosure, Article 57 does not apply, therefore, the scope of disclosure should not be confined to conventional and well-established treatment options. Innovative and emerging treatment options may fall within the duty to inform, even if there is not yet good evidence of their efficacy and safety.
<sup>
<xref ref-type="fn" rid="fn119-0968533212458430">119</xref>
</sup>
</p>
<p>This point is of particular importance because of China’s ‘integrated’ health care delivery system. Traditional Chinese Medicine (TCM), a form of ‘complementary and alternative medicine’ (CAM) in other jurisdictions, is one of the two ‘mainstream’ medicines in China, alongside Western medicine. TCM practitioners in China have a strong knowledge base of Western medicine, a fact which is attributable in the main to the integrative nature of the curriculum prepared for TCM students. Moreover, compared to CAM practitioners practising in Western countries, TCM practitioners in China enjoy a wider scope of practice, being able to use Western diagnostic methods and administer Western medical treatments. This lends weight to the argument that alternative Western medical treatments should more readily fall within Chinese TCM practitioners’ duty to inform about alternatives. For those ‘dual’ practitioners who have a Western medical degree and who have practiced Western medicine but have chosen to learn and practice TCM, patients’ expectation that they know and will disclose both conventional medicine and TCM treatments would be more justifiable.</p>
<p>Compared to TCM practitioners who are exposed to a strongly Western medicine-oriented integration, Western medicine practitioners in China have relatively weak knowledge about TCM. A TCM course is normally available for Western medicine students which would give them familiarity with basic TCM theories and therapies. According to the law, general practitioners and village doctors in China should possess basic TCM knowledge and know how to use basic TCM diagnosis and treatment methods to manage patients.
<sup>
<xref ref-type="fn" rid="fn120-0968533212458430">120</xref>
</sup>
Understandably, GPs and doctors in rural areas would have more access to, more frequent use of, and therefore more awareness of, TCM therapies than specialists and urban doctors.</p>
<p>Because of the ready availability of TCM practitioners and TCM practice in Chinese society, Western medicine practitioners tend not to learn and
<italic>practice</italic>
TCM or respond to patients’ demands to practice TCM. However, because they are exposed to an integrative medical culture and they know that TCM has a stable and widespread presence in health care, they have less excuse than their counterparts in Western developed countries to avoid mentioning TCM in their disclosure of alternative options. Moreover, patients in China are more likely to raise questions about TCM treatments. Furthermore, thanks to the integrated medical culture, the profiles of many TCM treatments and drugs, for example, prepared Chinese medicine, have been reformulated in the language of modern Western medicine. This, to some extent, eradicates linguistic barriers for Western medicine practitioners, enabling them to understand and move closer to TCM therapies. TCM therapies that have been rigorously tested under the Western medicine model, have clear risk–benefit profiles, and are comprehensible to Western medicine practitioners, ought perhaps therefore to fall within the ambit of Western medicine practitioners’ duty to disclose.</p>
<p>One final point worthy of comment is that the applicable medical levels in China vary greatly between urban areas and rural areas, between provincial hospitals and county hospitals, and between bigger cities and smaller towns. These facts raise another issue of whether a doctor needs to advise patients about ‘alternative providers’.
<sup>
<xref ref-type="fn" rid="fn121-0968533212458430">121</xref>
</sup>
For complicated, highly skill-dependent treatments, I would argue that less experienced practitioners need to honestly acknowledge their limitations and inform their patients of the availability of more experienced or skilled practitioners and medical institutions. It needs to be noted that the information to be disclosed is expressed in wide-ranging terms in the Chinese Tort Law. The Law adopts the potentially all-encompassing term ‘other information’ when formulating the scope of disclosure. It leaves open the possibility that a doctor needs to disclose ‘doctor-specific information’, such as a doctor’s inexperience and health, when that information, although extrinsic to treatments, poses additional risks to the patient’s health.</p>
</sec>
<sec id="section11-0968533212458430">
<title>Materiality</title>
<p>In framing the scope of information disclosure, the 2009 Tort Law is silent on the ‘materiality’ test. The author strongly recommends that the materiality test,
<sup>
<xref ref-type="fn" rid="fn122-0968533212458430">122</xref>
</sup>
together with the patient-oriented standard of information disclosure, be introduced into Chinese informed consent law. The materiality test only requires a doctor to give patients information to which those patients would attach significance. It strikes a good balance between a patient’s informational needs and a doctor’s disclosure burden. The notion of materiality is not completely new to Chinese medical law. For example, in formulating the doctrine of informed consent, China’s Code of Ethics for Human Assisted Reproductive Technologies has already adopted the phrase of ‘material information’.
<sup>
<xref ref-type="fn" rid="fn123-0968533212458430">123</xref>
</sup>
</p>
<p>Materiality usually means the
<italic>significance</italic>
a reasonable person in the patient’s position would attach to the undisclosed information in deciding whether to submit or not to submit to treatment.
<sup>
<xref ref-type="fn" rid="fn124-0968533212458430">124</xref>
</sup>
The definitional uncertainties associated with the concept may cause difficulties for the courts. There is no bright line separating the significant from the insignificant.
<sup>
<xref ref-type="fn" rid="fn125-0968533212458430">125</xref>
</sup>
The materiality test would summon the physician to second-guess the patient whose ideas on materiality could hardly be known to the physician.
<sup>
<xref ref-type="fn" rid="fn126-0968533212458430">126</xref>
</sup>
However, although a physician cannot know with certainty what the patient would consider important to his decision, medical training and experience can produce a
<italic>sense</italic>
of how the average, reasonable patient would probably react.
<sup>
<xref ref-type="fn" rid="fn127-0968533212458430">127</xref>
</sup>
</p>
</sec>
</sec>
</sec>
<sec id="section12-0968533212458430">
<title>Future directions for Chinese informed consent law</title>
<p>Notwithstanding the uncertainties set out above, the author remains optimistic about the future of Chinese informed consent law. The Chinese legislative process relies heavily on legal scholars’ input, and Chinese scholars are very open-minded towards developments in other jurisdictions, including civil law and common law jurisdictions. Japan and China not only share the same civil law tradition but also have some language similarity. These facts determine that Japanese law in particular, together with the laws of other jurisdictions, may influence the development of Chinese law. This article concludes by summarising Japanese informed consent law and presenting some observations which reflect the author’s hopes about the directions in which Chinese law should develop.</p>
<sec id="section13-0968533212458430">
<title>Following the Japanese route to informed consent?</title>
<p>Although it was once argued that the informed consent rule, which was developed in Western countries, did not fit comfortably with native Japanese culture, the view that the informed consent doctrine had universal value has finally prevailed in Japan.
<sup>
<xref ref-type="fn" rid="fn128-0968533212458430">128</xref>
</sup>
As far as the duty to disclose is concerned, Japanese courts used to adopt the ‘reasonable doctor’ test, attaching great weight to ‘the then-prevailing medical level’ or ‘a doctor’s reasonable discretion’ when measuring whether there was a breach of the duty to inform.
<sup>
<xref ref-type="fn" rid="fn129-0968533212458430">129</xref>
</sup>
From the 1990s judicial attitudes shifted towards a patient-oriented standard.
<sup>
<xref ref-type="fn" rid="fn130-0968533212458430">130</xref>
</sup>
Courts began to pay attention to the issues of whether the patient would attach importance to the undisclosed information and whether the doctor had actual or constructive knowledge of that fact.
<sup>
<xref ref-type="fn" rid="fn131-0968533212458430">131</xref>
</sup>
</p>
<p>Japanese scholars have articulated the duty to disclose as extending to (1) the patient’s condition; (2) the diagnosis and treatment proposed by the doctor; (3) alternative treatment options; and (4) the consequences of refusing proposed treatments.
<sup>
<xref ref-type="fn" rid="fn132-0968533212458430">132</xref>
</sup>
However, it was only after the 1990s that Japanese courts began to incorporate disclosure of
<italic>alternative treatment options</italic>
into the duty to inform.
<sup>
<xref ref-type="fn" rid="fn133-0968533212458430">133</xref>
</sup>
Earlier court judgments tended to treat the selection of treatment options as a matter for medical
<italic>discretion</italic>
.
<sup>
<xref ref-type="fn" rid="fn134-0968533212458430">134</xref>
</sup>
Since 1992, many cases concerning disclosure of alternative treatment options emerged. For the purposes of this article, this area of Japanese law is explored in the context of three hypothetical situations.</p>
<p>The first situation is where the doctor proposes an
<italic>experimental</italic>
treatment option. Similarly to the common law, Japanese law has embraced two basic rules. First, disclosure should differentiate between experimental and conventional or well-established treatments. A doctor proposing experimental treatment will attract a
<italic>more rigorous or strengthened</italic>
duty of disclosure
<sup>
<xref ref-type="fn" rid="fn135-0968533212458430">135</xref>
</sup>
and must inform the patient of alternative treatment options, especially
<italic>well-established</italic>
,
<italic>standard</italic>
, or
<italic>mainstream</italic>
treatment options.
<sup>
<xref ref-type="fn" rid="fn136-0968533212458430">136</xref>
</sup>
For example, when the new or innovative surgical treatment is proposed, the doctor should inform the patient of the availability of
<italic>conservative</italic>
treatment options and compare the risks and benefits of both options.
<sup>
<xref ref-type="fn" rid="fn137-0968533212458430">137</xref>
</sup>
</p>
<p>The second situation involves a doctor proposing
<italic> elective or cosmetic procedures</italic>
. Again, the elective or cosmetic nature of the proposed procedure triggers a
<italic>heightened</italic>
duty of disclosure.
<sup>
<xref ref-type="fn" rid="fn138-0968533212458430">138</xref>
</sup>
If the procedure does not have any therapeutic purpose, the doctor should fully disclose both sides of the procedure, especially its dark side, in order to counterbalance the patient’s unrealistic impression or overoptimistic expectation.
<sup>
<xref ref-type="fn" rid="fn139-0968533212458430">139</xref>
</sup>
Additionally, a procedure’s lack of urgency and necessity demonstrates and reinforces the need to disclose the available alternatives.
<sup>
<xref ref-type="fn" rid="fn140-0968533212458430">140</xref>
</sup>
</p>
<p>The third situation involves a doctor’s proposal of
<italic> well-established treatments and the availability of less well-established treatment options</italic>
. The controversial issue raised in this context is whether or not a doctor has the duty to disclose new, minority, or less well-established treatment options. This highlights the importance of clarifying the relationship between the ‘medical level’ theory and the scope of a doctor’s duty to inform. Precisely this issue was raised in a Japanese Supreme Court case in 2001.
<sup>
<xref ref-type="fn" rid="fn141-0968533212458430">141</xref>
</sup>
The case involved the choice between radical surgery (radical mastectomy) and the less disfiguring alternative (breast-conserving surgery). At the relevant time, breast-conserving surgery was not an orthodox or standard treatment for breast cancer patients in Japan and did not meet the medical level at that time in Japan.
<sup>
<xref ref-type="fn" rid="fn142-0968533212458430">142</xref>
</sup>
Breast-conserving surgery did, however, enjoy some degree of recognition in the academic and clinical field.
<sup>
<xref ref-type="fn" rid="fn143-0968533212458430">143</xref>
</sup>
Furthermore, the doctor concerned knew about the breast-conserving surgery, had performed it on two other patients and, according to the then-existing breast-conserving surgery guidelines, the patient was an appropriate candidate for the surgery. The doctor mentioned the breast-conserving surgery but only in an indirect and negative way. The patient claimed damages, alleging that the doctor breached his duty to
<italic>administer (provide)</italic>
and
<italic>disclose</italic>
the breast-conserving surgery. The Supreme Court held that the defendant doctor’s disclosures to the patient regarding the breast-conserving surgery were insufficient. The judgment observed that, when a disease has multiple treatment options available and all of the treatments are
<italic>well established</italic>
, it is easier to hold that a doctor should disclose the risks–benefits of all of those treatment options.
<sup>
<xref ref-type="fn" rid="fn144-0968533212458430">144</xref>
</sup>
The court did, however, attempt to formulate rules to apply when both well-established treatments and nonorthodox therapies were involved.
<sup>
<xref ref-type="fn" rid="fn145-0968533212458430">145</xref>
</sup>
</p>
<p>First, the treatments that a doctor proposes to
<italic>administer</italic>
are, generally, ones that are recognised by the medical level.
<sup>
<xref ref-type="fn" rid="fn146-0968533212458430">146</xref>
</sup>
This means that doctors generally
<italic>propose and administer </italic>
treatments which have been widely accepted and their safety and efficacy has been well established. Second, for treatments that have not been recognised by the medical level, a doctor does
<italic>not always</italic>
have a duty to disclose them.
<sup>
<xref ref-type="fn" rid="fn147-0968533212458430">147</xref>
</sup>
However,
<italic>under some circumstances</italic>
, a doctor needs to
<italic>inform</italic>
his patient of nonorthodox treatment options.
<sup>
<xref ref-type="fn" rid="fn148-0968533212458430">148</xref>
</sup>
The circumstances that the court contemplated as triggering discussion of the nonorthodox treatments included situations where:
<disp-quote>
<p>one therapy (mode of surgery) has been administered in many medical institutions, has
<italic>a significant number of cases of administration</italic>
, and is
<italic>being positively evaluated</italic>
by doctors who had administered it, and if the patient concerned is
<italic>a candidate for this therapy</italic>
(mode of surgery), and the doctor has already been explicitly informed that the patient has
<italic>a strong desire</italic>
to know whether or not she is a good candidate for this therapy (mode of surgery) and to know the possibility of administrating it,
<italic>even if the doctor adopts negative attitudes towards the therapy (mode of surgery) and refuses to administer it himself</italic>
, the doctor has the duty,
<italic>within his knowledge</italic>
, to inform his patient of content of the therapy (mode of surgery), its possibility of application or its risks-benefits, and the name and address of medical institutions that are administering the therapy (mode of surgery), and other information (emphasis added).
<sup>
<xref ref-type="fn" rid="fn149-0968533212458430">149</xref>
</sup>
</p>
</disp-quote>
The Supreme Court’s approach rightly honours the distinction between the duty to
<italic>administer</italic>
treatments and the duty to
<italic>disclose</italic>
information about treatments. It acknowledges that a doctor’s personal attitudes should not impinge upon his duty to disclose. When formulating the expansive approach, the court also defined the circumstances under which the approach would be applied. First, the treatment option that needs to be disclosed must enjoy a degree of acceptance in medical profession, and positive evidence of its safety and efficacy must be accumulating. Second, the court attached importance to the patients’
<italic>wishes</italic>
and informational needs. Third, the emerging method of surgery must have already fallen within the doctor’s actual
<italic>knowledge</italic>
. Fourth, considering her
<italic>condition</italic>
, the doctor would acknowledge that the patient is a
<italic>candidate</italic>
for the emerging mode of surgery. Finally, the relevance of lifestyle to the choice of breast cancer treatments played a part in the court’s thinking.
<sup>
<xref ref-type="fn" rid="fn150-0968533212458430">150</xref>
</sup>
</p>
<p>In the view of the Supreme Court, this approach would afford the patient an opportunity to consider whether to undergo the proposed radical mastectomy or to pursue the breast-conserving surgery in other medical institutions that provide it.
<sup>
<xref ref-type="fn" rid="fn151-0968533212458430">151</xref>
</sup>
<italic>Disclosing </italic>
the option of breast-conserving surgery does not mean that the doctor has a duty to
<italic>administer</italic>
the option himself.
<sup>
<xref ref-type="fn" rid="fn152-0968533212458430">152</xref>
</sup>
Nor does it mean that he has a duty to persuade the patient to receive the option in other medical institutions.
<sup>
<xref ref-type="fn" rid="fn153-0968533212458430">153</xref>
</sup>
Doctors can retain their own judgement that radical mastectomy is the best surgical option for the patient.
<sup>
<xref ref-type="fn" rid="fn154-0968533212458430">154</xref>
</sup>
</p>
<p>The line of thinking in this Radical Mastectomy Case has been followed by other Japanese cases.
<sup>
<xref ref-type="fn" rid="fn155-0968533212458430">155</xref>
</sup>
However, the case triggered debate; critics asserted that the Supreme Court’s approach ignored the doctor’s
<italic>personal attitudes</italic>
towards treatment and diluted the status of medical experts.
<sup>
<xref ref-type="fn" rid="fn156-0968533212458430">156</xref>
</sup>
The author who originally provided this account of Japanese law was also of the view that the law should not treat the duty to administer and the duty to inform differently.
<sup>
<xref ref-type="fn" rid="fn157-0968533212458430">157</xref>
</sup>
She argued that the medical level theory should be applied universally to the contexts of both treatment and information disclosure.
<sup>
<xref ref-type="fn" rid="fn158-0968533212458430">158</xref>
</sup>
The author of this article has challenged this view in the Chinese academic world.
<sup>
<xref ref-type="fn" rid="fn159-0968533212458430">159</xref>
</sup>
The significance of the case is its recognition of the inappropriateness of applying the medical level theory unthinkingly to the context of disclosure. The duty to
<italic>recommend</italic>
(even persuade) and
<italic>administer</italic>
is distinct from the duty to
<italic>inform</italic>
. The law should ensure that a doctor’s disclosure is not adulterated by personal preferences.</p>
<p>The Japanese Radical Mastectomy case involved an option intrinsically connected with lifestyle choices and a nonorthodox treatment option. It has special value in the discussion of a doctor’s duty to disclose
<italic>minority</italic>
,
<italic>emerging</italic>
and
<italic>developing </italic>
treatment options. Confining the duty to inform to well-established, orthodox treatment options does not always sit comfortably with the rationale underlying the informed consent rule. It also sends a message that a doctor has a duty to be kept informed of
<italic>new</italic>
treatment options where the safety and efficacy of these is becoming more established.</p>
<p>Other aspects of Japanese law (with which the author agrees) regarding disclosure of alternatives include the following: (1) A patient’s specific condition may determine the scope and the availability of treatment options. A doctor need only disclose treatment options that fit a patient’s condition.
<sup>
<xref ref-type="fn" rid="fn160-0968533212458430">160</xref>
</sup>
A patient’s condition may dictate that the treatment proposed by a doctor is the only option for the patient.
<sup>
<xref ref-type="fn" rid="fn161-0968533212458430">161</xref>
</sup>
(2) Where two or more (multiple) treatment options are available to a patient, and one forms the first best option and another constitutes the second best option, the doctor needs to disclose the risk–benefit balances of both options.
<sup>
<xref ref-type="fn" rid="fn162-0968533212458430">162</xref>
</sup>
</p>
<p>However, some aspects of the Japanese case law raise concerns. For example, when several treatment options have similar risk–benefit profiles, it has been suggested that the choice between these options is a matter for medical discretion to choose between options and there is no duty to disclose the risks and benefits of treatment options.
<sup>
<xref ref-type="fn" rid="fn163-0968533212458430">163</xref>
</sup>
This ignores the fact that the patients’ values, lifestyles, and risk tolerance levels may be different from those of the doctors. Further, some scholars take the view that there is no duty to inform of alternative treatment options when several treatment options have the same therapeutic significance, if the treatment proposed by the doctor is less risky than alternatives or entails the same risks as alternatives, and has the same benefits or more benefits than alternatives.
<sup>
<xref ref-type="fn" rid="fn164-0968533212458430">164</xref>
</sup>
This suggestion suffers from the same weaknesses that existed in the first example of rule. Moreover, both propositions set out above fail to recognise that the choice of treatment options is not a mere exercise of balancing medical risks and benefits but should accommodate patients’ personal circumstances. Furthermore, the significance of disclosure of alternatives is described by the author who introduced the Japanese law as being to convince patients to follow a doctor’s judgement and cooperate with treatments.
<sup>
<xref ref-type="fn" rid="fn165-0968533212458430">165</xref>
</sup>
It is difficult to agree with this utilitarian and instrumental approach as it does not grasp the real purpose of the informed consent rule.</p>
</sec>
<sec id="section14-0968533212458430">
<title>The English case of
<italic>Birch</italic>
: disclosure of alternatives in a
<italic>Bolam</italic>
-dominated jurisdiction</title>
<p>Like the Japanese radical mastectomy case, the recent English case of
<italic>Birch v University College Hospitals NHS Trust</italic>
also deals with the issue of disclosing alternatives.
<sup>
<xref ref-type="fn" rid="fn166-0968533212458430">166</xref>
</sup>
<italic>Birch</italic>
contemplates that there will be circumstances where a doctor’s duty to inform may encompass the ‘comparative risks’ of
<italic>different</italic>
procedures. However, the
<italic>Birch</italic>
court formulated its ruling with great caution.</p>
<p>
<italic>Birch</italic>
concerned a choice between two imaging methods, catheter angiography (angiogram) and magnetic resonance imaging (MRI). While the defendant was not found negligent in deciding to undertake an angiogram, the High Court found the defendant liable to the claimant because of a failure to discuss with the claimant the different imaging methods – catheter angiography and MRI – and the comparative risks.</p>
<p>The High Court found that the defendant’s decision to
<italic>choose</italic>
angiography over MRI represented ‘a responsible body of medical opinion’
<sup>
<xref ref-type="fn" rid="fn167-0968533212458430">167</xref>
</sup>
and could withstand ‘logical analysis’.
<sup>
<xref ref-type="fn" rid="fn168-0968533212458430">168</xref>
</sup>
Although there was a bias among neurosurgeons in favour of excluding an aneurysm because of the dramatic consequences of missing such a diagnosis,
<sup>
<xref ref-type="fn" rid="fn169-0968533212458430">169</xref>
</sup>
the defendant’s choice in favour of catheter angiography, albeit focusing on the aneurysm, involved a weighing of the risks and benefits.
<sup>
<xref ref-type="fn" rid="fn170-0968533212458430">170</xref>
</sup>
However, when it came to information disclosure, the court found that the defendant had a duty to discuss the comparative risks of the catheter angiography alongside MRI,
<sup>
<xref ref-type="fn" rid="fn171-0968533212458430">171</xref>
</sup>
envisaging that ‘there will be circumstances where … the duty to inform a patient of the significant risks will not be discharged unless she is made aware that fewer, or no risks, are associated with another procedure’.
<sup>
<xref ref-type="fn" rid="fn172-0968533212458430">172</xref>
</sup>
Third, the court distinguished ‘information disclosure’ from ‘recommendation’. Doctors are free to offer patients recommendations and preferences on the issue of which course of action would provide the optimum outcome for the patients and should be pursued instead of others. However, that should not inhibit them from presenting patients with ‘dispassionate’, ‘fair’ and ‘balanced’ information.
<sup>
<xref ref-type="fn" rid="fn173-0968533212458430">173</xref>
</sup>
</p>
<p>Despite those positive moves, we should approach
<italic>Birch</italic>
with great caution. The move in
<italic>Birch</italic>
is fact driven and easily distinguished. First, the court’s expansive approach to disclosure is confined to ‘unusual’ or ‘special’ circumstances, such as those present in
<italic>Birch </italic>
itself.
<sup>
<xref ref-type="fn" rid="fn174-0968533212458430">174</xref>
</sup>
The court felt difficulty ‘in delineating, in general terms, the circumstances in which the duty arises to inform of comparative risks’.
<sup>
<xref ref-type="fn" rid="fn175-0968533212458430">175</xref>
</sup>
Second, the court only envisaged that the patient needed to be made aware that ‘fewer, or no risks’ were associated with the alternative procedure.
<sup>
<xref ref-type="fn" rid="fn176-0968533212458430">176</xref>
</sup>
In the case, the undisclosed alternative procedure was noninvasive, conservative, and less risky than the proposed procedure. The case involved a specific context where the undisclosed alternative procedure offered brighter prospects than the proposed procedure. This factual context warrants a reservation about the
<italic>Birch</italic>
court’s seemingly generous approach. Third, although
<italic>Birch</italic>
raised the possibility of a doctor disclosing an ‘alternative’ procedure, its focus was still on the ‘risk’ aspect of disclosure. The task of the court was to explore what the duty to inform of ‘significant risks’, as formulated by Lord Woof MR in
<italic>Pearce</italic>
, would encompass.
<sup>
<xref ref-type="fn" rid="fn177-0968533212458430">177</xref>
</sup>
The question the court posed was, in addition to informing the patient of the
<italic>significant risks associated with the procedure which was performed</italic>
, the catheter angiogram, ‘[w]as it necessary for the defendant to go further and to inform [the claimant] of
<italic>comparative risk, how this risk compared with that associated with other imaging procedures</italic>
, in particular MRI?’
<sup>
<xref ref-type="fn" rid="fn178-0968533212458430">178</xref>
</sup>
</p>
<p>Finally, in formulating the rule regarding a doctor’s duty to inform about comparative risks of an alternative procedure, the court still followed the
<italic>Bolam-Bolitho</italic>
line of enquiry, looking at whether there was a responsible body of medical opinion that withstood logical scrutiny. Due to the paucity of authorities, the court turned to the
<italic>Bolam-Bolitho</italic>
two-step analysis to justify its conclusion that the defendant’s failure to disclose constituted a breach of duty.
<sup>
<xref ref-type="fn" rid="fn179-0968533212458430">179</xref>
</sup>
This creates confusion. As the court noted, there was
<italic>disagreement</italic>
among medical practitioners as to whether the claimant should have been informed of comparative risks of alternative procedures,
<sup>
<xref ref-type="fn" rid="fn180-0968533212458430">180</xref>
</sup>
and the defendant had many
<italic>followers</italic>
. The
<italic>Bolam</italic>
test, if applied, should save him. To justify its reasoning under the
<italic>Bolam-Bolitho</italic>
line of analysis, the court had no other choice but to favour and rely heavily on what
<italic>one</italic>
expert said.
<sup>
<xref ref-type="fn" rid="fn181-0968533212458430">181</xref>
</sup>
</p>
<p>In the author’s view, a patient-oriented test is more appropriate to the matter of disclosure of alternatives than a doctor-oriented one. The rationale of a doctor-oriented standard, such as the
<italic>Bolam</italic>
test, is to honour the differences of medical opinions. However, the core purpose of disclosure of alternatives is to require doctors to overcome their preferences and differences of medical opinions and to provide patients with balanced and contextualised information about alternatives. It is difficult, if not impossible, for a doctor-oriented test to fulfil that purpose.</p>
<p>Admittedly, it is not easy to define the precise parameters of the legal duty to disclose alternatives. Much will depend on a court’s evaluation of whether a reasonable person in the patient’s position would attach significance to the information about alternatives in making medical decisions. It is understandable, especially in the context of tort where a court needs to consider both the materiality of information and causation, to hold that the alternative treatment options that fall within a doctor’s duty to inform are those that have less or no risks than the proposed treatment. However, the law should not exclude the possibility that those alternatives that are more risky or less promising than the proposed treatment may fall within a doctor’s duty to inform. That is due to the fact that doctors and patients may have different values, risk–benefit balances, and risk tolerance levels. Fully engaging patients with the discussion of information and remaining sensitive to patients’ concerns becomes paramount.</p>
</sec>
</sec>
<sec id="section15-0968533212458430">
<title>Conclusion</title>
<p>The 2009 Tort Law introduces a new way of thinking about Chinese medical negligence, including the important issue of informed consent. It has many merits. It shows loyalty to the basic theory of fault-based liability and the objective test for standard of care. It follows the practice of allowing the medical profession an important, if not decisive, say on the standard of care. It attaches importance to statutory and professional practices in establishing the standard of care and negligence. It creates separate provisions governing informed consent and provides access to tort liability for patients alleging breach of the informed consent rule.</p>
<p>However, the 2009 Tort Law suffers from a lack of detail and clarity. Hopefully, future judicial interpretations will help overcome these uncertainties. Chinese law can then accommodate common law wisdom in formulating informed consent rules. This may also help Chinese tort law overcome its current low awareness of the distinctiveness of the informed consent rule; this article demonstrates that there is certainly room for Chinese law to distinguish information disclosure from diagnosis and treatment and to give the former context distinct rules.</p>
<p>Another weakness of the new Tort Law is that it is somewhat all embracing and too ambitious, and it fails to recognise that tort law does not always offer the best context to deal with medical law issues.
<sup>
<xref ref-type="fn" rid="fn182-0968533212458430">182</xref>
</sup>
If the law wants to lower the threshold for liability for breach of the informed consent rule, and to give a patient’s right of self-determination high priority, it can do it in other contexts. In this respect, New Zealand’s Code of Patients’ Rights
<sup>
<xref ref-type="fn" rid="fn183-0968533212458430">183</xref>
</sup>
and a Health and Disability Commissioner (HDC) offers a good example. A Chinese survey suggested that 91% of patient respondents believe that they need an independent body (like the existing China’s Consumers Protection Association) to protect and advocate their rights.
<sup>
<xref ref-type="fn" rid="fn184-0968533212458430">184</xref>
</sup>
New Zealand’s approach is better than the Chinese approach in protecting patients’ right to be informed. Unlike the context of medical negligence liability, New Zealand’s Code does not involve considerations of causation and damage. Whether the information about the undisclosed risks and alternatives would make a difference to a patient’s decision and injury has no bearing on the issue of whether there is a breach of the Code. The Commissioner will only consider the patients’ expectation and need
<sup>
<xref ref-type="fn" rid="fn185-0968533212458430">185</xref>
</sup>
with regard to information disclosure. The author would like to see Chinese medical negligence law and informed consent law supplemented by rigorous medical professional regulation.</p>
<p>The process of informed consent taking involves two stages: (1) the doctor discussing information with the patient and helping her/him to understand it; and (2) the patient signing the consent form. The first stage is more important than the second. This fact may partly explain why New Zealand’s Code affords patients a separate right to ‘effective communication’, along with the ‘right to be fully informed’ and the ‘right to make an informed choice and give informed consent’. Under the Code, every consumer/patient has the statutory ‘right to effective communication in a form, language, and manner that enables the consumer to understand the information provided’, and ‘the right to an environment that enables both consumer and provider to communicate openly, honestly, and effectively’.
<sup>
<xref ref-type="fn" rid="fn186-0968533212458430">186</xref>
</sup>
All of this would suggest that the role of professional regulation in proactively improving the process of informed consent taking should not be ignored.</p>
</sec>
</body>
<back>
<ack>
<title>Acknowledgements</title>
<p>The author thanks the anonymous reviewers for their helpful comments and suggestions. The author also thanks Professor Peter Skegg and Professor Mark Henaghan for their encouraging comments on an earlier draft of this article. Thanks also go to Huiyun Chan (PhD candidate, Faculty of Law, University of Otago, New Zealand) and Kaan Sheung-Hung Terry (Associate Professor, Faculty of Law, National University of Singapore) for their kind helps in locating Malaysia and Singapore law materials. The author is responsible for the arguments presented in this article and for any errors.</p>
</ack>
<fn-group>
<fn fn-type="financial-disclosure" id="fn187-0968533212458430">
<label>Funding</label>
<p>This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.</p>
</fn>
</fn-group>
<fn-group>
<fn fn-type="other" id="fn1-0968533212458430">
<label>1</label>
<p>Y. Zhang, F. Sun ‘Localization of Informed Consent in China: The Trend of Informed Consent in the Context of Chinese Culture’
<italic>Medicine and Philosophy</italic>
25 (2004), pp. 12, 12–15 (arguing for the doctrine of informed consent being ‘localised’ or ‘contextualised’ in Chinese culture rather than copying it uncritically and without adjustment into Chinese context); H. Chen ‘A Reflection on Informed Consent from the Different Perspectives of Chinese and Western Cultures’
<italic>Medicine and Philosophy </italic>
30 (2009), pp. 17, 17–19.</p>
</fn>
<fn fn-type="other" id="fn2-0968533212458430">
<label>2</label>
<p>Q.Dai ‘Informed Consent in China:
<italic>Status Quo</italic>
and Its Future’
<italic>Medical Law International</italic>
6 (2003), pp. 53, 54–56; A. Zhang, Y. Dong ‘Analysis on the Reasons for Difficulties in Enforcing Informed Consent’
<italic>Chinese Medical Ethics</italic>
23 (2010), pp. 30, 30–31.</p>
</fn>
<fn fn-type="other" id="fn3-0968533212458430">
<label>3</label>
<p>J. Nie ‘Is Informed Consent Not Applicable in China? Intellectual Flaws of the ‘‘Cultural Difference Argument’’
<italic>Medicine and Philosophy</italic>
23 (2002), pp. 18, 18–22 (citing ‘truth telling and terminal disease’ as an example to illustrate that, when concealing or withholding truth in the context of terminal disease, Chinese doctors nowadays actually followed the old Western biomedical mode and forgot the standard medical practice of telling the whole truth in traditional China).</p>
</fn>
<fn fn-type="other" id="fn4-0968533212458430">
<label>4</label>
<p>Nie, ‘Informed’, p. 21.</p>
</fn>
<fn fn-type="other" id="fn5-0968533212458430">
<label>5</label>
<p>M.C.Tai, T.Tsai ‘Who Makes the Decision? Patient’s Autonomy vs Paternalism in a Confucian Society’
<italic>Croatian Medical Journal</italic>
44 (2003), pp. 558, 558–561.</p>
</fn>
<fn fn-type="other" id="fn6-0968533212458430">
<label>6</label>
<p>Y. Wang, Y. Xu ‘Survey on Implementation of the Informed Consent Rule in Hospitals’
<italic>Hosp Admin J Chin PLA</italic>
16 (2009), pp. 52, 53.</p>
</fn>
<fn fn-type="other" id="fn7-0968533212458430">
<label> 7</label>
<p>Wang, ‘Survey’, p. 53.</p>
</fn>
<fn fn-type="other" id="fn8-0968533212458430">
<label> 8</label>
<p>Y. Su, L. Li ‘Progress Research on Attitudes to the Patient’s Right of Informed Consent Among the Patients, Their Relatives and Medical Staffs’
<italic>Medicine and Philosophy </italic>
29 (2008), p. 28.</p>
</fn>
<fn fn-type="other" id="fn9-0968533212458430">
<label> 9</label>
<p>Su, ‘Progress’, p. 28.</p>
</fn>
<fn fn-type="other" id="fn10-0968533212458430">
<label>10</label>
<p>G. Zhang, J. Han ‘Comparison of the Preoperative Psychological Condition of the Patients Who Gave Informed Consent Themselves and Those Whose Family Members Did Instead’
<italic>Chinese Mental Health Journal</italic>
22 (2008), pp. 383, 383–386.</p>
</fn>
<fn fn-type="other" id="fn11-0968533212458430">
<label>11</label>
<p>Zhang, ‘Comparison’, p. 29.</p>
</fn>
<fn fn-type="other" id="fn12-0968533212458430">
<label>12</label>
<p>Zhang, ‘Comparison’, p. 29.</p>
</fn>
<fn fn-type="other" id="fn13-0968533212458430">
<label>13</label>
<p>In China, media exposure of some extreme, high-profile cases reinforced the public’s negative perception of the medical profession. Sometimes patients resort to threatened or actual violence to resolve the doctor–patient disputes because they mistrust the existing dispute-resolving schemes. Doctors are also the victims of the bad relationship. When people investigate the reasons for the situation, they find that doctors are not the only party to blame, although some doctors, by seeking red envelopes (
<italic>Hong Bao</italic>
(红包)) (a monetary gift in exchange for favourable service) from patients and receiving financial kickbacks (
<italic>Hui Kou</italic>
(回扣)) from drug companies, damaged the reputation of the profession. There are many governmental, economic, legal, social, medical and cultural contributing factors. The insufficiency in governmental supervision, regulation of medical profession and investment in health care is one of the major reasons</p>
</fn>
<fn fn-type="other" id="fn14-0968533212458430">
<label>14</label>
<p>See editorial Chinese Doctors Are Under Threat,
<italic>The Lancet</italic>
376 (2010), p. 657. See also Yi Yang et al. ‘Facing up to the Threat in China,
<italic>The Lancet</italic>
376 (2010), pp.1823–1824 (responding to the Editorial).</p>
</fn>
<fn fn-type="other" id="fn15-0968533212458430">
<label>15</label>
<p>Z. Fu et al.
<italic>Empirical Analysis on Adjudication of Medical Lawsuits</italic>
(People’s Court Press, Beijing, 2006), p. 13.</p>
</fn>
<fn fn-type="other" id="fn16-0968533212458430">
<label>16</label>
<p>Fu, ‘Empirical’, p. 18.</p>
</fn>
<fn fn-type="other" id="fn17-0968533212458430">
<label>17</label>
<p>
<italic>General Principles of the Civil Law of the People’s Republic of China</italic>
(1986, NPC).</p>
</fn>
<fn fn-type="other" id="fn18-0968533212458430">
<label>18</label>
<p>
<italic>Regulation on the Handling of Medical Accidents</italic>
(2002, State Council).</p>
</fn>
<fn fn-type="other" id="fn19-0968533212458430">
<label>19</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC).</p>
</fn>
<fn fn-type="other" id="fn20-0968533212458430">
<label>20</label>
<p>
<italic>General Principles of the Civil Law of the People’s Republic of China</italic>
(1986, NPC), Article 98 (‘Citizens shall enjoy the rights of life and health.’).</p>
</fn>
<fn fn-type="other" id="fn21-0968533212458430">
<label>21</label>
<p>
<italic>Regulation on Dealing with Medical Accidents </italic>
(1987, State Council);
<italic>Regulation on the Handling of Medical Accidents</italic>
(2002, State Council).</p>
</fn>
<fn fn-type="other" id="fn22-0968533212458430">
<label>22</label>
<p>Supreme People’s Court’s Reply to Tian Jin High People’s Court Regarding How to Apply Laws in Adjudicating the Medical Accident Compensation Case of
<italic>Li Xin-rong v The Affiliated Hospital of Tian Jin No. 2 Medical College </italic>
(1992, SPC); 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); 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); 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, accessed 28 November 2011,  http://www.cmda.gov.cn/yishiweiquan/weiquanzhishi/2009-02-25/5311.html. The Supreme People’s Court has the power to give general
<italic>interpretation</italic>
on the application of laws in
<italic>judicial</italic>
proceedings (‘judicial interpretation’(‘司法解释’(
<italic>Si Fa Jie Shi</italic>
))).</p>
</fn>
<fn fn-type="other" id="fn23-0968533212458430">
<label>23</label>
<p>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).</p>
</fn>
<fn fn-type="other" id="fn24-0968533212458430">
<label>24</label>
<p>
<italic>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</italic>
(2003, SPC).</p>
</fn>
<fn fn-type="other" id="fn25-0968533212458430">
<label>25</label>
<p>
<italic>Law on Practising Doctors of the People’s Republic of China</italic>
(1998), Article 26 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn26-0968533212458430">
<label>26</label>
<p>‘Practising Doctors’, Article 26.</p>
</fn>
<fn fn-type="other" id="fn27-0968533212458430">
<label>27</label>
<p>‘Therapeutic privilege’ means ‘a privilege, on therapeutic grounds, to withhold the specific diagnosis where the disclosure of cancer or some other dread disease would seriously jeopardize the recovery of an unstable, temperamental or severely depressed patient’. See,
<italic>Natanson v. Kline</italic>
, 350 P.2d 1093, 1103 (Kan. 1960).</p>
</fn>
<fn fn-type="other" id="fn28-0968533212458430">
<label>28</label>
<p>‘Practising Doctors’, Article 26.</p>
</fn>
<fn fn-type="other" id="fn29-0968533212458430">
<label>29</label>
<p>‘Practising Doctors’, Article 37 (8). According to 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 six months and one year by the administration departments of health; (2) for serious cases, their practising certificates being revoked; (3) for criminal offenses, criminal liabilities being investigated.</p>
</fn>
<fn fn-type="other" id="fn30-0968533212458430">
<label>30</label>
<p>
<italic>Regulation on Medical Institutions</italic>
(1994, State Council).</p>
</fn>
<fn fn-type="other" id="fn31-0968533212458430">
<label>31</label>
<p>
<italic>Rules for Implementing the Regulation on Medical Institutions</italic>
(1994, Ministry of Health).</p>
</fn>
<fn fn-type="other" id="fn32-0968533212458430">
<label>32</label>
<p>
<italic>Chapter 6 of Regulation on Medical Institutions</italic>
(1994, State Council);
<italic>Chapter 7 of Rules for Implementing the Regulation on Medical Institutions </italic>
(1994, Ministry of Health).</p>
</fn>
<fn fn-type="other" id="fn33-0968533212458430">
<label>33</label>
<p>
<italic>The Regulation on the Handling of Medical Accidents</italic>
(2002, State Council), Article 11.</p>
</fn>
<fn fn-type="other" id="fn34-0968533212458430">
<label>34</label>
<p>‘Medical Accidents’.</p>
</fn>
<fn fn-type="other" id="fn35-0968533212458430">
<label>35</label>
<p>‘Medical Accidents’.</p>
</fn>
<fn fn-type="other" id="fn36-0968533212458430">
<label>36</label>
<p>‘Medical Accidents’, 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 …’).</p>
</fn>
<fn fn-type="other" id="fn37-0968533212458430">
<label>37</label>
<p>C. Jiang ‘On the Patient’s Right to Informed Consent: Cases Survey and Thinking’
<italic>Nanjing University Law Review</italic>
3 (2006), pp. 113, 116–117.</p>
</fn>
<fn fn-type="other" id="fn38-0968533212458430">
<label>38</label>
<p>Jiang ‘Patient’s Right’, pp. 118–119.</p>
</fn>
<fn fn-type="other" id="fn39-0968533212458430">
<label>39</label>
<p>Jiang ‘Patient’s Right’, pp. 120–121.</p>
</fn>
<fn fn-type="other" id="fn40-0968533212458430">
<label>40</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC). It became effective on July 1, 2010.</p>
</fn>
<fn fn-type="other" id="fn41-0968533212458430">
<label>41</label>
<p>For example, Chapter 5 of the Tort Law discusses liability for defective products. The principles are consistent with provisions of China’s
<italic>GPCL</italic>
,
<italic>the Law on Protection of Consumer Rights and Interests (Consumer Rights Protection Law)</italic>
(1993),
<italic>the Product Quality Law </italic>
(1993, revised 2000), and
<italic>the Food Safety Law</italic>
(2009), and relevant interpretations of the Supreme People’s Court.</p>
</fn>
<fn fn-type="other" id="fn42-0968533212458430">
<label>42</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 2.</p>
</fn>
<fn fn-type="other" id="fn43-0968533212458430">
<label>43</label>
<p>Academically ‘liability for medical damage’ is defined as a tort liability where medical institutions and health care 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 L. Yang ‘Study on the Concept of Medical Damage Liability’
<italic>Politics and Law</italic>
3 (2009), pp. 75, 79.</p>
</fn>
<fn fn-type="other" id="fn44-0968533212458430">
<label>44</label>
<p>If a patient suffers damages caused by
<italic>defective</italic>
drugs, disinfectants, medical devices or transfusion of
<italic>substandard</italic>
blood, the patient may seek compensation
<italic>either</italic>
from the manufacturer
<italic>or</italic>
the blood-supplying institution,
<italic>or</italic>
from the relevant medical institution. Medical institutions,
<italic>after paying</italic>
compensation to the patient, are entitled to claim reimbursement from the manufacturer or blood-supplying institution. These provisions reflect China’s reality that medical institutions play dual roles of prescriber and seller of medical products.
<italic>See</italic>
,
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 59. Although this provision reflects Chinese reality that medical institutions gain great benefits by selling drugs and medical devices to patients, I am not comfortable with it because it actually imposes strict liability on medical institutions in the area of defective drugs. China is proposing a health care reform, aiming to separate heath care from sale of drugs. Article 59 is destined to be short-lived. </p>
</fn>
<fn fn-type="other" id="fn45-0968533212458430">
<label>45</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 54.</p>
</fn>
<fn fn-type="other" id="fn46-0968533212458430">
<label>46</label>
<p>For detailed discussion,
<italic>see</italic>
, T. Ji ‘Who Exercises the Right of Informed Consent in the Therapeutic Context’
<italic>Zhe Jiang Social Science</italic>
2 (2010), pp. 10, 10–13.</p>
</fn>
<fn fn-type="other" id="fn47-0968533212458430">
<label>47</label>
<p>
<italic>Law on Practising Doctors of the People’s Republic of China</italic>
(1998), Article 26.</p>
</fn>
<fn fn-type="other" id="fn48-0968533212458430">
<label>48</label>
<p>
<italic>Regulation on Medical Institutions</italic>
(1994, State Council), Article 33.</p>
</fn>
<fn fn-type="other" id="fn49-0968533212458430">
<label>49</label>
<p>
<italic>Regulation on the Handling of Medical Accidents</italic>
(2002, State Council), Article 11.</p>
</fn>
<fn fn-type="other" id="fn50-0968533212458430">
<label>50</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 55 (1).</p>
</fn>
<fn fn-type="other" id="fn51-0968533212458430">
<label>51</label>
<p>‘Tort Liability’, Article 55 (2).</p>
</fn>
<fn fn-type="other" id="fn52-0968533212458430">
<label>52</label>
<p>‘Tort Liability’, Article 56. According to Chinese Family Law and Inheritance Law, ‘close family members’ include spouses, parents, children, siblings, grandparents, and grandchildren. In Singapore’s practice, informed consent can be given by the signature of two consultants if family’s consent cannot be obtained. This applies for both emergency and nonurgent procedures. This is to ensure that due diligence has been performed in checking to see if there are indeed any party who can give consent on behalf of the patient.</p>
</fn>
<fn fn-type="other" id="fn53-0968533212458430">
<label>53</label>
<p>It answers concerns raised and highlighted in a high-profile tragedy (
<italic>Z. Xiao</italic>
(肖志军) event). In that story, a pregnant woman and the baby died because the medical institution could not obtain consent to the operation.</p>
</fn>
<fn fn-type="other" id="fn54-0968533212458430">
<label>54</label>
<p>See also H. Liang ‘On the ‘Medical Damage Liability’ of the Tort Liability Law’
<italic>Studies in Law and Business</italic>
6 (2010), pp. 35, 37 (favouring protection of self-determination).</p>
</fn>
<fn fn-type="other" id="fn55-0968533212458430">
<label>55</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 54. As a general principle, medical institutions are liable and have to pay compensation if the medical institution and/or any of its health care professionals are at
<italic>fault</italic>
and
<italic>damage</italic>
is
<italic>caused</italic>
to a patient during diagnosis and treatment.</p>
</fn>
<fn fn-type="other" id="fn56-0968533212458430">
<label>56</label>
<p>In determining ‘fault’ or ‘medical negligence’, the Tort Law will ask if a health care professional failed to exercise care comparable with the then-prevailing medical standards or ‘the then-prevailing medical level’ D.S.d.Y.L.S. Ping. See
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 57.</p>
</fn>
<fn fn-type="other" id="fn57-0968533212458430">
<label>57</label>
<p>Medical institutions shall be
<italic>presumed</italic>
<italic>to be ‘at fault’</italic>
if they: (i) violate Laws, Administrative Regulations, Rules, or other stipulations regarding diagnostic and treatment practices; (ii) conceal or refuse to provide relevant medical records with respect to the disputes; or (iii) forge, falsify or destroy medical records. See,
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 58.</p>
</fn>
<fn fn-type="other" id="fn58-0968533212458430">
<label>58</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(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/fails 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.’).</p>
</fn>
<fn fn-type="other" id="fn59-0968533212458430">
<label>59</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(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/fails to cooperate with the medical institution in performing
<italic>diagnosis and medical treatment </italic>
that conforms to
<italic>diagnosis and treatment </italic>
standards; (2) the medical staff have exercised reasonable duty of
<italic>diagnosis and medical treatment</italic>
under emergency situations such as rescuing the life of the patient who is in critical condition; (3) effective
<italic>diagnosis and medical treatment</italic>
is impossible at the current medical treatment level …. ’ (emphasis added)).</p>
</fn>
<fn fn-type="other" id="fn60-0968533212458430">
<label>60</label>
<p>[1957] 2 All ER 118, 122,
<italic>per</italic>
McNair J. (‘A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. . . . Putting it the other way round, a doctor is not negligent, if he acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view.’).</p>
</fn>
<fn fn-type="other" id="fn61-0968533212458430">
<label>61</label>
<p>
<italic>Rogers v Whitaker </italic>
[1992] 175 CLR 479 (HCA).</p>
</fn>
<fn fn-type="other" id="fn62-0968533212458430">
<label>62</label>
<p>
<italic>Reibl v Hughes </italic>
[1980] 114 DLR. (3d) 1, 13 (SC.C).</p>
</fn>
<fn fn-type="other" id="fn63-0968533212458430">
<label>63</label>
<p>
<italic>Civil Liability Act 2003</italic>
(Qld), s 22(5),
<italic>Civil Liability Act 2002</italic>
(NSW), s 5P;
<italic>Civil Liability Act 1936</italic>
(SA), s 41(5);
<italic>Civil Liability Act 2002</italic>
(Tas), s 22 (5).</p>
</fn>
<fn fn-type="other" id="fn64-0968533212458430">
<label>64</label>
<p>
<italic>Canterbury v Spence</italic>
, 464 F.2d 772, 785 (1972);
<italic>Cobbs v Grant</italic>
, 502 P.2d 1, 10 (1972);
<italic>Wilkinson v Vessey</italic>
, 295 A.2d 676, 688 (RI 1972).</p>
</fn>
<fn fn-type="other" id="fn65-0968533212458430">
<label>65</label>
<p>
<italic>R. Chen v China People’s Armed Police Hospital of Shanghai</italic>
, 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).</p>
</fn>
<fn fn-type="other" id="fn66-0968533212458430">
<label>66</label>
<p>
<italic>Natanson v Kline</italic>
, 350 P.2d 1093, 1106 (Kan 1960);
<italic>Aiken v Clary</italic>
, 396 S.W.2d 668, 674 (Mo 1965);
<italic>Woolley v Henderson</italic>
, 418 A 2d 1123, 1131 (Me 1980). </p>
</fn>
<fn fn-type="other" id="fn67-0968533212458430">
<label>67</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 57.</p>
</fn>
<fn fn-type="other" id="fn68-0968533212458430">
<label>68</label>
<p>L. Yang ‘Proof and Burden of Proof of Medical Negligence’
<italic>Journal of Law </italic>
6 (2009), pp. 1, 3.</p>
</fn>
<fn fn-type="other" id="fn69-0968533212458430">
<label>69</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 58 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn70-0968533212458430">
<label>70</label>
<p>H. Liang ‘On the ‘Medical Damage Liability’ of the Tort Liability Law’,
<italic>Studies in Law and Business</italic>
6 (2010), pp. 38–39; Project Group of ‘Study on Judicial Interpretation of Tort Liability Law’
<italic>Suggestion and Discussion Draft of Judicial Interpretation of Tort Liability Law of People’s Republic of China</italic>
, Available at: http://www.civillaw.com.cn/article/default.asp?id=49876 (last accessed July 12, 2010), Article 101.
<italic>Compare</italic>
, W. Lin ‘Exploration of Some Issues regarding Medical Damage Liability of ‘‘Tort Liability Law’’
<italic>Journal of Law Application</italic>
7 (2010), p. 21 (interpreting ‘presumption of fault’ as giving the defendant an opportunity to rebut the presumption); Wang Yue ‘Exploration on Issues regarding Medical Damage Compensation’
<italic>Chinese Journal of Forensic Sciences</italic>
, 49 (2010), p. 36 (reading ‘presumption of fault’ as meaning that judges can directly presume fault, without the need to organize authentication); H. Liao ‘How to Establish Medical Fault: Understanding and Applying Medical Damage Liability Law’
<italic>Politics and Law</italic>
5 (2010), p. 24 (reading Article 58 as ‘shifting burden of proof’).</p>
</fn>
<fn fn-type="other" id="fn71-0968533212458430">
<label>71</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 60 (2).</p>
</fn>
<fn fn-type="other" id="fn72-0968533212458430">
<label>72</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2d official discussion draft, December 21, 2008), Article 57 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn73-0968533212458430">
<label>73</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 57 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn74-0968533212458430">
<label>74</label>
<p>See H. Liang ‘On the ‘Medical Damage Liability’ of the Tort Liability Law’,
<italic>Studies in Law and Business</italic>
6 (2010), pp. 37–38 (interpreting that ‘the duty of diagnosis and treatment’ is a type of ‘the duty of care’).</p>
</fn>
<fn fn-type="other" id="fn75-0968533212458430">
<label>75</label>
<p>
<italic>Bolam v Friern Hospital Management Committee</italic>
(1957) 2 All ER 118, 122, per McNair J. (‘A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art …. Putting it the other way round, a doctor is not negligent, if he acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view.’).</p>
</fn>
<fn fn-type="other" id="fn76-0968533212458430">
<label>76</label>
<p>See
<italic>Chester v Afshar</italic>
[2004] 4 All ER 587, 603, para 57, per Lord Hope of Craighead (indicating that English
<italic>Bolam</italic>
test is a reasonable doctor standard).</p>
</fn>
<fn fn-type="other" id="fn77-0968533212458430">
<label>77</label>
<p>(1999) 48 BMLR 118, 124; (1999) PIQR 53, 59.</p>
</fn>
<fn fn-type="other" id="fn78-0968533212458430">
<label>78</label>
<p>
<italic>Bolitho v City and Hackney HA</italic>
[1997] 4 All ER 771, 779.</p>
</fn>
<fn fn-type="other" id="fn79-0968533212458430">
<label>79</label>
<p>
<italic>Sidaway v Bethlem Royal Hospital Governors </italic>
[1985] 1 All ER 643, 659 (Lord Diplock), 661 (Lord Bridge), 664 (Lord Templeman).</p>
</fn>
<fn fn-type="other" id="fn80-0968533212458430">
<label>80</label>
<p>
<italic>Smith v Auckland Hospital Board</italic>
[1964] NZLR 241; revd (1965) NZLR 191, 206, per Turner J.</p>
</fn>
<fn fn-type="other" id="fn81-0968533212458430">
<label>81</label>
<p>
<italic>Rogers v Whitaker </italic>
[1992] 175 C.L.R. 479 (HCA).</p>
</fn>
<fn fn-type="other" id="fn82-0968533212458430">
<label>82</label>
<p>
<italic>Rogers’</italic>
, p. 490 (ending with the qualification that ‘[t]his duty is subject to the therapeutic privilege’).</p>
</fn>
<fn fn-type="other" id="fn83-0968533212458430">
<label>83</label>
<p>
<italic>Rosenberg v Percival</italic>
[2001] 205 CLR 434, 459 per Gummow J.; 500, per Callinan J.</p>
</fn>
<fn fn-type="other" id="fn84-0968533212458430">
<label>84</label>
<p>Rosenberg, per Kirby J., pp. 482–483.</p>
</fn>
<fn fn-type="other" id="fn85-0968533212458430">
<label>85</label>
<p>Rosenberg, per Gummow J., p. 459.</p>
</fn>
<fn fn-type="other" id="fn86-0968533212458430">
<label>86</label>
<p>Rosenberg, per Callinan J., p. 500.</p>
</fn>
<fn fn-type="other" id="fn87-0968533212458430">
<label>87</label>
<p>Rosenberg, per Gummow J., p. 459.</p>
</fn>
<fn fn-type="other" id="fn88-0968533212458430">
<label>88</label>
<p>Rosenberg, per Gummow J., p. 459.</p>
</fn>
<fn fn-type="other" id="fn89-0968533212458430">
<label>89</label>
<p>
<italic>F. v R. </italic>
[1983] 33 S.A.S.R, pp. 189, 192–193, per King C.J.</p>
</fn>
<fn fn-type="other" id="fn90-0968533212458430">
<label>90</label>
<p>Rosenberg, per Gummow J., p. 458.</p>
</fn>
<fn fn-type="other" id="fn91-0968533212458430">
<label>91</label>
<p>Rosenberg, per Gummow J., p. 458.</p>
</fn>
<fn fn-type="other" id="fn92-0968533212458430">
<label>92</label>
<p>Rosenberg, per Gummow J., p. 458.</p>
</fn>
<fn fn-type="other" id="fn93-0968533212458430">
<label>93</label>
<p>Rosenberg, per Gummow J., p. 458–459.</p>
</fn>
<fn fn-type="other" id="fn94-0968533212458430">
<label>94</label>
<p>Rosenberg, per Gummow J., p. 459.</p>
</fn>
<fn fn-type="other" id="fn95-0968533212458430">
<label> 95</label>
<p>
<italic>Dr K. James and Another v Gunapathy d/o Muniandy and another appeal</italic>
[2002] 2 SLR 414; (2002) SGCA 25.</p>
</fn>
<fn fn-type="other" id="fn96-0968533212458430">
<label> 96</label>
<p>‘James’, paras. 52–65.</p>
</fn>
<fn fn-type="other" id="fn97-0968533212458430">
<label> 97</label>
<p>‘James’, paras. 132–143. It needs to be noted that the Court admitted that ‘this is not the appropriate place to address a fully argued appeal on the merits of a doctrine of informed consent’ since that issue was not fully vented in that case. See, para. 142.</p>
</fn>
<fn fn-type="other" id="fn98-0968533212458430">
<label> 98</label>
<p>
<italic>JU and Another v See Tho Kai Yin</italic>
[2005] 4 SLR 96; (2005) SGHC 140; paras. 63-64;
<italic>D’Conceicao Jeanie Doris (administratrix of the estate of Milakov Steven, deceased) v Tong Ming Chuan </italic>
[2011] SGHC 193, paras. 113-125.</p>
</fn>
<fn fn-type="other" id="fn99-0968533212458430">
<label> 99</label>
<p>
<italic>D.J. Doris (administratrix of the estate of Milakov Steven, deceased) v Tong Ming Chuan </italic>
[2011] SGHC 193, para. 125.</p>
</fn>
<fn fn-type="other" id="fn100-0968533212458430">
<label>100</label>
<p>‘Doris’, para. 145.</p>
</fn>
<fn fn-type="other" id="fn101-0968533212458430">
<label>101</label>
<p>‘Doris’, para. 204.</p>
</fn>
<fn fn-type="other" id="fn102-0968533212458430">
<label>102</label>
<p>
<italic>F.F. Na v Dr Soo Fook Mun and Anor </italic>
[2007] 1 MLJ 593.</p>
</fn>
<fn fn-type="other" id="fn103-0968533212458430">
<label>103</label>
<p>
<italic>Na, para.</italic>
78. See also
<italic>Chien Tham Kong v Excellent Strategy Sdn Bhd & Ors</italic>
[2009] 7 MLJ 261 (following
<italic>Foo Fio Na</italic>
).</p>
</fn>
<fn fn-type="other" id="fn104-0968533212458430">
<label>104</label>
<p>Na, para. 39.</p>
</fn>
<fn fn-type="other" id="fn105-0968533212458430">
<label>105</label>
<p>Na, para. 39.</p>
</fn>
<fn fn-type="other" id="fn106-0968533212458430">
<label>106</label>
<p>
<italic>Rules for Implementing the Regulation on Medical Institutions</italic>
(1994, Ministry of Health), Article 88. For definitions in other jurisdictions, See,
<italic>Health Care Consent Act </italic>
(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
<italic>Substitute Decisions Act, 1992</italic>
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.’).</p>
</fn>
<fn fn-type="other" id="fn107-0968533212458430">
<label>107</label>
<p>
<italic>Tort Liability Law of People’s Republic of China</italic>
(2009, Standing Committee of NPC), Article 55.</p>
</fn>
<fn fn-type="other" id="fn108-0968533212458430">
<label>108</label>
<p>
<italic>Rules for Implementing the Regulation on Medical Institutions</italic>
(1994, Ministry of Health), Article 88.</p>
</fn>
<fn fn-type="other" id="fn109-0968533212458430">
<label>109</label>
<p>
<italic>Haughian v Paine</italic>
[1987], 37 D.L.R. (4th) 624; (1987) 4 WWR 97.</p>
</fn>
<fn fn-type="other" id="fn110-0968533212458430">
<label>110</label>
<p>Haughian, pp. 636–638 (citing
<italic>Hopp v Lepp </italic>
[1980], 112 D.L.R. (3d) 67 (S.C .C.);
<italic>Reibl v Hughes</italic>
[1980] 114 D.L.R . (3d) 1 (S.C .C.);
<italic>Videto v Kennedy</italic>
[1981] 125 D.L.R. (3d) 127 (Ont. C.A.)).</p>
</fn>
<fn fn-type="other" id="fn111-0968533212458430">
<label>111</label>
<p>Haughian, pp. 638–639.</p>
</fn>
<fn fn-type="other" id="fn112-0968533212458430">
<label>112</label>
<p>Haughian, p. 639.</p>
</fn>
<fn fn-type="other" id="fn113-0968533212458430">
<label>113</label>
<p>
<italic>D-J. Doris (administratrix of the estate of Milakov Steven, deceased) v Tong Ming Chuan </italic>
[2011] SGHC 193, paras. 130–131. The Guideline 4.22 (‘Informed Consent’) of the Singapore Medical Council (‘SMC’) Ethical Code and Ethical Guidelines states that: ‘It is a doctor’s responsibility to ensure that a patient under his care is adequately informed about his
<italic>medical condition and options</italic>
for treatment so that he is able to participate in decisions about his treatment. If a procedure needs to be performed, the patient shall be made aware of
<italic>the benefits, risks, and possible complications of the procedure and any alternatives available to him</italic>
.’ (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn114-0968533212458430">
<label>114</label>
<p>Borrowing the Canadian legal thinking, ‘treatment plan’ may deal with more than one health problem, and may combine more than one treatment option. See
<italic>Health Care Consent Act</italic>
1996
<sc>s.o.</sc>
, 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’.).</p>
</fn>
<fn fn-type="other" id="fn115-0968533212458430">
<label>115</label>
<p>
<italic>Rules for Implementing the Regulation on Medical Institutions</italic>
(1994, Ministry of Health), Article 88.</p>
</fn>
<fn fn-type="other" id="fn116-0968533212458430">
<label>116</label>
<p>See
<italic>W. An v The People’s Hospital of Xinjiang Uygur Autonomous Region, etc.</italic>
, The Urumqi Intermediate Court of Xinjiang Uygur Autonomous Region [2010] Wu Zhong Min Yi Zhong Zi No. 840 (finding that the doctor was negligent in both selecting the proposed surgery and informing the patient of alternatives to the proposed surgery).</p>
</fn>
<fn fn-type="other" id="fn117-0968533212458430">
<label>117</label>
<p>See,
<italic>G. Xu, etc. v Guangdong Province People’s Hospital</italic>
, The Guangzhou Intermediate Court [2004] Sui Zhong Fa Min Yi Zhong Zi No. 1352 (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).</p>
</fn>
<fn fn-type="other" id="fn118-0968533212458430">
<label>118</label>
<p>Editorial ‘Chinese Doctors Are Under Threat’,
<italic>The Lancet</italic>
376 (2010), p. 657 (admitting that Chinese doctors have a financial incentive to over-investigate and over-treat).</p>
</fn>
<fn fn-type="other" id="fn119-0968533212458430">
<label>119</label>
<p>H. Liao ‘How to Establish Medical Fault: Understanding and Applying Medical Damage Liability Law’,
<italic>Politics and Law</italic>
5 (2010), p. 22.</p>
</fn>
<fn fn-type="other" id="fn120-0968533212458430">
<label>120</label>
<p>
<italic>Regulation on Traditional Chinese Medicine of People’s Republic of China</italic>
(2003, State Council), Article 12.</p>
</fn>
<fn fn-type="other" id="fn121-0968533212458430">
<label>121</label>
<p>In the United States, the expansive approach of suggesting disclosure of the experience-related information started with the revolutionary case
<italic>Johnson By Adler v Kokemoor</italic>
, where the Supreme Court of Wisconsin audaciously embraced the need of disclosure to the patient of the provider-specific risk information (such as inexperience) and the availability of a better-equipped facility in certain circumstances. See
<italic>Johnson By Adler v Kokemoor</italic>
, 545 N.W. 2d 495, 498 (Wis. 1996). The Canadian case law keeps open the question of whether an
<italic>inexperienced</italic>
physician has a duty to reveal his inexperience and refer his patient to a better-staffed and better-equipped facility when an
<italic>inquisitive</italic>
patient makes a specific inquiry about his experience and
<italic>attaches much importance to the place and expertise. </italic>
See
<italic> Hopp v Lepp </italic>
[1980], 112 D.L.R. (3d) 67 (S.C .C.); [1980] 2 S.C.R. 192. In the Australian case of
<italic>Chappel v Hart</italic>
, Gaudron J. reformulated the matter in this way: ‘[i]f the foreseeable risk to Mrs Hart was the loss of an opportunity to undergo surgery at the hands of a more experienced surgeon, the duty would have been a duty to inform her that there were
<italic>more experienced surgeons</italic>
practising in the field.’ (emphasis added) See
<italic>Chappel v Hart</italic>
[1998] HCA 55; [1998] 195 CLR 232;156 ALR 517; [1998] 72 ALJR 1344 (HC of A).</p>
</fn>
<fn fn-type="other" id="fn122-0968533212458430">
<label>122</label>
<p>Under the materiality test, ‘materiality’ is usually said to be ‘the
<italic>significance</italic>
a reasonable person, in what the physician knows or should know is his patient’s position, would attach to the disclosed [information] in deciding whether to submit or not to submit to surgery or treatment.’ (emphasis added) See
<italic>Wilkinson v Vessey</italic>
, 295 A.2d 676, 689 (RI. 1972). For similar formulation, see also
<italic>Rogers v Whitaker </italic>
[1992] 175 C.L.R. 479, 490 (HCA);
<italic>Fitzpatrick v White</italic>
[2008] 3 IR 551, 564 p. 35 per Kearns J.</p>
</fn>
<fn fn-type="other" id="fn123-0968533212458430">
<label>123</label>
<p>
<italic>Code of Ethics for Human Assisted Reproductive Technologies </italic>
(2001, Ministry of Health), Principle 2(2).</p>
</fn>
<fn fn-type="other" id="fn124-0968533212458430">
<label>124</label>
<p>
<italic>Wilkinson v Vessey</italic>
, 295 A.2d 676, 689 (R.I. 1972) (but confining to information about ‘risk or risks’). See also
<italic>Rogers v Whitaker </italic>
[1992] 175 CLR 479, 490 (HCA);
<italic>Fitzpatrick v White</italic>
[2008] 3 IR 551, 564 per Kearns J.</p>
</fn>
<fn fn-type="other" id="fn125-0968533212458430">
<label>125</label>
<p>
<italic>Canterbury v Spence</italic>
, 464 F.2d 772, 788 (1972).</p>
</fn>
<fn fn-type="other" id="fn126-0968533212458430">
<label>126</label>
<p>Canterbury,  p. 787.</p>
</fn>
<fn fn-type="other" id="fn127-0968533212458430">
<label>127</label>
<p>Canterbury, p. 787.</p>
</fn>
<fn fn-type="other" id="fn128-0968533212458430">
<label>128</label>
<p>Y. Xia
<italic>Medical Malpractice Law</italic>
:
<italic>Reflections on Japanese Law</italic>
(Law Press, Beijing, 2007), pp. 321–358.</p>
</fn>
<fn fn-type="other" id="fn129-0968533212458430">
<label>129</label>
<p>Xia, ‘Medical
<italic></italic>
’, pp. 381–384.</p>
</fn>
<fn fn-type="other" id="fn130-0968533212458430">
<label>130</label>
<p>Xia, ‘Medical’, pp. 384–390.</p>
</fn>
<fn fn-type="other" id="fn131-0968533212458430">
<label>131</label>
<p>Xia, ‘Medical’, pp. 384–390.</p>
</fn>
<fn fn-type="other" id="fn132-0968533212458430">
<label>132</label>
<p>Xia, ‘Medical’, pp. 368–369.</p>
</fn>
<fn fn-type="other" id="fn133-0968533212458430">
<label>133</label>
<p>Xia, ‘Medical’, pp. 369–370.</p>
</fn>
<fn fn-type="other" id="fn134-0968533212458430">
<label>134</label>
<p>Xia, ‘Medical’, pp. 370–371.</p>
</fn>
<fn fn-type="other" id="fn135-0968533212458430">
<label>135</label>
<p>Xia, ‘Medical’, pp. 435–438.</p>
</fn>
<fn fn-type="other" id="fn136-0968533212458430">
<label>136</label>
<p>Xia, ‘Medical’, pp. 371–372.</p>
</fn>
<fn fn-type="other" id="fn137-0968533212458430">
<label>137</label>
<p>Xia, ‘Medical’, p. 372.</p>
</fn>
<fn fn-type="other" id="fn138-0968533212458430">
<label>138</label>
<p>Xia, ‘Medical’, pp. 438–440.</p>
</fn>
<fn fn-type="other" id="fn139-0968533212458430">
<label>139</label>
<p>Xia, ‘Medical’, pp. 438–440.</p>
</fn>
<fn fn-type="other" id="fn140-0968533212458430">
<label>140</label>
<p>Xia, ‘Medical’, pp. 441–442.</p>
</fn>
<fn fn-type="other" id="fn141-0968533212458430">
<label>141</label>
<p>The Supreme Court, 3rd petty bench, 2001.11.27, 55 Minshu 1154, 1769 Hanji 56, 1079 Hanta 198. In this case, patient X, aged 44, was diagnosed with breast cancer in 1991. Doctor Y proposed and performed
<italic>radical mastectomy</italic>
. </p>
</fn>
<fn fn-type="other" id="fn142-0968533212458430">
<label>142</label>
<p>Information concerning breast-conserving surgery was limited in Japan at the time of operation. Breast-conserving measures were utilised in only 12.7% of all breast cancer operations. Most surgeons thought that many problems remained to be resolved before it could become a standard practice for breast cancer treatment.</p>
</fn>
<fn fn-type="other" id="fn143-0968533212458430">
<label>143</label>
<p>Since 1989, breast-conserving surgery had attracted academic attention and study in Japan. From 1990, more and more medical institutions had tried the treatment. Case study and positive evaluation about the treatment and clinical guidelines for the treatment had emerged. In the United States and Europe, it was then widely recognised that both the recurrence rate and survival rate after treatment with breast-conserving surgery were comparable to radical mastectomy.</p>
</fn>
<fn fn-type="other" id="fn144-0968533212458430">
<label>144</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn145-0968533212458430">
<label>145</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn146-0968533212458430">
<label>146</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn147-0968533212458430">
<label>147</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn148-0968533212458430">
<label>148</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn149-0968533212458430">
<label>149</label>
<p>Xia, ‘Medical’, p. 696.</p>
</fn>
<fn fn-type="other" id="fn150-0968533212458430">
<label>150</label>
<p>Xia, ‘Medical’, pp. 696–697.</p>
</fn>
<fn fn-type="other" id="fn151-0968533212458430">
<label>151</label>
<p>Xia, ‘Medical’, p. 697.</p>
</fn>
<fn fn-type="other" id="fn152-0968533212458430">
<label>152</label>
<p>Xia, ‘Medical’, p. 697.</p>
</fn>
<fn fn-type="other" id="fn153-0968533212458430">
<label>153</label>
<p>Xia, ‘Medical’, p. 697.</p>
</fn>
<fn fn-type="other" id="fn154-0968533212458430">
<label>154</label>
<p>Xia, ‘Medical
<italic></italic>
, p. 697.</p>
</fn>
<fn fn-type="other" id="fn155-0968533212458430">
<label>155</label>
<p>Xia, ‘Medical’, pp. 698–700.</p>
</fn>
<fn fn-type="other" id="fn156-0968533212458430">
<label>156</label>
<p>Xia, ‘Medical’, p. 554.</p>
</fn>
<fn fn-type="other" id="fn157-0968533212458430">
<label>157</label>
<p>Xia, ‘Medical’, p. 555.</p>
</fn>
<fn fn-type="other" id="fn158-0968533212458430">
<label>158</label>
<p>Xia, ‘Medical’, p. 555.</p>
</fn>
<fn fn-type="other" id="fn159-0968533212458430">
<label>159</label>
<p>Xiju Zhao ‘Adoption and Disclosure of Emerging Therapies’
<italic>Oriental Law</italic>
6 (2009), p. 119.</p>
</fn>
<fn fn-type="other" id="fn160-0968533212458430">
<label>160</label>
<p>Xia, ‘Medical’, p. 376, footnote 2.</p>
</fn>
<fn fn-type="other" id="fn161-0968533212458430">
<label>161</label>
<p>Xia, ‘Medical’, p. 376, footnote 2.</p>
</fn>
<fn fn-type="other" id="fn162-0968533212458430">
<label>162</label>
<p>Xia, ‘Medical’, pp. 372–373.</p>
</fn>
<fn fn-type="other" id="fn163-0968533212458430">
<label>163</label>
<p>Xia, ‘Medical’, p. 375.</p>
</fn>
<fn fn-type="other" id="fn164-0968533212458430">
<label>164</label>
<p>Yun, ‘Medical’, p. 375, footnote 2.</p>
</fn>
<fn fn-type="other" id="fn165-0968533212458430">
<label>165</label>
<p>Xia, ‘Medical’, p. 374.</p>
</fn>
<fn fn-type="other" id="fn166-0968533212458430">
<label>166</label>
<p>(2008) EWHC 2237 (QB).</p>
</fn>
<fn fn-type="other" id="fn167-0968533212458430">
<label>167</label>
<p>EWHC 2237, para. 68.</p>
</fn>
<fn fn-type="other" id="fn168-0968533212458430">
<label>168</label>
<p>EWHC 2237, paras. 69–70.</p>
</fn>
<fn fn-type="other" id="fn169-0968533212458430">
<label>169</label>
<p>EWHC 2237, para. 69.</p>
</fn>
<fn fn-type="other" id="fn170-0968533212458430">
<label>170</label>
<p>EWHC 2237, para. 69.</p>
</fn>
<fn fn-type="other" id="fn171-0968533212458430">
<label>171</label>
<p>EWHC 2237, para. 77.</p>
</fn>
<fn fn-type="other" id="fn172-0968533212458430">
<label>172</label>
<p>EWHC 2237, para. 74 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn173-0968533212458430">
<label>173</label>
<p>But in the context of establishing causation in the informed consent cases see
<italic>Birch v University College Hospitals NHS Trust </italic>
(2008) EWHC 2237 (QB), para. 81: ‘The issue is
<italic>not</italic>
whether she would have understood the nature of the procedures or what she would have
<italic>in the face of a recommendation</italic>
as to catheter angiography. The crucial issue is what she would have decided when given
<italic>a dispassionate account</italic>
along the lines indicated, in other words of the two procedures for imaging, and the advantages and disadvantages of each for someone with her background …. It is clear to me that had she been given
<italic>a fair and balanced account</italic>
in the way I have held was necessary she would have rejected catheter angiography in favour of MRI. In other words, properly informed she would have declined the procedure leading to her stroke’ (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn174-0968533212458430">
<label>174</label>
<p>Those ‘unusual’ or ‘special’ circumstances include: (1) the claimant was correctly diagnosed by a
<italic>neurologist</italic>
, and the initial plan was sensible; (2) things started to go wrong when, for reasons which were unclear, the specifically recommended MRI for the claimant was blocked; (3) the claimant was then transferred to the defendant-hospital (centre) to exclude two life-threatening possible diagnoses; (4) due to the unavailability of bed in the neurology wards, the claimant fell into the hands of the
<italic>neurosurgeons</italic>
; (4) initially both an MRI and catheter angiography were identified as possibilities; (5) however, later on, maybe due to the
<italic> ascertainment bias among neurosurgeons</italic>
at the defendant-hospital, the focus was shifted to the possibility of an aneurysm, the priority was given to eliminate the possibility of an aneurysm by catheter angiography, and, thus, the possibility of MRI was discarded; (6) it turned out that, with hindsight, the claimant was subject to an unnecessary procedure which caused a stroke. See,
<italic>Birch v University College Hospitals NHS Trust </italic>
[2008] EWHC 2237 (QB), at 78, 82.</p>
</fn>
<fn fn-type="other" id="fn175-0968533212458430">
<label>175</label>
<p>EWHC 2237, para. 74 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn176-0968533212458430">
<label>176</label>
<p>EWHC 2237, para. 74.</p>
</fn>
<fn fn-type="other" id="fn177-0968533212458430">
<label>177</label>
<p>EWHC 2237, para. 74.</p>
</fn>
<fn fn-type="other" id="fn178-0968533212458430">
<label>178</label>
<p>EWHC 2237, para. 74 (emphasis added).</p>
</fn>
<fn fn-type="other" id="fn179-0968533212458430">
<label>179</label>
<p>EWHC 2237, para. 79.</p>
</fn>
<fn fn-type="other" id="fn180-0968533212458430">
<label>180</label>
<p>EWHC 2237, para. 79.</p>
</fn>
<fn fn-type="other" id="fn181-0968533212458430">
<label>181</label>
<p>EWHC 2237, para. 79.</p>
</fn>
<fn fn-type="other" id="fn182-0968533212458430">
<label>182</label>
<p>Medical malpractice legal proceedings are costly and time-consuming. A Chinese survey showed that 73.3% of hospitals surveyed attach importance to the hospital
<italic>reputation</italic>
. 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.
<italic>See</italic>
, Z. Fu et al.
<italic>Empirical Analysis on Adjudication of Medical Lawsuits</italic>
, (People‘s Court Press, Beijing, 2006), p. 12.</p>
</fn>
<fn fn-type="other" id="fn183-0968533212458430">
<label>183</label>
<p>
<italic>Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996</italic>
, Schedule.</p>
</fn>
<fn fn-type="other" id="fn184-0968533212458430">
<label>184</label>
<p>Z. Fu et al.
<italic>Empirical Analysis on Adjudication of Medical Lawsuits,</italic>
(People‘s Court Press, Beijing, 2006), p. 48.</p>
</fn>
<fn fn-type="other" id="fn185-0968533212458430">
<label>185</label>
<p>See Right 6 (1) and (2) of the Code.</p>
</fn>
<fn fn-type="other" id="fn186-0968533212458430">
<label>186</label>
<p>Right 5 of the Code.</p>
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<namePart type="given">Xiju</namePart>
<namePart type="family">Zhao</namePart>
<affiliation>University of Otago, New Zealand</affiliation>
<affiliation>Xiju Zhao, Faculty of Law, University of Otago, PO Box 56, Dunedin 9054, New Zealand Email:</affiliation>
<affiliation>E-mail: xijuzhao@yahoo.com</affiliation>
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<abstract lang="en">Chinese informed consent law is in a period of fundamental transition. The recently enacted Tort Liability Law offers a new way of thinking about Chinese informed consent law in the therapeutic setting. It includes distinctive provisions relevant to informed consent, thereby creating a generous duty to inform, including a duty to inform about alternative treatment options. However, the rule as presently cast suffers from a lack of detail and clarity, fails to clearly identify the distinctiveness of the duty to disclose, and may be criticised for being all-embracing and overambitious. Nevertheless, one has reason to be optimistic about the future of Chinese informed consent law. This article offers a detailed tour through the new Tort Liability Law in the specific context of disclosure to patients and sets out certain suggestions for future development. These suggestions include that Chinese law should clearly distinguish the task of information disclosure from diagnosis and treatment, should introduce the ‘materiality’ test of information disclosure, and should also acknowledge the role of professional regulation in honouring and promoting the doctrine of informed consent. In the course of this examination, the author draws comparisons with the laws of Japan and also Commonwealth countries, including Asian common law jurisdictions, such as Singapore and Malaysia.</abstract>
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