The Connection Between Medical Self-determination and the System of Adult Guardianship
— The Institutional Construction of Medical Proxy
LI Min*
Abstract: China has established the basic rules of informed consent in the medical field through Articles 1219 and 1220 of the tort liability part of the Civil Code of China to address the legality of medical conduct. Since patients’ capacity to consent is the prerequisite, when the patient is a fully competent person, it is sufficient to give consent based on valid notification by the doctor. However, for those who are unable to give valid consent, especially adult patients with impaired capacity, resolving the legality of the doctor’s medical conduct remains an issue when it infringes on the patient’s body and health. To solve this issue, someone must give consent in place of the patient when the adult is unable to give valid consent. However, the personal and exclusive nature of the right to medical consent, which is informed consent, makes it impossible to simply delegate it to a guardian or other person to exercise it on behalf of the patient. In this paper, we borrow the concept of “medical proxy” proposed by Japanese scholar Teruaki Tayama, and for the first time, we discuss the construction of medical proxy from the perspective of adult guardianship by connecting the two systems from the standpoint of interpretive theory.
Keywords: medical proxy · medical self-determination · adult guardianship · capacity to consent
Introduction
China has established the basic rules of informed consent in the medical field through Articles 1219 and 1220 of the tort liability part of the Civil Code of China to address the legality of medical conduct. Tracing the origin, the principle and practice of “informed consent” were established in the 1957 California Court of Appeals decision in Salgo v. Leland Stanford Jr. University Board of Trustees.1 The theory and practice of informed consent not only have been accepted by other states in the US but also have been “exported” to many countries such as Japan and Germany, where they have been adopted by medical laws. Nowadays, the principle of informed consent has become a ground for doctors to be exempt from liability when carrying out medical conduct, and its significance cannot be underestimated. In other words, if there is consent without valid notification or without the patient’s consent at all, the doctor’s medical conduct would constitute an infringement on the patient’s body and health rights due to the invalidity of the exemption, and in serious cases, may even constitute the crime of intentional injury or even intentional homicide in criminal law.
Since patients’ capacity to consent is the prerequisite, when the patient is a fully competent person, it is sufficient to give consent based on valid notification by the doctor. However, for those who are unable to give valid consent, especially adults with impaired capacity, resolving the legality of the doctor’s medical conduct remains an issue when it infringes on the patient’s body and health. To solve this issue, someone must give consent in place of the patient when the person is unable to give valid consent. However, the personal and exclusive nature of the right to medical consent,2 which is informed consent, makes it impossible to simply delegate it to a guardian or other person to exercise it on behalf of the patient. As a result, many countries have enacted statutory provisions for the substitute exercise of medical self-determination that are distinct from adult guardianship, based on special legislation or authorization. Specifically, Austria has made relevant provisions within the framework of adult guardianship law that require special authorization to exercise such powers;3 Germany once stipulated in the German Civil Code (Bürgerliches Gesetzbuch) (1900) that guardians could exercise medical self-determination on behalf of the patients but later abolished the guardianship system through separate laws in 1990, 1999, and 2009 and established statutory medical representatives and designated agency powers;4 the UK regulated the substitute exercise of medical self-determination through the Mental Capacity Act in 2005; 5 Switzerland incorporated provisions for the substitute exercise of medical self-determination, distinct from the adult guardianship system, in the second part of the Civil Code on family law and the third part on adult protection.6 The issue is still under heated discussion in Japan, where Professor Teruaki Tayama proposed the concept of medical proxy.7
As an essential part of human rights, the individual’s rights to life and health cannot be restricted or deprived at any time. Medical self-determination involves the issue of whether patients themselves can autonomously control their personal and health rights and are an important component of human rights issues. The issue of substitute exercise of medical self-determination, in essence, grants someone other than the patient the right to control the patient’s life and health, concerning the core of human rights issues and requiring cautious verification.
In view of the current domestic research, which mainly explores the issue from the perspective of informed consent in Tort Liability Law, this paper will be based on interpretive theory, connecting the two systems from the perspective of adult guardianship. By borrowing the concept of “medical proxy” proposed by Japanese scholar Teruaki Tayama and considering the current lack of a medical proxy system in China, we explore the establishment of medical proxy within the framework of the existing adult guardianship system, with the aim to provoke further discussion and seek advice from colleagues.
I. China Should Establish a “Medical Proxy” System Distinct from the Adult Guardianship System
A. The provision allowing close relatives to exercise medical self-determination on behalf of adult patients lacks a clear legal basis
Article 55 of the Tort Liability Law stipulates that the duty of medical personnel to inform patients can be divided into two main categories. The first is a pure duty to inform, which arises during general medical activities when medical personnel should explain the patient’s condition and medical measures. In this case, as medical conduct usually does not lead to severe consequences, it is sufficient to inform the patient without requiring their consent. The second category is based on the premise of carrying out surgery, special examinations, or special treatments when there is a higher risk and the possibility of causing significant harm to the patient. In this case, the patient’s explicit consent is required. From a legislative perspective, Article 55 (1) of the Tort Liability Law only considers individuals with full civil capacity as the subjects of regulation and does not stipulate how to exercise the right to informed consent when the patient lacks full civil capacity. In response to this, some scholars argue that such cases should be included in the category of “not suitable for informing the patient” and that the patient’s close relatives should exercise the right to informed consent.8 The subsequent first draft of the tort liability part of the Civil Code of China did not make any changes to the wording of the Tort Liability Law but the second draft made adjustments, changing “not suitable for informing the patient” to “unable or not suitable for informing the patient.” The Civil Code of China continued to use the content of the second draft. Therefore, when a patient lacks the full capacity to act, it falls under the “unable” category of “unable or not suitable for informing the patient” and the patient’s close relatives should be informed and their explicit consent should be obtained. However, when further examining why close relatives should exercise the right to informed consent, we cannot see the underlying legal reasoning.
Regarding the situation of “not suitable for informing the patient,” it refers to circumstances where medical personnel, during the diagnosis and treatment process, do not inform or do not fully inform the patient as per legal provisions, as doing so may hinder the treatment effect. Instead, they inform the patient’s close relatives. In this case, is the right to informed consent of close relatives a legally independent right or a statutory agency right based on the protection of the patient’s best interests? Some scholars believe that in situations where it is “not suitable for informing the patient,” the general view is to avoid adverse consequences.9 Therefore, medical institutions usually adopt protective measures,10 such as concealing the patient’s condition from critically ill patients. Exercising the duty to inform close relatives involves a statutory agency right based on the protection of the patient’s best interests.11 A different view is that Eastern societies, unlike Western ones centered on individualism, are more family-oriented. When an individual cannot bear the heavy medical costs, family members often become the direct bearers of medical expenses and consequences. At the same time, family members can jointly exercise medical autonomy with the patient to avoid being controlled by medical personnel and compensate for disadvantages brought by the vulnerable position. Based on the above reasons, close relatives are the subjects of the right to informed consent, rather than exercising it on behalf of the patient.12
As for the “unable” category of “unable or not suitable for informing the patient,” when close relatives attempt to exercise the right to informed consent on behalf of the patient to prevent the illegality of medical conduct, the legal basis behind their actions needs further exploration. Whether this is based on a statutory agency’s right to protect the patient’s best interests or the close relatives exercising this right as independent subjects remains to be further examined.
B. According to the UN Convention on the Rights of Persons with Disabilities, states have an obligation to assist in the realization of the right to informed medical consent
In June 2008, China ratified the UN Convention on the Rights of Persons with Disabilities without reservation. Article 12 of the Convention establishes the following three obligations for state parties: first, states shall recognize and respect the equal legal capacity (including the capacity to hold rights and the capacity to act) of persons with disabilities and shall not infringe upon it; second, states shall protect persons with disabilities from infringement of this right by third parties; third, states shall ensure the realization of this right for persons with disabilities, with the safeguards provided being commensurate with the extent to which these measures affect individual rights and interests.
Based on the provisions of Article 12, Article 25 of the Convention further stipulates the obligation of persons with disabilities to receive medical and health services, as well as “requiring medical personnel to provide care of the same quality as that received by others based on the free and informed consent of persons with disabilities,” and “raising awareness of the human rights, dignity, autonomy, and needs of persons with disabilities.” It follows that persons with disabilities who can freely express their consent have the right to be informed and their autonomy over their personal and health decisions should be respected to the greatest extent possible, with doctors obtaining their consent before performing medical procedures. For persons with disabilities who cannot normally give valid consent, states need to assist them in realizing their autonomy over their personal and health decisions, and the safeguards provided should be commensurate with the degree of individual rights and interests and not exceed necessary limits.
From the above, we can see that when patients cannot exercise their medical consent rights, states need to provide institutional assistance or protection to help them exercise their medical consent rights. For adults with limited capacity to act, states need to actively help them realize their medical consent rights to achieve the purposes and objectives of the Convention.
C. The adult guardianship system cannot solve the problem of substitute execution of medical self-determination
Adult and minor guardianships, as corresponding legal concepts in private law, together constitute the guardianship system in civil law. The adult guardianship system was initially established in ancient Roman law to protect family interests. Subsequently, with the development of human rights concepts and continuous reforms, the adult guardianship system has become a civil legal system for supervising and protecting the personal and property interests of adults with disabilities, especially those with reduced judgment due to mental disorders.13 The adult guardianship system includes internal and external relations; the internal relation mainly deals with the relationship between the guardian and the ward, such as the determination of the guardian, the enumeration of guardianship responsibilities, etc., while the external relation mainly covers the effectiveness of legal acts of the ward and their legal representatives.14 However, there are still many gaps in the legislation, which need to be further improved.
According to Article 28 of the Civil Code of China, close relatives and others can become guardians of those adults with limited capacity to act. According to Article 34, the guardian must represent the ward in civil legal acts, protecting their personal rights, property rights, and other legal rights and interests. It is evident that although the content of this provision includes the protection of the ward’s rights, the guardian’s duties are limited to representing the ward in legal acts.
Regarding the legal nature of consent in the right to informed consent, informed consent is not a legal act, as legal acts refer to actions intended by the actor to produce specific legal effects. In contrast, consent in informed consent merely constitutes allowing another person to engage in a particular factual act within the permitted scope of rights.15 Furthermore, factual acts have no relation to the actor’s intentions,16 while consent in the right to informed consent includes both the inner intention and the external expression, where the former is more important than the latter.17 Therefore, informed consent is not a factual act. Based on the importance of the inner intention and the lack of legal effect, the general theory considers the nature of informed consent to be a quasi-legal act.18 It follows that the content of the guardian’s duty concerning personal rights must necessarily exclude medical self-determination, which is based on the right to informed consent.
Thus, when forming a medical contract, an adult guardian can act on behalf of the ward. However, since medical self-determination, as mentioned above, does not fall under the category of legal actions, and due to its strong personal and exclusive nature, it is closely related to the identity and personality of the parties involved.19 Consequently, the principle of non-representation is applied and countries such as Japan exclude this kind of representation from the scope of a guardian’s responsibilities. At this point, a practical dilemma arises: How can the legality of medical conduct be determined when a subject who cannot consent is unable to exercise their medical self-determination, leading to an inability to give informed consent and receive timely medical treatment? To address this issue, we need a new concept to help exercise medical self-determination on behalf of the adult patient. Since it involves the content of a substitute promise, this right should be named “medical proxy.”
II. Medical Proxy Is Applicable When Patients Cannot Consent
A. In the field of medical self-determination, the capacity to consent should replace the capacity to act
1. Distinguishing between the capacity of intention and the capacity to act
The capacity of intention is the normal decision-making ability of an average person, consisting of two elements: first, the ability to accurately recognize the actions one wants to take, which refers to the understanding capacity; and second, the ability to appropriately control the actions that are about to occur according to this recognition, which refers to the capacity for self-determination.20 To facilitate social interactions and reduce judgment costs, The Civil Code of Japan specifically addresses people with a generally poor capacity of intention, classifying them as persons with the impaired ability to act due to a lack of full capacity to do so. In most cases, the capacity to act replaces the capacity of intention, and limited capacity to act implies a lack of capacity of intention.21 Regarding the relation between guardianship and the ability to act, although the mainstream academic view believes that the two should be “decoupled,” the current adult guardianship system still requires the lack of capacity to act as a necessary prerequisite.
Based on the following reasons, we believe that the capacity of intention should replace the capacity to act in the field of medical self-determination. First, the standards for the capacity to act often appear too absolute and rigid. The interdiction system with the capacity to act as a precondition is based on the concept of negative protection and imposes excessive restrictions on the freedom of the interdicted person, which is not conducive to the realization of personal rights and the right to health autonomy. As a result, this system has been abolished in many countries and regions such as France in 1968, Germany in 1990, Japan in 1999, Taiwan (China) in 2009, and South Korea in 2011. In its place is a new type of adult guardianship system based on the concept of the capacity of intention, which is different from the capacity to act, and is in line with the respect for self-determination as a model for assisted decision-making.
Second, as a signatory to the UN Convention on the Rights of Persons with Disabilities, China must abide by the provisions of Article 12 of the Convention on the equal “legal capacity” of persons with disabilities and the protection of the right to informed consent under Article 25. In addition, the Universal Declaration on Bioethics and Human Rights, drafted by UNESCO and unanimously adopted by member states in October 2005, emphasizes respect for the autonomy of the individual and the principle of obtaining the individual’s consent as the highest principle in medical self-determination in Articles 5, 6, and 7.
Third, the capacity to act focuses on safeguarding financial interests and is not designed for personal rights and interests, while a patient’s capacity of intention to recognize medical actions reflects their ability to control their body. Compared with the capacity to act as a generalized expression of a natural person’s recognition ability in legal terms, the capacity of intention is the actual recognition ability of a natural person.22 The reason for adopting the capacity of intention is that complex actions require higher judgment ability, while simple actions only need simple judgment ability.23
2. Capacity to consent is the specific recognition ability of the capacity of intention in the medical field
Medical self-determination differs from property management affairs in the adult guardianship domain, as it has a strong personal and exclusive nature and involves invasive medical procedures on a patient’s body. Therefore, it requires the victim’s consent as a defense for any tortious act. This highlights the need for appropriate capacity to consent in medical self-determination, which is distinct from the guardianship system. So, what is the relation between the capacity of intention and the capacity to consent? Fundamentally, the capacity of intention corresponds to the German term “Willensfaehigkeit,”24 which is no longer mentioned in contemporary German civil law literature. Japanese civil law theory and judicial practice have long used this concept, which entails the correct recognition of one’s actions and the reasonable control of one’s impending behavior.25
In medical practice, medical decision-making requires patients to understand specific medical conduct, the possibility of a cure, alternative treatment options, the accompanying opportunities and risks, and the interests related to the decision. In the medical field, therefore, a patient’s expression of consent based on valid notification requires their ability to discern and judge. Discernment includes the cognitive ability to understand facts and causal relations and the evaluative ability to assess them. Judgment refers to the ability to make decisions based on this cognition and assessment and communicate them to the outside world.26 Thus, the capacity to consent is the specific capacity of intention in the medical domain.
In countries such as Germany and Austria, a victim’s capacity to consent is judged based on their recognition ability in individual cases rather than their general capacity to act. This is because the ability to make decisions can vary depending on the environment one faces. Consequently, a person may be able to handle a particular matter but lack the necessary ability for others.27 Due to this, it is challenging to determine whether an individual has recognition ability at a specific moment. For patients with Alzheimer’s disease who gradually lose the capacity of intention, we cannot tell whether they have the recognition ability when they make important medical decisions. To ascertain whether a patient has recognition ability, countries such as Germany and Austria use the Mini-Mental Status Test for individual case assessments. Some scholars in China who adopt the theory of the capacity of intention also believe that individual case reviews should be used,28 providing a valuable reference.
B. When patients have the capacity to consent, the first principle is to respect their will
For adult wards, although they lack recognition ability, their rights, will, and preferences must be respected according to Articles 12 and 25 of the Convention on the Rights of Persons with Disabilities. Therefore, relevant medical decisions should be based on the ward’s will, implementing the principle of prioritizing their will. This means that even when patients with the capacity to consent make decisions that contradict medical common sense or seem foolish to doctors, their will must be respected and should be the primary guiding principle. Section 1(4) of the Mental Capacity Act 2005 of the UK stipulates the content of respecting foolish behavior, stating that a person is not to be treated as unable to make a decision merely because he makes an unwise decision. However, if a patient’s choice is unreasonable or even foolish from a professional perspective because they cannot understand information, weigh, or evaluate the information obtained when making a decision, they should be deemed to lack the capacity to consent. Therefore, whether to respect the patient’s decision or initiate medical proxy-related procedures depends on examining whether their ability to understand information, remember information, and weigh and evaluate the decision-making process is impaired.29
Moreover, patients can make directives in advance while they still possess recognition ability specifying what medical decisions they want to be made if they lose their capacity, which means advance directives. This system, called health care proxies or the living will in Anglo-American law, first appeared in the US in 1969, later adopted by the Patient Self-Determination Act (PSDA) of 1990 and the Uniform Health-Care Decisions Act (UHCDA). Section 1901 of the German Civil Code and the Mental Capacity Act 2005 of the UK also contain relevant provisions. Advance directives are commendable for maximizing respect for a patient’s will but also present some unresolved issues, such as how to handle conflicts between advance directive content and a doctor’s medical judgment when the patient has already lost recognition ability.
The UK regulated advance directive content in 2005, but the system only applies to “negative” decisions of refusing medical treatment and cannot be used for “positive” decisions of “requesting specific medical treatment.”30 If a patient gives explicit instructions in an advance directive for life-sustaining treatment they should receive, should it be considered an absolute directive that doctors must follow, and can this specific and “positive” medical decision be similarly applied to all treatments? For this controversial point, the following conclusion was reached during legislative amendments: When a patient requests specific treatment in an advance directive, this expression of intent can serve as evidence of the patient’s past hopes and emotions, providing a reference when making a decision that best serves the patient’s interests. However, it cannot be considered a legally binding directive that compels doctors to perform the medical treatment. Instead, the case should still be handled according to previous judicial precedents and medical experts’ clinical judgment.31
C. Patients with limited capacity to consent require assistance from others in making medical decisions
Influenced by the UN Convention on the Rights of Persons with Disabilities, many signatories have abandoned the system of interdicted persons, which allows for making decisions on behalf of adult wards. Instead, they have established a new system of adult guardianship that supports decision-making. Medical self-determination, which has a highly personal and exclusive nature, should also adhere to the principle of minimal interference with the self-determination rights of adult wards. As long as patients can make medical decisions with the assistance of others, they should be allowed to make these decisions themselves. After all, medical decisions made by others are not equivalent to those made by the patient.
The Mental Capacity Act 2005 of the UK stipulates that when a patient cannot consent, all possible methods to assist the patient in making a decision should be exhausted before the medical proxy can be exercised (Section 1.3). The person exercising medical proxy must consider whether the patient might recover the capacity to consent and, if so, when (Section 4.3). If recovery is imminent, the patient should wait until they can make their own medical decision, unless it is a medical emergency. Even if a decision cannot be postponed, the possibility of regaining the capacity to consent may still influence the content of the decision.32 The person exercising medical proxy on behalf of the patient should involve them as much as possible in the decision-making process and strive to increase their participation (Section 4.4).
The Austrian Civil Code (Allgemeines Bürgerliches Gesetzbuch) states that when a patient has the capacity to consent, even if they grant medical self-determination to a legal or intended guardian through special authorization, the patient must still make the medical decision themselves. This provision differs from the rule that the appointment of a guardian automatically entails the loss of the ward’s capacity to act (Section 280 of the Austrian Civil Code). When a patient cannot consent at the time of the decision, the legal or designated guardian may exercise the medical proxy on their behalf for medical interventions, similar to emergency medical actions. In all situations where medical decisions need to be made, guardians must first determine whether the patient can consent; if the patient can make decisions regarding simple medical conduct, they should do so themselves, and only when they cannot understand complex medical conduct should the guardian decide on their behalf.
In comparison to the Austrian Civil Code, the German Civil Code places greater emphasis on cooperation between doctors and guardians. Section 281(2) of the German Civil Code specifies the guardian’s duty to explore the patient’s wishes. For significant medical conduct, the guardian is obliged to provide information to the patient and seek the possibility of the patient making their own medical decision.
D. When exercising medical proxy, the principle of maximizing the patient’s best interests should be followed, which is different from medical self-determination
Medical consent rights require respecting the individual’s will to the greatest extent possible. However, this is not necessarily the case when the medical proxy is exercised. Even decisions made by spouses or relatives who are closest to or most familiar with the patient will deviate from the decisions the patient would have made themselves. Can the person exercising medical proxy make decisions that seem to align with the patient’s wishes but are objectively harmful or even potentially damaging?
Regarding this issue, the UK’s law stipulates that when a patient makes their decisions, even seemingly unwise or even foolish decisions should be respected based on the principle of respecting their will. However, when someone else exercises the medical proxy, a different principle must be followed, which requires that the medical decision maximizes the patient’s interests.
In understanding the concept of “maximizing the patient’s best interests,” Lord Justice Lewison of the UK believes that centering the decision around the patient does not mean speculating on how the patient would have acted if they had not lost the capacity to consent and then making the same decision, i.e., the so-called substituted judgment test.33 Nor does it mean pursuing only the patient’s objective interests, but rather taking into account the patient’s wishes, values, and various other factors to make the decision that is most beneficial to them.34
When making decisions in the best interests of the patient, to what extent should the patient’s wishes be considered? The UK’s court judgments have listed several factors worth considering: (1) the patient’s residual capacity to consent; (2) the attitude and consistency of expressing opinions; (3) the likelihood of being affected when it is known that the wish cannot be realized; (4) the reasonableness, careful consideration, trustworthiness, and feasibility of the wish; (5) the probability that the wish, when realized, would be consistent with the judgment issued by the court for the patient’s best interests, and so on.35
III. Developing Medical Proxy Through the Connection with the Adult Guardianship System
A. In the medical field, adult guardians can be specially authorized to exercise medical proxy
Medical proxy aims to address the issue of control over personal autonomy for patients lacking the capacity to consent, which is based on personal rights. Therefore, it cannot be simply exercised through an agency. For this reason, many countries do not include the medical proxy in the duties of adult guardians by default in their legal provisions. According to Article 34 of the Civil Code of China, a guardian’s duties are to represent the ward in implementing civil legal actions and to provide protection for the ward’s person and property. In the medical field, the most typical legal action is the conclusion of a medical contract. The process and content of the medical contract conclusion bear the characteristics of legal actions and quasi-legal actions of informed consent intertwined and inseparable.
In other words, for medical contracts, the academic community generally believes that registration and charges imply the establishment and effectiveness of a doctor-patient contract. However, this is merely the beginning of the doctor-patient relationship. When a medical contract is established, its content is in a generalized state, and the patient’s needs are not yet clear or certain. As diagnosis and examination work progresses, medical professionals’ judgments on the patient’s illness and physical condition will gradually become clearer, making the content of the medical contract dynamically evolving and changing.36 The clarification of the contract content relies on informed consent, mainly reflected in the communication process of informing and agreeing, clarifying the specific rights and obligations of both parties in the contractual relationship. At this point, consent includes both explicit and implied. For general medical treatment activities, if medical professionals provide appropriate information and explanations and the patient does not express refusal or opposition, the patient’s consent can be considered obtained. For special medical treatment, medical professionals need to use more specific and easily understandable methods to explain and clarify medical risks and alternative treatment options, and the patient should give explicit consent after fully understanding the situation.37 If a hospital fails to fulfill its duty to explain, the patient may request compensation for damages based on the provision of incomplete performance. Medical self-determination based on the effective information provided by the medical institution is a manifestation of the self-determination right based on personal rights and cannot be exercised through the agency of others. Therefore, from the perspective of both tortious acts and medical contracts, the issue of the legality of medical conduct is resolved through medical self-determination based on informed consent. If the patient cannot consent due to mental disorders, intellectual disabilities, or dementia, the medical proxy must be exercised by someone else to address the legality of the medical conduct.
Given the intertwined characteristics of legal actions and quasi-legal actions of informed consent in medical contracts, the coordination between adult guardianship, which serves as the agency for legal actions concerning the person and property, and medical proxy based on personal rights becomes an important issue. Considering legislative costs, the legality of medical conduct can be effectively addressed by specially authorizing adult guardians to exercise medical proxy. Next, we attempt to construct a medical proxy system by exploring the connection between adult guardianship and the medical proxy system.
B. The subjects of adult guardianship and medical proxy do not necessarily coincide
1. In cases of legal guardianship, individuals or organizations other than close relatives should be excluded from the subjects of medical proxy
(1) The subject of informed consent in place of the patient in current laws. According to the Civil Code of China, in the case of “unable or not suitable for informing the patient,” close relatives should exercise the right to informed consent. At the same time, Article 5 of the Interpretation of the Supreme People’s Court on Several Issues concerning the Application of Law in the Trial of Cases Involving Disputes over Medical Malpractice Liabilities (2020) stipulates that in the case of operation, special examination, or special treatment, a medical institution shall assume the obligation of explanation and obtain the express consent of the patient or his or her close relative. In addition, Article 32 of the Regulations on the Administration of Medical Institutions(2022) uses the phrase “explain them to the close relatives of their patients, and obtain the explicit consent of the close relatives.” Article 6 of the Technical Specifications for Clinical Blood Transfusion (2000) stipulates that before deciding on blood transfusion treatment, the consent of the patient or family members should be obtained. Article 26 of the Law on Practicing Doctors (2009) states that doctors shall get approval from the hospital and the consent of the patient or family members before conducting clinical treatment on an experimental basis. Article 10 of the Basic Norms for Medical Record Writing issued by the Ministry of Health in 2010 stipulates that for medical activities requiring written consent from the patient when the patient does not have the full civil capacity, the legal representative should sign; when the patient is unable to sign due to illness, authorized personnel should sign; and for the rescue of the patient, if the legal representative or authorized person cannot sign in time, the person in charge of the medical institution or the authorized person in charge can sign. Article 43 of the Mental Health Law (2018) stipulates that when a medical institution conducts the following treatment measures on a patient with mental disorders if it cannot get the opinions of the patient, it shall obtain the written consent of his or her guardians. It can be seen from the current legal provisions that when the patient is unable to exercise the right to informed consent, the “close relatives,” “legal representatives,” “authorized persons,” and “guardians” exercise it and sign on their behalf. Since the scope of each identity is different, it is necessary to identify whether the scope of personnel is consistent.
(2) “Close relatives,” “relatives,” and “family members.” According to Article 1045 of the Civil Code of China, spouses, parents, children, siblings, paternal and maternal grandparents, and paternal and maternal grandchildren are close relatives. Relatives include spouses, blood relations, and relations by marriage. “Family members,” as a subordinate concept to “close relatives,” specifically include spouses, parents, children, siblings, grandparents, maternal grandparents, grandchildren, and maternal grandchildren “living together.” Article 822(3) of the Marriage and Family Book of the Civil Code (Third Draft for Review) once stipulated that “parents, parents-in-law, sons-in-law, and daughters-in-law living together are considered close relatives,” but this was eventually deleted due to reasons such as difficulties in determining “living together” raised by National People’s Congress representatives. The result was to continue to use the provisions of close relatives in Article 12 of the Opinions of the Supreme People’s Court on Several Issues Concerning the Implementation of the General Principles of the Civil Law of the People’s Republic of China (Trial). It can be seen that the legislative body generally adopts the family model centered on the core family and the direct family,38 and is cautious about including direct in-laws in close relatives. As for family members, this is a product of the feudal patriarchal system, referring to other family members who lived together to share life under the command of the head of the family in the feudal law of past dynasties, subordinate in status and not limited to relatives.39 “Family members” is not a concept in the Civil Code of China.
(3) “Close relatives” and “legal representatives.” According to Article 23 of the Civil Code of China, the guardian of a person without capacity for civil conduct or with limited capacity for civil conduct shall be the statutory agent of the person; according to Articles 28 and 32 of the Civil Code of China, the legal guardians of persons with no civil capacity or limited civil capacity adults are, in order, spouses, parents, children, siblings, grandparents, maternal grandparents, grandchildren, maternal grandchildren, and other individuals or organizations willing to act as guardians with the consent of the urban residents’ committee, villagers’ committee, or civil affairs department of the place of the adult’s domicile; where there is no person legally qualified for guardianship, the civil affairs department may or the urban residents’ committee or villagers’ committee of the place of the ward’s domicile satisfying the conditions for performing the duty of guardianship may act as the guardian. It is clear that the scope of “legal representatives” is broader than that of “close relatives.” It includes not only close relatives but also other individuals or organizations.
In summary, the terms “relatives” and “family members” do not conform to the provisions of Articles 1219 and 1220 of the Civil Code of China. Therefore, they need to be changed to “close relatives,” and the scope of legal guardians is broader than that of “close relatives.” So, what criteria should be used to define the subject of medical proxy in legal guardianship when we develop the medical proxy system? It is evident that for legal guardians, the relationship is established based on factors such as blood relationship, life contact, and emotional foundation. In today’s society, generally, only close relatives live with the patient and assume the responsibility of taking care of the patient and paying for treatment, having a certain dependence on personal or financial aspects. Close relatives in a close relationship with the patient are better able to understand the patient’s will regarding diagnosis and treatment and know what would be the most beneficial decision for the patient. As the scope of legal guardianship is broader than that of “close relatives,” we believe that for the sake of the patient’s best interests, the subject of medical proxy should be based on factors such as blood relationship, life contact, and emotional foundation, excluding individuals or organizations other than close relatives in legal guardianship. In other words, even if individuals or organizations other than close relatives within legal guardianship are specifically authorized, they cannot establish a valid medical proxy.
2. Granting medical proxy to intended guardians
(1) The necessity of granting the medical proxy to intended guardians. It is beyond doubt that close relatives based on blood relationships should be the subject of the medical proxy, but can the intended guardians with a relationship solely based on trust exercise medical proxy? In principle, an intended guardianship agreement is a contract of agency, which can be either general or limited (Article 920 of the Civil Code of China). The content of the contract becomes the scope of authorization, and based on the contract, the trustee may carry out legal actions with third parties or handle factual actions such as paying taxes.40 In addition to agreeing on property management in the intended guardianship agreement, intended guardians can also specify the conclusion of care contracts and the selection and change of caregivers, as well as specific care for the ward; actions such as admitting and discharging the ward from the hospital and concluding medical contracts with medical institutions; and arrangements for the ward’s diet, daily life, and other personal rights and interests.41 Since the intended guardian’s representation of certain personal medical conduct with some personal and exclusive nature can easily infringe on the ward’s rights and interests,42 many countries exclude such actions from intended guardianship agreements. Compared with legal guardianship, intended guardianship agreements can directly reflect the individual’s intentions by appointing a guardian in advance and do not differ significantly from the legal guardianship system that respects the individual’s choice of adult guardians, as they are designed with the same nature.
In the Civil Code of China, the tort liability part only stipulates the right of informed consent for close relatives. Is it permissible for patients to authorize others to represent their consent through the intended agency? Some scholars believe that without violating mandatory laws and basic social ethics, patients should be allowed to authorize others, including medical institutions, to make decisions, but close relatives of patients have no right to authorize others or medical institutions to make decisions.43 Another view is that allowing people other than close relatives to exercise decision-making power may result in irresponsible decisions or decisions that do not represent the patient’s best interests.44
Considering the arrival of an aging society, the number of patients without close relatives will gradually increase, and we still face the problem of the legality of medical conduct for these people. To solve this problem, we believe that intended guardians can be granted medical proxies under the premise of effectively regulating conflicts of interest.
(2) In current law, the terms “authorized person in charge” and “related person” can be interpreted as intended guardians. According to Article 43 of China’s Mental Health Law implemented in 2018, when a medical institution conducts a surgery resulting in the loss of function of a human organ, or experimental clinical treatment relating to the treatment of mental disorders on a patient with mental disorders, it shall inform the patient or his or her guardians of the medical risks, alternative medical plans and information; if it cannot get the opinions of the patient, it shall obtain the written consent of his or her guardian. Since “patients with mental disorders” are included as those “without the capacity for civil conduct or with limited capacity for civil conduct” in Article 28 of the Civil Code of China, it can be inferred that when such patients have mental disorders and lack or have limited civil capacity, the right to medical consent based on valid informed consent can be exercised by guardians, including intended guardians.
Additionally, Article 10 of the Basic Norms for Medical Record Writing issued by the Ministry of Health in 2010 stipulates that when a patient cannot sign due to illness, an authorized person should sign on their behalf. To save the patient, if the legal representative or authorized person cannot sign in time, the person in charge of the medical institution or the authorized person in charge can sign. For protective medical measures, if the patient has no close relatives or the patient’s close relatives cannot sign the consent form, the patient’s legal representative or related person should sign the consent form. Article 33 of the Regulations on the Administration of Medical Institutions (2016) stipulates that when offering surgery, special examination, or special treatment, a medical institution shall obtain the consent of a patient, and obtain the consent and signature of his or her family or related. If the patient’s opinion cannot be obtained, the consent and signature of family members or related persons should be obtained. From the wording of the provisions, the terms “authorized person in charge” and “related person” in Article 10 of the Basic Norms for Medical Record Writing, and the “related person” stipulated in Article 33 of the Regulations on the Administration of Medical Institutions, involve the possibility of including “intended guardians.” In judicial practice, the court in the Li Liyun case 45 treated Xiao Zhijun, her boyfriend living with her with no support relationship or common property, as a “related person.” In the Hu Guibao case,46 the patient sought medical treatment due to participating in a company-organized travel activity, and the court considered the accompanying personnel as activity managers and “related persons.” Regardless of whether the court’s judgment is correct since the boyfriend and company activity managers can be the subjects of medical self-determination, intended guardians based on a trust relationship can be even more qualified as medical proxies.
Some scholars argue that provisions regarding “related persons” making medical decisions should be removed, as the decisions they make might be irresponsible or not representative of the patient’s best interests. For example, in the Li Liyun case, Xiao Zhijun was her boyfriend living with her but the two had no support relationship or common property basis. He later explained that he refused to sign the consent for a cesarean section because he was afraid that if Li Liyun died, her parents would hold him responsible. Therefore, Xiao Zhijun’s decision might be irresponsible due to the lack of consequences.47 Intended guardians should not be determined arbitrarily and must be based on a special authorization in the agency contract; medical institutions should not make decisions on who the related person is.
C. Handling disagreements between guardians and between guardians and doctors
1. The order of priority for close relatives to exercise medical proxy
Chinese law does not specify the order of priority for close relatives to exercise medical proxy. Some scholars suggest that priority should be given to spouses, parents, and adult children, followed by other close relatives, and finally other relatives and related persons. They also note that if the opinions of the priority relatives are inconsistent, the hospital ethics committee should make the final decision.48 Other scholars propose that the second priority should be given to siblings, grandparents, and maternal grandparents, and the third priority should be given to adult grandchildren and maternal grandchildren. If a consensus cannot be reached among close relatives, the majority opinion should be followed.49 The Supreme People’s Court, in its [2020] No. 17 judicial interpretation, believes that Article 18 of the Interpretation does not explicitly define the order of close relatives, nor does it grant priority rights to the priority close relatives to express treatment opinions. Instead, it holds that as long as the opinions of close relatives contacted by the medical institution are inconsistent, we should refer to the circumstances stipulated in this article.
We believe that although this approach can simplify the operating procedures in practice, it cannot solve the problem of inconsistent opinions among close relatives. For this issue, the approach of not determining the order of close relatives in the judicial interpretation can be followed. When the opinions of close relatives are inconsistent, they should first reach a consensus, and if a consensus still cannot be reached, the intervention of public authorities should be sought to resolve the issue.
2. Handling disagreements between legal guardians and doctors
In principle, doctors cannot take medical measures that are contrary to the opinions of the medical proxy, as this would not prevent illegal reasons. However, in practice, there are indeed cases where the opinions of legal guardians and doctors are inconsistent. When the opinions of legal guardians conflict with those of doctors, it is necessary to distinguish between situations where legal guardians do not act according to the wishes of the patient and those where legal guardians disagree with the doctor’s opinion to protect the patient’s interests. How should this be handled?
Japanese scholars believe that German practice can be referenced in such cases. In other words, when doctors have reasonable grounds, they can notify the family court, which can issue instructions to adult legal guardians and even remove them in serious situations. In contrast, when adult legal guardians refuse to accept high-risk medical measures proposed by doctors to protect the patient, according to Section 1904(1) and (2) of the German Civil Code, the court’s approval is required. Upon receiving the notification, the court must first determine whether the adult legal guardian has adequately investigated and confirmed the patient’s wishes. When the patient and doctor have opposing opinions due to the refusal of high-risk treatment, according to Section 298(2) of the German Act on Proceedings in Family Matters and in Matters of Non-contentious Jurisdiction (FamFG), a procedural assistant must be appointed, and the court’s decision takes legal effect within two weeks after notifying the adult legal guardian and the procedural assistant. Medical measures taken irrespective of the patient’s wishes, which involve infringing on the patient’s bodily rights or personal rights, can be subject to a preliminary injunction and a claim for prevention of infringement according to Section 1004(1) of the German Civil Code, by analogy. Additionally, claims for damages can be made based on tortious acts under Section 823(1) or breach of medical contract under Section 280(1). The German approach to involving public authorities is worth learning from.
D. Medical conduct subject to the medical proxy
Due to the invasive nature of medical conduct, patients must decide whether or not they want to accept a particular medical conduct. However, there are many types of medical conduct, and the degree of invasiveness varies depending on the act. Different kinds of medical proxies are established for different medical conduct. So, what is the scope of medical proxy? To answer this question, we must first consider the types of medical conduct and the criteria for developing the medical proxy.
1. Types of medical conduct
We believe that the connotation and extension of medical self-determination depend on the establishment of the concept of medical conduct, so it is first necessary to explore what is medical conduct. In practice, the definition of “medical conduct” is based on the concept of “diagnosis and treatment activities” in Article 88 of the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions. “Diagnosis and treatment activities” means “the activities of making a judgment on diseases, eliminating diseases, alleviating diseases, relieving pain, improving functions, prolonging life and helping patients to recover through a variety of checks and by using drugs and equipment, offering surgeries, and taking other methods.” A broad definition of medical conduct can be found in existing theories, including the most generalized medical conduct theory, the diagnosis and treatment purpose theory, and the medical purpose theory. The most generalized medical conduct theory holds that medical conduct refers to the comprehensive activities necessary for maintaining patients’ life and health, provided by medical institutions and medical personnel through their medical knowledge, professional skills, instruments, equipment, and drugs, such as emergency treatment, examination, diagnosis, treatment, nursing, medical cosmetology, and logistics and management services for these activities.50 It can be seen that non-diagnosis and treatment activities in legal provisions are also generalized medical conduct, including logistics and management conduct for diagnosis and treatment services. The diagnosis and treatment purpose theory limits medical conduct to actions implemented for diagnosis and treatment purposes,51 which is more in line with the legal provisions than the most generalized medical conduct theory.
Recently, some scholars have considered the fact that the advancement of modern medicine and medical technology has expanded medical conduct beyond traditional diagnosis and treatment and into other areas, and have proposed the medical purpose theory. According to this theory, conduct performed for purposes other than diagnosis and treatment, such as medical cosmetology for appearance improvement, correcting deformities, helping or avoiding childbirth, etc., are also medical conduct.52 We believe that medical decisions in civil law often involve medical ethics, so we will elaborate based on the third theory.
According to the medical purpose theory, there are four types of medical conduct: conduct aimed at diagnosing diseases, conduct aimed at treating diseases, conduct aimed at preventing diseases, and other medical conduct. Conduct aimed at diagnosing diseases include necessary minimal medical invasive conduct for diagnosing conditions, such as palpation, X-ray, blood test, etc. Conduct aimed at treating diseases include (1) general medication, injections, infusions, treatment for fractures, suturing of wounds, etc.; (2) practice in situations where the disease can be controlled and ultimately cured, despite the invasion of the body, such as surgery for early-stage stomach cancer; (3) treatments to alleviate current pain, such as chemotherapy for late-stage cancer; (4) surgeries that involve not only the invasion of the body but also carry a high risk of complications, such as the occurrence of cerebrovascular disorders or orthopedic diseases after treatment. Conduct aimed at preventing diseases include (1) physical examinations and various checks (excluding checks accompanied by significant surgical risks) and vaccinations (such as COVID-19 vaccinations in nursing homes); (2) checks accompanied by bodily invasion and pain. Other activities beyond traditional diagnosis and treatment conduct include medical cosmetology, conduct to help or avoid childbirth, organ transplantation, experimental treatments such as new drug trials, medical measures aimed not at treating diseases but at prolonging life, etc.
2. Factors for determining the applicability of medical proxy in traditional medical conduct
First, the invasiveness of a medical procedure is the primary factor in determining the applicability of the medical proxy. Medical self-determination, which is the foundation of the medical proxy, is the starting point for considering the scope of medical proxy. Since invasive medical procedures involve potential harm, consent is required as a valid defense. Medical proxy largely helps to address the liability concerns arising from medical conduct on behalf of the patient. Therefore, whether medical conduct is invasive is the primary factor in determining the applicability of medical proxy. In the aforementioned classification of medical conduct, those that are diagnostic (such as physical examinations and X-rays) or preventative demonstrate minimal invasiveness and do not require the activation of the medical proxy; they can be managed by a legal adult guardian. Japanese scholars believe that the Austrian approach is instructive. Austrian civil law divides medical conduct into simple conduct and major conduct, with the latter involving those lasting for more than 24 days. For major medical conduct, a guardian must make the medical decision and an independent doctor’s diagnosis is required, which includes proof that the patient lacks the necessary cognitive and judgment abilities and that the treatment is necessary. If the independence of the second doctor providing the diagnosis is in doubt (a common situation in practice), the guardian’s decision requires court discretion.53 For minor medical conduct, only the decision made by a guardian with medical self-determination is needed. Germany has similar provisions; according to Section 1904 of the German Civil Code, a legal guardian must obtain court permission before deciding on major medical conduct. Major medical conduct is those with high risks, which may involve the patient’s death during the invasive procedure or a long-term risk of health impairment.54
Second, we need to consider whether the medical conduct is beneficial to the patient. In this regard, some conduct aimed at treating diseases in categories (1) and (2) above may be highly invasive but are significantly beneficial to the patient, and their benefits do not conflict with the interests of those around the patient, making the situation relatively simple.
Third, for treatment procedures that involve bodily invasion and high postoperative risks, as well as medical conduct that may result in complications such as cerebrovascular disorders after treatment, the outcome is relatively clear. However, the person deciding on behalf of the patient needs to consider post-treatment care and who will bear the costs. Therefore, the opinions of those who will bear the financial burden of care should be taken into account. In such cases, although medical proxy applies, conflicts of interest between the proxy and the patient may arise, potentially necessitating intervention by public authorities, such as notary offices or judicial bodies like courts.
Last, for treatment procedures such as late-stage cancer chemotherapy that involve bodily invasion and painful examinations, the refusal of treatment or examination may mean giving up on treating a severe illness. Choosing to refuse an examination could result in the abandonment of life. Therefore, it is necessary to evaluate the possible continuation of life, pain, and uncertainty associated with refusing the examination, and other factors. In this case, public authorities can also intervene to assist in making decisions.
3. Medical conduct beyond traditional medical diagnosis and treatment requires individual judgment
First, medical conduct such as medical aesthetics, helping or avoiding childbirth, and medical interventions aimed at prolonging life should, in principle, be based on the patient’s medical decisions and not subject to the medical proxy. In these cases, other auxiliary means can be used to help the individual exercise their medical self-determination, or the patient can establish an advance medical directive to resolve issues related to liability exemptions. For example, experimental treatments, such as new drug trials, do not aim to cure diseases but rather to prolong life.
Second, in experimental treatments, the issue of individuals without the capacity to consent being treated as tools for the benefit of third parties, thus violating human dignity, is controversial. On this point, German law serves as a useful reference. The Directive 2001/20/EC of the European Parliament of April 4, 2001, Article 41 of the German Medicinal Products Act (AMG), and Article 17(2) of the Biomedical Convention set limits for “research beneficial to group members,” allowing research to be conducted within the minimum risk range and with the minimum burden. The term “beneficial to group members” refers to benefits for other individuals without consent capacity in the same situation, but does not bring greater benefits to the test subjects themselves. In such cases, if it is assumed that an individual without the capacity to consent already possesses the necessary capacities, even though the experiment does not benefit their health, it should be allowed based on the likelihood that they would consent. This is an idea worth borrowing. In these situations, public authorities should intervene to determine whether the research qualifies as “beneficial to group members.”
Third, regarding organ transplantation, the current standard for determining death in China is still “cardiac death.” It is believed that only cardiac death truly signifies the end of life. “Brain death” refers to the irreversible loss of all brain functions, including the brainstem. Without recognizing “brain death” as the legal standard for death, there can be no real organ transplantation. After the human heart stops beating, blood clots completely, and the organs cannot be used for transplantation. The organs have a short period of viability and must be perfused within a few minutes after the heart stops beating. They can be preserved for at most a dozen hours. If “brain death” is not recognized, heart transplantation becomes nearly impossible. Currently in China, to improve the success rate of organ transplantation in clinical practice, medical institutions generally require the family members of brain-dead organ donors to sign a consent form to donate organs and another form to abandon medical treatment on behalf of the patient, after obtaining their agreement. Some scholars have raised concerns that this practice still carries the suspicion of illegally harvesting living organs,55 but as it requires the patient to decide whether to accept brain death and donate organs, the clinical practice follows the principle of respecting the individual’s wishes to the
greatest extent possible. According to Article 1006 of the Civil Code of China, which continues the provisions of the Regulations on Human Organ Transplantation, a compromise approach is adopted, allowing the donation decision by close relatives unless the individual strongly opposes it.56 This approach is mainly adopted because allowing the donation of a deceased person’s body by their close relatives does not constitute an infringement on the individual’s dignity, as long as the person did not explicitly express their opposition during their lifetime.57 However, in China, when a person is “brain-dead” but not “cardiac-dead,” the issue of lacking the capacity to act and judge arises. At this point, organ transplantation based on the consent of the family involves the proxy of medical self-determination. For organ transplantation, if the patient has not expressed a clear intention to donate, relying solely on the medical proxy of close relatives may violate the medical proxy. In such controversial cases, public authorities should intervene and jointly decide with medical institutions, rather than relying solely on the proxy of close relatives to prevent their illegality.
In summary, whether to apply medical proxy should be determined based on the invasiveness of the medical conduct; special medical proxy may be required in cases where complications such as post-treatment care conflict with the interests of the patient’s surrounding individuals, and if necessary, public authorities may need to intervene in the decision-making process. Last, the medical proxy does not generally apply to activities beyond traditional medical conduct, and judgments should be made by medical institutions and public authorities.
Conclusions
The construction of medical proxy aims to solve the legal problems of medical conduct due to patients’ inability to provide consent to effectively exercise their right to informed consent. Since medical proxy is a substitute commitment for personal rights, and does not constitute a legal act. Therefore, it cannot be exercised by a guardian on behalf of the patient and does not fall within the scope of a guardian’s responsibilities. However, since medical contracts intertwine legal actions and the exercise of the right to informed consent, the existing guardianship system can be connected to the structure of medical proxy, granting guardians special medical proxy in practice. In short, for legal guardians, the medical proxy cannot be granted to individuals or organizations other than close relatives; for intended guardians, as the aging population continues to increase, it is appropriate to include them within the scope of the medical proxy, provided that conflicts of interest can be effectively resolved. Not all medical conduct can be subject to a medical proxy. For minimally invasive medical conduct, such as vaccinations and simple blood tests, when the patient cannot consent, no special authorization is needed, and the medical proxy can be exercised by an adult guardian. For more invasive medical conduct, which may involve postoperative care, potential complications, and conflicts of interest with the patient’s immediate circle, special authorization is required to exercise the medical proxy. Last, the principle of medical proxy does not generally apply to conduct outside the scope of traditional medical conduct.
(Translated by SU Yilong)
* LI Min ( 李敏 ), Lecturer at the Law School of Dalian Maritime University and part-time Researcher at the Beijing Ageing Law Research Association. This article is a stage achievement of the Research on the Deregulation of Enterprise Annuity Funds in Liaoning Province, a 2020 Liaoning Provincial Social Science Fund project (Project Approval No. I20AFX004).
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2. In many documents, the term “medical consent” is used to describe medical self-determination. However, some scholars argue that because patients have the right to accept or refuse medical procedures recommended by physicians, the term “medical consent” should be used to indicate that patients have the right to give or withhold their consent to medical treatment. This falls under the legal rule of victim consent and is a typical case of illegal obstruction. See Sun Yelong, “The Legal Regulation of Surrogate of Health-care Decision-making,” Studies in Law and Business 6 (2018): 4.
3. Sachwalterrechts-Andenmgsgesetz 2006, BGBL I 92/2006.
4. 3. Betreuungsrechtsanderungsgesetz, BGBL I S. 2286.
5. Department for Constitutional Affairs, Mental Capacity Act 2005 Code of Practice, (2007).
6. Articles 377-381 of the Swiss Civil Code.
7. Teruaki Tayama, The Medical Consent and Legal Representation Rights of Adult Guardianship (Tokyo: Sanseido, 2015).
8. Wang Zhu, “Liability for Infringement of Patient’s Informed Consent Right from the Perspective of Interpretive Theory,” Law Science Magazine 11 (2011): 96.
9. Article 26(1) of the Law on Practicing Doctors, and Article 11 of the State Council’s Regulations on the Handling of Medical Accidents.
10. Articles 61 and 62 of the Detailed Rules for the Implementation of the Regulation on the Administration of Medical Institutions by the Ministry of Health, and Article 10(2) of the Basic Norms for Medical Record Writing by the Ministry of Health.
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25. Makoto Arai, “Capacity for Rights, Capacity for Intention, Capacity for Actions, and Capacity for Responsibility,” 16.
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45. Ibid., 76.
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49. Wang Zhu, “Liability for Infringement of Patient’s Informed Consent Right from the Perspective of Interpretive Theory,” 93-100.
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54.Jurgeleit-Kieβ,Betreuungstecht3 § 1904 BGB Rn44f.
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