| The patient's informed consent refers to the right of patients with the ability to consent in medical behaviors to fully accept and understand various important diagnosis and treatment information without compulsory status,and on this basis,to make voluntary choices for the diagnosis and treatment plan formulated by medical staff.The principle of medical "informed consent" is a product of the common law system.It has gradually developed in our country which is approved by Article 33 of the Regulation on the Administration of Medical Institutions,Article 62 of the Detailed Rules for the Implementation of the Regulation on the Administration of Medical Institutions,Articles55 and 56 of the Tort Law,Articles 1219 and 1220 of the Civil Code.The principle of informed consent makes the patient no longer the object of medical behavior,but an equal subject with the medical institution which plays a special system function of protecting the patient's physical rights.In addition to the Anglo-American law system,Germany,France,Austria,Japan and other countries in the civil law system also attach great importance to the protection of patient's informed consent.There are rich theories on terms of the attributes of rights,the typification of notification obligation,the subject of proof of violations,the judgment of causality,mental damage compensation and other aspects.From the "Li Liyun case" in 2007 to the "Ma Rongrong case" in 2017,the patient's informed consent was once again placed on the cusp of the storm,and it is urgently needed to protect patient's personality rights through legal social control.The Civil Code separates the right of personality,precisely because the right of personality is the most basic right of civil subjects,and it is related to the personal dignity of everyone.The patient's informed consent protects the patient's personal dignity during the medical process,and it is of great practical significance to improve and refine the system.This article conducts in-depth research on the relief for infringement of patient's informed consent by taking the legislative purpose of "protecting patient's informed consent" as the main line,basing on the core values of socialism,and adopting research methods such as historical analysis,empirical analysis,comparative analysis,and big data analysis,extracting specific issues from practice case of infringements of patient's informed consent-problem-oriented,integrating academic viewpoints inside and outside the territory.Compared with the existing research results,this article takes the problems reflected in judicial practice as a guide,insists on being based in our country,sticks to the independence of responsibility for infringing patient's informed consent,and puts forward a specific system concept suitable for our country to protect patient's informed consent by clarifying the rights attributes and exercise subjects of patient's informed consent,identifying illegal acts that infringe on patient's informed consent,clarifying the principles of liability and the judgment of causality in the scope of responsibility for infringements of patient's informed consent,determining the calculation ideas of property damage compensation for infringements of patient's informed consent,and the factors and calculation methods of the mental damage comfort payment,enriching the liability methods for infringing patient's informed consent,comprehensively considering the protection of patient's informed consent interests under the path of contract law.In addition to the introduction,this article consists of seven chapters which are the basic theory of patient's informed consent,the boundaries of private law relief for infringement of patient's informed consent,the illegality of infringements on patient's informed consent,the presumption of fault and causality in the scope of responsibility for infringements on patient's informed consent,responsibility for infringement of patient's informed consent,the remedy path of contract law for infringement of patient's informed consent,and the conclusion.The first chapter is "Introduction".The article introduces problems through cases involving infringement of patient's informed consent.It intends to combine the status quo of domestic and foreign research,use case analysis,comparative analysis and other methods to carry out research,sum up possible innovations in academic thinking,academic viewpoints and research methods,and point out that the data Master and study the possible deficiencies in the system.The second chapter is "the Basic Theory of Patient's Informed Consent".This chapter is based on three aspects: the legal basis,attributes,and the subject of exercise of the patient's informed consent.It starts from the historical background of the birth of the patient's informed consent,the theory and practice of the principle of informed consent to protect legal interests,and the multi-category legal provisions of the exercise subject.The following opinions are conclusively put forward:The human rights movement in the United States and the human experiment in Germany gave birth to the principle of informed consent.As a legal subject,the loss of self-determination is equivalent to the loss of human dignity.Personal dignity is the concretization of human dignity in the category of personal rights.Personal dignity is the basic value of the legal order realized by the constitution and civil law.The body is a close field that shows human dignity,so the self-determination of the body embodies the protection of human dignity.However,in order to balance the interests of doctors and patients and respect the social existence of individuals,the informed consent has its boundaries,and medical institutions may retain appropriate discretion based on the "best interests of patients".The controversial views on the protection of legal interests of this principle in our country are basically the same as those outside the territory,mainly including the theory of self-determination,the right of privacy,the theory of physical rights,the hybrid theory of self-determination and the theory of the right to life and health.Adopting the theory of physical rights is more in line with our country's legislative system.The legal benefit of the protection of the right of body covers the freedom of will of the "right to self-determination",which is specifically manifested in the autonomous determination of the integrity of the body.The belief that the two objects are completely different is a narrow understanding of body rights and an overemphasis on freedom of will.The subject of informed consent is the patient,but it is an exclusive right based on physical rights,so others can exercise it on their behalf.Determining the subject of the patient's informed consent is the basis for constructing the medical informed consent system,which can be divided into three levels: scope,consent ability,and order.As far as the scope of the subject is concerned,the concept of related parties should be abolished,and the terms of relatives and family members should be discarded and expressed by close relatives.In addition,the concept of close relatives should be extended to widowed daughter-in-law and son-in-law who live together.As far as the subject's consent ability is concerned,the ability of will should be established as a criterion for judging whether it has the right to medical consent.At the same time,it should be distinguished between improper and impossible,and medical institutions have the burden of proof for improper notification.The "Civil Code" has stipulated that it cannot,which can be understood as including the objective inability state that the patient cannot decide on its own,such as a coma,and the subjective inability state that the patient lacks the ability to consent under the circumstances other than the foregoing.As far as the order of subjects is concerned,the precondition for others to make medical decisions on behalf of the patient is that the patient cannot agree,and the interests of close relatives may not necessarily represent the interests of the patient.Therefore,it should seek patient's opinion as much as possible when performing surgery that has a major impact on the patient's future lifestyle.The prerequisite for others to make medical decisions is to respect the patient's decision-making power on major matters,and the principle is the patient's best interests.Moreover,the order of close relatives should be determined from the perspective of close relatives,degree of property dependence,and decision-making ability.The medical institution determines the scope of the emergency according to the relevant diagnosis and treatment standards for emergency treatment.If the patient refuses treatment,the medical institution should judge whether the patient's decision is in the public interest based on the principle of public order and good morals;if the close relative refuses treatment,it should be in the patient's best interest,but not necessarily the best health interest.At the same time,the approval procedure for the person in charge of emergency treatment should be abolished.The third chapter is "the Boundary of Private Law Relief for Infringement of the Patient's Informed Consent".The article starts with the four-level cause of "Disputes over the responsibility for infringement of the patient's informed consent" under the three-level cause of "Disputes over medical injury liability" in the Notice of the Supreme People's Court on Issuing the Revised Provisions on Causes of Action in Civil Cases.It analyzes the regulated targets of private law relief for infringement of patient's informed consent,the independence of responsibility for infringement of patient's informed consent,the exclusion of circumstances that do not infringe patient's informed consent,and the basis of the request for infringement of patient's informed consent.The following opinions are conclusively put forward:The obligation to inform and explain is considered to be an obligation under both contract law and tort law.Based on the content of the obligation to inform and explain,it can be divided into "obligation to obtain the patient's consent",which infringes the body's rights,and "economic loss",which results in the loss of pure economic benefits,and "obligation to evade the explanation of adverse results" that violates the right to life and health.The latter is subdivided into "the obligation to explain the instructions and guidance of the recuperation method","the obligation to explain the advice to transfer to the hospital" and " obligation to explain the results of medical treatment." The object of responsibility norms for infringing the patient's informed consent is the obligation to inform and explain for the purpose of obtaining the patient's consent.There are three theories of "independent type theory","non-independent type theory" and "special type theory" as to whether the responsibility for infringing the informed consent of patients in the academic circles is independent.The difference between the latter two theories and the former lies in the understanding of "medical damage liability".The Civil Code has followed the expression of "diagnosis and treatment activities" in the Tort Law,but "activity" is not a legal term,and "behavior" is a legal term.In terms of comparative law,both the United States and Japan adopt a broad interpretation of medical behavior.Therefore,our country should not adopt an enumeration method for the definition of medical behavior,but summarize the core elements-technical elements and dangerous elements,and then determine the scope of patients-the object of the medical act.Medical damage responsibility must be based on medical behavior,not responsibility related to medical behavior,so the responsibility for medical product defects is medical damage responsibility,but the responsibility for keeping and providing medical records,infringing on privacy,and interfering with medical order does not belong to medical damage liability in the strict sense,that is,the Civil Code tort liability chapter 6stipulates "the broadest medical damage liability".The broad sense of medical damage liability is divided into medical technology damage liability,patient's informed consent damage liability,and medical product damage liability.The narrow medical damage liability refers to medical technology damage liability.The independence of responsibility for infringing on the patient's informed consent is embodied in its regulatory notification obligation and protection of the body's right.The notification obligation is independent of technical obligation.The obligation of diagnosis and treatment is the upper concept,and the violation of technical obligations and product quality obligations infringes the lives of patient's right to life and health.Our country's informed consent system is mainly composed of Articles 1219 and 1220 of the Civil Code.The former is the provision of informed consent in non-emergency situations,and the latter is the provision of informed consent in emergency situations.Wrong birth cases,recommended referral cases,pre-hospital medical emergency cases,illegal disposal of placenta cases,and prompt autopsy cases are not disputes involving infringement of the patient's informed consent.The first category involves pure economic losses and is handled in the field of contract law.The second,third,and fifth categories involve medical technology damage liability,and the fourth category involves general tort liability.In non-emergency situations,the basis of the right to request for the infringement of informed consent is Article 1219 of the Civil Code,and there is no need to add Article 1165 or 1218 of the law,because Article 1219 is a specific clause.In an emergency,the basis of the right to request for the infringement of informed consent depends on different circumstances.The consent procedure for violation of Article 1220 shall be based on Article 1218 or 1219.The fourth chapter is "the Illegality of the Infringement of the Patient's Informed Consent".The article starts with the content of notification obligation stipulated in Article 55,paragraph 1 of the Tort Law whether it affects the patient's right to consent,and comprehensively examines the types of violations,the subjects that bear the burden of proof for the violations,and the ways to reduce the burden of proof for the violations.The following opinions are conclusively put forward:An illegal act that infringes the patient's informed consent is a breach of the obligation to inform and explain for the purpose of obtaining consent,and can be divided into non-fulfillment of the obligation of notification and explanation and defective performance of the obligation of notification and explanation.In judicial practice,the former can be further subdivided into failure to inform the patient or close relatives of the explanation,notification of the wrong object,failure to perform the approval procedures of the person in charge,and the latter can be further subdivided into failure to notify the medical risk,failure to notify alternative medical plans,failure to notify the change of the surgical plan,failure to inform in detail that medical measures have been taken,and failure to fully inform the condition of the disease.Theoretically,the judging standards for the obligation to inform and explain include the rational doctor standard,the rational patient standard,the specific patient standard,and the double standard.The double standard is a combination of the rational doctor standard and the specific patient standard,which can more balance the interests of doctors and patients.Our country's judicial practice has applied different notification standards to different notification content,but different notification content should adopt the same notification standard.Whether or not the obligation to inform and explain is violated varies depending on the circumstances of each case.It is disputed whether the patient should bear the burden of proof for the medical institution's breach of the obligation of notification and explanation or whether the medical institution should bear the burden of proof for fulfilling the obligation of notification and explanation.The mainstream view of my country's judicial adjudication supports the former,and the main viewpoints of foreign theories support the latter.According to the basic procedural law rules of "who advocates who gives evidence",patients should bear the burden of proof for the medical institution's breach of the obligation of notification and explanation.The second paragraph of Article 1219 of the Civil Code is a complete article,and it can be judged to belong to the right generation norm through the literal interpretation method,but the system interpretation method combined with Article 1219 paragraph 1 should also be used to determine which specific content is proved by the patient when the claim is established,which specific content is proved by medical institution when the reason for the defense is established.Negative facts are difficult to prove,but they are not impossible to prove.Negative facts that medical institutions violate the obligation of notification and explanation are not complicated,and can be classified according to typed conclusions.At the same time,patients can use the appraisal opinion to prove that the medical institution violated the obligation to inform and explain,but the specific appraisal content is not stipulated in Article 11,paragraph 2(3)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,and the appraisal content should only involve medical risks and alternatives and the aforesaid content usually informed by rational doctors,as for "whether the obligation of explanation has been fulfilled",it is a legal judgment made by the court based on the expert opinion and the merits of the case.It cannot be used as a substitute for the trial,and "a written consent of the patient or the patient's close relatives is obtained",it is a matter of fact.Based on negative facts that are difficult to prove,and patient's data processing capabilities for medical records are not as good as medical institutions,the patient's burden of proof for breaches of the obligation of notification and explanation should be reduced.The best way is to impose harsh denial obligations on medical institutions with reasons.Therefore,the " inversion of burden of proof " in Article 5,paragraph 2,sentence 2 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 should be revised to strengthen the "obligation to deny with reasons ".Specifically,it means to abide by the obligation of true representation in litigation and supply with evidence.It should also be emphasized that whether it is under the path of tort law or under the path of contract law,the subject who bears the burden of proof for breach of the obligation of notification and explanation is the patient.The fifth Chapter is "the Presumption of Fault and the Causality Scope of Liability for Infringement of the Patient's Informed Consent".This chapter is divided into two aspects: "presumption of fault for infringement of patient's informed consent" and "Causality scope of liability for infringement of patient's informed consent." The former starts with the relationship between the elements of fault and the elements of illegality,while the latter starts from the lack of causal judgments on the scope of responsibility based on consent in trial practice.The following opinions are conclusively put forward:In the infringement of informed consent,the important significance of the fact that the element of fault is independent of the element of illegality is that different degrees of illegality result in different degrees of fault.Based on the inclusive relationship between Article 1218 and Article 1219 of the Civil Code,the constitutional elements of the responsibility for infringement of informed consent should adopt the theory of four elements.The mainstream views both in theory and practice hold that the presumption of fault is applicable.Since the diagnosis and treatment specifications include technical specifications and notification specifications,whether the notification description is adequately related to the current medical technology level,so the violation of Articles1219 and 1220 falls under Article 1222(1)of the Act.The presumption stipulated in Article 1222 is rebuttable,because compliance with the diagnosis and treatment standards does not mean fulfilling the diagnosis and treatment obligations corresponding to the current medical level.Before the presumption of fault,the three elements of illegal behavior,causality,and damage should be completed.Specifically,in the case of infringement of informed consent,the first step is to determine the illegal elements in accordance with Articles 1219 and 1220 of the Civil Code.At this time,the impact of breach of the obligation of notification and explanation on the choice is not considered.The second step is to determine the elements of damage,measuring the difference in benefits before and after the medical action.The third step is to determine whether there is a causal relationship between the damage and the illegal act based on the difference of whether the breach of the notification obligation affects the patient's choice.Finally,the presumption of fault is established based on the first three elements.The purpose of determining the causality of the scope of liability is to determine which damages are caused by the illegal acts of medical institutions,so the facts of damage should be determined first.Medical damage is the harm caused by medical behavior to the patient,which is personal damage.Personal injury refers to the damage of personal hurt,which refers to property damage and non-property damage caused by the person being infringed,including life and health damage and bodily injury.Infringement of informed consent is essentially an infringement of the right to body,and may incidentally infringe the right to life and health.Therefore,property damage mainly refers to the non-interest of property caused by the infringement of informed consent alone or the right to life and health at the same time;rather than damage to property,when infringing informed consent alone,there are differences due to the failure to inform and explain whether the obligation affects the patient's consent.If the failure to inform and explain affects the patient's choice,it mainly refers to the mental pain that the patient cannot decide to control his body according to his own will.If it does not affect the patient's choice,it mainly refers to the mental pain caused by the sudden change of physical integrity after the operation,but the latter cannot support the compensation for mental damage because it does not reach the level of serious mental damage.If the right to life and health are infringed at the same time,it also includes the resulting compensation for mental damage.Article 17 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 further clarifies "damage" in Article 55,paragraph 2 of the Tort Law as "personal damage".The purpose is to exclude compensation for mental damage that only violates informed consent and limit personal injury to the unprofitable property that is equivalent to injury to life and health,which is inconsistent with the legislative spirit of Article 1183,paragraph 1,of the Civil Code.Only after the scope of damage is determined,the prerequisite for discussing causality is available.In judicial practice,the vast majority of courts fail to recognize that consent(choice)plays an important role in determining the causal relationship of the scope of responsibility.In essence,it is a question of whether to approve the theory of legal alternative behavior in medical disputes.If the medical institution fulfills the obligation to inform and explain,and the patient will not change the choice,the damage to the right to life or health is not within the protection scope of the informed consent norm,because the illegal behavior does not increase the risk,and the legal alternative behavior defense theory is accepted at this time;However,due to the fact that the lack of notification infringes the right of the body,it may cause the patient to suffer mental pain due to the sudden change of the body integrity after the operation,and such damage will not occur if the obligation of notification and explanation is fulfilled in advance,so the theory of defense of legal substitution behavior is not recognized.Theoretically,the criteria for judging the causality of the scope of responsibility for infringement of informed consent mainly include specific patient standards and reasonable patient standards.In our country's judicial practice,both standards apply to the determination of causality,and specific patient standard applies to the denial of causality.However,in a type of dispute,the judging standards for illegal acts,faults,and causality should be unified.Therefore,revised specific patient standards,that is,specific patient standards foreseeable by rational physicians,should be adopted.Regardless of whether the legal substitution behavior is discussed under the causality of the establishment of the responsibility or the causality of the scope of the responsibility,the patient should bear the burden of proof.The sixth Chapter is "Responsibility for Infringement of Patient's Informed Consent".The article starts with the court's failure to comply with the principle of complete damages in trial practice,tendency to support mental damage compensation that has not caused personal injury(in the case,it refers to life and health injuries),and the denial of the application of apology.The civil liability for infringement of informed consent is analyzed from three aspects: compensation for property damage,compensation for mental damage and apology.The following opinions are conclusively put forward:The principle of complete damage compensation should be adhered to in property damage compensation.The role of the proportional liability theory is to make up for the shortcomings of traditional causality in the establishment of liability,and it has strict applicable prerequisites.It cannot be a weapon for medical institutions to assume responsibility when they are at fault.In terms of the scope of liability,after the scope of compensation for damages caused by medical institutions has been determined by a considerable causal relationship,it is no longer appropriate to apply proportional liability,otherwise the interests of the victims will not be fully protected.Failure to perform the obligation of notification and explanation is presumption of negligence.Therefore,the fair loss sharing rule is not applicable to disputes over infringement of informed consent,and the loss of opportunity theory should be applied to determine the property damage compensation.When the medical institution violates the obligation of notification and explanation,if it only infringes on the right to the body,the liability for compensation is mental damage comfort money or pure economic loss;if at the same time the right to life and health is infringed,the liability for compensation also includes compensation for life and health injuries caused by the loss of other treatment opportunities and its mental damage comfort money.Since the damage caused by the medical institution's breach of the obligation of notification and explanation to the patient is the loss of the opportunity to obtain a better possible result,the difference in property interest before and after the damage event can still be calculated by using the margin theory at this time.Since physical rights are independent of the right to life and health,compensation for mental damage caused by infringement of physical rights is independent of compensation for mental damage caused by the right to life and health.The precondition for compensation for mental damage is to cause "serious mental damage." The "serious" standard is a flexible rule,and the "serious" in the infringement of informed consent disputes is based on whether the decision to change the meaning is considered.In judicial practice,the compensation for mental damage caused by the infringement of the patient's informed consent is applicable to Article 10 of the Interpretation of the Supreme People's Court on Problems regarding the Ascertainment of Compensation Liability for Emotional Damages in Civil Torts,but this provision is mainly for the violation of the right to life and health rather than the right to body,so the investigation factors should be determined into the following five categories: the degree of fault of the doctor,the position of the infringement of the body,the patient's trust in the doctor,the patient's gender and age,and other individual conditions and regions.When it comes to the calculation of compensation for mental damage,the replacement method can be considered which means one of the joys of life-the soothing money obtained,can be used to offset the suffering.The amount of compensation for mental damage is based on the disposable income of the local people,and is determined by the method of multiplier + upper limit.At the same time,compensation for mental damage cannot be multiplied by the liability ratio,because the amount has been determined by considering the degree of fault.The notification defect that does not cause the patient to change the decision cannot cause serious mental damage,but it may still cause minor mental damage.An apology can be used as a form of liability for minor mental damage caused by infringement of physical rights.Although the current judicial practice basically denies the application of an apology to the liability for medical damage,according to Article 995 of the Civil Code,an apology can be requested if the right of personality is violated,not limited to the right to name,right of reputation and other spiritual personality right.An apology can only be applied after the plaintiff has filed it.It does not require the perpetrator to have deliberate or gross negligence,and only needs to exceed minor negligence,and does not require the consequences of damage.It shall take precedence over the application of mental damage relief.As for the execution form of an apology,the judgment document must be made public except for statutory circumstances.Therefore,the second publicly effective judgment document stipulated in Article 1000 of the Civil Code obviously cannot achieve the effect of an apology.The publication of condemnation statements initiated by scholars is a path.The seventh Chapter is " The Remedy Path of Contract Law for Infringement of Patient's Informed Consent ".The article takes the theoretical dispute of the contract law path of medical dispute as the breakthrough point,and paves the way for the practical dispute of contract law path of informed consent dispute,and analyzes the beneficial supplement of contract law path to the protection of patient's consent and informed interests outside the tort law path.The following opinions are conclusively put forward:Objectively,whether to recognize the medical relationship as a contractual relationship is related to the basic medical and health promotion system of the country.Our country's academic circles have failed to reach a consensus on whether the contract law path is applicable to medical injury disputes.The significance of the naming of medical service contracts lies in: firstly,to provide behavioral rules for medical behaviors that are not for the purpose of diagnosis and treatment;secondly,to satisfy patient's requirements for the commitment of medical institutions to medical service results;thirdly,to standardize the standard clauses in the informed consent form;Fourthly,it is beneficial to provide protection for patient's informed consent interests who have not been elevated to rights under tort law.As far as the time for the establishment of the medical service contract is concerned,the "time of registration" should be adopted.As far as the legal application of medical service contracts is concerned,the Protection of Consumer Rights and Interests is... |
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