1. Mixed Fault-Free Reimbursement Schemes Implementing Injury Preventability Criterion (Scandinavian Countries)

Anticipating the consideration of the specific features of mixed schemes of compensation without fault, applicable to cases of medical errors in the Scandinavian countries, we emphasize that the general operation principle of absolutely all schemes of compensation without fault without exception is the exclusion or limitation of the rules on tort obligations in parallel with the introduction of the institution of insurance of risk of harm, as well as the establishment of the foundations of the legal status of «health courts», other administrative or arbitration bodies created specifically for the assessment and settlement of claims related to harm to health. For example, in Sweden all medical organizations and private practitioners are required to take out a comprehensive insurance that combines life and health insurance of patients and insurance of their professional liability. Two prerequisites are established for the payment of insurance compensation, namely: the preventability of injury, understood as the ability to avoid such injury, including through an equally effective, but fundamentally different medical procedure or treatment strategy, and the severity of the harm caused to health, determined according to formal criteria (at least 30 days of hospitalization or 10 days during which there is permanent disability). In the Swedish health care system, 17 district medical councils and 4 regional authorities are responsible for organizing the provision of the necessary medical care to the population, which organize the financing of public hospitals and the purchase of medical services from private providers at the expense of the regional share of income tax. They also act as insurers in respect of property interests related to harm as a result of treatment, and the only insurer - the County Council Mutual Insurance Organization (Landstingens Ömsesidiga Försäkringsbolag, LÖF), guided in its activities by the Patient Injury Act 1996 (PIA 1996)⁸ - considers all material claims of the affected patients. Comprehensive insurance acts as liability insurance when a tort claim is filed against an organization or a doctor.

The exclusion of the component of guilt from the list of conditions for the appointment of compensation does not mean that the subjective component has no legal significance in the investigated legal relationship. The rule of avoidability is a special criterion for determining subjective grounds for material claims, which, according to the most common doctrine approach, is regarded as a cross between the traditional criterion of guilt and the evidentiary standard of independence from it, adopted in the construction of strict liability (^{Andrew Roy & Nina Ross, 2020, р. 221}). Compensation is awarded to patients with avoidable injuries under optimal conditions, insofar as they could be prevented by the efforts of an «experienced specialist» with the best special care. The «experienced specialist» standard, in turn, assumes that all the risks and benefits of various treatment options are considered retrospectively, based on the consequences that have occurred, however, for each case, it is taken into account that there are developed clinical protocols for the treatment of the disease during the period of medical service. In addition to preventable injuries, the insurance indemnity covers: material injuries as unavoidable damage to health caused by a defect or improper use of medical devices or hospital equipment, infectious injuries as cases of contracting an infectious disease from an external source during the provision of medical care, injuries caused by an accident, - as unavoidable injuries that occurred in exceptional circumstances during the treatment period (for example, as a result of a fire in a healthcare facility).

Determination of the amount of harm is carried out in accordance with the general rules for compensation for harm in the procedure of bringing to tort liability, set out in the Compensation Act 1972,⁹ with the only procedural feature, which is that the consultants involved in evaluation of claims must have legal and medical education. At the same time, the basic principle remains the principle of full compensation, and the payments themselves cover material (loss of earnings (income), treatment costs - in the part not covered or not provided by other types of insurance and social assistance) and moral damage (monetary value of pain and suffering, disability and related disabilities, permanent physical disfigurement, etcétera). The assessment of material damage is always carried out according to the actual costs (losses), and to determine the amount of compensation for moral damage, unified tables have been developed, the algorithm for applying which is based on knowledge of the type, severity of damage and the duration of treatment. We also note that the victim was granted the right to additional one-time compensation in the presence of persistent disorders of the body's functions, established as a percentage based on the results of a medical examination. There are no specific criteria for calculating it for medical injuries, and therefore tables created by the Association of Road Insurers are subject to application - here the payment amounts are indicated for a specific percentage of disability for each type of injury.¹⁰

State insurance systems for indemnification of damages, built by analogy with the Swedish one, exist in all Scandinavian countries. However, they have some differences in the conditions of application and the amount of compensation. In particular, in Finland, the category of insured events includes not only «medical injuries», the understanding of which is similar to that adopted in Sweden, and exceptions similar in meaning (nosocomial infection, injuries caused by the failure of medical equipment, etcétera), and so-called «unreasonable damage to health» - cases of deterioration of the patient's health, not associated with the course of the initially identified disease or exacerbation of chronic conditions.¹¹ Compensation of injury is determined by the observance of five prerequisites, including: 1) bodily harm received by the patient; 2) connection of health damage with the process of treatment or provision of medical care; 3) the condition of the victim in the status of a patient, i.e. a person undergoing medical examination or treatment; 4) getting injured during the period of the said law’s duration; 5) the occurrence of the relevant event within the geographical territory of Finland. At the same time, insurance payments are made only for significant injuries, while the criterion of significance is complex - it is required to establish adverse consequences in the form of persistent limitation of life, irreversible aesthetic damage and/or incurring treatment costs in excess of 200 euros. The decision on compensation for harm is made by the Patient Insurance Center (Potilasvakuutuskeskus) in two stages: at the first, a conclusion on the compensability of the injury is prepared, at the second, the claims evaluators determine the amount of the payment based on objective data and additional information provided by the applicant (prescriptions, receipts for drugs and medical services, documents on compensation and benefits provided under other insurance systems).

The amount of compensation in Finland is also determined in accordance with the general tort law and includes the costs of medical treatment and other necessary expenses caused by injury, compensation for temporary incapacity for work (until 2006, the corresponding amount was taken into account as part of moral damage), for permanent disruption of body functions (disability), for irreversible aesthetic damage, reimbursement of lost earnings (income), as well as, if there are grounds, reimbursement of costs for outside care services or reimbursement of lost earnings (income) in favor of close relatives of the victim who provide such services to them free of charge. When a victim files a tort claim, the Patient Insurance Center acts on behalf of the medical organization or doctor who is believed to have committed a medical error. However, such representation is of an exclusively procedural nature and is not associated with the obligation to compensate for the damage caused, since the Center does not provide professional liability insurance.

A distinctive feature of Denmark is the existence of two separate legal regimes for injury compensation for injuries caused by treatment (Patient Insurance Act)¹² and the use of drugs (Medicines Compensation Act).¹³ The preventability rule and the «experienced practitioner» standard are also used to determine the relevance of health damage to the scheme, however, unlike in Sweden and Finland, the retrospective rule does not apply here. Compensation of injury is assessed according to the «rule of tolerance», which assumes the possibility of compensation for harm only for unusual or serious injuries that entail such permanent damage to health that could not be foreseen and rationally assumed, taking into account the severity of the underlying disease, the required course of treatment, the severity and likelihood of side effects. Like in Sweden, injuries resulting from the refusal or misuse of medical equipment are included into a separate category of insured events, but health damage due to accidents in health care facilities is considered in this capacity only if there is evidence of a guilty offense. The threshold requirements for the payment of insurance indemnity are based on the criterion of the significance of the amount of the claim (at least DKK 10,000 in total and at least DKK 1,000 in the case of dental injuries caused by private dentists), at the same time, such reimbursement includes the components of material and moral harm calculated in accordance with the general provisions of civil law.

The Norwegian Innocent Patient Compensation System, implemented by the public insurer (Norsk Pasientskadeerstatning, NPE), through the mandatory insurance premiums of healthcare organizations and municipalities, is characterized by the most emphasis on the subjective background of each case and the establishment of mixed eligibility criteria for a claim. The harm caused to the patient's health is subject to compensation, if: 1) it is a consequence of a medical error or omission (in fact, a guilty misconduct of a medical worker) that occurred in the process of medical examination (diagnosis), treatment and follow-up of the patient; 2) it is sufficiently serious and unforeseen, taking into account the assessment of the risks to which the patient had to agree in advance.¹⁴ As you can see, not only the behavior of a medical worker is subject to legal assessment, but also of the patient themselves (for the latter, in terms of voluntarily assumed risks). As in other Scandinavian countries, Norway has a minimum amount of damage caused (at least NOK 5,000), but compensation can be awarded even if this threshold is not reached if the injury is irreversible and / or has resulted in permanent disability. The compensation includes reimbursement of lost earnings (income), treatment costs and the purchase of drugs, travel to the place of treatment and back, as well as additional compensation in case of permanent disability (at least 15%), the purpose of which does not depend on the availability or evidence of specific material losses. The filing of a standard tort claim is acceptable in cases not covered by the scheme, as well as if the victim incurs additional costs in the future.

In the examples, the innocent schemes are of a mixed nature due to attempts to take into account the subjective prerequisites for the occurrence of medical injuries (the criterion of preventable injury, the rule of tolerance and the standard of an experienced specialist), they are designed for a wide range of situations in which the patient's health is harmed. They are considered a priority legal remedy because tort claim is only allowed on the basis of subsidiarity and exclusivity. In rare cases, the legislator takes a different path, maintaining the tort and innocent regime of payments as independent subsystems, and each of them is designed for a specific type of unfavorable phenomena in the field of medicine, i.e. the mixed nature of the type of scheme under consideration is realized in conditions of equivalence of available legal means of compensation and providing the victim with an alternative to choose between them.

2. Mixed schemes of compensation without fault, based on the principle of equivalence of legal means of compensation (France and Belgium)

In France, the Code of Public Health provides for both a general construction of civil liability, accompanied by its compulsory insurance, and compensation without fault.¹⁵ To make a claim within the framework of the compensation system without fault, it is necessary to reach a certain severity level of the damage to health (at least 24% of total disability) and agree to the consideration of the claim by a special administrative body - the Regional Commission for Settlement and Compensation (Commission Régionale de Conciliation et d'Indemnisation, CRCI). The no-fault redress scheme covers only «medical accidents» where the harm to health is an abnormal consequence of a medical procedure or treatment, provided that such consequences could be assessed and determined. The proposed alternative legal regime for compensation without fault - as noted in the doctrinal sources - is neither contractual nor tort in nature (^{Eldo E.Frezza, 2020, р. 89}).

From a procedural point of view, the implementation of the right to compensation after the transfer of the case to the CRCI implies a comprehensive medical and legal assessment of the case for compliance with the criteria for the severity and urgency of the harm caused, based on the available information about the previous state of health of the victim and the predicted risks of the disease development. The decision on the legal regime of compensation is taken only after such an assessment, while in the case of the fault of the medical worker or the organization, payments are made by professional liability insurers, in the absence of fault - by the National Directorate for Compensation for Damage Caused by Health Accidents (National d'Indemnisation des Accidents Médicaux, ONIAM). In any case, patients retain the right to go to court with traditional tort claims, and insurers are given the right to challenge the basis for payments and the amount of compensation, as a result of which the entire scheme adopted for the consideration of claims for medical injuries in France is criticized as unnecessarily overloaded with additional administrative procedures (^{Lionel Collet, 2020, р. 598 y 600}). In addition, attention is drawn to the lack of consistency in the interpretation of the term «medical accidents», which manifests itself in the fact that each situation is assessed by the CRCI individually, without an established understanding of the parameters of «foreseeability» and «extremeness» of the injury, as well as the «undesirability» of the consequences (^{Isabelle Parizot et al., 2017, р. 99 y 105}).

A similar scheme is used in Belgium, where the severity and abnormality of the damage to health opens up access to compensation from a specially created fund (Fund for Medical Accidents, FMA) (^{Kenneth Watson & Rob Kottenhagen, 2018, р. 1, 15}). A significant difference here is that the creation of a special body for settling claims frees the victim from the need to go to court and prove certain legal significant circumstances, the presence of which, as a general rule, is necessary for the appointment of compensation (including guilt and the amount of damage caused). However, the very content of these legally significant circumstances remains unchanged, as well as the structure of tort liability to be applied. Consequently, the Belgian scheme can be seen rather as a transitional type, but not as a redress without fault.

1. Rationale and content of special judicial-legal presumptions for cases of medical errors in Germany

Having analyzed the systems of compensation without fault, let us dwell separately on the trends in the development of guarantees of legal protection of the patients’ interests in states that have not developed special organizational and legal mechanisms for resolving material disputes with the participation of victims. One of the striking examples of such countries is Germany, where, according to the no-fault model, only compensations for harm caused by drugs are regulated,¹⁶ and the strict liability rule is limited to the usual scope of product liability norms in European countries¹⁷ (i.e. can only go about defective medical products). The legal basis for awarding compensation for harm caused to the patient's health as a result of a medical error remains Sect. 823 (1) BGB¹⁸ on tort liability, in turn, negligence is considered among the conditions for the occurrence of such a refusal to exercise reasonable care, regardless of the risky nature and other features of the existence of the relevant legal relationship.

Of particular interest in the German legal system is the standard for establishing guilt in the form of negligence, which in its most general form implies that reasonable care is not considered to have been exercised if «a conscientious medical professional with average experience in the relevant field and a positive reputation» consciously and with understanding possible adverse consequences takes on tasks related to treatment, without having sufficient competence, solves such tasks contrary to the existing knowledge, standards and professional qualifications. A causal relationship is also essential for the satisfaction of a tort claim, which means that in each case of a guilty violation by a doctor of his official duties, the patient must confirm that the injury occurred precisely in view of the specified violation, and not as an inevitable consequence of the underlying disease. German law uses here the formula «conditio sine qua non», which limits liability to cases in which the delinquent's guilt cannot be «mentally removed» without the patient's trauma also ceasing to exist. In practical terms, this means that the physician's misconduct must be justified as a necessary condition for causing harm, which is generally straightforward, given that the injury usually occurs within the risk from which the physician was obliged to protect his patient. At the same time, some difficulties may arise when excluding accompanying risk factors, the complexity of which is a typical situation in medicine, from among the circumstances, each of which can serve as an independent actual cause of injury (^{Klaus Fischer, 2020, р. 516, 517}). Their resolution is currently associated with the application of special evidentiary standards developed by German jurisprudence.

Among the most significant judicial and legal presumptions should be noted the presumption of «gross error in treatment» («grobe Behandlungsfehler» - German), which is informative in nature and suggests that a causal relationship is considered established if the treatment was especially careless and created more than negligible risk of injury in a particular situation. Specifying the concept of «gross error in treatment», the Federal Court of Germany notes that in order to fulfill this criterion, it is not enough to establish the fact of any violation by a doctor of his official duties, since such can be committed by a sufficiently prudent and conscientious specialist. It is not «subjectively unforgivable» violations that should be considered as a gross error, but such cases of non-performance or improper performance of official duties, which are manifestly unreasonable given the requirements for the level of professional training and qualifications that medical workers must have.¹⁹

In addition, a very special case of injury to a patient in Germany is considered to be an injury resulting from the failure of medical professionals to comply with the obligation to obtain informed consent from the patient. Regardless of the severity of the risk related to the treatment process, inadequate disclosure of information about it is treated as «unlawful bodily harm» according to Sec. 823 (1) BGB, which eliminates the need for additional justification of guilt and causality to satisfy a claim for damages. The jurisprudence maintains high standards of disclosure of information about the risks associated with the provision of medical services, focusing on the doctor's obligation to disclose all information available to them about the nature and purpose of treatment, its available risks and alternatives, as well as any other significant aspects of foreseeable risks, if these are related to treatment, they can affect the patient's consent to treatment or subsequently have any significant impact on the patient's lifestyle. In cases of this category, it is presumed that the treatment itself is an unlawful act due to the lack of legal grounds for it, while trauma is the result of this offense. The only defensive argument for the doctor is the justification of the fact that if there was information about the controversial risk, the patient would still agree to treatment («hypothetical consent», or «hypothetische Einwilligung» - German), i.e. refusing treatment would objectively run counter to his interests.²⁰

In order to compensate for the harm caused to the patient due to a medical error, Germany has a professional liability insurance («Haftpflichtversicherung»), and although the conclusion of an insurance contract is not considered a prerequisite for starting a medical practice, the health authorities strongly recommend this measure in order to protect against the risks of insolvency for both medical organizations and individual private practitioners. The amount of damage is calculated according to general rules and includes a material component based on financial losses («materielle Schdden»), and non-pecuniary damage, reflecting the monetary value of the patient's pain and suffering («immaterielle Schdden / Schmerzensgeld»). Material damage includes actually incurred and future costs of treatment, rehabilitation and outside care, costs of re-equipment of the house, lost earnings (income). Despite the voluntariness of professional liability insurance, the procedure for resolving disputes over medical injuries is distinguished by the existence of a special organizational and legal mechanism that makes it possible to achieve compensation without going to court. The main role in this mechanism is assigned to expert and arbitration commissions (Gutachterkommissionen und Schlichtungsstellen), subordinate to the state medical associations of the states (Landesdrztekammer), operating throughout Germany (^{Johannes Riedel, 2019, р. 294}; ^{Peter Glanzmann, 2021, р. 159}). Contacting the association is free for the injured patient, and the procedure itself includes the preparation of a report on the nature and severity of health damage (carried out by an expert commission) and a medical-legal opinion on the existence of grounds for assigning responsibility to a doctor or a medical organization (prepared by an arbitration commission, which includes a lawyer). All conclusions are formulated on the basis of an analysis of the evidence agreed by the parties, at the same time, the final decision does not prevent the victim from going to court.

We see that the German approach to compensation for harm caused in the course of medical activity is characterized by a significant margin of appreciation of the courts, which allows the latter to develop judicial and legal presumptions that modify the traditional structure of tort liability in the interests of the victim. The result of such an approach may be excessive compensation, however, in the doctrine, such a development of events is more often viewed as a permissible expression of corrective justice, carried out, inter alia, through the redistribution of losses in a democratic social state (^{Marc S.Stauch, 2011, р. 1149 y 1150}). It should also not be forgotten that a significant part of the losses incurred by the victims is compensated in kind within the framework of compulsory health insurance and social security, as a result of which the question of the possibility of introducing special compensation systems in this area, built on the model of compensation without fault, is not is on the agenda of the legislator in Germany.

2. Specific examples of the normative consolidation of special legal presumptions for cases of medical errors in selected countries

In some jurisdictions, the normative consolidation of the concept of a medical error and its types has been adopted, while the detection of one or more of the listed violations allows us to consider the fact of a guilty violation of the legal obligation to provide medical assistance or treat a specific patient, as well as the causal relationship between the violation and the damage to health established. For example, in the UAE, a medical error is a violation committed by a practicing physician, which consists in: 1) ignorance of certain technical aspects of treatment, which should be known to any practicing specialist of the same specialization and level of training; 2) non-compliance with recognized professional (medical) standards; 3) lack of due diligence; 4) negligence and carelessness. It is allowed to specify the types of serious medical error in the sub-legal regulations²¹. In the United States, in most states (excluding the specialized compensation systems in Florida and Virginia), as opposed to proving a direct causal relationship, the patient only needs to demonstrate a sufficient relationship between a violation of professional standards and the injury that is the «immediate cause» of the injury (^{Bhajanjit Bal, 2009, р. 339, 344}). In addition, in order to limit judicial discretion and speed up the trial, strict guidelines are used to calculate the amount of compensation, limiting its maximum amount: for the amount of all types of losses and expenses, including material and moral damage (states of Louisiana, Colorado, Indiana, Virginia), only for non-pecuniary damage (Florida, Hawaii, Idaho, Georgia), depending on the medical professional's form of guilt (Alaska, Maine, Maryland, Oregon, Wisconsin), depending on whether the medical services were provided by a public medical organization, a private clinic or a private practitioner (Colorado) (^{Meghana S.Chandra & Suresh B. Math, 2016, р. 21 y 25}). India, Germany and Canada also have a standardized benefit, and the UK has experience with alternative legal mechanisms for dispute resolution with injured patients outside of Germany, where the National Health Service (NHS) implements a national program to protect against the risks of clinical malpractice based on the voluntary participation of medical organizations and individual specialists in professional liability insurance (including ensuring the payment of life compensation to victims in the event of disability) (^{Thi B. Nguyen, 2019, р. 1, y 15}).

It should be noted that referring to the example of other states that have retained the structure of tort liability as the main legal remedy for compensation for harm caused as a result of a medical error, suggests that the establishment of special legal presumptions is permissible in relation to any of the conditions for the occurrence of such liability. In other words, movement towards doctrinal justification and legislative consolidation of schemes of compensation without fault is seen here as far from the only alternative.