Compensatory legal mechanisms of social protection of a physician- scientist

Taking into account the approach chosen in this paper, which reveals the mutual influence of risks that relate to CT and are based on the effect of an unexplored drug on the human organism and entail both the risks of deterioration of the patient's health and professional risks for the physician-scientist, it is necessary to agree with N.A.

Sokolova, who emphasizes that professional risk, being a kind of social risk, bears the basic features of the latter. The common feature of both professional and social risks, based on the narrow approach analyzed in the second chapter and currently employed by the legislator, is that they represent the danger of loss of earnings or other labour income. "A special feature of professional risk is the causal relationship between the loss of earnings and the professional activities of a person." [422]. In the legal relations under consideration, it is the legal aspect of the professional risk of the physician- scientist conducting the CT that is of vital importance, as was previously indicated. In connection with the specifics of this kind of activity, his professional risks are multiply amplified (in comparison with standard medical activities) precisely at the expense of the legal component of risk, expressed in the danger that the physician- scientist may be brough to legal liability.

Such consequences for the physician-scientist do seem quite wide. They may include: material compensation to the patient or relatives of the patient for a professional error committed by the physician, administrative or criminal liability, loss of professional reputation, termination of employment contract and loss of earnings. In addition to the preventive measures analyzed earlier, it is necessary to dwell on the possibility of implementing compensatory measures for the social protection of a physician-scientist[423], which should be applied in cases when the patient has had adverse consequences for life and health due to his participation in CT.

Compensation (from Latin compesatio meaning "indemnification") refers to a material component. Therefore, proceeding from the current legal doctrine and practice, it is correct to point out that the professional risks of the physician- scientist are mainly related to the need to satisfy monetary claims of the patients

participating in CT, when they suffered a harm to their health, and also of the patient's relatives, when as a result of his participation in CT a fatal outcome occurred. Of course, at present there is a legal mechanism designed to compensate for the harm caused to the patient's property interests, in view of his participation in the CT. Such a mechanism is compulsory insurance provided by the Law on the circulation of medicines and the Insurance Rules, the legal analysis of which was carried out in the second chapter of this work. However, in the same place, it was stated that there is a legal uncertainty in establishing the criteria for the insured event related to the patient's participation in CT, due to the lack of uniform application and interpretation of regulations, in particular in the Insurance Rules.

As an example, we may refer to paragraph 7 of these Rules that provides that the insured event is the death of the insured person or deterioration of his health, in particular resulting in the establishment of a disability in the presence of a causal relationship between the onset of this event and the person's participation in the CT. At the same time, in subparagraph "i" of paragraph 22 of the Insurance Rules, it is the Insurer's duty to reimburse the insured person's expenses incurred in the course of expert examinations to establish of a causal link between the death of the insured person or the deterioration of his health and consumption of the medicine.222

The mentioned legal norms indicate that there is no clear and unambiguous determination of what is meant by the phrase "participation of the specified person in CT": all possible risks flowing from the patient's participation in CT, including those related to the actions of medical workers, or rather those risks that are associated only with the use of an experimental medicine.

Moreover, such an indefinite approach of the legislator to the core essense of the insured event leads to the fact that the research sponsors introduce into the CT contracts the provisions that distinguish insured events that occurred as a result of the effects of medicines and cases of injury to the patient caused of the physician-scientist' actions, such as this one: "The Institution shall continue being responsible for conducting CT in good faith in the circumstances where the patient's accident or disease occurs due to an error of the Institution or its employees. The CT Sponsor shall not be liable for claims arising out of any injuries suffered by patients as a result of bad faith, malicious acts, inability to follow the protocol by the employees of the Institution."223 "The Sponsor arranges insurance against damage or harm caused by the introduction and use of the tested medicine, in accordance with the Protocol of the study, applicable laws and regulations. The Sponsor is not required to provide insurance for the Research Organization/Researcher in respect of the damage or harm suffered as a result of negligence, inaction or willful failure to perform duties under the Agreement or under the law by the Research Organization/Researcher participating in the study."224

In this paper, the practice in cases involving judicial claims for harm caused by the patients' participation in CT has already been investigated. Thus, the analysis of forensic medical examinations has shown that not only the causal relationship between the patient's involvement in CT and the harm to his health, but also the specific reasons for the occurrence of such harm, is to be established. If the harm to the health or death of the patient has occurred due to natural causes, the insurance compensation is not payable.

In case if the causal link between the health of the patient participating in CT and the effect of the drug is established, the patient receives the insurance indemnity due.

If the damage to the patient's health has occurred due to the actions of the physician-scientist (for example, violations of the CT protocol, etc.), then this event will not be recognized as an insurance event, since insurance covers only the consequences of the drug being untested, presuming the professionalism of specific CT performers, which is preventively proved, firstly, by licensing of the Medical Entity, including, among other things, the requirements for the

qualification of the entity's employees, and secondly, additional Qualification requirements for the specific employee performing the CT (physician-scientist).

The damage to life and health, which is not recognized as an insurance event, does not require insurance indemnification, so the patient (the patient's relatives) is compelled to file a claim for compensation for harm to health or moral harm directly to the perpetration in accordance with the provisions of Chapter 59 of the Civil Code of the Russian Federation[424], establishing general Provisions on compensation for harm, and section 9 paragraph 5 of Article 19 of Law No. 323- FZ,[425] containing a provision that the patient is entitled to compensation for harm caused to health in the provision of medical care, since participation in CT means getting medical care, and not just a participating in a scientific experiment.

Therefore, it is obvious that this type of insurance, i.e. mandatory insurance of a patient in CT, cannot be considered as a measure of social protection for a physician-scientist who is exposed to occupational risks during CT. At the same time, as follows from the provisions of the CT contracts, the physician-scientist directly performing CT can do actions that may lead to the risk of adverse consequences for patients. As an example, one can point to the insufficient professionalism in selecting the patients for participation in CT, during which the inclusion criteria and exclusion criteria prescribed in the CT Protocol were not strictly observed; untimely detection of serious adverse events (SAE) that the patient shows; as well as other significant events from a medical point of view.

Thus, for the purposes of this dissertation paper, it is important to identify in the legislation the legal means allowing to implement of legal regulation aimed at compensation-related protection for researching physicians conducting CT. In other words, it is necessary to consider all aspects of the functioning of compensatory legal mechanisms that minimize the consequences of the professional risks of a physician-scientist in the event of adverse consequences for

the life and health of the patient who are causally related to the activity of the physician-scientist.

At the same time, the legal arguments in question allowed to divide the adverse consequences for life and health of the patient, due to his participation in CT, the consequences of the drug and the consequences of the physician-scientist's actions. Accordingly, given that, according to paragraph 2 of Art. 1064 of the Civil Code, the basis for liability for damage is the guilty behavior of the perpetrator,[426] and, taking into account the research tasks of determining the measures of social protection of the physician-scientist, it will be right to consider the legal construction built on the existence of a causal relationship between the onset of adverse consequences for life and health of the patient and the professional activity of the physician-scientist in CT.

Assessing the effectiveness of the mechanism of compensation-related protection of a physician-scientist, first of all, it is necessary to start with the legal position in which he is when doing CI, acting within the powers granted to him by the employer on the basis of his employment contract. Due to this specificity, the legal liability of the physician-scientist in the course of performance of his duties is also based on the provisions of the Russian legislation governing the persons having labor law status.

On the basis of Art. 1068 of the Civil Code of the Russian Federation, it can be concluded that the harm caused by the employee in the performance of labour (official) duties is compensated either by himself or by a legal entity that instructed and controlled the employee.

It is worth to agree with the opinion of S.M. Kovalevsky that the person who is liable for the harm caused to the patient is a corresponding medical entity or a doctor engaged in private practice. As for medical workers, their liability, as well as the liability of any other persons working under an employment contract, arises not in the framework of civil, but in the framework of labour legislation, of course, on condition of finding out the fact of a labor law violation. According to Art. 232-233 of the Labour Code of the Russian Federation material liability arises for the employee as against his employer, the Medical Entity, and not the patient. The purpose of liability is compensation for damage caused to the other party to the employment contract, the employer, and not the compensation for harm caused to the life and health of the patient [427].

Considering this legal construction, determined by the norms of labor legislation, it should be borne in mind that at present the amounts of compensation for harm to the health and life of patients are significant even for a large medical entity, and recently there has been a tendency in judicial practice to increase them, while Article 241 of the LC RF[428] fixed the size of the material liability of the employee according to the general rule only within a an average monthly salary (when referring to the physician-scientist with a recourse claim from the Medical Entity).

Thus, we can conclude that Russian law provides for sufficiently effective compensatory measures that allow to substantially minimize the property losses of the physician-scientist. These measures should be considered as a legal tool contained in the construction of a labour law compensatory mechanism for the social protection of a physician-scientist. [429] Consequently, the compensatory protective mechanism of a physician-scientist is not limited only by his labor law status, but also implies a discretionary judicial protection of his property interests.

As practice shows, the compensation collected from the employee will not cover even a small part of the amount already paid by the Medical Entity in favor of the patient (the patient's relatives). In this case, there is a reason to talk about the effective use of compensatory mechanisms of social protection of the physician- scientist, which should stimulate the Medical Entity to provide quality medical care, including through the selection and promotion of qualified medical personnel.

Taking into account the fact that the features of labour law in the sphere of compensatory measures applied to employees in the event of professional risks are wide enough and diverse, as well as the need for a systematic approach to the arrangement of the social protection of the physician-scientist, it seems important to identify possible additional remedies, flowing from the labor law relationship of the physician-scientist and the Medical Entity.

Thus, as an option to provide additional protection of medical researchers, it is possible to propose the creation of collegial bodies directly within the Medical Entity itself that perform the functions of coordinating the work on the CT, assessing the course of CT, and also for analyzing the performance of the professional doctor's duties by the physician-scientist in terms of the validity of his actions in the process of CT. It seems that the composition of such a collegial body should include specialists in the field of medicine and pharmacy, depending on the direction of each research conducted by the medical entity. This body will not be a structural unit whose employees fulfill their responsibilities for coordinating and evaluating the progress of CIs as officers, but will be an independent body whose members use their special professional knowledge to improve the quality of ongoing research, as well as providing methodological assistance to the physician- scientist.

Since, in accordance with Art. 5 of the RF Labour Code, labour relations and adjacent relations, in addition to labour legislation, are also regulated by collective agreements and local regulatory enactments containing the norms of labour law, the regulation of the activity of such body should be fixed in the local regulation of the Medical Entity. It should be pointed out that such examples exist in the practice of some Russian medical entities that have CT accreditation. To achieve the research objectives of this thesis, as examples of local regulations governing the establishment and procedures of the aforementioned collegial bodies we considered "Regulations for conducting clinical trials," developed in the State Educational Institution of Higher Professional Education " Samara State Medical University" and the state budget educational institution of higher professional education "Kuban State Medical University of the Russian Federation Ministry of Health".[430]

Thus, in these educational entities, for the purposes of organization and conduct of CT, the Rector's order established special functional bodies - the group for organization of clinical trials (hereinafter the OCT Group). The competence of the OCT group includes various organizational arrangements that allow for greater transparency and legitimacy of the CT process by coordinating the activities of the structural units involved in this activity, as well as monitoring the direct process of their conduct. At the same time, the creation of the OCT group does not entail shifting of responsibilities and division of responsibility for the results of CT, the responsible person for their proper conduct, due to mandatory provisions of the legislation previously considered in this work, is a physician-scientist.

Since the OCT group includes medical specialists, it seems that the activity of the OCT group can be work not only on the organizational aspects of CT, but also to provide methodological and professional assistance to the physician- scientist. So, it is possible to give the group of OCT the powers to assess the quality of the research and the validity of the professional actions of the physician- scientist in case of the assumption that a professional error was committed during the CT. This mechanism can be used when patients (relatives of the patient) approach the insurance company asking, or when they apply for judicial protection, by analogy with the mechanism provided for by the labour dispute commission under art. 384 of the LC RF.

With the collegial mechanism of resolving cases related to possible professional errors and omissions during the CT, the right of the physician-scientist

to objectively and comprehensively examine the possible improper performance of his duties will be realized, taking into account the opinion of relevant specialists, including from the clinical point of view. It seems that the conclusion of a group of OCT may contain judgments about the presence or absence of a disciplinary offense, the presence or absence of intent in one's actions, as well as assessing the consequences of a violation of the course of CT. Depending on these conclusions, the members of the group may apply to the employer for the release of the physician-scientist from liability, in accordance with art. 240 of the LC RF, which gives the employer the right to refuse to collect damage from the employee.

As a result, the proposed mechanism should be a guarantee of objective examination of the actions of a physician-scientist with the involvement of persons with professional knowledge in the field of medicine and, in fact, an additional measure of social protection for the physician-scientist.

Summing up the above statements, we should point out the private law nature of the compensatory mechanisms examined. In support of this position, one can refer to the opinion of N.I. Diveeva, the legal responsibility in the labor law has specificity, consisting in the fact that its implementation takes place within the framework of the employment relationship, the basis of which is the employment contract. Such responsibility comes not before the state, but before the employer. In this sense, responsibility in labour law can be treated as private law institution. The state establishes only certain limits, the limits of the employer's power, introducing elements of publicity into it.232

As another argument in favor of the private law nature of the compensatory defense mechanism of the physician-scientist, it is necessary to point out the very method of judicial protection of the violated right, mediated by the norms of the civil process and carried out in private. Accordingly, the mechanism of compensatory protection, which we considered, aimed at minimizing the consequences of the professional risks of a physician-scientist, based on the norms of labuor legislation and providing, if necessary, judicial protection, does function in the private law regime.

Finally, summing up the analysis of the compensatory legal mechanism for the protection of the physician-scientist, one more legally significant conclusion is that it is impossible to apply this legal construction, based on labor law responsibility, when the physician-scientist performs his own civil law contract in the "two-tier contractual model of the CT." And even if we "throw aside" the fact that the physician-scientist is simply not competent to conclude a civil law contract for the CT, then, if it is still concluded, what will follow, among other things, the legal responsibility of the parties to such a contract. Thus, taking into account the provisions of paragraph 2 of Art. 1064 of the Civil Code of the Russian Federation, the physician-scientist, being the subject of such responsibility, will have to assume personally all the adverse consequences of professional risks in CT, and independently respond to the demands of patients (relatives of patients) for compensation for damage and compensation for moral harm.

For the purposes of this dissertation, which is aimed at identifying and evaluating the legal mechanisms for the social protection of the physician-scientist, it should be noted that the very practical activities of the participants in the CT are currently developing other approaches that make it possible to use the mechanisms of compensatory insurance-based protection for the physician-scientist. Such an initiative of the subjects of legal practice seems to be absolutely justified, especially since legal scientists point to the need for further development of issues related to the compensation of occupational risks for certain categories of workers, taking into account that the most complete compensation of professional risk is possible only with the interaction between labour law and related spheres of law: social security law, civil law, etc.[431]

In this context, it is necessary to consider the civil liability insurance applied in CT, which may now be carried out voluntarily. Therefore, we can talk not only about labor law compensation mechanisms, but also about civil law compensatary (insurance-based) mechanisms aimed at protecting researching physicians from the adverse effects of their professional risks.

Thus, as an example, we can refer to the legal practice implemented by the leading insurance company involved in CT in Russia, the Insurance Public Joint Stock Company Ingosstrakh that developed and approved on 24 June 2015 its "Rules of Civil Liability Insurance for Clinical (Preclinical) Means"[432]. Based on these Rules, the Insurants, usually the research sponsors, formulate liability insurance policies for conducting clinical trials, including professional liability insurance for doctors (for damage to the life and health of patients). In accordance with the abovementioned Rules and the Policy, the persons responsible for causing harm to the insured person (the insured) are: the Insurant, as well as other persons (sponsors of clinical trials, contract research organizations, medical institutions, doctors/medical specialists conducting CTs. [433] The object of insurance is the property interests of the Insurant or the person whose risk of liability is actually insured in accordance with the legislation of the Russian Federation, related to his obligation to compensate for harm caused to life and health, as well as property of third parties caused as a result of the insured activity and reimburse other additional expenses incurred in connection with the infliction of harm.[434]

It is necessary to once again pay attention to the fact that the subject of civil liability that may be insured, for harm caused to the patient in CT, is the Medical Entity that hired the physician-scientist. Accordingly, in the case under consideration, it is necessary to speak specifically about the liability insurance of the Medical Entity for causing harm when conducting CT in accordance with Art. 931 Civil Code. At the same time, the Rules contain a detailed list of persons whose liability may be subject to insurance, including the physicians who conduct

CTs. This approach is absolutely justified, since it is the physicians carrying out CTs that has an increased risk.

It is exactly so in the analyzed Rules, that among the insurable risks, among others, there are the professionals risks of the researching physicians, such as: insufficient level of qualification and/or experience of specialists and personnel due to unintentional mistakes in the selection of specialists and personnel participating in the study of the drug; Insufficiency of information on contraindications as to a person participating in a clinical trial of a medicine; Unintentional errors and omissions in the selection process of persons participating in the clinical trial of the drug and in selection of clinical databases; Other unintentional errors and omissions of specialists and personnel.237

Thus, the Research Sponsor, in addition to compulsory insurance of the patient in the CT, separately insures the civil liability of the Medical Entity as a party to the contract that conducts the CT. At the same time, insurance coverage extends to a physician-scientist, since in fact, his CT related professional risks are insured.

This voluntary initiative should certainly be noted as a positive legal practice, since it, on the one hand, shows a high level of legal awareness and social responsibility of the research sponsors, and on the other hand, provides insurance protection to the Medical Entity, and, consequently, to the researching physicians, which contributes to the sustainability of their social status. This situation provides not only protection of the property interests of the physician-scientist, but also has a psychological aspect, expressed in the presence of the confidence of the physician-scientist that he is protected against any result of CT.

It should be pointed out that this civil liability insurance for individuals in the conduct of CT is carried out in accordance with Art. 927-931 of the Civil Code, governing the voluntary insurance, insurance of property interests, as well as liability insurance for causing harm. Such insurance, by virtue of its voluntary

character, has not yet become a widespread phenomenon, however, it is significant that the parties to legal relations arising during the CT, independently, without state coercion, have started using liability insurance as an effective legal mechanism that allows to provide compensatory insurance protection to researching physicians

It should be noted that RF Government Resolution No. 1293-r dated 22 July 2013 "On the Approval of the Strategy for the Development of Insurance Activity in the Russian Federation until 2020" states that "compulsory insurance should be resorted only in cases where it is the most effective method of solving socially significant problems. This applies mainly to civil liability insurance related to activities that create an increased danger"[435]. Drugs undergoing CTs, as untested, do fully meet the characteristics of a source of increased danger. Therefore, proceeding from this premise, the legislator has a reason to think about the mandatory nature of this type of liability insurance, which would significantly increase the level of social protection of researching physicians, in case of negative consequences of professional risks in the course of CT, the reliability of the CT itself and the level of social protection of patients that are subjects of CT, and the level of social protection of an undefined circle potential consumers of medicines.

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Источник: Маценко Елена Игоревна. Социальная защита лиц в клинических исследованиях лекарственных препаратов для медицинского применения. Диссертация на соискание ученой степени кандидата юридических наук. Санкт-Петербург, 2017. 2017

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Еще по теме Compensatory legal mechanisms of social protection of a physician- scientist:

  2. Introduction
  3. General characteristics of social protection and its legal mechanisms for individuals participating in clinical studies of medicines for medical use
  4. General characteristics of approaches as to the construction of legal mechanisms for the social protection of a physician-scientist.
  5. Compensatory legal mechanisms of social protection of a physician- scientist
  6. Conclusion
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