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Compensatory legal mechanisms of social protection of patients

International legal instruments regulating the CT process, such as the Helsinki Declaration,[351] the Convention on the Protection of Human Rights and Dignity of Human in Connection with the Use of the Achievements of Biology and Medicine (the Convention on Human Rights in Biomedicine) [352] contain the rules on mandatory fair compensation payable to a person who has suffered damage in the course of the trial, under conditions and mechanisms as provided by law.[353] Thus, international legal norms establish the compulsory mechanism of compensation, emphasize its importance as an element of the patient's social protection in CT and require its reflection in the national legal systems of countries conducting CT in accordance with the Rules of Good Clinical Practice.

In this context, it is necessary to emphasize that in the legal system of the Russian Federation, especially in social and security legislation, the institution of compensation is one of the most widely used and effective elements of social protection for those who need it. At the same time, many scientists note that in the science of social security law there is no definition of compensation as a legal term, and the norms establishing compensation payments are scattered among themselves and scattered across legislative acts of various levels. At the same time, the condition for the payment of almost any compensation is the onset of social risks, and the purpose of their payment is compensation for damage incurred. Highlighting this feature of compensation as social benefits, T.S. Guseva points out that the legislator needs to take into account and develop the special nature of these benefits as an adequate

mechanism for restoring property status, compensating for adverse consequences that correspond to the nature of the harmful impact or actually incurred expenses, in cases recognized by the state as socially significant.[354].

While agreeing with the expressed opinion, it is necessary to pay attention to the fact that the compensatory function can be realized in different ways (through delict, through insurance).

According to the general rule, defined normatively, compensation for harm caused to the life and health of the patient during the provision of medical care is carried out by medical organizations in the volume and order established by the legislation of the Russian Federation (Article 98 of the Federal Law N 323-FZ). The main legal instruemnt to protect the patient's rights is the Civil Code of the Russian Federation (in particular, Chapter 59 "Obligations as a result of harm"). But, since CTs are a high-risk area, the mechanism for insuring the onset of such risks and their consequences is one of the most effective. Such a mechanism is initially based on the recognition of the risky nature of certain spheres of the life activity of society and involves the formation of pre-defined monetary funds to protect citizens from various kinds of status risks, professional risks, etc.

In this regard, it seems reasonable to consolidate in the Russian legislation the mandatory life and health insurance of patients in CT (hereinafter - compulsory insurance of patients in CT) as the most effective compensatory mechanism in cases of occurrence of social risk consequences possible during the experiment involving a human as a subject. Thus, the principle of fair compensation for persons who suffered damage in the study is realized in the legislation of Russia through compulsory insurance of patients in CT.

Such a requirement is enshrined in an imperative form in Art. 44 of the Law on the circulation of medicinal products. According to it, "An organization that has been authorized to organize a clinical trial of a medicinal product for medical use is required to insure itself as a policyholder from a risk of harming the life and health of a patient as a result of conducting a clinical trial of a medicinal product for medical use at its own expense by concluding a compulsory insurance contract".

From the definition of this rule it follows that the patient's participation in CT is a situation in which the onset of harm to his health and life is a social risk, and therefore the patient's interests should be protected by the most effective legal mechanism that allows to compensate for the damage caused to the patient. At the same time compulsory insurance is the only legally fixed mechanism for compensation of damage to life and health of patients due to their participation in CT, therefore, in this paper, the terms "compensatory mechanism" of social protection and "insurance mechanism" of social protection will be used interchangeably.

This type of insurance is regulated solely by private law rules, set forth in Chapter 48 of the Civil Code of the Russian Federation. Is this correct? Is it necessary to supplement this insurance with public law components to fully protect the rights of the patient as the weakest and most dependent participant in CI? Can such insurance, established by law, be called compulsory social insurance (taking into account the social and legal consequences of such an interpretation), because what is insured in CT is the social risk, i.e. the onset of harm to the life and health of the patient? At the same time, we should not forget that the social protection provided directly to the patient also indirectly protects an indefinite range of potential consumers of medicines.

It appears that in order to assess the effectiveness of insurance protection used as a compensatory mechanism, to determine its essence as compulsory social insurance, it is important to highlight the legal features of the patient's insurance in CT.

First, it is necessary to note the compulsory nature of this type of insurance, which certainly indicates that the legislator recognizes its social significance. The contract of compulsory insurance of patients in the CT should be concluded by the research sponsor with the insurance company before the start of the CT, because by virtue of the rule of section 14, Art.

44 of the Law on the circulation of medicines, [355] the patient's participation in the conduct of a clinical trial of a medicinal product in the absence of a compulsory insurance contract is not allowed. Accordingly, the consolidation of the requirement for compulsory insurance of patients as a compensatory measure in the federal law indicates the establishment of priority of the patient's rights and interests in CT and recognition of the effectiveness of the insurance mechanism applied for his (patient's) social protection.

Secondly, compulsory insurance of the patient in CT is personal insurance, which follows from the systemic interpretation of legal norms. So, in accordance with Art. 934 of the Civil Code of the Russian Federation under the contract of personal insurance, one party (the insurer) undertakes to pay a fee (insurance premium) paid by the other party (the insured), at the same time or pay periodically the sum (insurance sum) stipulated by the contract in case of causing harm to the life or health of the insured or another individual named in the contract. In paragraph 3 of Art. 44 of the Law on the circulation of medicinal products it is determined[356] that the insured event under the compulsory insurance contract is the patient's death or deterioration of his health, including entailing the establishment of a disability, in the presence of a causal relationship between the onset of this event and the patient's participation in the clinical trial of the medicinal product. Thus, compulsory insurance of patients in CT refers to the sphere of personal insurance, because health is not separable from the individual. And since personal and inalienable benefits, which are recognized as life and health, can not be an object of civil turnover, and their compensation in kind is not possible, only the valuable interests of individuals can be the object of compulsory insurance. In this context, it is significant that the subject of compulsory insurance of a patient in CT is his property interest associated with the harm to his life or health as a result of a clinical trial of the medicinal product for medical use.

Thus, the damage to the life and health of the patient that arose as a result of his participation in the CI is assessed and is compensable only in monetary form, despite the fact that this damage is associated with causing harm to the personal non-property rights of the subject.

Also, it should be pointed out that Art. 44 of the Law on the circulation of medicinal products and section 8 of the RF Government Resolution No. 714 dated September 13, 2010 "On approval of the Model Rules for compulsory life and health insurance of the patient participating in clinical trials of a medicine" [357] (hereinafter - the Insurance Rules) have established the amounts of compensatiosn depending on the severity of the harm caused to life or health of the patient. At the same time, paragraph 9 of the Insurance Rules provides that these amounts may be increased on the basis of a court decision, that is, in spite of the terms of the insurance contract and the mandatory fixation of insurance payments, this rule allows for judicial discretion in the resolution of this category of cases.

The Law on the circulation of medicinal products contains an indication that the terms for making claims as to the compensation for harm caused to the life or health of the patient in CT are determined in accordance with civil law.

Presently, both in theory and in practice of legal implementation, the institution of compulsory insurance of patients in CT is formed in the framework of protecting the private law interest of the subject. In cases when the life and health of the patient participating in the CT are damaged, compensable by an insurance mechanism, the subject of the experiment (his relatives) has the opportunity to submit claims to the insurance company for payment of an insurance compensation (sections 11 and 25 of the Insurance Rules). In this case, the insurer is obliged to pay the insurance sum, in the manner, terms and amount, which are stipulated in the Insurance Rules and the contract, to inform the insured about the implementation of the insurance sum (a copy of the insurance act).

In case of non-recognition of the case by insurance, it must send to the insured person

(beneficiary) a reasoned refusal to make insurance payment and inform the insured thereof."

It should be noted that in the Insurance Rules there is no procedure for determining the cause and effect relationship between the adverse consequences that have come about for the life and health of the patient and his participation in CT in terms of the criteria and methods of assessment, according to which the case is recognized or not recognized as insurance. Legal practice concerning such issues shows that insurers, upon receipt of an application for an insurance event, to recognize it as such, are involved in the assessment of a staff expert who is an employee of an insurance organization and, accordingly, an interested person. In the overwhelming majority of cases, the experts in their conclusions come to the conclusion that there is no causal relationship between the adverse consequences for the life and health of the patient and his participation in CT. Thus, based on the internal corporate expert opinion, insurance companies (judging from the materials available) almost never satisfy claims for harm compensation voluntarily. However, in spite of the fact that in such circumstances the expert opinion does not meet the criterion of objectivity due to the interest of the insurance company in the negative result, the actions of the insurer are legitimate from the point of view of the law, since the procedure for recognizing the case by the insurance legislation is not regulated in any way. Obvious is the fact that due to the conflict of interests, the true causes of adverse consequences for the life and health of the patient remain unclear, and the question of the safety and efficacy of the drug remains unclarified.

Consequently, in the proposed circumstances, the actual implementation of compensatory measures for the patient's social protection in CT at the stage of pretrial settlement is practically impossible. And, therefore, it is necessary to recognize that such insurance social protection does not fulfill its function both in relation to patients in CT, and in relation to an unlimited number of potential drug users. At the same time, it is necessary to emphasize once again that the legal relations of participants in the CT process are on par with the private law and public law component. The latter is due to the need to protect the common social good, which is the life and health of the patient, as well as the high social significance of the research process that protects an unlimited number of persons from dangerous and ineffective medicines.

Taking into account the above arguments, it would be appropriate to strengthen the public law regulation of compulsory insurance of patients in CT in resolving the dispute at the pre-trial stage. To this end, it is necessary to fix in the Insurance Rules a rule that obliges the insurer to report on receipt to him of an application for compensation for harm from the insured person (beneficiary) not only to the insured (the research sponsor), but also to Roszdravnadzor as the body supervising the CT process. Thus, the necessary administrative control will be provided in cases of identifying possible undesirable phenomena associated with the action of the drug on the human body, both in the process and after the end of the CT. Such application of the element of public law regulation in the insurance mechanism would allow not only to protect the patient's rights in CT, but also would protect the rights of an indefinite number of persons, which is consistent with the objectives of the state's social policy to ensure medicinal safety.

If the insurance company refuses to meet the patient's requirements (the patient's relatives), it is possible to go to court. The implementation of this mechanism takes place with the help of a civil litigation. At the same time, an essential feature of this category of civil cases is that the court practice almost does not know cases of handling claims initiated by the patients themselves as a result of deterioration of their health due to participation in CT. In the process of studying this issue, there were no such judicial cases revealed, where the claimants themselves were the patients who took part in the CT. Courts only considered the claims of relatives of patients against insurers in cases of death of a patient. Probably, this situation is connected with the lack of awareness of the majority of the country's population about the opportunities and conditions for implementing such legal mechanisms, as well as the lack of confidence that it is possible to prove the link between deterioration of health and participation in CT. It seems that the

damage to the health of the patients who took part in the research, which did not lead to death, is now latent, and is not reflected in the reports on the CT. We have to state the fact that compulsory insurance at this stage does not fulfill its function of social protection, since patients do not receive compensation for which they could count.

In the context of studying the issue of the efficiency of the judicial order, within which the insurance protection of patients in CT is currently being implemented, the opinion expressed by K.V. Aranovsky, S.D. Knyazev, and E.B. Khokhlov is worthy of mentioning: "The law deserves recognition if it is protected, especially if it really receives such protection. Most truly, the existence of rights is confirmed by judicial protection, maybe not strictly, but close to the English saying: "No remedies - no rights" (without procedural remedies there is no material right)."145 Unfortunately, this statement, reflecting the purpose of the judiciary - which is to serve as a guarantor of the legitimacy, justice and humanity of the decisions made - has nothing to do with the practice of law enforcement that has now developed as to the resolution of disputes arising from the mandatory insurance of patients in CT. The study of such practice shows that cases of this kind, which are considered in courts of general jurisdiction, do not differ in the uniformity of law enforcement, and are characterized by a formal approach of the judges as to the dispute resolution, which clearly does not contribute to the proper protection of the rights of the subjects of CTs.

In order to establish the reasons that prevent the effective judicial protection of the legitimate rights and interests of patients in such cases, we have carried out an analysis of available judicial decisions. It seems that in order to objectively reflect these reasons, it is necessary to give some formulations of court decisions that are the most characteristic and frequently occurring, and also allow to establish "weak links", both in the field of legislative regulation and the application of law by courts.

The main difficulty in resolving the group of cases analyzed is the establishment of a causal relationship between the patient's involvement in CT with negative consequences that have become negative for him, which is obligatory for the recognition of the case by insurance (the onset of insurance risk). Thus, in the judgment in case No. 2-4/14 the court found: "Between the parties there was a dispute as to the presence or absence of a causal relationship between the patient's admission for the clinical trial of the tested drug and the death that took place afterwards, for which a forensic medical examination was appointed by the court ruling. According to the conclusion of the examination ... between the death of the patient and the taking of the medicine "A" there is a causal relationship ... In the sense of the provisions of Article 86 of the Code of Civil Procedure of the Russian Federation, the expert opinion is one of the most important kinds of evidence in the case, since it is distinguished by the use of special knowledge and scientific methods of research, and nevertheless, the court, in the presence of the expert's opinion in the materials of the case in question, cannot neglect other evidence obtained in the case, in which connection, the legislator in Article 67 of the Code of Civil Procedure of the Russian Federation stated that no evidence has a pre-established value for the court, and in the provisions of part 3 of Article 86 of the CCP RF it is noted that the expert's conclusion for the court is not binding and shall be considered along with other evidence. However, this does not mean the court's right to independently resolve issues requiring special knowledge and definitions in the field of science ... Having evaluated the evidence available in the case materials in their totality, including the conclusion of forensic medical examination No. 62, the court comes to the conclusion that the defendant's refusal to pay the insurance sum to the plaintiffs in full was unlawful, as well as to the conclusion that there are legal grounds for satisfying the claims in terms of recovery of the insurance sum."146 Thus, from the above decision it follows that the court, in accordance with the requirements of the

Law on the circulation of medicines and the Insurance Rules, has recognized the insured event as such, taking into account the established cause-effect relationship, both on the basis of an expert opinion and on the totality of evidence, given that the insurance company had previously denied payment to the relatives of the patient.

A somewhat different position of the courts is presented in the judgment in case No. 2-1455/14, which differs from the first one, since the experts established not only the existence of a causal link, but also detailed its form: "Under the court's ruling, a commission for medical forensic expertise was appointed. As it follows from the forensic examination report No. 313, it cannot be ruled out that taking the FG-4592 medication by a patient could worsen the state of his health (in terms of the negative impact on the development of acute cardiac arrhythmias) ... Between the taking of the drug and the onset of the patient's death there an indirect causal link ... The court accepts the expert's opinion No. 313 as evidence of the presence of an indirect causal relationship between the patient's admission of the experimental drug and his death, that in accordance with section 7 of the Basic Regulations 147 approved by the respondent, is an insured event entailing the insurer's obligation to make an insurance payment." It should be recognized that the court identified the "possible presence of an indirect causal relationship" with a cause-effect relationship, which is the basis for payment of insurance compensation. Of course, this position of the court, which applies a broad interpretation of the rule of law, serves the purpose of providing social protection for patients in CT, however, can this be the subject of judicial discretion? In addition, there are a number of questions about the nature of the "indirect causal relationship" and its relationship to the safety and efficacy of the drug. After all, in this case, it is important not only to satisfy the plaintiffs' claims, but also to establish the truth in the case, determining by examining the effect of the studied drug on the human body in order to protect an undefined circle of potential drug users.

Another example is the court decision in case No. 2-2088/13 containing the following conclusions: "At the request of the plaintiffs, a complex forensic medical examination was appointed. According to the expert's opinion No. 10, the main cause of the patient's death was the severity and nature of his existing disease, i.e. right lung cancer, while the use of drug "B" led to a worsening of the condition, could contribute to the onset of a lethal outcome, but the serious side effects of this drug did not constitute the cause of the death of the patient, between taking the drug "B" and the onset of the patient's death there is no direct causal relationship... The evidence that would disprove the correctness of the conclusions of the examination is not presented in court. Having assessed in accordance with the provisions of Art. 67, 86 of the Code of Civil Procedure of the Russian Federation the expert opinion, together with other evidence in the case, the court comes to the conclusion that the causal relationship between the patient's death and his participation in CT is absent, the patient's death is not an insurance event under the compulsory life and health insurance contract of a person participating in the CT".148 It is noteworthy that the examination established the absence of a direct causal relationship, and not a causal relationship as such. Consequently, in this situation it is necessary to be guided by the legal meaning that the legislator puts into the very concept of "causal relationship". Since normative legal instruments, as well as official explanations on this issue are not available, a legal vacuum is developing, in which courts arbitrarily identify, in some cases, an indirect relationship with a causal relationship, and in others they believe that the indirect causal relationship does not take place. As in the previous case, the questions regarding the safety and efficacy of the drug were omitted in the expert opinion.

Thus, the analysis of these judgments gives grounds to believe that it is necessary to issue a regulatory act that strictly regulates the procedure for conducting an expert examination on cases establishing a causal relationship between the onset of adverse consequences for the life and health of the patient and his participation in the CT. It is quite obvious that the expert doctors conducting such examinations in the state institutions of forensic medical examinations are not specialists in the field of CT and can not assess the effect of the experimental drug on the human body. In this connection, they carry out expert examinations in analogy with examinations on the establishment of harm to the health of the patient in the provision of medical care, where it is obligatory to divide the cause-effect relationship into direct and indirect ones, as this determines the further qualification of the medical personnel and the distribution of legal liability: either in criminal law or civil law. However, in cases of establishing harm to the life and health of a patient in CT, it is necessary to establish a causal relationship, without further differentiation. Accordingly, this type of expertise should be handled by experts who are experts from the Federal State Budget Institution "Information and Methodological Center for Expertise, Accounting and Analysis of Treatment of Medical Applications" of Roszdravnadzor,[358] who conduct expert examinations of samples of medicinal products coming in for CT. It would be logical to entrust them with further expert evaluation of the effect of the drug on the human body, especially in cases where there is reason to believe that there are serious adverse events (SIDS) that occurred during CT. This, of course, would enhance the insurance protection of the patient in CT, and would also serve as a guarantee that the drug will be safe and effective when entering the market for use by an unlimited number of individuals.

It should be noted that the above judicial decisions, regardless of the conclusions made by the court, are still based on the results of forensic medical examination. However, in jurisprudence there are cases in which forensic medical examination is not conducted at all and the causal relationship between the death of the patient and his participation in CT is not established due to the lack of the possibility of its establishment.

Thus, the decision in case No. 2-1535/14 contains the following conclusions: "Having analyzed the legally significant evidence and factual circumstances of the case, the court considers the findings of the insurance company in refusing recognition of the event by the insurance case corresponding to the submitted medical documents, since the plaintiff did not provide the court with sufficient evidence supporting the presence of a causal relationship between the patient's participation in CT and the onset of her death. According to the opinion of the forensic medical expert, it is not possible to answer the question as to the existence of a causal relationship between the patient's participation in CT and her death, since the reliable cause of her death is not established - no pathoanatomical study was conducted ... The interviewed expert explained to the court that for determining the cause of death, the causal relationship between taking the drug and the patient's death, it is necessary to conduct a forensic examination of the corpse. However, since a lot of time has passed since the patient's death, the forensic examination of the corpse is inadvisable, since the results will be unreliable ... Since the case materials do not contain adequate evidence of the causal relationship between the patient's participation in CT and her death, i.e. proof of the occurrence of the insured event, the court finds no grounds for satisfying the claims."150 Thisjudicial act testifies as to the serious imperfection of the legislation in the field of CT. The court, as a subject that does not possess special knowledge, without the conclusion of a forensic medical examination, cannot establish a causal relationship, and in this case the examination was impossible due to the absence of pathoanatomical research. It should be noted that at present the Standard assigns the responsibility of the researcher to inform the Sponsor of a study of any serious adverse events (SIDS) that have occurred during CT, including the onset of disability and death. In the case of death reports, the investigator must provide any additional information (for example, an autopsy report and posthumous epicrisis)

1 upon the request of the Research Sponsor. However, in practice, when the patient dies, the organizers do not request additional information. Thus, autopsy and pathoanatomical research may not be carried out at all, unless the investigating physicians themselves have linked the fatal outcome with the participation of the patient in the CT. It is obvious that the absence of pathoanatomical research, which should be carried out at the time of the patient's death, gives rise to legally significant consequences, such as the refusal of the claim due to the lack of evidence of the causal relationship between the patient's death and his participation in CT, therefore both the insurance and judicial protection of the subject of the experiment lose their meaning.

Essential is the fact that the absence of a protocol of pathoanatomical autopsy of a patient who died in CT is quite often encountered in practice. Therefore, it seems important to assign it as mandatory in the Standard, as a duty of the Medical Entity, that provided the clinical basis for the CT, to perform such an autopsy in cases when the patient participating in the study dies during the CT, and also within a certain time after its completion.[359] [360] This measure will allow not only to use the materials of such a pathoanatomical autopsy as evidence in court in the case of a particular patient, but will also contribute to greater transparency of the CT, and, therefore, greater reliability of the results obtained in its course.

In addition, it seems also to provide a solution to the problem of gathering evidence by the injured party as a plaintiff in case, who, as a rule, does not have either medical or legal knowledge to conduct a case in court. In this connection, the decision made in case No. 2-1535/14 is indicative: "During the CT the patient died. According to the medical certificate of death issued by the therapist, the cause of death is cancer intoxication, thyroid cancer with metastases to the lymph nodes of the neck. An autopsy was not performed. The defendant refused to the plaintiff in the production of the insurance payment because of the lack of a causal

link between the CT conducted and the death of the insured person. Having evaluated in aggregate all the evidence available in the case, the court concluded that the plaintiff, contrary to the requirements of Art. 56 CCP RF, there is no evidence of a causal relationship between the patient's participation in the clinical study of the drug and the death of the patient ... The court has no reason not to trust the death certificate issued by the doctor. Claims of the plaintiff about the lack of necessary knowledge of the doctor are unfounded. The plaintiff's arguments about the patient's death from taking the experimental drug are based on assumptions and are not supported by anything. Thus, in the absence of a causal relationship between the patient's participation in CT and her death, the court considers that the insured event has not occurred and the defendant has no obligation to pay insurance compensation, therefore, the claim must be refused."[361] The resulted decision testifies that the court, having limited to absolutely formal arguments, did not use the judicial authority for an establishment of truth in the case, despite the fact that in accordance with Art. 57 of the Code of Civil Procedure of the Russian Federation,[362] the court is obliged to assist the parties in gathering evidence.

M.Yu. Fedorova (as to disputes in the field of social insurance) stated that the insured do not usually seek help from lawyers because they do not have sufficient funds, they have to independently understand the subtleties of legislation, but it is not always possible to formulate their arguments in a qualified and logical manner, which leads to inequality of the citizen and the state body as parties of the process. [363] This statement can be fully attributed to the cases concerning insurance compensation associated with the participation in CT. Due to their material situation, the lack of special knowledge in the field of medicine, and also the dependence on the presence or absence of an autopsy report and other

documents in the case, it is practically impossible for claimants in this category of cases to present evidence and act as an equal party in the process.

In the context of the above, we share the point of view of N.G. Balibardina as tp the distribution of the burden of proof in the civil process in cases involving CT.[364] It is obvious that a citizen who is harmed due to his participation in CT is not able to know the reasons for the inconsistency of medicines with the requirements established by the law, and is also unable to establish the fact of violations committed by participants in the pharmaceutical market due to his lack of special knowledge and the opportunities of establishing these facts, and therefore the distrubition of the burden of proof of the circumstances on which each side refers, as the basis for their claims, as stipulated in Part 1 of Article 56 of the Code of Civil Procedure of the Russian Federation, becomes inadmissible for the plaintiff (patient). In order to protect a side that is so weak, the law should establish evidentiary presumptions, which, on the one hand, "shift the burden of proof" to the opposite side, and on the other - allow the court to surmount the existing barrier of reliability and sufficiency of evidence in the case, when the opportunities of research and establishing the facts needed are fully exhausted.

It seems that there is a need to amend the civil procedural legislation with regard to the redistribution of the burden of proof: from the patient (the patient's relatives) to the insurance company, which can be called an "evidentiary presumption" ensuring equality of parties in the litigation.

In scientific discussions another proposal is made, related to the protection of rights and legally protected interests of patients, about the establishment of a presumption of a causal relationship between the harm to the patient's health caused during CT and the action of the experimental drug for which it is conducted.[365] It should be noted that the main argument of the proposed concept of the lack of study of the drug, which gives grounds to establish a priori the existence of a cause-effect relationship, is not justified from the point of view of medicine or from the legal point of view. If such a presumption is applied, there will be no need to establish the true causes of the patient's death, therefore, the effect of the drug on the human body will not be studied, which in turn will not allow the collection of data on its safety and effectiveness. Consequently, the main reason for the CT will be lost, consisting precisely in obtaining in the course of a scientific experiment of reliable information about a certain medicine.

Summarizing the above, we must state that the institution of compulsory insurance as a compensatory mechanism for the social protection of patients in CT in its purely private law interpretation, proposed by the legislator today, does not achieve the purpose for which it was created, i.e. compensation for harm to life and health of patients who participated in CT. In addition, attention is drawn to the fact that in cases where claims of relatives of patients were satisfied (which actually confirms the negative impact of the test medication on the life of the patient), information on the adverse effects of the drug is of legal importance only for the insurance company obliged to pay the insurance indemnity (private-law interest), as well as for the patient's relatives, whose private-law interest is again satisfied by such a decision. In accordance with the current legislation, information on the fact of causing harm to the health of the patient as a result of taking the experimental drug is not sent to the research sponsor or Roszdravnadzor, which must have information about the adverse effects of the study medication on the human body. Consequently, the private law mechanism for the implementation of compulsory patient insurance in CT does not provide an opportunity to publicize the information about the effect of the drug on the human body in cases of establishing this data during the trial. This allows to leave a number of negative consequences of the drug in the "blind zone" for the control and supervisory authorities, designed to provide medicinal safety for all citizens - potential consumers of medicines.

The above arguments show that the existing legal framework in which the legislator, considering that obtaining insurance compensation for compulsory insurance of the patient in CT is a purely personal interest of the subject of the experiment (his relatives) and having provided for only private legal mechanisms for regulating these relations, is not complete. In addition, it should be taken into account that the identified legal defects of compulsory insurance indicate nonobservance of the principle of the constancy and continuity of the social protection of patients in CT because compensatory measures that are a necessary continuation of preventive measures do not perform their protective function effectively either in respect of the patient, nor for an indefinite number of persons. It seems that the regulation of the relationship of compulsory insurance of the patient in CT should be carried out not only by private law but also by public legal mechanisms, since the activity of compulsory life and health insurance of patients is socially significant, related to the provision of medicinal safety. In this connection, it seems that it is necessary to focus on the social nature of this protection mechanism, considering the opportunities of applying of such public law mechanisms that are characteristic for legal relations in the field of compulsory social insurance.

Taking into account the research tasks posed in this paper, it is necessary to indicate that the recognition of the type of insurance being analyzed as social/non- social has an important theoretical significance, but is not an end in itself. The theoretical aspect of this issue implies the "purity" of scientific approaches, the search for arguments for classifying a particular group of social phenomena to one class, if the characteristics of such phenomena coincide in essence. In this case, it is not critical that the legislator for any reasons adheres to a different approach, because the identification of such causes is also very productive for science. At the same time, the practical importance of recognizing compulsory insurance of a patient in CT as social insurance is undoubtedly playing a greater role, since such recognition allows one to move to the plane of improving legal mechanisms for the realization of citizens' right to receive social benefits and effective protection of citizens from social risks.

The approach of the legislator to social insurance, which establishes that only the social and economic risks associated with the loss of income by the economically active population can be compensated in insurance form,[366] largely predetermines the positions of representatives of the legal science. In the opinion of the majority of representatives of science, the mandatory criteria for classifying insurance as a social one are its obligation (by force of law) and the implementation of insurance payments in connection with the occurrence of an insured event solely at the expense of an insurance fund formed by charging contributions based on wages or other income of the insured person.[367].

It seems that linking the social nature of insurance solely with socioeconomic risks does not allow to objectively consider all of its aspects, and on the whole considerably narrows the regulatory opportunities of such an important instrument of social protection of citizens, does not meet the social tasks of society. It seems that different approaches to understanding this phenomenon are needed, which are offered by the legal science. In particular, M.A. Kovalevskiy differentiates insurance for social, and for insurance, which is not so, depending on the degree of its social significance, not linking it only with the mandatory or voluntary insurance. The scientist believes that the main criterion for determining the sociality of an insurance is its focus on protecting individuals from social risks that threaten social benefits. Thus, the social component of insurance is treated to them from the point of view of its focus on protecting social goods as a broader category than just social and economic benefits.[368]. One can not but agree with this, because it is obvious that the absence of this or that kind of insurance, fixed in

the Federal Law in the status of "compulsory social insurance", does not change the social nature of the relations that are subject to social protection.

In the context under consideration, it is necessary to take into account such an important argument that the compulsory insurance of the patient in CT is related to social insurance, as an increased risk of the research process itself, which is a medical experiment involving a human as a subject but beneficial to society. Therefore, prior to the initiation of CT, an assessment should be made of the ratio of the projected risk and inconvenience to the expected benefit for the subject of the study and society. The very same research can be started and continued only if the expected benefit justifies the expected risk. In addition, the Standard specifies that the researcher conducting the CT is required to report all circumstances that affect his research and/or increasing the risk to the subjects, and these risks and their decrease/increase should be reflected in the Research protocol and other documents.161 That is, in the conduct of CT there are both predictable risks that are susceptible to a preliminary assessment and unpredictable risks that arise during the experiment, therefore the patient's participation in CT is a risk situation for him, and this risk is of a social nature. And one of the protective mechanisms designed to compensate (minimize) this risk is mandatory life insurance and health of patients in CT.

The personal nature of this type of insurance indicates the similarity between it and compulsory social insurance, which allows representatives of the science of social security rights to compare them among themselves. "Here the same insurance risks, the circle of participants in the arising relations, similar insurance payments, etc. Personal insurance can be compulsory ... and voluntary ... However, social insurance is different from civil-law personal insurance by the degree of compulsion, the regime of legal regulation and the way of financial security ... But they interact with each other, because the compensation of social insurance Risks is also possible in the system of civil-law personal insurance ".[369].

It seems that one can critically comprehend the proposed differences between compulsory social insurance and compulsory insurance of patients in CT as personal insurance.

First, the degrees of compulsory nature of these types of insurance are equal, since each of them is mandatory because of the requirements set forth in federal laws.

Secondly, the regime of legal regulation of these types of insurance can not be a criterion for distinguishing them, since the regime is a secondary phenomenon, mediating the essence of the regulated phenomenon. And if we recognize this or that kind of insurance as social one, then we regulate its implementation in a certain way, for example, deriving, for example, from the "umbrella" of a purely private law in the direction of greater publicity. So, with compulsory social insurance, the insured person has a much broader range of legal opprtunities for restoring the violated right, including a variety of jurisdictional forms of protection, including administrative ones, which is not available in compulsory insurance of patients in CT.

Thirdly, it is necessary to emphasize that all patients participating in CT receive experimental treatment as part of providing them with medical assistance under the state guarantee program in accordance with the legislation on compulsory medical insurance, which is social legislation. In this case, the need for medical care is provided in art. 7 FZ No. 165 - FZ[370] in the first place among social insurance risks, confirming that the citizens' constitutional rights to life and health are an undisputed priority for the state. Moreover, those patients who participate in CT either belong to a circle of potential or already real participants in

social and supportive relationships, because of the severity or social significance of the disease, the presence of a disability, etc.

Fourthly, the way of financial security of payments in connection with the occurrence of an insured event is of insurance nature both in social insurance, and in the insurance of patients in CT. In the latter case, the insurance fund is formed at the expense of insurance coverage by the research organizer, and not at the expense of a special insurance fund formed by charging contributions in respect of the salary or other income of the insured person. However, it should be noted that the method of financial provision of insurance payments can not be the only decisive criterion determining social insurance or not. It seems that the more convincing opinion had M.A. Kovalevsky, who believed that the main factor in classifying this or that type of insurance as social, is its focus on protecting social goods. It is this kind of protection of the social good - the life and health of the subject of the experiment (private interest), in which the whole society is interested in obtaining a medicinal product for many citizens (public interest) - is provided by compulsory insurance of the patient in CT. After all, the social insurance of wage earners in its legal nature is "a system of two interrelated obligations: a public legal one, which can be called primary (arising between the insured and the insurer for payment of insurance premiums) and secondary (between the insurer and the insured person) The secondary obligation, along with public-law components, also includes private law related to the realization of the interests of the insured

164

person."

It should be noted that in legal relationships for compulsory insurance of patients in CT, there are similar private-public obligations. Compulsory insurance of patients in CT is carried out in accordance with the current legislation and is imposed by the state in an imperative order on the research organizer. Permission to conduct CT will not be issued by the Ministry of Health of the Russian Federation, if the insurance policies of patients are not included in the package of documents for obtaining such CT. This is a public law aspect. Since the insured person's property interests are the object of insurance, the receipt of insurance compensation by the patient (relatives of the patient) is a private legal interest, and in case of refusal to pay compensation by the insurance company, it is resolved in the civil procedure.

Taking into account the above comparative analysis, it should be noted that compulsory insurance of patients in CT is social insurance by nature. This conclusion has a practical focus on the possibility of applying in legal compulsory insurance to patients in CT legal means specific to compulsory social insurance, first of all, so that insurance can effectively implement its inherent functions.

Thus, the legislator should provide for not only civil means of protecting the rights of the insured, but also the jurisdictional administrative procedure for such protection. This is possible through the application of a mixed, administrative- judicial mechanism, characteristic of relations in the field of social insurance. A citizen must be able to file a complaint with the relevant state authorities before filing a lawsuit in court. Since Roszdravnadzor is the body that executes the state's administrative functions in the field of ensuring medicinal safety, it could conduct control and supervisory activities when the patient (the patient's relatives) turns to the insurance company for payment of insurance compensation. As already noted, almost all appeals to insurers result in denial of insurance payments due to the absence of a causal relationship between the patient's participation in CT and the adverse consequences that have occurred. The insurer's decision could be lodged with a complaint to Roszdravnadzor, which would be obliged to organize an independent forensic medical examination, which will help to collect evidence for the weakest side of the dispute, which is the patient (the patient's relatives). At the same time, the authority authorized by the state to monitor the treatment on the market of medicines, to check them for safety and effectiveness, in all cases of treatment of patients (relatives of patients) in the insurance company would have information about the possible adverse effects of the study medication on the human body. Therefore, in the private law case, such important information would be given a public communication, which fully corresponds to the socially significant goals of the CT process, which is aimed at establishing the safety and effectiveness of the new drug.

The proposed initiative seems to increase the level of compensatory social protection of patients in CT, and also serves the purposes of social protection for an unlimited number of potential consumers of medicines - being for them a preventive protection.

In addition to the measure that is currently proposed by the legislator as the only compensatory measure (life and health insurance), other legal compensatory mechanisms for social protection of subjects of the experiment can and should be applied. As it was already mentioned, all patients - participants of CT receive experimental treatment as part of providing them with medical assistance under the program of state guarantees in accordance with the legislation on compulsory medical insurance. Therefore, in order to improve the effectiveness of compensatory social protection of patients in CT, it is worth considering several areas for improving legislation, while relying on the high importance for the state and society of individual human rights to life and health, and, at the same time, guaranteeing social interest - the health of all citizens. This may include the inclusion in the social security legislation of legal mechanisms that establish additional social support measures for patients who have undergone CT. They should be aimed at creating the most favorable conditions for access to socially significant benefits in the field of medical care and medicinal supply for patients who have deteriorated health status as a result of their participation in CT.

Thus, in the Insurance Rules, discussing an insured event, in addition to the death of a patient, it is also stipulated that the I, II and III group disability is established for the subject, consisting of a causal relationship with his participation in the CT. 165 Depending on the disability group, insurance payments to the subjects of the experiment are differentiated. However, it appears that the receipt of a lump sum payment is not a sufficient compensation measure in the case of a significant loss of health, which provides for the establishment of disability. Therefore, additional legislative provisions are needed to overcome and compensate for the adverse consequences for the life and health of patients associated with their participation in CT, since they are to some extent at risk for the common good.

Currently, the legislation in the field of social protection of disabled people includes measures for sanatorium and health resorts and medicines. In accordance with Art. 6.1. Federal Law No. 178-FZ dated 17.07.1999 "On State Social Assistance",[371], disabled people are provided with a set of social services, which includes the provision in accordance with the standards of medical care with the necessary medicinal products for medical use on prescription drugs, prescriptions for medical products, as well as the provision, in the presence of medical indications, of a permit for sanatorium treatment to prevent major diseases. However, this general rule does not reflect the specifics associated with the consequences of the use of experimental drugs in patients with CT. Guided by the thesis on the application to each category of persons in need of social protection special targeted measures aimed at improving the quality of life of citizens, taking into account the characteristics of their social status, it seems appropriate, in addition to the general measures outlined above, to develop special measures. Such compensatory measures could not only improve the quality of life of the patient (disabled person), but would also allow analyzing the delayed effect of the experimental drug and the consequences it creates for the patient's health.

It should be noted that the social and security legislation of the Russian Federation has developed measures of social support for certain categories of citizens whose health damage is caused by socially significant events whose adverse effects have a continuing effect. As an example, the Law of the Russian Federation dated 15.05.1991 No. 1244-1 "On the social protection of citizens

exposed to radiation due to the Chernobyl disaster", art. 24 of which provides for citizens affected by radiation as a result of the Chernobyl disaster, compulsory special medical supervision (medical examination) throughout life. 167 In connection with the fact that the deterioration of health caused by dangerous factors associated with the effect of radiation on the human body has similarity to the situation of damage to the life and health of the patient with the drug being tested in CT, this measure of social support would be absolutely appropriate for the subjects of the experiment. Since the source of damage to the subjects is an experimental drug, the safety of which has not yet been proved in the CT process, and interaction with other drugs and substances has not been investigated, the provision of medical assistance in a special order could be an effective compensatory measure for patients (disabled). Currently, in the normative legal instruments in the field of social protection of disabled people, such a measure is not provided at all. However, in order to provide truly effective compensatory social protection, patients need to provide in the social security legislation measures that provide opportunities for special medical supervision. So, it could be medical examinations and medical examinations of patients, provided within the framework of the program of state guarantees of providing free medical care to citizens of the Russian Federation, taking place at certain intervals, depending on the pharmacological action of the drug and the severity of the damage to health.

As to the measures provided by the Federal Law of 17.07.1999 No. 178-FZ "On State Social Assistance" for providing medicines to persons with disabilities, it will also be appropriate to provide for patients after CT a special procedure for providing it. First of all, the specificity of the CT process, connected with harming the patient's health by an unexplored drug, must be taken into account. In view of these circumstances, drug therapy should be selected and the procedure for its provision should be established.

It seems that the proposed legal mechanisms for the social protection of the patient to be applied, if in the course of CT his health was harmed, entailing the establishment of disability, will allow the effective use of compensatory protection, the purpose of which is to minimize the adverse consequences of the social risks of the subject of the experiment. Also, the proposed measures fully correspond to the principle of targeted approach when providing social support measures, which is stipulated in the state program of the Russian Federation "Social support of citizens",[372] because they are based on the assessment of the need for these measures of a narrow category of citizens - patients who received a disability in connection with participation in CT, and do not apply to other categories of disabled people.

At the same time, it should be recognized that to date, in cases in which the patient's health has been slightly harmed without causing a disability, or the patient's health in CT has not been harmed at all, CT subjects have actually been left out of public attention, on them None of the compensatory measures of social protection applies. It seems that this situation does not meet the goals of the social policy of the state, nor the social role of CT. Due to the high social significance for the state and society of the process of production of a medicinal product, it is justified to provide social protection to all subjects of the experiment. Since the participation of patients in CT is associated with taking a drug, the most reasonable is the priority provision of measures related to their medical care and medicines. In Art. 30 the Helsinki Declaration states that upon completion of the study, each patient included in the study should be guaranteed access to the best methods of prevention, diagnosis and therapy, a specific study.[373] But, as experts point out, in practice this is not always the case, although, in relation to patients who have completed CT, several ways of further tactics for their management are possible. They may be asked to become participants in another CT study of a medicinal product for the treatment of the same nosology, recommendations for further acceptance of the original innovative drug (if it is registered in the country and represented on the pharmacy network), or recommendations for continuing the receipt of the generic version of the same Preparation. In addition, a drug with a similar effect can be selected from already registered drugs.[374]

As the measures of medical assistance, it is possible to grant subjects of CT the right to periodic medical examinations, explorations and surveys for a certain period of time, which is set to address depending on the pharmacological effect of the tested drug. This measure of social support for patients in CT would not only provide protection and maintenance of the patient's immediate health, but also simultaneously monitor the delayed pharmacological effect of the test drug on the body. Data obtained from periodic medical examinations on the effect of the medicinal product should be included in the documentation of this CT and, thereafter, be taken into account for the purpose of clarifying or supplementing side effects, as well as for detailing the indications for use, which will then be an effective social protection for an indefinite circle of persons. Currently, neither the legislation on CT, nor regulatory instruments in the field of social security, do provide these measures of social support.

It seems that in this case, the improvement of legislative regulation can proceed in different ways.

So, for the purpose of social protection of this category of patients in CT, as well as an undefined circle of potential consumers of medicines, it is necessary to develop and adopt a special regulatory instument regulating in certain cases the selection of a special drug therapy for a patient after CT, as well as the subsequent medical observation. Also, it is important to provide for the procedure for recording, processing and further use of information obtained during observation of the subject of the experiment, in order to mandatory fix important data on the delayed pharmacological action of the study drug. The proposed legislative changes containing compensatory mechanisms for the restoration and preservation of a certain state of health of subjects after CT will be, by their legal nature, socially-protective measures that enhance the social protection of individuals in CT, and also ensure compliance with the principle of constancy and continuity of such protection. In the proposed version, the implementation of these sociosecurity measures should be consolidated as a State's duty.

However, taking into account the current trends in the development of legislative regulation in the field of social law, one can consider the possibility of establishing appropriate responsibilities for the research sponsor responsible for the production of a safe and effective drug on the market. In this connection, it is necessary to agree with M.Yu. Fedorova, who indicates that the modern state, while retaining the role of the main subject of the social security system, encourages the participation of non-state actors in it so that this system is multilevel and allows to compensate as much as possible the consequences of social risks.[375] Therefore, it is possible to add to the Standard the additions providing for the responsibility of the Sponsor of a trial to provide medical supervision for a certain time for patients who took part in CT in order to determine the possible deterioration of their health, as well as to determine the causes of such deterioration with mandatory fixation of results and subsequent introduction of these data on the delayed action of the drug in the CT documents. Even at the stage of CT planning in the CT Protocol, it is necessary to envisage the implementation of these measures at the final stage of CT, thus ensuring compliance with the principles of the constancy and continuity of social protection of individuals in CT.

Now therefore, it seems that in addition to the private law insurance mechanism currently envisaged by the legislator as a measure of the social protection of patients in CT, it is necessary to add a public law component. Such changes should go in two directions: first, to strengthen the role of administrative procedures in the mechanism of life and health insurance of patients, and secondly, to establish additional measures of social support for persons who participated in CT, as this helps to maintain their health, damaged partially for the benefit of the whole society, and also serves the purposes of social protection for an unlimited number of persons, serving for them as a preventive defense.

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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 patients:

  1. TABLE OF CONTENTS
  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 approaches to the analysis of legal mechanisms of social protection of patients
  5. Compensatory legal mechanisms of social protection of patients
  6. General characteristics of approaches as to the construction of legal mechanisms for the social protection of a physician-scientist.
  7. Compensatory legal mechanisms of social protection of a physician- scientist
  8. Conclusion
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