Introduction

Relevance of the research subject. The issues of providing the Russian population with safe and effective medicines constitute an important topic of the policy of the state, which called social welfare state in its own Constitution.

Federal Law No. 61-FZ of April 12, 2010 "On the circulation of medicines" specifies the stage of clinical trials of a medicine for medical use (hereinafter referred to as "CI") with the participation of a human subject of the experiment for the purpose of evaluation its (medicine's) safety and/or efficacy, as well as the identification and/or confirmation of therapeutic properties. Thus, the exact (in accordance with the legislation) conducting clinical trials of medicines is one of the guarantees of ensuring the medicinal safety of the state (as a public interest). These circumstances determine the high degree of significance of the CT process, which completes the development of a new medicine, during which it is tested as to its safety and effectiveness.

As the final stage of the production of the medicinal product, CT is also a medical experiment, within the framework of which medical assistance is provided according to the rules of compulsory medical insurance to patients subject to CT, which also raises a number of questions, introducing additional social risks into the process, preventive and compensatory protection against which may be a matter for a private person (participant in the CT), but is publicly significant due to the special importance of CT.

In addition, it is necessary to pay attention to an analysis of social risks and the ways to protect against them of a physician-scientist who conducts CT, since he, when

providing medical assistance, operates under conditions of uncertain information as to the effectiveness of the medicine and its effect on the patient's organism.

In the Russian Federation, the CT process started much later than in other countries, but each year their number is steadily growing. So, in 2014, the Ministry of Health of the Russian Federation issued 750 permits for all types of CT, in 2015 already 804 permits were provided.^[220] Due to the fact that CT for Russia is a relatively new social institution that has become widespread only in the last decade, their social and legal nature has not been practically studied by scientists, and therefore, the nature of the risks of CT participants, the social and legal consequences of the onset of such risks, their interrelation and interdependence with the interests of an indefinite circle of potential consumers of medicines, for the protection of whom the CTs are carried out. This explains the lack of a systematic approach to the formation of doctrinal provisions of the legal science in terms of regulatory regulation of this sphere of public life.

As the systemal analysis of international legal norms shows, the Russian legislation, the analysis of law enforcement practice, the mechanisms of protecting individuals in CTs proposed in normative acts do not always achieve their goals, which requires their legal interpretation and adjustment.

The degree of academic elaboration of the problem. The subject and content of this dissertation are fundamentally new areas of scientific research. Issues related to the need to implement social protection for each of the participants in the CT in the context of ensuring the safety and efficacy of medicines for the benefit of the entire population of the country were not investigated (and not surveyed) by representatives of domestic and foreign legal science.

Specialists in the field of jurisprudence are studying only certain aspects related to the legal regulation of the CT process, some of them are doing it at the level of Ph.D. theses. Thus, N.G. Balibardina considers the civil law features of the contractual registration of the CT process.^[221] The works by A.S. Kontsevenko and E.V. Tarasyants

built on the analysis of international legal norms in the field of human rights protection in biomedical research.^[222] Yu.D. Sergeev and M.I. Litovkina have raised in their studies the general issues of protecting patients' health during CT, while Yu.B. Belousov has discussed the issues of ethical review. At the same time, the are also the representatives of medical science seeking to analyze the legal basis for conducting CT (A.P. Grunenko).

The object of this dissertation research is the social relations that develop in the conduct of CT, the resulting social risks, the consequences of elimination of such risks.

The subject-matter of this dissertation research constitutes the legal mechanisms for the social protection of individuals in CT, examined through the analysis of Russian and international legal instruments that regulate CTs, the norms of social security, labor, administrative and civil legislation that mediate the CT process, as well as enforcement practices in this area.

The purpose of the dissertation research is to carry out a comprehensive analysis of the legal status of the participants in CT, their social risks, the definition and evaluation of the effectiveness of legal mechanisms of social protection, allowing to protect both CT participants directly and to protect an undefined circle of potential consumers of medicines.

The pursuance of this purpose was carried out through the formulation and solution of the following tasks:

1. To discuss the category of "medicinal supply" as a social obligation of the state, showing its correlation with the category of "medicinal safety".

2. To substantiate the importance of the process of conducting CT as a stage of medicinal supply, the process of rendering medical care, one of the guarantees for ensuring the medicinal safety of the country's population.

3. To disclose and analyze the legal nature and characteristics of the CT, related to the increased riskiness of the process, the conflict of interests of its participants, the specificity of regulatory activity.

4. To investigate the nature of the risks to which the participants are exposed during the CT in order to identify the need for social protection measures to be applied to them.

5. To formulate the concept of social protection of individuals in CT as a complex legal institution, proceeding from the interdependence of risks in CT and observance of the balance of interests of participants in the process.

6. To identify and classify legal mechanisms for the social protection of individuals in the conduct of CT.

7. To analyze and evaluate the effectiveness of legal mechanisms for the social protection of individuals in CT, in order to make theoretical and practical suggestions for their improvement.

8. To identify the main problems arising in the implementation of social protection of individuals in CT, and justify their relationship with the protection of an unlimited range of potential consumers of medicines.

The methodological basis of the research consists of general scientific and special methods. Among the general scientific can include systematic, historical, structurally-functional, formal-logical methods. To solve specific research problems, special methods are used: formal legal, comparative legal, and others.

The normative basis of the research is consists of international legal norms in the sphere of CT, legislation of the Russian Federation, including laws and subordinate legal acts. As a basis for comparative analysis, the normative and legal acts of foreign states have been used. The empirical basis of the research is based on materials of judicial practice, law enforcement acts of state bodies, materials of international, all-Russian and regional scientific-practical conferences and seminars, periodical press materials, Internet resources.

The theoretical basis of the dissertation research consists of the scientific works of representatives of the theory of law S.S. Alekseev, A.V. Malko, N.I. Matuzov, Yu.A. Tikhomirov, Yu.K. Tolstoy, and others.

Defining role at the theoretical level have been played by the works of Russian scientists in the field of social security law and labor law: M.O. Buyanova, T.I. Belokolodova, Yu.V. Vasilyeva, V.P. Galaganov, S.Yu. Golovina. ON. Gorelov, K.N. Gusov, N.I. Diveeva, M.L. Zakharov, T.V. Ivankin, S.I. Kobzeva,

S.M. Kovalevsky, I.I. Lukashuk, A.M. Lushnikov, M.V. Lushnikova, E.E. Machulskaya, T.K. Mironova, Yu.P. Orlovsky, E.I. Petrova, N.A. Sokolova, G.V. Suleymanova, E.G. Tuchkova, M.V. Filippova, M.Yu. Fedorova, E.B. Khokhlov, V.Sh. Shaykhatdinov.

When considering many issues the basis has been added by the works of Russian lawyers specializing in other branches of law such as: K.V.Aranovsky, N.G. Balibardina, S.V. Bakhin, D.N. Bakhrakh, S.D. Knyazev, M.A. Kovalevsky, K.K. Lebedev, A.P. Sergeev, E.V. Tarasyants, Yu.D. Sergeev et al.

In view of the specifics of the selected topic, the works of specialists in the field of medicine, medical ethics, and sociology have been studied as the theoretical basis of the work: Yu.B. Belousov, G.Yu. Budarin, A.P. Grunenko, S.L. Plavinsky and others.

Scientific novelty of the work. For the first time in the legal science at the monographic level, a study of social relations that take place in the implementation of social protection measures for individuals in CT, the need for comprehensive implementation of such protection by effective legal mechanisms, balanced from the point of view of their regulation by public and private branches of law, is proved.

The following theoretical propositions aimed at improving the mechanisms of legal regulation of social protection of subjects in the conduct of CTs are justified and put on defense in the dissertation:

1. On the basis of theoretical and practical approaches to the definition of the concept of "medicinal supply", the social and legal essence of this type of activity is examined, which is considered broader than the component part of providing medical

assistance or providing medicines to certain categories of citizens.

2. It is proved that the control and supervisory activities of the state related to the production, release and circulation of medicines, including monitoring of their safety, is a natural consequence of the public nature of the state's obligations in the field of public health and health that ensure medicinal safety on a national scale. In the light of the foregoing, medicinal safety should be understood as the state-guaranteed protection of the citizen's right to have access to medicines with proven efficacy for the treatment of a particular disease, and the safety of these agents for the body, implying the risk / benefit ratio from its application to the patient. On this basis, the leading role of the process of clinical trials of medicinal products for medical use in the implementation of medicinal safety policy is disclosed.

3. The conclusions about the social essence of the CT process with the participation of a person as a subject are argued. This is due to the fact that, firstly, the goal of such a process is to achieve the public good, which is expressed in protecting the interests of an unlimited range of potential consumers for quality and effective medicines; Secondly, the CT process is not just a scientific experiment, it is a service to provide medical care to patients who are subjects of research. The paper reveals the existence of a continuous and logically conditioned interrelation between social protection of the interests of an indefinite circle of persons and the social protection of patients who are subjects of an experiment in CT risking life and health due to the unconfirmed efficacy of the study medication, to a certain extent, in the public interest.

4. The thesis proves that historically the original normative regulation of CT was aimed at protecting the interests of just an unlimited circle of potential consumers of medicines, which was the beginning of mandatory CT, and only then (through a transition from the general to the specific) did the idea of protecting the patient's interests and Priority of his rights over the interests of science and society. On this basis, the work proves that the risks in CT are of a social nature and concern not only the named subjects, but also the doctor-researcher who conducts CT. In addition to the fact that medical activity itself is a high-risk area, the investigator in CT is exposed to increased occupational risks when conducting treatment with the help of an experimental drug in the absence of reliable data on its effects, side effects and, accordingly, the range of medical interventions that may It is required.

5. The presence of social risk determines the need to build social protection of people during clinical trials through legal mechanisms. Such protection is defined in the system of legal measures aimed at the sustainability of the social situation and achieving a balance of interests of participants in clinical trials - a physician-scientist and patient - by the application of preventive methods of protection against social risks that are inevitable during the experiment involving human subjects, and in the occurrence of such risks in order to minimize and compensate for their effects, while providing the reliability of the results of the study in order to protect an unlimited range of potential consumers of medicines.

6. It is determined that the social protection of individuals in CT is an integrated interdisciplinary legal institution built on the interaction of various legal means that determine the symbiosis of the mechanisms of public and private law that allow balancing all interests in CT. This thesis is based on the fact that the relevant legal norms, which provide for the social protection of individuals in the CT, are significantly isolated, "territorially" in various branches of law, are studied by science and implemented in practical activities in isolation from each other. This affects their regulatory function, not allowing to use the considerable potential of such norms with the aim of constructing effective legal protective mechanisms for individuals in CT. The paper substantiates the thesis that the analysis of the identified legal norms through the prism of the realization of social rights (first of all, the right to health protection) allows us to construct from the various public law and private law means the most effective legal mechanisms that realize the goals of social protection of individuals in CT.

7. The paper proposes a classification of legal mechanisms for the social protection of individuals in the conduct of CT by several criteria. So, according to the functional orientation - the way to influence social risk (leading or subsequent) - legal mechanisms are differentiated into preventive and compensatory ones, which is consistent with the principles of constancy and continuity of social protection at all stages of the research. Based on the analysis of the order of legal activity for the protection of subjective rights, jurisdictional and non-juridical legal mechanisms are distinguished. According to the role played in society and the nature of interests protected by certain norms, the mechanisms are divided into private law and public law ones.

8.. Preventive public legal mechanisms for the social protection of patients in CT are linked, first, with the observance of the rules and standards for the provision of medical care to patients, and secondly, in compliance with regulatory requirements (administrative procedures) for the organization and conduct of the CTs themselves. Compensatory legal mechanisms of social protection of patients today is reduced solely to compulsory insurance of their life and health in CT, carried out within the framework of civil law regulation, which generates large quantities problems in law enforcement, making this kind of mechanism is not always effective in protecting the rights of the patients themselves. In addition, the available resources of a private law character is almost impossible to protect the general public from dangerous drugs. Therefore, the paper suggests treating patients 'insurance in CT as a social one, which allows them to adjust legal means of protecting patients' rights in the direction of greater publicity. In addition, another direction is proposed to improve the compensatory protection of patients in CT, i.e. the application to them of special measures of social support after the completion of CT related to medical care and medicinal supply.

9. The paper specifies that under current Russian legislation, CTs can only be conducted by a licensed Medical Entity that has received permission to conduct CT in an authorized body and has concluded a contract for CT with the Study Sponsor. The direct executor of the CT is a physician-scientist who (in accordance with the system analysis of Russian laws) must necessarily be in labour law relations with the relevant Medical Entity that conducts CT. Such a legislative requirement also pursues practical goals, which are to determine the specifics of both the preventive public law and compensatory mechanisms for its social protection in the event of harm to the life and health of the patient during CT. Such mechanisms are determined by the application of the norms of labour law as a social sector, rather than civil law norms. In addition, for the most effective protection of the professional risks of the researcher in CT, it is proposed to create in the Medical Entities the collegial bodies (based on the experience of CT in several medical universities), coordinating the work on CT, assessing the course of CT, and also analyze the performance by a physician-scientist of his professional duties in terms of the validity of his actions.

10. In the course of the entire study, the idea of the interconnection of legal mechanisms for the social protection of individuals in CTs, which require coordination in their construction and implementation, is emphasized. Thus, in the implementation of preventive measures for the social protection of patients, the preventive social protection of the physician-scientst is simultaneously carried out. In addition, all legal mechanisms, both preventive and compensatory, are preventive for social protection of an unlimited number of potential consumers of medicines.

Theoretical significance of the research consists in the definition of new conceptual approaches to the content of the state policy in the field of medicinal supply and medicinal safety. Theoretical conclusions made in the work on the legal nature of the CT process, the social nature of the risks of its participants, the relationship between the well-being of the subject of the experiment and the well-being of potential consumers of medicines, the mechanisms for the legal regulation of the social protection of individuals in CT enrich the general legal doctrine as well as the branch of social security law and can be the basis for further scientific developments in this field.

The practical significance of the research is to formulate proposals aimed at improving the regulatory and legal regulation of the CT. The findings can be of practical importance for the implementation of supervision activities of Roszdravnadzor, the activities of forensic experts, as well as those of law enforcement agencies.

The materials of the research can be applied in the educational process of educational institutions of higher education, in which the teaching of social security law, medical law, legal basis for CTs is carried out.

Approbation of the results of the research. The thesis has been carried out and discussed at the Department of Labour Law and Safety of Labour of St. Petersburg State University and recommended for defense.

The main scientific conclusions and theses of the dissertation were presented in the works published by the author, as well as in the reports at scientific (scientific and practical) conferences and seminars at St. Petersburg University, Moscow State University and the International Congress on Public Health Law of the countries of the CIS and Eastern Europe.

The resulsts of the thesis were used by the author in the process of exercising professional legal activity, as well as in the teaching process at the Federal State Budgetary Educational Institution of Higher Education of Medicine named after I.I. Mechnikov of the Ministry of Health of Russia.

Structure of the work. The thesis consists of an introduction, three chapters combining nine paragraphs, conclusions, a list of normative sources and scientific literature.