Conclusion

This research on the issue of "Social protection of individuals in clinical trials of medicinal products for medical use" made it possible, for the first time in legal science, to consider the issues relating to the implementation of social protection for each participant in CT, and in particular it has been done in the context of ensuring the safety and efficacy of medicines in the interests of the whole population of the country.

The goal of this paper was to carry out complex analysis of the legal status of the CT participants and their socail risks and to determine and measure the effectiveness of the legal mechanisms of social protection of both the participants themselves and of the indefinite circle of potential consumers of the tested medicines. This goal has been reached due to the setting of certain problems; the integrated and logically determined solution of these problems led us to make the following findings possessing scientific novelty.

Thus, as a result of the analysis of what the Russian state does as social welfare state in the context of the need for medicinal supply of the population, an approach is proposed and justified, in which the notion of "medicinal supply" is considered as part of the state's social policy aimed at preserving the life and health of citizens. Such a policy should be carried out by consolidating the state's obligations to conduct a set of economic, organizational and legal measures that ensure both the provision of medicines to all citizens (in particular, within the state guaranteed distribution programs) and, in general, the control over the circulation of safe, effective and affordable medicines.

human organism, implying the ratio of risk/benefit from its use to be in favor of the patient.

In the proposed context, the author has demonstrated high social significance of the CT, which is both the stage of circulation of medicines, and the guarantee of safety of a medicine for the entire population of the country. Thus, CTs serve the purpose of achieving the public good, but in the process of conducting such studies, medical assistance is provided to specific patients who are subjects of the experiment and are treated with the most modern and innovative medicines. In this connection, this thesis substantiates the existence of a connection between the social protection of an undefined circle of persons who are potential consumers of medicines and the social protection of subjects receiving treatment, but risking life and health, to a certain extent, in the public interest. The obvious existence of such a relationship is also confirmed by the conducted research of the regulatory governance over the CT procedures, which in historical retrospect was initially aimed at protecting the interests of just an unlimited circle of potential consumers, and only then (through a transition from general to private) the need to provide legal protection to the subject of the experiment, thereby ensuring the priority of his interests over the interests of science and society.

As a result of the analysis of public relations involving CTs, their features were revealed, such as the presence of a conflict of interests of participants, apriori inherent in the nature of CT, as well as the increased risk of this activity, given that it is simultaneously scientific, medical and pharmaceutical.

Such protection is defined in the paper as a system of legal measures aimed at the sustainability of the social situation and the achievement of a balance between the interests of the participants in the CT - the researcher and the patient - by applying preventive methods of protection against social risks that are unavoidable in an experiment involving a human subject and, if such risks really occur, then allowing to minimize and compensate for their consequences, while ensuring the reliability of the research results for the protection of an unlimited circle of potential consumers of medicines.

The athour's special attention was directed to the disclosure of the interdisciplinary nature of the social protection of individuals in CT, due to the fact that legal means mediating it are closely intertwined, public relations in the CT process are regulated by various branches of law (social security law, administrative law, labour law, civil law). Therefore, social protection is a legal structure that provides a symbiosis of public and private law mechanisms to observe the balance of all interests in the CT.

This approach to the problem of social protection of individuals in CT allowed to analyze the specifics of the legal regulation of this activity, and also, to determine the effectiveness of legal mechanisms, to study the practice of law enforcement (both administrative and judicial). To this end, legal mechanisms have been classified according to a functional orientation - a method of influencing social risk (advanced or subsequent) - into the groups of preventive and compensatory mechanism, which is consistent with the principles of the persistence and continuity of social protection at all stages of the study.

In the course of this study, the author has identified several principal conclusions regarding the effectiveness of social protection measures in favor of the individuals in CTs. Thus, the preventive legal mechanism for the social protection of patients in CTs (and through them an undefined circle of potential consumers of medicines) is ensured by strict compliance with the regulatory requirements (administrative procedures) for organizing and conducting CTs, observing the rules and standards of medical care, and can be referred to as preventive public law mechanism. Compensatory legal mechanism for the social protection of patients today is reduced solely to compulsory life and health insurance for CT patients under civil law rules, which gives rise to a large number of problems in law enforcement practice, making such a mechanism not always effective for protecting the rights of the patients themselves. In addition, given the private law legal means currently offered by the legislator exclusively it is almost impossible to protect an unlimited number of persons from dangerous drugs. Therefore, the paper suggests amending the legal means to protect patients' rights by dragging them into the public law level, for example by interpretive the compulsory insurance in CT as social insurance. In addition, there is another direction, which is proposed in order to improve the compensatory protection of patients in CTs, which is practically absent in the current legislation, that is the application of special social support measures to them after the completion of CT, related to additional guarantees of medical care and medicines.

Considerable attention is paid in the paper to the development of legal mechanisms of social protection of the researcher who conducts CTs, since his professional risks are also social risks.

In the course of the entire work, the conclusion is substantiated as to the mutual relation between legal mechanisms of social protection of individuals in CT, the effectiveness of each of them affects the effectiveness of the other. So, in the course of implementation of preventive measures for the social protection of patients, the same social protection should be provided to ther researching physician simultaneously. In addition, all legal mechanisms for the social protection of the patient and the physician-scientist (both preventive and compensatory) are preventive for social protection of an unlimited number of potential consumers of medicines.

The conclusions made in the study, among other things, can be considered as actual and effective proposals that allow to make changes to the regulatory framework governing CT, especially when developing and implementing the legislation regulating the implementation of pharmacovigilance.

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