General characteristics of social protection and its legal mechanisms for individuals participating in clinical studies of medicines for medical use

Since the medicinal supply is one of the most important areas of the social policy of the state, which has an impact on the national security of the Russian Federation, at all stages of the development of medicines, including the CT stage, the state should take measures aimed at protecting the rights and legitimate interests of its respective subjects (participants) to obtain a safe and effective drug.

It is necessary to take into account that the category of "social protection" is closely connected with the category of "social law", which, according to many experts, is a complex legal phenomenon that determines the state's policy in the social sphere.^[288] Such a conclusion seems to be absolutely applicable to the CT process, since the study of medicines on patients, as well as the subsequent use of drugs by an undetermined number of persons, affect not only the personal right to health and life, but is significant for the health of the nation whose provision is a matter of public interest.

Without claiming that our arguments are unconditioned, complete and undisputable, it is necessary to give a general vision of the category "social protection" in order to investigate the legal mechanisms of social protection of individuals in conducting a clinical trial of a medicinal product for medical use.

At present, this term does not have clearly defined boundaries and contents, as a result of which it has to deal with its various interpretations from the beginning of the 1990s in the current regulatory instruments^[289], in academic^[290] and educational literature, not only by representatives of the Russian legal science, but also sociologists, and economists.^[291] Often it is confused with other similar terms, for example, such as social security, social assistance, social support measures and so on.

Moreover, considering that the present study of the social protection of individuals in CT is in the plane of jurisprudence, it is important to highlight precisely the legal component of such protection for assessing its effectiveness and sufficiency, taking into account all the features of the CT process.

First of all, the definition of social protection is associated with activities as an active process to achieve certain goals through a system of measures of an economic, legal and organizational nature. In some cases it is defined that such activities are carried out exclusively by the state,^[293] in others it is determined as the activity of state and non-state bodies and organizations.^[294]

Many studies emphasize the relationship of social protection with the social

policy of the state,^[295] implemented when certain socially significant circumstances (events) occur, social risks. M.L. Zakharov, E.G. Tuchkova (using the category of "social risks") rightly characterize the social protection of the population as "a more universal system of social support than social security, oriented not only to classical social risks (old age, disability, loss of bread-winner, temporary disability, etc.), but also the risks externally introduced into the life of society ... by the formation of another economic system in the country. "^[296] M.Yu. Fedorova also traces the interrelation between social risks and social protection, arguing that social risks in a broad interpretation act as the basis for social protection.^[297]

As to the question of who should fall into the orbit of social protection in the literature there are different positions.

Therefore, in modern socio-economic conditions, social protection is formed as a system of measures aimed at preventing social and risk situations, eliminating, compensating and minimizing their consequences, by stabilizing and raising the standard of living (acceptable level of material and social well-being) for the purpose of free development of a person, ensuring his dignity and independence.^[301]

In this regard, most researchers express a broad view of the problem, pointing out that under the social protection system it is necessary to understand not only the provision of legislative measures that citizens need in connection with their special status at a particular stage of their life, but also the measures aimed at improving and maintaining a standard of living for all citizens, which protects the basic inalienable rights. ^[302] Thus, social protection in the above context is an interdisciplinary legal institution that should be implemented in all branches of law, while ensuring the most important social constitutional rights of a person and citizen, including the right to social security, the right to health care and medical assistance.

The proposed general approaches deserve support for the purposes of this study due to the fact that they are more suited to the tasks that face social protection of persons in carrying out research taking into account the characteristics of the CT process.

First, an indication in the definition of "social protection" on the need to protect all citizens, and not just those who found themselves in difficult life situations. This, of course, is correlated with the statement in the present work on the importance of the overall drug supply and the high social significance of CT, arising from the need to ensure the safety and efficacy of medicines intended for use by an unlimited number of individuals. In other words, it should be about all Russian citizens whose medicinal safety is guaranteed by reliable CT results, will be a manifestation of social protection by the state.

Secondly, the need for social protection of the inalienable human rights to life and health, closely intertwined with the most important social rights to social security, health protection and medical assistance, proclaimed by the Constitution of the Russian Federation. Such a position on the interrelationship and interpenetration of the rights of the first generation - personal rights and social rights, or rights of the the second generation - was also examined in the first paragraph of this chapter precisely in connection with the absolute importance of these rights for everyone and society as a whole, which obliges the state to form protective mechanisms for their (rights) unconditional implementation. Thus, it is necessary to emphasize that for the purposes of this dissertation research, the social protection of individuals in CT is considered in the context of protecting the personal rights of citizens, which are simultaneously the most important social rights.

Third, the definition of social protection as an interdisciplinary legal category. This approach is relevant for the CT process, since public relations in this sphere are diverse, regulated by various branches of law, but, nevertheless, they must have a coordinated system of measures of protection for effective implementation of CT.

Fourth. In determining the social protection of individuals in CT, it is necessary to pay attention as to the risky nature of this process itself, which combines medical activity and a scientific experiment involving a human as a subject of such an experiment, connected with the influence of an unexplored drug on the human body. Such risks, on the one hand, give rise to negative consequences, related in general to the patient's medical care, as well as the possibility of worsening the patient's health up to a lethal outcome (in the course of a scientific experiment), and, on the other hand, a researcher who is fully responsible for the welfare of the patient and the subject of the experiment at the same time.

These risks in the conduct of CT have a very high incidence and are almost unpredictable. And since the social meaning of the CT process is the achievement of the public good (obtaining in the course of patient treatment safe and effective medicines intended for use by all individuals) - then, while considering the risks associated with causing harm to the life and health of the patient in CT, a mention should be made of the relationship and interpenetration of private interests of the individual with the public interests of the state and society. The drug is tested on the subjects of the experiment and is intended for consumption by an indefinite circle of persons, therefore, the risk of deterioration of the health of a particular patient in CT, being his personal risk, is also a social risk to society as a whole.

In addition, the risk of deterioration of the patient's health in CT up to his death is also undoubtedly social in nature precisely because the right to health protection is the most important social right of a citizen of the Russian Federation, providing each person with his personal, inalienable right to life. At the same time, modern researchers discuss not just the guarantees of life that the state provide to its citizens, but also a decent level and a certain quality of life.^[303] Negative consequences associated with deterioration of the level and quality of life of the patient may occur during CT (as a medical activity and as a scientific experiment), so this risk should be recognized as social.

Identifying the nature of risks of a physician-scientist in the conduct of CT, it is necessary to take into account that they are in the plane of professional risks, which the national legal doctrine traditionally refers to the category of socioeconomic risks associated with the loss of a person's earning potential. At the same time, the social aspect of these risks must also be viewed in a broader perspective, since the activity of the investigator in CT is socially directed medical activity aimed at preserving and improving the health of the subject. Thus, S.M. Kovalevsky, assessing the professional activity of medical workers, says that by providing medical care, they risk in the interests of the other, i.e. in the patient's interests. Especially, the state of increased risk for medical workers is characteristic for cases when due to the severity of the patient's condition, a positive outcome of medical interventions is possible, but their results are not predictable enough.^[304] Of course, such a judgment applies fully to CT, in which, due to the possible unpredictable deterioration of the patient's health status resulting from the taking of the experimental medicine, the likelihood of bringing the researcher to legal liability, coupled with the onset of negative consequences for him, does increase. Thus, it is necessary to recognize that the professional risks of the physician-scientist under consideration during the CT are also of a social nature, and therefore its activity requires social protection.

Given the above arguments, under the social protection of persons in CT we should understand the legal system of measures aimed at the sustainability of the social situation and achieving a balance of interests of participants in clinical trials - the researching physician and the patient - by the application of preventive methods of protection against social risks that are inevitable during the experiment involving human subjects as the subject, and in the event of such risks in order to minimize and compensate for their effects, while providing the reliability of research results in order to protect the general public - potential consumers of drugs.

Thus, the content of the social protection of individuals in CT should be disclosed through legal measures to protect individuals directly involved in the CT process (the researching physician and the patient who is the subject of the experiment), as well as the social protection of an indefinite number of persons- potential consumers of those drugs that are tested during the study. As to the other participants in the CT (the sponsor of the research, the Medical Entity), then their social protection cannot take place, but the consideration of their interests imposes a clear imprint on the choice of legal measures of social protection in CT of other participants - individuals. Moreover, it seems important to emphasize that the closest and most tangible relationship can be traced between the protection of the patient and the protection of the entire population from low quality or deadly dangerous medicines. It can be said that social protection, effectively implemented directly for one particular subject, is also an effective system aimed at indirect protection of all potential consumers of medicines.

It should be noted that the very social protection of individuals in CT, social risks in the conduct of CT, their prevention and compensation in the scientific literature were not subjected to legal analysis, and in this connection there were no common approaches to legal mechanisms for social protection of CT participants.

While we fully share the opinion that there is a need for an integrated, cross-sectoral approach to the social protection of citizens, it seems absolutely justified to apply a similar approach to the social protection of individuals in CT, taking into account the peculiarities of legal relations of this process.

Thus, in CT, social relations between the subjects in the CT, the researching physician and the Medical Entity related to the subject of social security law, as well as the area of regulation of medical legislation, due to the fact that the study itself is always part of the process of providing medical care, And the subject of the experiment is the patient to whom this assistance is provided. In addition, the consequences of participation in CT for citizens can also be associated with the effect of social security standards.

The sphere of civil law regulation in CT is the contractual relationship between the research organizer and the medical entity carrying out the research provided for in Art. 41 of the Law on the circulation of medicines. Also, mandatory insurance of patients in CT is currently carried out in accordance with

Chapter 48 of the Civil Code and compensation for harm to the health of patients, which is made according to the rules of Chapter 59 of the Civil Code of the Russian Federation.^[305]

Labour law relations arise between the researching physician directly conducting the research and the Medical entity that concluded the contract for CT, due to the fact that by virtue of part 1 of article 40 of the Law on the circulation of medicines ^[306] only such a legal design is possible, with which the study can be conducted only by the Medical Entity, whose head may appoint the order physician scientist of the CT (which indicates the labour law nature of the legal relationship between these CT participants).

However, due to the social nature and public nature of CT as one of the stages of medicinal supply aimed at protecting the health and life of citizens, the regulation of this activity is also governed by the rules of administrative law, characterized by the existence of power regulations for their conduct by state bodies. Thus, the whole process of CT will be subjected to state administration, which is manifested in its regulation mainly by mandatory norms contained in federal laws, Government resolutions, orders of the Ministry of Health of the Russian Federation (Ministry of Healthcare and Social Development), Roszdravnadzor orders and other regulations. In particular, Art. 5 FZ of the Law on the circulation of medicinal products fixes extensive powers to regulate CT for executive bodies not only in the form of development and approval of regulatory documents, but also in the form of control and supervision over their implementation. ^[307] The Government of the Russian Federation established the requirements and procedure for accrediting medical organizations authorized to conduct CT, the procedure for compulsory life and health insurance for patients participating in CT. The issues of direct implementation of the CT, the

requirements for documenting the process and presentation of the research results are detailed in the Standard.^[308]

The fact that the above-mentioned legal norms, which provide for the social protection of individuals in CT, are "territorially" located in different branches of law, affects their regulatory function, without allowing the potential of such norms to be used in building effective legal protection mechanisms for individuals in CT. It seems that the analysis of the identified legal norms through the prism of social law will make it possible to determine the most effective legal mechanisms that implement the goals of social protection of individuals in CT. It is not by chance that Yu.V. Vasilieva, considering the problems of codification in the structure of the RF legislation on social security (which is known to be a narrower concept in comparison with the notion of "social protection of the population"), identifies three groups of normative legal acts: purely sectoral acts directly and directly regulating the relations that arise In connection with the social security of citizens; interdisciplinary (complex) acts aimed at the social protection of the population; acts of other branches of legislation, including certain important norms of social security law.^[309]

In connection with the above important aspect to consider the legal mechanisms of social protection in CT is that the distinctive feature of legal relations arising in the sphere of CT is the close intertwining of the public interests of the state and society and the private legal interests of CT participants. In this context, it is worth to share the opinion of N.D. Egorov^[310] that the norms of public law are formulated in such a way that they actually protect public interests (the interests of the state as a whole) and thereby ensure the protection of the interests of individuals, both participating and not participating in public relations governed by these norms of law. The norms of private law are primarily aimed at protecting the interests of individuals participating in the social relations regulated by these norms, and thereby ensure the protection of the interests of the whole society as a whole, interested in the normal functioning of these social relations. With regard to CT, such public interest is to ensure the efficacy and safety of medicinal products, the consumer of which is an unlimited number of citizens. On the other hand, the provision of social protection for a research physician whose professional activity is associated with an increased danger created by the action of an unexplored drug on the human body, and, most importantly, the social protection of the patient as an experimental subject in the conduct of CT are the private legal interests of the participants o the research. Thus, these interests are intertwined, and require effective inter-sectoral legal regulation that takes into account both public and private interests of the subjects.

In this regard, in order to build a truly functioning legal mechanism for conducting CT and social protection of individuals in CT, it is necessary to turn to the category of legal means, since taken in unity they provide a productive impact on public relations.^[311] The need for such an approach is obviously conditioned by the diversified nature of the regulation of CT, which does not allow us to speak about the prevailing method of legal regulation of this group of social relations, but raises the question of a reasonable combination of appropriate methods and methods of regulation. It is legal means in their diversity that do not belong exclusively to individual branches of law, constitute the general legal category, and, combined in a certain way, are the main working elements of the legal regulation mechanism.^[312] Such an approach seems to be extremely important in the framework of this work, which makes it possible to determine whether the mechanisms of legal regulation of public relations arising in the course of a study are effective, whether they allow sufficient social protection of individuals in CT.

Legal norms and principles of law, law enforcement acts, contracts, juridical facts, subjective rights, legal obligations, bans, benefits, incentive measures, penalties, acts of the exercise of rights and duties, etc. serve as legal means. The application of this or that set (arsenal) of legal means leads to legal consequences, concrete results of one degree or another of effectiveness or inadequacy of legal regulation.^[313]

K.K. Lebedev draws attention to the fact that in relation to public and private law, any structural subdivisions of the legal system act as their derivatives, based on the basic objective basic provisions of either public or private law. At the same time, certain groupings of legal norms can be so closely related to each other on the subject of regulation, which form a single set of legal norms ... All that has been said fully applies to medical law.^[314] A similar point of view with respect to social law is expressed by M.V. Filippova, saying that "... private interest is protected by public means through public binding of the state and its public agents to perform certain actions stipulated by law, and not by the contract, while the interest in the sphere in question differs from classical private interest, because here private interests are not as isolated interests of independent individuals, but as a result of the simultaneous merging of individual interests into a common interest." ^[315]

It should be pointed out that the proposed construction can be considered applicable to the socially oriented CT process. At the same time, the peculiarity of the legal regulation of this process is that the legal mechanisms containing the public legal component are used to a greater extent. This is due to the public nature of the relationship associated with the social orientation of the process of creating a new medicinal product, as well as the need to protect the subjects of the experiment from the risks associated with CT, although their interests are of a private legal nature. And this means that the ways of legal protection of the interests of the participants in the CT should correspond to the high degree of social significance that CTs correspond to, ensuring and protecting the personal and social rights of citizens. Thus, given the public interests of the state, societies, and the private interests of the research participants (including the Sponsor and the Medical Entity), which are interwoven with the CT, it is necessary to develop such a combination of legal means (legal instruments) that would effectively protect the rights of the physician-scientist, patient and all citizens - potential consumers of medicines.

Taking into account the above arguments, the term "legal mechanism of social protection of individuals in CT" in this dissertation is understood as a complex interdsciplinary association of legal means used in unity that provide effective regulation aimed at the social protection of individuals in CT.

It is important to note here that the study of directly ethical and professional (clinical) regulation as applied to the social protection of individuals in CT is beyond the scope of this work. However, due to close contact, and in some cases, competition of legal, ethical and clinical norms that mediate CT activities, it seems advisable to analyze the legal mechanism of social protection in CT in conjunction with the study of the role of other social regulators, which will allow to determine Indeed, the most effective regulation of social relations in the designated sphere.

Guided by the research tasks being solved in the present work, it seems appropriate to consider the legal mechanisms for the social protection of individuals in CT, classifying them in certain ways.

First, it is necessary to differentiate the aforementioned legal mechanisms in accordance with their functional orientation. The most important and relevant (in relation to the CT process) are legal measures that, on the one hand, prevent the onset of adverse circumstances (due to the riskiness of the CT process for the trial participants), and on the other hand, to effectively minimize their consequences (in the event of risks, due to the characteristics of the Ct). In this connection, it is possible to discuss such legal mechanisms of social protection of persons in CT as preventive and compensatory. This classification is based on the way to influence the social risk - the leading ones or the subsequent ones.

Secondly, taking into account the above approaches to conducting CT, based on both public and private law, using a legal combination in which private interest is protected by public funds and public interest is protected by private means, it will be right to analyze protective mechanisms taking into account these features. It seems that in order to achieve effective social protection of the investigating physician, the patient, and also the unlimited range of potential drug users, a special mechanism of legal regulation is required, containing optimal combination and intertwining of the norms of private and public law.

Third, the procedural (procedural) means that are constituent parts of the legal mechanism are of great importance for determining the effectiveness of social protection of individuals in CI, since it is impossible to implement effective legal regulation without legal procedures. In the legal literature, the idea of jurisdictional and non-jurisdictional methods of protecting the violated right is consistently pursued. Thus, M.V. Lushnikova and A.M. Lushnikov point out that in the jurisdictional form of the protection of the law, it is a question of the activities of statutory bodies for the protection of rights provided for by law, in non-jurisdictional form citizens or associations of citizens carry out independent actions without seeking assistance from the competent authorities. ^[316] Accordingly, when investigating the operation of the legal mechanism, it is necessary to subject the implementation of social protection of livelihoods to CT by means of both jurisdictional legal means and non-jurisdictional ones. However, it should be recognized that the legislation on CT is currently constructed in such a way that jurisdictional legal means largely prevail over nonjurisdictional ones. However, the application of jurisdictional methods is carried out most often when there is already a need to restore the violated right (and not in case of preventing the onset of social risk).

Summarizing the above, it should be emphasized that the analysis of the current legal mechanisms of social protection of individuals in CT has not only theoretical but also applied value for assessing the effectiveness of measures taken in this direction. In other words, it is important to determine whether the goal of real social protection is achieved for both direct participants of CT and for an unlimited number of potential consumers of medicines. Such an analysis, in turn, will make it possible to formulate specific proposals on changing the legislation on CT aimed at social stability and security of CT participants, observing the balance of their interests, possible minimization of risks from experimental activities and achieving reliable research results.