General approaches to the analysis of legal mechanisms of social protection of patients

Identified in the first chapter hereof, the social significance of the CT process as a stage of supply of the medicines to the population, as well as the specifics of the social protection of individuals in conducting such studies, allow us to identify and uncover the features inherent in the legal mechanism for the social protection of individuals in CT as to the patients subject of an experiment.

As a rule, the legal literature is concentrated upon the legal rights of patients in CTs. Yu.D. Sergeev and M.I. Litovkina in their study on the realization of the patients' constitutional right to health care during CTs, indicate that subjects of experiments do exercise this very right to a large extent. ^[317] They have the legal and physical ability to dispose of their body at their own discretion and receive reliable and timely information about the factors that affect their health. In addition, they are provided with legislative guarantees to minimize risks in the conduct of CT by improving the legal framework of CT, conducting ethical review of documents related to CT,

compulsory life and health insurance, expanding the list of categories of patients who can not participate in CT.

In this connection, it is necessary to emphasize that the legislation contains legal norms that must protect patients proactively, and also serve as a guarantee to minimize the consequences of the risks of deterioration of health or death in the event of such risks.

Therefore, while considering the legal mechanisms of social protection for patients in CT, it is also necessary to evaluate their (mechanisms') efficiency from the point of view of the opportunity to protect an undefined range of potential consumers of medicines. The existence of an inseparable and logically conditioned relationship between the social protection of experimental subjects and potential drug users is due to the CT's most targeted focus as the process of testing a new drug for safety and efficacy before its release to the pharmaceutical market. It is no accident that Article 17 of the Convention for the Protection of Rights and Dignity of the Human Being with Regard to the Application of the Achievements of Biology and Medicine (the Convention on Human Rights in Biomedicine)^[318] provides that the aim of the study is ultimately to promote (by deepening and improving scientific knowledge of the state of human health and of a disease or disorder) in obtaining medicines that may have beneficial effects both for the health of the subject and for others who suffer from the same illness or disorder or who are in a similar condition.

Thus, taking into account the above-mentioned social tasks that should

be addressed during the CT, it is necessary to emphasize that their solution (through legal mechanisms) must be based on the principles of constancy and continuity at all stages of CT (preliminary, main and final) in order to prevent the social risk associated with the deterioration of health (death) of the subject, considering that similar risks may arise in the future for the potential consumers of this drug.

So, already at the preliminary stage of the CT, it is necessary to define what are the effective ones amongst both preventive and compensatory defense mechanisms, and afterwards (at subsequent stages of the study) to use them for effective protection of patients. ^[319] The same goal is pursued by the international legislation in the field of CT, emphasizing the need to prevent risks for patients by strictly observing the rules of conducting an experiment involving a human person as a subject. The generality of the main and final stages of CT, built on the principles of constancy and continuity, can be traced in the relationship of legal measures designed for the patient with the protection of an unlimited range of persons who are potential consumers of medicines.

Following the methodology defined in the first chapter of this paper, it is appropriate to highlight the preventive mechanism of the patient's social protection in CT, which, strictly speaking, is the embodiment of the most important ethical and legal principles of conducting biomedical research, such as voluntary participation of the subject in the experiment, balancing the damage and the benefit for the subject, inadmissibility of unreasonable risk in the presence of a real threat to the life and health of the patient.

However, in the conduct of CT due to the specifics of this process, related to the lack of study of the drug's effect on the human organism, the risk of negative health effects and possibly the death of the patient can be assumed. In this regard, in the event of such adverse consequences, the mechanisms aimed at minimizing the consequences of such risks should be used. Compulsory application of compensation measures in such cases is one of the main provisions of the international legal norms on CT, implemented in the Russian legislation.^[320] Therefore, it is necessary to identify and analyze the compensatory legal mechanism of social protection of patients in CT.

In addition, following the logic defined in the first chapter of this study, within the framework of general approaches to the mechanisms of social protection of persons with respect to patients, there is a need to consider jurisdictional and non-jurisdictional mechanisms that are the most important legal instruments aimed at implementing protective measures. Jurisdictional mechanism is related to the activities of state bodies authorized to protect the subjective rights violated or put to danger. It is based on the application of a person who believes that his rights have been violated by unlawful actions addressed to state bodies authorized to take the necessary measures to restore the violated right. It was decided to allocate a general (judicial) and special (administrative) order (mechanism) for the protection of violated rights. In cases stipulated by law, a mixed administrative and judicial mechanism is applied, under which a citizen must file a complaint with the relevant state authorities before bringing an action in court. Non-jurisdictional defense mechanism is usually called self-defense of rights, and presupposes the actions

of citizens to protect rights and interests, undertaken by them independently, without recourse to authorized state structures.

What are the specific features of the relevant legal mechanisms with regard to the social protection of the patient in CT? If we are talking about a jurisdictional administrative mechanism, it should be noted that the scope of the CT is subject to the state control and supervision activities carried out by Roszdravnadzor in accordance with its powers set forth in Resolution of the Government of the Russian Federation No.

In accordance with these Regulations, Roszdravnadzor is a federal executive body that exercises control and supervision functions in the public health sector under the jurisdiction of the Ministry of Health of the Russian Federation. Roszdravnadzor (section 5.11 of the Regulations), organizes the reception of citizens, ensures timely and full consideration of citizens' applications, takes decisions on them and sends the replies to the applicants within the period established by the legislation of the Russian Federation. Thus, the patient who is the subject of the CT, for the purpose of his own social protection, has the right to apply to this state body. At the same time, with reference to the activity of Roszdravnadzor in the process of CT, it is necessary to discuss the existence of a jurisdictional administrative mechanism of the patient's social protection in a broader sense too. This body, implementing control and supervision functions in the sphere of medicinal products circulation, shall carry out: independent checks (and not only in cases when there are citizens' applications); pharmaceutical supervision; application of measures to suppress violations of mandatory requirements identified in the sphere of drug circulation and (or) to eliminate the consequences of such violations; bringing to legal liability for these violations, etc.

Therefore, Roszdravnadzor is the executive authority of the Russian Federation, which controls the conduct of the CT for compliance with the requirements of Russian and international legislation by conducting inspections. Thus, it is necessary to discuss the social protection of patients in CT by applying a jurisdictional administrative mechanism aimed at preventing violations during CT, that is, for preventive purposes.

The second jurisdictional mechanism for the social protection of patients in CT is the judicial system.

Regarding the non-jurisdictional mechanism of social protection of patients in CT (self-defense), we must note the fact that patients have practically no effective methods and means that could effectively perform a protective function for them. As to the relationship between the main participants in CT, such as the researcher and the patient who is the subject of the experiment, it is easy to see that they are not only absolutely unequal sides of the process, but even more, the subject is completely dependent on the researcher, since the latter has special medical knowledge and experience so that he could adequately assess the patient's state of health and take appropriate measures on his own if it worsens during the experiment. In other words, the patient, being a weak and dependent party in the process of CT and being subject to the possible and even presumed onset of the risk of deterioration of health and even death, needs effective social protection that must be provided by the state, regardless of whether the patient takes active or passive position. At the same time, the minimal opportunities for the patient in the framework of self-defense still remain. Perhaps, as an example, we can refer to the statutory right of the patient to refuse to participate in the CT and not to sign the

informed consent, as well as the right to leave the research at any time.¹ .

It is worthwhile to share the conclusion made by E.I. Petrova applied to the sphere of social and security relations, in which, in her opinion, selfprotection by citizens of their rights does not have special significance, or is absent altogether. As a rule, traditional tools for protecting the rights and legitimate interests of citizens are in effect, which is implemented through authorized state structures, and which is essentially an act of response by the competent authority aimed at restoration of the violated rights.^{[322] [323] Therefore, in view of the fact that the patient, in order to protect his rights (for the foregoing reasons), has to resort to the assistance of authorized state bodies, the legislator needs to build legal regulation in such a way that jurisdictional mechanisms fulfill their protective function in the most efficient manner.}

Based on the above classification of the mechanisms of social protection of patients in CT, including preventive and compensatory legal mechanisms, as well as jurisdictional administrative and jurisdictional judicial mechanisms, and, based on the approach chosen in the present work, aimed at determining a reasonable combination of public law and private law regulation, it is important to investigate the legal tools used for that. Accordingly, it is necessary to determine whether those legal tools used in various mechanisms of social protection of the patient in CT are correctly selected and therefore effective.

So, the relations that mediate the process of the patient's participation in CT are regulated to a greater extent by imperative norms. This is due to the very public nature of drug treatment activities, of which CT is a part, as well as the need to protect in the process of CT the personal non-property rights of citizens that are also social rights. Accordingly, the legal apparatus should also be selected based on public methods of regulating relations that perform a protective function and that have in their arsenal such means as binding, prohibiting, as well as liability measures. In this regard, the laws and regulations contain clear rules, compliance with which is mandatory in the conduct of the CT and is controlled by a special body that performs an administrative supervisory function, i.e. Roszdravnadzor. In other words, by introducing imperative regulation to ensure compliance with regulatory requirements for CT, the state ensures the social protection of patients who are subjects of the experiment in the research while protecting the entire population from unsafe medicines entering the pharmaceutical market.

At the same time, when considering the issues of the patient's social protection in CT, one should not forget that each subject has his own private law interest, which makes him decide to participate in the study. Such a purely personal interest for the patient, who became the subject of the experiment, is the opportunity of improving the state of health with the studied medication. Accordingly, it is necessary to recognize that in the sphere of CT there are private law relations that develop between the patient and other participants of CT. So, for example, within the framework of these relations, the Research Sponsor makes payments to patients as a compensation for travel expenses to the research site and in other cases provided for by documents on a specific CT.

More important examples of private law relations arising in the process of CT are, firstly, the fact that participation in CT for a patient is essentially the provision of medical care with th used of a tested drug, and therefore is equipped with legal mechanisms established by law, guaranteeing the order and quality of its delivery. The second example of private law relations arising in the process of CT is mandatory health and life insurance of the patient (hereinafter referred to as mandatory insurance) carried out by the research sponsor, which follows from clause 1 of Article 935 of the Civil Code of the Russian Federation, according to which the persons indicated in the law may be entrusted with the obligation to insure the life, health or property of others defined in the law of persons in the event of harm to their life, health or

property. The requirement that the Sponsor of the research must carry out such mandatory insurance is in an imperative form indicated also in Article 44 of the Law on the circulation of medicines. Thus, in this situation, the mechanisms of the patient's social protection in CT use the legal tools inherent in regulating private law relations with the permissible prescriptions and presumption of equality of parties that are characteristic for him.

Summarizing the above, it would be appropriate to assume that an evaluation of the effectiveness of legal protection mechanisms (depending on the public or private procedure used) should be used to conduct a comprehensive and in-depth analysis aimed at identifying the "weak links" of such mechanisms. But it will be correct not only to discover such "failures", but also to offer such a combination of legal means that will be in the best way able to exercise a protective function and ensure observance of the patient's rights in CT.

Following the indicated logic the following paragraphs will proceed to the analysis the social protection of the patient in CT, in accordance with the designated legal mechanisms - preventive and compensatory, jurisdictional administrative and jurisdictional judicial - at the same time the legal instrument used to implement them - publicly or privately. At the same time, it is important to pay attention to the fact that the investigated law-enforcement practice predetermined in a certain way the interrelated consideration of these social protection mechanisms. Thus, an approach is considered appropriate in which the preventive mechanisms of the patient's social protection in the CT are evaluated jointly with the jurisdictional administrative mechanism, which is due to their interrelated application. This gives grounds to define such mechanisms as preventive public legal mechanisms of social protection of patients in CT. Another justified approach is the analysis of compensatory legal mechanisms through the definition of the effectiveness of the components of their private legal components, determined by the legislator, as well as the

construction of public law components of such mechanisms, which in fact are additional social security guarantees for patients during CT.

2.2.