Preventive public law mechanisms of social protection of a physician-scientist

Carrying out the analysis of the preventive legal mechanisms of the social protection of a physician-scientist, it is first of all reasonable to proceed from the statement formulated above that the CT is highly risky for both the patient and the physician-scientist due to the unexplained properties of the experimental drug and its effect on the human organism.

At the same time, it should be pointed out that, in addition to the legal regulation of the CT considered earlier, for the purposes of each type of a study there special local documents that provide clear framework for all medical and organizational activities in this CT. In accordance with section 3 of Art. 40 of the

Law on the circulation of medical products, the physician-scientist, before the beginning of the CT, should get assess the results of the preclinical study of the medical product contained in the investigator's brochure, the draft protocol for the clinical trial of the medical drug for medical use prepared by the developer of the medical drug.^[391] Accordingly, during the CT, the physician-scientist should be guided by these documents, which provide for protective mechanisms of mostly preventive character, which is also a measure of the social protection of both the subject of the experiment and the investigator himself.

Also, as specified in clause 4.1.3 of the Standard, the physician-scientist must know and comply with GSP and regulatory requirements. It should be noted that the Standard, which is a special normative act containing detailed rules for conducting the CT, is absolutely identical to the Guidelines for Good Clinical Practice of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.^[392] This points to the fact that the requirements for conducting the CT for investigating physicians in the Russian Federation are in line with internationally accepted rules (GSP), which is an international ethical and scientific standard for planning and conducting research involving a person as a subject, as well as a documentary formalization and presentation of such studies.^[393]

Therefore, it would be right to confirm that the legislation on the CT, especially the Standard, do contain the regulatory requirements for scientific planning, clinical and ethical aspects of the CT, which form the necessary legal regime and serve as a legal instrument creating a preventive protective mechanism in the interests of both the physician-scientist and the patient. Such a mechanism can be reliably attributed to the public law sphere, and its application is determined by the high social importance of the CT as a stage of the supply of medicines to the population of the country, as well as by the need to provide effective protection of such values as life and health of the subjects of an experiment.

In addition to this, the Russian legal system also provides another preventive mechanism for the social protection of a physician-scientist. The legal framework discussed in the previous paragraph, based on the existence of labour relations between the physician conducting the CT and a Medical Entity, is aimed, inter alia, at social protection of that very physician. It is well-known that labour law is an of dual character, which includes both public-law and private-law elements.

In this context, it is necessary to once again emphasize that the law contains a special requirement that Medical Entities conducting CT must undergo state accreditation and the list of these entities as well as the register of issued permits should be published by the Ministry of Health on their official website on the Internet. The procedure for accreditation is established by RF Government Resolution No. 683 dated 03 September 2010 "On Approval of the Rules for the Accreditation of Medical Entities for the Right to Conduct Clinical Trials of Medical Products for Medical Use,"^[394] which details the requirements for Medical Entities. The purpose of accreditation is pointed out in paragraph 3 of this resolution as confirmation of the competence of the Medical Entity to conduct the CT, and for that it (the organization) is obliged to provide the Ministry of Health of the Russian Federation with a license for medical practice, local acts regulating the CT process, and in some cases, a license for activities related to circulation of narcotic drugs, as well as documents confirming the existence of an intensive care unit.^[395]

Given these legislative provisions, we can conclude that the procedure for accreditation of Medical Entities is, on one hand, a certain method of providing legal influence on socially significant activities that allows to increase the level of trust of the state and society towards the process and the results of the CT, and on the other hand, is a preventive protective mechanism for the employee of such an entity (physician-scientist), since it imposes on the Medical Entity the obligation to provide necessary labour conditions and create facilities necessary for carrying out clinical trials on high organizational and professional level, aimed at preventing the risks specific to such studies.

In the context of the stated problem, it is worthwhile paying attention to the problem existing in the practice of legal implementation, related to the lack of a unified approach to the contractual formalization of the CT process in Medical Entities, caused by the inconsistencies and gaps in legislative regulation. This problem has a significant impact on the social protection of individuals in the CT.

The thing is that the Research Sponsor concludes a contract with the Medical Entity for the CT, which is implemented by a physician-scientist working under an employment contract. And this is the immutable requirement of the law. What is controversial in theority and in practice, is the question is whether it is possible for the Research Sponsor to make an additional direct agreement with the physician-scientist. Representatives of civil law science say that despite the existence of firm rules for concluding a CT contract in the Law on circulation of medicines that form the so-called "single-level contract model of CI", the practice has developed another "two-tiered" approach to structuring legal relations as to the study, reflected in a separate contract concluded between a physician-scientist (in addition to the specified agreement with the Medical Entity), which is the basis for payment of an additional reward to the researcher for conducting the CT.^[396] Arguments in favor of the existence of a "two-level" model, according to the authors of the concept, is an indication of a legislative absence of a direct ban on the conclusion of an additional agreemnt, invoking the fundamental principle of civil law called the freedom of contract. Thus, the legitimacy of the existence of a direct contract between the research sponsor and the physician-scientist is justified in parallel with the CT, concluded between the research sponsor and the Medical Entity.

However, this point of view seems controversial based on the following reasons.

First, the Sponsor's ability to conclude a some kind of a contract raises with a physician-scientist raises a number of questions as to its legal nature, the grounds for concluding, the subject-matters, rights and obligations of the contractor, that is, the physician-scientist, taking into account his labour law status. After all, in this case, the doctrinal provisions of several branches of law do intersect: labour law, civil law, administrative law, social security law.

So, first of all, it is necessary to point out that in the "two-level contractual model of the CT", there are two C T contracts in parallel, while the principal under these contracts is one and the same, i.e. the research sponsor, while the contractor, in the case expressly provided by law, is the Medical Entity in which the physician-scientist works, in another case the physician-scientist is the direct contractor under the contract. In other words, in both cases the question concerns the contracts for provision of paid services, the subject-matter of which is the trial of a medical product in accordance with the CT protocol, and both of which are regulated by Art. 779-783 of the Civil Code of the Russian Federation. ^[397] However, it is necessary to pay attention to the fact that in the event of the conclusion of a CT contract with a Medical Entity, the requirements of the RF legislation are fully observed, since only a Medical Entity that has a license for medical activity and appropriate accreditation is authorized to conclude such a contract. This can not be said of a physician-scientist who, not being a private practitioner, does not have his own license for medical activities, and also does not have the CT accreditation. Moreover, such accreditation for individuals, as well as the conclusion of the CT contracts with an individual is not provided for by the legislation of the Russian Federation.

Consequently, the rules of law in their interpretation indicate the lack of a legitimate opportunity for a physician-scientist to conclude a separate civil law contract for carrying out the CT, since he, being an individual, is not endowed with a legal status necessary to be a party thereof.

Thus, it is necessary to state that the only legal and possible activity for conducting the CT by a physician-scientist octor can only be his work within the framework of his duties as an employee of the Medical Entity. Article 60.2 of the LC RF stipulates that the additional work assigned to the employee as to another profession (position) may be carried out by combining the professions (positions), and additional work assigned to the employee for the same profession(s) can be carried out by expanding the service areas and increasing the scope of work.^[400] In this case, this work can be entrusted to the employee based only on his written consent. The CT work is a work assigned to the physician-scientist as an additional work, along with his main job duties, and therefore these relations are regulated by the norms of labour law.

This legal analysis allows to come to an unambiguous conclusion that the application of the "two-level contractual model of the CT" as to of the Sponsor's direct contract with the physician-scientist falls under the definition of an "void transaction", which in accordance with Article 168 of the Civil Code of the Russian Federation covers a transaction that violates the requirements of a law or other legal act, and at the same time infringing upon public interests or rights and the interests of third parties protected by law. Article 169 of the Civil Code establishes that when a transaction is void, it does not entail legal consequences, except for those related to its invalidity.^[401]

Secondly, while recognizing as legitimate the "two-level contractual model for conducting the CT", representatives of civil law theory did not take into account the fact that the conclusion of a direct civil-law CT contract by a physician-scientist with an employment law status would entail an inevitable violation of labour legislation of the Russian Federation.

Thus, the working time of a physician-scientist, as an employee of a Medical Entity, is regulated by art. 91 of the Labour Code of the RF "The concept of working time. Normal working hours ", according to which the working time is the time during which the employee, in accordance with the rules of the internal labour regulations and the terms of the employment contract, must perform labour duties, as well as other periods of time which, in accordance with this code and other federal laws and regulations of the Russian Federation refer to the working time. At the same time, being in the organizational subordination of the employer and by performing duties in his interest, the physician-scientist can not engage in the CT as an independent contractor. Otherwise, they would violate the discipline of labour and the rules of the internal labour regulations of the Medical Entity, which constitutes a disciplinary offense that is the basis for applying disciplinary punishment against a doctor, in accordance with Art. 191-192 of the LC RF.^[402]

In addition, in the analyzed CT contracts, the Research Sponsor requires the Medical Entity to have the necessary material and technical facilities, usually including facilities for inspections; medical equipment for the implementation of procedures defined by the Protocol; means of hospitalization, in case of the patient in the CT requires hospitalization; means for the collection of biological samples (laboratory and diagnostic complex), etc. These material resources used in CT are owned by the Medical Entity and constitute the workplace (working equipment) for the physician-scientist that he uses to perform his duties. It seems that by performing his direct civil law contract and using at the same time the material resources of the employer, as well as utilities in the workplace in his personal compensated interest, the physician-scientist causes material damage to the employer that in accordance with the rules provided for in section XI of the LC RF

"Material liability of the parties to the employment contract" will be the basis for bringing him to liability.

These arguments once again convincingly prove that, in fact, the physician- scientist, having labour law status in the CT, fulfills his labour duties based on the order of the Employer, the Medical Entity, using all the necessary material resources provided to him, and the conclusion of a separate civil law contract as to the CT is devoid of any legal meaning. The sole purpose of concluding such an agreement is for the physician-scientist to receive additional remuneration directly from the Research Sponsor. Thus, we can talk not only about the insignificance of the transaction by virtue of the law, but also that such a transaction is void as a sham transaction, by virtue of Art. 170 of the Civil Code, that is a transaction made only for the sake of appearance, without the intention to create the corresponding legal consequences, since the obligations under the transaction are carried out in the framework of a different legal relationship.^[403]

In addition to the above arguments as the illegality of the "two-level CT contractual model" and, based on the objectives of this dissertation, it is necessary to confirm that when it is applied (precisely because of the violations of legislation within the organization of the CT, as well as labour legislation allowed by a physician-scientist) the implementation of social protection measures against him becomes impossible. The preventive public law mechanisms for social protection of the physician-scientist that were investigated earlier simply will not fulfill their function, since the legal construction of the CT, in which these mechanisms are embedded, is "broken".

And, finally, we point out that S.S. Stefanishin and A.V. Glebashev^[404] have chosen, as a target orientation of their research, finding the possible ways of obtaining additional remuneration directly from the research sponsor by the physician-scientist. In favor of the legitimacy of such "direct payment", they refer to the insufficient legislative regulation of this sphere. Indeed, the legal regulation of the CT process, despite the ongoing improvement of the relevant legislation, still has certain gaps and is contradictory in some cases. At the same time, it is necessary to take into account that in carrying out the CT the most important task requiring precise legislative regulation is not to create an opportunity for a physician-scientist to receive additional payment from the research sponsor, but to conduct the research based on the rules that allow obtaining reliable data in order to protect an undetermined number of persons, who are potential consumers of medicines, as well as ensuring the welfare of the subject of the experiment. During the CT, the systems of values that influence the legal conscience of the participants in the study should be formed on the basis of the principles of the social benefit of this process for society, in this connection, a possible conflict of interests with socially significant interests arising when the physician-scientist receives additional payment from the research sponsor should be completely ruled out. At the same time, one should ask the question: why do research sponsors so persistently want to pay remuneration for the CT to the researching physicians directly and in addition to the remuneration paid by the employer. As a rule, in the contracts with the Medical Entity, the CT contains the following wording in this regard: "At least XX% of the cost of the works under this Agreement payable by the Customer to the Contractor's account, the Contractor shall transfer to a physician-scientist and co-investigators, including the salary accruals. The amount of remuneration of each member of the research team payable by the Contractor from the salary fund is established basedo on actual distribution of duties and the contribution of each person to the clinical study "...^[405]

This remuneration should be paid in accordance with the provisions of Art. 151 of the LC RF, which establishes that the amount of surcharge for the performance of additional work is determined by agreement between the parties to the employment contract.^[406] Since additional work is done within the working hours, along with the main work, no new employment contract is required. The agreement on the scope and amount of additional work, the amount of the surcharge and its substance is usually formalized by and between the employee and the employer in an additional agreement to the employment contract.

The studied practical materials show that it is quite often that the CTs are conducted in accordance with the requirements of the law. Thus, as an example of a conscientious and responsible attitude of the CT participants, i.e. the research sponsor, the physician-scientist and the Medical Entity, the following terms of the contract can be cited: "The Organization (the Medical Entity) undertakes to conduct the study in accordance with the CT Protocol. For the purposes of fulfilling this obligation, the Organization appoints the Researcher (physician- scientist). In all cases where the reference to the obligations placed on the Researcher is made in the text of this agreement, such reference shall specify the obligations of the Organization. The organization guarantees that the Researcher and all persons involved in the study, including, in particular the personnel of pharmacy, labouratory, pathology, cardiology, and nursing staff, have the knowledge and experience to conduct the CT, and will conduct the research professionally and competently, with full accuracy, efficiency and expediency. Obligations under this agreement that are assigned to the Researcher and that should be performed by the Researcher are considered as obligations performed by the Researcher in favor of the Organization of which he is an employee. In this regard, any breach by the Researcher of the obligations under this agreement is considered to be a violation of the obligations of the Organization. The Organization, however, undertakes to ensure that the Researcher that it has hired is properly performing its duties within the study."^[407].

At the same time, one has to acknowledge the fact that in practice the Organizer usually includes other provisions in the CT Agreement: "Hereby the Institution (Medical Entity) confirms that the Sponsor (the research sponsor) makes a separate agreement and makes direct payments to the Researcher (physician-scientist) for the services rendered in connection with the research. The institution declares and guarantees that the Researcher may conclude an agreement with the Sponsor directly and receive direct payments for the services provided by the Researcher, without violating the conditions of the Researcher's employment agreement or his arrangements with the Institution or the rules of the Institution."²⁰⁵.

In addition to purely legal negative approaches to the existence of a direct contract with a physician-scientist, one can also turn to the moral side of the problem leading to negative social consequences. After all, in a situation in which the resercher receives additional compensation from the research sponsor who is interested in the fastest registration of a new drug and releasing it to the market for further profit, the doctor also becomes interested in obtaining positive results from the CT. At the same time, there is a reason to talk about a conflict of interests that can obviously lead not only to violation of patients' rights, but also to reflect on the results of the study of the safety and effectiveness of the drug itself, which in turn will lead to violation of the rights of an undefined range of persons.

In support of this position, we can refer to a number of articles in the mass media on the issues under analysis, which quite clearly illustrate the "degree of heat" that has developed around this situation. Thus, based on the materials of the audit of the Financial Control Committee of the Government of St. Petersburg compiled in the report "On the results of checking the legality, efficiency and targeted use of the budget of St. Petersburg", the journalists stated: "Never before in Russia has the true background of financing the clinical drug research been revealed - and meanwhile, the economic benefits that a narrow circle of people have received and are still receiving so far are estimated at hundreds of millions of rubles. For the research on one subject (that is, one patient), a doctor receives from 60 to 700 thousand rubles, and these fees by the way are transferred directly to the bank accounts of doctors. In some St. Petersburg hospitals, besides the main contract between a hospital with a sponsoring company, there is another contract, which is between the doctor and the sponsor. All this is against the law! Both the contract between a doctor and a pharmaceutical company, and the fees that the sponsor pays directly to the doctor bypassing the hospital's bookkeeping are illegal. As the inspectors found out, only 10 percent of the total amount spent on the study actually went to the budget, the remaining 90 percent of the fee were distributed among the doctors." ^[408] In this publication, the authors concluded that the field of clinical drug research is very delicate as itself - both from the point of view of the law and from the ethical standpoint. The physician-scientist, who is actually sitting on the salary of the sponsoring pharmaceutical company, whose commercial interest is obvious, is unlikely to be guided in its activities only by the interests of patients and to think about the safety of the drug. ^[409]

Such a high degree of public concern as to these examples of "nontransparent" CT conduct is shared by some representatives of legal science. In particular, analyzing the conditions for the legality of conducting biomedical research with the involvement of human patients from the standpoint of criminal law, Yu.A. Chernyshova points out that the selfish or other personal interest of a medical worker, acting not for the benefit of the patient, but for the sake of achieving his own goals, is the basis for the recognition of such an act as a crime.^[410] Further, the author suggested a legislative initiative to to criminalize the conflict of interests of a medical worker in the field of biomedical research, including the CT.

There are examples where the legal systems of many states established legal mechanisms aimed at eliminating conflicts of interest and observing financial "transparency" of the CT, in order to maintain the reliability of research results, and to minimize the risks to life and health of the subjects of the experiment.

In the field of this study, an example will be the novelties of legal regulation of the CT sphere undertaken in Ukraine, since it is closely related to Russia having a similar legal system. In Ukraine until 2012, the "two-level contractual model of the CI" was also actively applied. At the same time, the investigation of the Office of the Procurator-General of Ukraine revaled the facts of serious financial and economic irregularities related the CT in research institutes and medical institutions whereby a second contract was concluded directly between the CT sponsor and the physician-scientist. Due to this, the payments made by the CT sponsors to medical institutions under the contract did not cover the costs of the CTs, which caused material damage to state budget institutions. Based on these circumstances, the General Prosecutor's Office of Ukraine considered bringing the heads of medical budgetary institutions to criminal liability for inflicting damage to the budget of Ukraine. However, law enforcement agencies of Ukraine came to the conclusion that in this case the actions of the heads of medical institutions do not constitute a crime in view of the absence of unlawfulness, since unlawful behavior can only be expressed in violation of certain legal norms, while the proper legal and regulatory framework in the field of the CT was missing.

The establishment of this fact was one of the reasons for adopting a new version of the Procedure for Conducting Clinical Trials of Medical Products and Examining the Materials of Clinical Trials approved by Order No. 523 of the Minister of Health of Ukraine dated 12 July 2012 "On Amending the Order of the Ministry of Health of Ukraine dated September 23, 2009 No. 690."^[411] In particular, section 9.1 in chapter "Conducting a clinical trial" was supplemented with the following requirements for the conclusion of CT contracts: "Sponsor concludes an agreement with the medical entity for conducting a clinical trial of medical products in accordance with the requirements of applicable law. Payment for additional work performed by researchers, which is not related to the performance of their duties in the medical entity or research institution, or higher medical education institution of III-IV level of accreditation, is carried out by the sponsor on the basis of a separate contract concluded with the responsible researcher (if necessary, with the co-investigators) in accordance with the requirements of applicable law. This agreement should provide for a clear delineation of the functions of the medical entity and the responsible researcher, which they must perform during their off-hours and are associated, as a rule, with the performance of intellectual activity (analysis, instruction, consultancy, drafting of clinical trial reports, etc.). If, in the course of such works (services provided by the responsible researcher), he uses the material and technical base of the medical entity, the corresponding expenses of the medical entity should be reimbursed by the sponsor, in accordance with the contract concluded with him, which, in particular, must contain a separate provision on such an obligation to be borne by the sponsor or by the responsible researcher under a separate contract concluded between him and the medical entity."^[412]

In addition, in order to strengthen legal responsibility of the persons conducting the CT, the Criminal Code of Ukraine was amended on 05 May 2012 by adding article 3212 called "Violation of the established procedure for preclinical study, clinical trials and state registration of medicines".^[413]

While giving legal assessment to the mentioned legislative changes in the sphere of th CT in Ukraine, it is necessary to emphasize that these legal novels can be assessed positively in connection with the fact that they are aimed at eliminating serious legal contradictions that led to violations of both administrative and labour legislation. However, in addition to a positive assessment of the changes under consideration, it will be right to note the ambiguity of the legal meaning invested in them, as well as the ambiguity of their goal setting.

So, the prohibition of direct payment to a physician-scientist for the CT is intended, among other things, to minimize the dependence of the physician- scientist on the CT Sponsor, and, as a consequence, to prevent conflict of interests of the participants. At the same time, a direct indication of the possibility of concluding another agreement raises the risk of concluding sham transactions that are intended to serve as a legal tool for obtaining additional fees by a physician- scientist, with dubious aiming. Accordingly, under such circumstances, the study will not be absolutely "transparent", and therefore it is not possible to guarantee the reliability of the results of such CT, as well as effective social protection to the subject of the experiment. After all, in a situation where, in addition to formal remuneration for the CT, the researcher receives additional compensation, the amount of which is not declared and is not limited to any legal regulations, the likelihood of improper fulfillment by the latter of his obligations under the contract increases due to the existing financial interest.

Another approach of legislation in the sphere of the CT is found in the United States, which is the founder of regulatory controls over drug research. Therefore, the regulation of the CT, which exists today in the national legal system of the United States, deserves attention as the most developed historically and conditioned by the need to provide legal form to dynamically developing social relations.

First of all, it is necessary to take into account that, due to the organization of the health care system, which is different as compared with those in the Russian Federation and Ukraine, mediated by certain rules, the CT process in the United States is significantly different as regards its participants. So, an important organizational and legal peculiarity of the healthcare system in the United States is that medical care for the population is usually provided by private practitioners who receive payment for the provided medical services directly from the patient or through an insurance organization. In this regard, doctors themselves must have the necessary permission to carry out medical activities (license) and obtain mandatory insurance of their professional responsibility.^[414]

Thus, the legal status of a doctor as an independent subject of medical activity qualified to provide medical assistance to patients not as an employee of a Medical Entity, but independently as part of his private practice determines the presence of direct legal relations as to the CT arising between the research sponsor and the physician-scientist. At the same time, the US national legislation contains legal mechanisms aimed at eliminating the conflict of interests of CT participants. Thus, a separate chapter in the Code of Federal Regulations^[415] regulates the process of disclosing financial information by clinical researchers, with the aim of eliminating a conflict of interest that could affect the reliability of information received during the CT regarding the safety and efficacy of the drug, while determining that:^[416] "One of the potential sources of inaccurate data on clinical trials is the financial interest of the clinical researcher, his interest in the results of the research as well as methods of payment. The FDA will use the disclosure of financial arrangements between the Sponsor and the clinical researcher in conjunction with information on design and objectives of the study, and also with information coming from validation assessments conducted on-site."^[417]

Also, section 54.2 of this chapter contains descriptions of those "financial mechanisms" that the FDA considers to be infringements: "any financial arrangements concluded between the Sponsor and the clinical researcher participating in the research that may influence the results of the study, such as: equity participation in the Sponsor's share capital, interest in the product (patents, trademarks, licenses and other copyright), royalty interest, any significant payments, fees and compensations, including grants and equipment. At the same time, disclosure of financial information should be updated all the time, both during the research and within one year after its completion. The information shall be submitted in an application form FDA 3454, confirming the absence of financial interests and arrangements. Such a statement is submitted as to the clinical researcher himself, as well as to the spouse and each dependent child. "^[418].

Further, in the process of processing the financial information indicated, the FDA conducts an assessment of the financial interests of the clinical researcher to determine whether its financial interests have any effect on the reliability of the CT results, and also to exclude (or confirm) the bias of the clinical researcher due to his financial interests. In the event that the FDA determines that the integrity of the financial interests of the clinical researcher raises serious questions, the FDA may take any measures it deems necessary to ensure the reliability of the data.^[419]

Thus, the regulatory controls over the CT in the US, while admitting that there may be direct contractual relations, including direct payments, between the research sponsor and the physician-scientist, is built upon the transparency of their financial relationships. We should pay special attention to the fact that the financial transparency of contractual relations in the process of conducting CT does not aim at controlling the payments for the work of the physician-scientist as an independent subject (for example, for tax purposes), but is designed to exclude a conflict of interests in conducting CT. Thus, the reliability of their results and the safety of the drug as the ultimate goal. Fixing at the legislative level the mechanism of financial transparency of the CT as an instrument for achieving the social purpose of CT, which is the basis for their conduct, is worthy of attention.

Taking into account the foregoing, it is necessary to critically evaluate Article 74 of the Federal Law on the circulation of medicines, because the definition of this provision prohibiting medical workers from accepting money from pharmaceutical companies contains a reservation, "except for remuneration under contracts for clinical trials of medical products ". Thus, the legal consturction chosen by the legislator is ambiguous in its interpretation and thus misleading for the CT participants, and, moreover, serves as a ground for abuse, such as the application of a "two-tier contractual model for conducting CT".

It can be assumed that the legal meaning implied in the rule in question is to enable medical workers to lawfully conclude any civil agreements having various subject-matters, such as: scientific advice; preparation of a scientific papers related to CT; special education, etc.

It seems that the wording of Article 74 of the Law on the circulation of medicines^[420] It seems that the wording of is a clear example of "substandard" legal regulation that does not have a proper legal effect on the behavior of legal actors. In such a situation, it is necessary to support the opinion expressed by lawyers that the law is intended to reflect social interests in a concentrated conceptual form, to act as the main regulator of public relations, as a guarantor of human rights and freedoms, to take the leading place in the legal system, as its legal force determines the dynamics and the contents of all other legal instruments.^[421] However, in the case under consideration, we can observe a hardly positive effect of the jurisdictional impact by the legal provisions of the federal law, quite the contrary, it is a negative one, generating ambiguity of interpretation, and, as a consequence, leading to abuses in the socially significant sphere to be done by medical workers, persons of an increased degree of social responsibility.

Thus, in order to resolve the legal uncertainty in this matter, the legislator should remove the specified reservation from the definition of the norm. Such improvement of the legislation will allow to exclude the conflict of interests in CT, by ensuring transparency of the remuneration of the physician-scientist, which will increase the efficiency of his social protection, as well as the social protection of

the patient, to ensure the reliability of the research, in order to protect an undefined circle of persons, potential consumers of medicines.

Summarizing the analysis of the legal preventive mechanisms of social protection of the physician-scientist and relying on the arguments presented in this parapraph, it will be correct to formulate the following conclusions regarding the covered issues:

First, at present the legislation contains legal mechanisms capable of carrying out preventive social protection of a physician-scientist who is exposed to professional risks during the CT. These protection mechanisms have both supranational and national legal nature, are mediated by the rules of the administrative and labour legislation and function in a public law regime.

Secondly, due to the defects in the legislation expressed in the gaps and contradictory norms, the legal regulations at issue can be perceived as ambiguous by those who apply them, including a physician-scientist, which leads to a violation of the CT procedures, and also contributes to the formation of a conflict of interests, expressed in the financial interest of a physician-scientist, that may influence his performance in CT. The existence of "financial opacity" in the CT entails additional risks for the subjects of the experiment, and raises doubts as to reliability of the results of the study. Under such circumstances, the legal construction, combining the interrelated mechanisms of social protection of a physician-scientist, a patient and an indefinite circle of potential consumers of medicines, does not fulfill its functional purpose, which leads to devaluation of the very principle of social protection of individuals in CT.

3.3.