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Characteristics of the mechanism of legal regulation in relation to the field of medical activity
Studying the stages of legal regulation in the traditional theoretical and legal sense, one should turn to the works of V.V. Lazareva and S.V. Lipenia, which distinguish the following stages of the legal regulation mechanism:
- the stage of regulation of public relations, the formation and general operation of law;
- the stage at which the addressees of the legal norms of subjective rights and obligations;
- the stage of realization of subjective rights and obligations in the lawful behavior of legal entities * (77).
In turn, the most appropriate approach to prof. S.G. Stetsenko, who, analyzing the stages of the mechanism of legal regulation in the field of medical activity, highlights:
- publication of a legal norm in the legislation on health protection and its regulatory impact on public relations in the field of medical activity;
- the emergence of rights and obligations of subjects of medical legal relations;
- the realization of rights and obligations due to the actual, real behavior of subjects of medical legal relations;
- application of law * (78).
The first stage of the mechanism of legal regulation in the field of medical activity is the publication of a legal norm. In Russia, since the beginning of the 90s of the last century, there has been a fairly high legislative activity in the field of legislative regulation in the field of protecting public health. During this period, more than twenty fundamental federal laws regulating public relations in the field of medical activity were adopted.
At the same time, one cannot but note the numerous objects of legal regulation, which are still not adequately regulated by the rules of law. We are talking about such problematic objects as:
- development of mechanisms for the implementation of the rights of patients and ways to protect the legitimate interests of citizens receiving medical care;
- the legal status of medical workers in the context of the development of market relations in domestic health care;
- a detailed legal analysis of cases of inadequate medical care and adverse outcomes of medical interventions;
- iatrogenic diseases and their legal assessment and much more.
It should be emphasized the importance of the very first stage of legal regulation: the publication of a legal norm. Before the advent of a specific legal norm, subjects of medical legal relations independently choose behavioral options depending on circumstances of an objective and subjective nature, which does not add controllability to the entire healthcare system. While a legal norm either prescribes (prohibits) a certain behavior, or recognizes as legitimate one of several pre-existing behaviors, thereby providing state support for this particular, well-defined behavior of citizens.
The emergence of rights and obligations of subjects of medical-legal relations is, in essence, a transition from abstract formulations of legal norms to specific recommendations, due to which public relations are streamlined by endowing each of the parties with clearly defined rights and obligations. For any person, a simple listing of rights in the field of health care will not be tangible until he or she contacts a medical institution for an illness or necessary examination. It is at this moment that he gains the legal status of the patient. His rights begin to be updated, including due to the corresponding obligations of entities providing medical care and ensuring the implementation of this process.
The third stage of the mechanism of legal regulation in the field of health care - the realization of rights and obligations due to the actual, real behavior of subjects of medical and legal relations is the most important from the standpoint of the correlation of categories such as "alleged" and "real". Considering all possible options for the implementation of the rights and obligations of any of the subjects of medical legal relations (in particular, patients): compliance, enforcement and use; then we can assume various options for the implementation of legal norms. But, in any case, the main thing is to streamline social relations, since it is at this stage that legal regulation actually reaches its goal.
When receiving medical care in a hospital, and without violating the internal rules, the patient complies with certain legal standards.
Following the instructions of the doctor and the recommendations of medical personnel regarding the implementation of diagnostic, medical, rehabilitation medical interventions approved by the standards of medical care, the patient complies with certain legal standards.
Providing free informed consent based on adequate awareness of one of the proposed options for medical intervention, the patient uses certain legal norms that guarantee him this opportunity.
Considering the methods of legal regulation, as an important characteristic of the mechanism of legal regulation, it should be noted the variety of manifestations of the methods of legal regulation in the field of medical activity. The traditionally known theories of law methods: imperative and dispositive, also called methods of subordination and coordination, or centralization and decentralization, have their own practice of application in the field of medical activity. One of the key features of this application is the relatively proportionate use of these two methods.
History convincingly indicates that the system of government is reflected in the regulation of almost all spheres of public relations. The sphere of medical activity of the Soviet historical period was not an exception to the general rule. Public relations in health care were regulated primarily through the imperative method of legal regulation, when the objects of management (and to them, without a doubt, include medical institutions and patients, as well as patients) had no other option than a predetermined * (79). In this case, it is necessary to take into account the administrative-command style of management inherent at that time, both in the entire health care system and in the field of medical activity, in particular.
In the healthcare sector of modern Russia, there are manifestations of both an imperative and a dispositive method of legal regulation of public relations.
Firstly, the public administration of the healthcare system, even in the presence of private medicine facilities, has been preserved and is aimed at the practical implementation of one of the social functions of the state.
Secondly, private law principles, which stipulate the use of the dispositive method of legal regulation, are increasingly penetrating the sphere of medical activity.
State support for the development of a private health system; expanding opportunities for paid medical care; practical implementation of patients' rights to choose a doctor, medical institution and medical insurance organization; wide employment opportunities for medical workers; - all these and many other facts indicate an ever wider use in the regulation of medical and legal relations of dispositive methods of legal regulation in domestic health care, in general, and in the field of medical activity, in particular.
The realities of the present time indicate the necessity and validity of the allocation of medical law as an independent complex branch of law. The subject of legal regulation of this industry is the numerous social relations that arise in the process of providing medical care to citizens. The methods of legal regulation of medical and legal relations are traditionally known in law methods: imperative and dispositive.
Considering one of the mandatory signs of independence of any branch of law - the existence of a method of legal regulation, it is necessary to note the following important circumstances.
1. The widespread use of only two traditional methods of legal regulation (imperative and dispositive) in various branches of law does not exclude the existence of a significantly larger number of branches of law that are recognized as independent.
2. Active introduction into the scientific revolution of the concept of "integrated branch of law", which is related to branches of law that have their own subject of legal regulation.
3. The regulation of public relations, which are the subject of the study of complex branches of law, is carried out at the expense of the norms of other branches of law, using traditional methods of legal regulation.
Methods of legal regulation, as characteristics of the mechanism of legal regulation in the field of healthcare, are based on traditional theoretical and legal options: obligation, prohibition and authorization. However, in the field of medical activity, the listed methods of regulation are characterized by certain features of manifestations.
The examples that will be given later, in combination with the objective laws of the development of domestic legal regulation in the field of medical activity, provide an opportunity to formulate definitions for each of the methods of legal regulation.
Obligation, as a way of legal regulation in the field of medical activity, can be illustrated by the obligation of medical workers to provide medical care regardless of the time, place, or situation in which the need arose for this assistance. Legislative consolidation of this method of legal regulation was obtained both in the regulatory framework governing the protection of public health and in criminal law. Article 124 of the Criminal Code of the Russian Federation defines as a crime “Failure to provide assistance to a patient without good reason by a person who is obliged to provide it in accordance with the law or with a special rule, if this entails, through negligence, moderate damage to the patient’s health ..., death of the patient or serious harm to his health ...) "* (80).
In addition, the Ministry of Health and Social Development of the Russian Federation is obliged to register with the Ministry of Justice of the Russian Federation those regulatory documents that govern the rights and obligations of subjects of medical and legal relations or are of an interdepartmental nature. The meaning of this obligation is to prevent the issuance of by-laws and regulations that contradict the existing regulatory framework or violate (worsen) the legal status of patients, medical workers, etc.
Thus, under the obligation, as a way of legal regulation in the field of medical activity, it should be understood that the subjects of medical-legal relations have responsibilities for certain active actions.
The ban is an important regulator of public relations in the field of medical activity, since it, as one of the methods of legal regulation, prevents the commission of unlawful actions prohibited by the norms of the law that could harm individual citizens or society as a whole.
Taking into account the personal and universal value that represents human health and life, one can assess the importance of prohibitions as regulators of the behavior of subjects of medical and legal relations. There are not many areas of public relations where a violation of accepted rules of conduct (standards, medical care protocols, instructions) would be comparable in importance to the negative consequences that may occur in the field of medical activity when it comes to health, and sometimes the lives of one or more people.
For example, as an effective way of legal regulation of conducting clinical trials of drugs, one should take the ban on the performance of certain actions by medical personnel and other persons participating in these studies. In particular, in accordance with the Federal Law of the Russian Federation of June 22, 1998 N 86-ФЗ "On Medicines", it is forbidden to pay the labor of specialists of a healthcare institution conducting clinical trials of a medicinal product, directly by the organization - the developer of the medicinal product, other legal and physical persons financing the clinical trials of the medicinal product * (81).
The provisions of the same law, according to which the conduct of clinical trials of drugs in the following categories of citizens are prohibited, are very important:
- on minors who do not have parents;
- on pregnant women, unless clinical trials of drugs intended for pregnant women are carried out, when the necessary information can be obtained only during clinical trials of drugs on pregnant women and when the risk of harm to the pregnant woman and the fetus is completely excluded;
- on military personnel;
- on persons serving sentences in places of deprivation of liberty, as well as on persons detained in pre-trial detention facilities * (82).
Due to the high profitability of the pharmaceutical industry, there are often cases of illegal clinical trials associated with violation of legislative regulation by representatives of the pharmaceutical business. The introduction of such prohibitions is quite justified and expedient, because thanks to these prohibitions, the state protects the rights and legitimate interests of socially vulnerable groups of the population who are unable for any reason to independently ensure the exercise of their rights and freedoms.
Thus, under the ban, as a way of legal regulation in the field of medical activity, it should be understood that the assignment of obligations to the subject of medical and legal relations to abstain from performing certain active actions.
Attention should be paid to the essential feature of prohibitions in the field of medical activity. The bans have a dual purpose: on the one hand, they prohibit certain actions that are contrary to the norms of law, on the other hand, they indicate to the subjects of medical and legal relations that their other actions are legitimate and are under legal protection.
Permission can be considered as the most progressive way of legal regulation in the field of medical activity, since it is a legal opportunity, the use of which completely depends on the will and desire of the subjects of medical and legal relations.
Considering a medical worker as a subject of medical-legal relations, it should be pointed out that he has the right to go to work in a state or municipal medical and preventive institution, as well as the right to engage in private medical practice.
The patient, from the standpoint of considering him as a subject of medical and legal relations, if necessary, seek medical help, has the right to choose a medical institution at the place of residence (in accordance with the policy of compulsory medical insurance) or contact a private medical institution. It is appropriate to recall that in Soviet times, patients were deprived of this right. Currently, the norms of the modern legal framework of health care allow him, in accordance with his wishes, to commit such actions or to refrain from committing them.
Thus, permission, as a way of legal regulation in the field of medical activity, is the granting to subjects of medical-legal relations of the right to commit any active actions or to abstain from such.
Summarizing the discussions on the methods of legal regulation in the field of medical activity, it should be noted that only a reasonable combination of them can lead to the formation of such legislation on health care that will meet all the requirements of state expediency in respect of rights, freedoms and protection of legitimate interests, as individual citizens, and society as a whole.
And finally, when analyzing the last of the planned characteristics of the mechanism of legal regulation in the field of medical activity - types of legal regulation, the following should be noted.
Общедозволительный тип правового регулирования, характеризующийся принципом "разрешено все, что прямо не запрещено законом", в большей степени применим к правовому статусу субъектов медико-правовых отношений, получающих медицинскую помощь (пациентам). Действительно, нормативно-правовая база содержит сравнительно небольшое количество норм, запрещающих пациентам совершать каких-либо действия при оказании им медицинской помощи. Это объясняется, прежде всего, исходным отношением законодателя к пациенту: пациент нуждается в медицинской помощи, находится в более уязвимом (зависимом) положении, в определенной степени вынужденно вступает в правовые отношения с остальными субъектами медико-правовых отношений.
Разрешительный тип правового регулирования, характеризующийся принципом "запрещено все, что прямо не разрешено законом", более свойствен субъектам медико-правовых отношений, которые оказывают или обеспечивают оказание медицинской помощи (медицинские работники, страховые медицинские организации и пр.).
Например, в соответствии с действующим законодательством РФ, право на занятие частной медицинской практикой имеют лица, получившие диплом о высшем или среднем медицинском образовании, сертификат специалиста и лицензию на избранный вид деятельности. Разрешение на занятие частной медицинской практикой выдается местной администрацией по согласованию с профессиональными медицинскими ассоциациями и действует на подведомственной ей территории*(83).
Иными словами, в сфере оказания частных медицинских услуг государством определен разрешительный тип: их могут оказывать лишь те лица, которые отвечают определенным в законе критериям - обладают диплом, сертификатом, лицензией, разрешением и т.п.
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