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SECTION 3. MEDICAL LAW

Chapter 8. Structural and legal basis of healthcare
8.1. Concept of Medical Law

According to the RF Constitution, Russia is a social state whose policy is aimed at creating conditions for a worthy life and a free development of man. Health of people is considered as the major prerequisite for comfortable life and capacity to fully realize their interests, ability to labour, build a family and do many other things to feel themselves essential parts of the civil society and state in general. Securing man, his rights and freedoms as the supreme value in Article 2 of the RF Constitution, as well as obligations of the state to re­cognize, observe and protect them, gives confidence in the present and in the future to each member of society. The right to life, the right to healthcare and medical aid, the right to free medical aid provided at government and municipal healthcare institutions, the right to privacy and inviolability of private life secured by the RF Constitution are directly related to the legal status of man and citizen including in the field of healthcare.

Despite the current state of medicine and scientific achievements in diagnosis, treatment and prevention of human diseases that increase life expectancy, human health is affected by various external and internal factors that may result in its deterioration. All these factors together create a series of medical, economic and social problems that require improvement of the procedural and institutional regulation. Thus, at the present development stage of Russia, health of its population becomes the major object of regulation at all levels of state power but mainly at legislative and executive levels. In this context, major tasks are to ensure implementation and protection of rights and freedoms of man in the area of healthcare, to resolve organizational issues in medical activities and to improve healthcare.

Presently, there is an individual legal environment that has been established in the area of healthcare in Russia. Within this environment, various interrela­ted and comprehensive public relations are being formed. During the formation of the medical legislation, three areas of its understanding and defining have emerged within the legal system of Russia.

The first approach is to consider medical law as a sub-branch of the social security law. Supporters of the second approach consider medical law as a complex branch of legislation. And the third approach considers medical law as an independent complex branch of law.

The first approach is no longer supported by the majority of researches in this field, since specific features and diversity of new public relations in healthcare cannot be integrally included in the subject of the social security law. The second approach gives rise to general-theory issues with respect to the subject of regulation. In legal science, the main criterion for distinguishing such concepts as the independence of the branch of law and its complexity is quality of the type of social relations. Complexity is conditioned by the presence of a set of rules relating to various branches of law and regulating different types of social relations which, at the same time, constitute an independent sphere of civil society.

The issue of distinguishing medical law as an independent complex branch of the Russian legal system (the third approach) is still relevant today. Medical law as an independent branch was considered by A.A. Mokhov, who wrote as early as in 2003: “the scale, complex nature and significance of public relations regulated by medical (healthcare) law make it possible to distinguish it as an independent branch of law”. Other authors also consider medical law as an independent complex branch of law.

The main criteria for distinguishing an independent branch of law are the subject and the method of legal regulation. At the present time, the subject of medical law has acquired a clearer outline. And if S.G. Stetsenko et al. (2011) define the subject of medical law as “public relations arising in the process of medical activities”, Yu.D. Sergeyev (2014) considers the subject of medical law as public relations “that arise with respect to the protection of the health of citizens and medical activities, as well as public relations in the process of healthcare functioning and development”.

The method of legal regulation is a set of methods and techniques for legal control of the subject of the law branch. Based on the diversity of healthcare public relations regulated by medical law, we can state that the process of legal regulation uses a complex of methods among which legal administrative and legal civil methods prevail. This does not preclude using other methods of regulation.

The main attributes that characterize medical law as a complex branch of law are:

  • the constitutionally defined right of citizens to health protection and healthcare;
  • availability of individual regulatory acts dedicated exclusively to the regulation of public relations in the field of public healthcare;
  • public relations emerging in the field of medical activity, regulated by both special rules and rules contained in other branches of law (criminal, civil, administrative, etc.); availability of general principles specific to medical law and characterizing its content;
  • a coherent system and clear structure of medical law containing legal sub-branches, institutions and norms;
  • the inability of other branches of law to provide high-quality legal regulation of specific public relations in the field of health protection.

Regarding legal relations developing in the field of healthcare, we can definitely state that they are also characterized by diversity and uniqueness due to specific features of social relations which are the subject of medical law, as well as to lack of legislative and uniform theoretical definition of “medical legal relations” category. Such definitions as “healthcare for citizens” and “medical activities” stipulated in Federal Law No. 323-FZ of 21/11/2011 make it possible to assess the scale and the area of legal relations. For example, based on Article 2, para. 2 “healthcare for citizens (hereinafter — healthcare) is a system of political, economic, legal, social, scientific, medical (including sanitary and disease control) measures performed by Russian government bodies, government bodies of subjects of the Russian Federation, local self-government bo­dies, institutions and their officials and other persons and citizens in order to prevent diseases, maintain and strengthen physical and mental health of each person, long and active life by providing healthcare”. According to Article 2,
para. 10 of Federal Law No. 323-FZ of 21/11/2011, “medical activity
means professional healthcare measures, medical expertise, medical surveys and health examinations, sanitary and disease control (preventive) measures and professional activities related to transplantation of organs and/or tissues, turnover of donated blood and/or its components for medical purposes”. Analyzing these concepts, we can outline only a certain scope of both public relations and the main components of legal relations (the subject, the object, the content) in the field of healthcare. According to A.A. Röhricht, medical legal relations can be attributed to public relations that arise in the course of medical activities, and the wide range of subjects of legal relations consists of individuals and legal entities that “apply special medical knowledge in order to change the patient’s state of health”. According to the author, the scope of medical legal relations includes “public relations pertaining to organization and management, scientific research and other activities ensuring the basic (therapeutic and preventive) relations connected to the provision of healthcare to patients”. Medical legal relations include public relations that arise during therapeutic, sanitary and hygienic or other healthcare and medical activity, and distribute such relations among the following clusters:

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