A WORD TO THE READERS
KUTAFIN UNIVERSITY CHRONICLE
EXPERT OPINION
In recent years, the issues of early defibrillation have received increased attention from both the professional medical community and health care organizers, politicians and legislators. In many countries, special programs have been developed and implemented that can reduce the mortality of people who have suffered a sudden cardiac arrest. The complex of measures taken can significantly reduce the mortality of citizens from acute pathology. The development and implementation of affordable defibrillation in Russia, along with medical, social and organizational issues, also requires a full-fledged study of the legal aspects of this program.
One of the main problems that need to be solved is the admission of nonmedical workers and other persons with special training (police officers, rescuers, etc.) to the intervention at the scene of the incident. The implementation of the affordable defibrillation program will require a number of amendments and additions to the federal legislation on the protection of public health, as well as related legislation.
VECTOR OF LEGAL SCIENCE Legal Background for Genetic Research
The accelerated development of genetic technologies in the Russian Federation and their consistent use in health care, agriculture and industry for full implementation require the availability of effective organizational tools that allow not only to develop new genomic technologies but also their practical application. The article explores the legal aspects of the functioning of medical and pharmaceutical clusters; analyzes the possibilities of using a cluster approach to the organization of genomic research; it is stated that the advantage of the cluster is the concentration in a small territory of interconnected scientific organizations, educational institutions and innovative industries.
One of the trends of modern state policy is the development of biological and genetic, aimed at solving socio-economic problems and problems caused by global challenges and threats associated with the consequences of the coronavirus pandemic, climate change, reduced biodiversity, and other negative manifestations. In these conditions, there is a need to revise the conceptual approaches to the legal regulation of relations in the field of the use of biological and genetic technologies, taking into account natural and social relationships. The article shows the need to apply to these relations the ecosystem approach, the concept of sustainable development, the interdisciplinary approach “Unified Health”, four “bio”, an integral part of which is to ensure safety (environmental, biological, genetic, sanitary-epidemiological, biosphere). The issues of improving the Russian legislation in the field of application of biological and genetic technologies on an intersectoral basis in connection with the environmental, sanitary and epidemiological, natural resource, agricultural and other industries are considered.
The directions of harmonization of the domestic regulatory framework with international norms and treaties, including the assessment of the risks of possible harmful effects of the use of biological and genetic technologies on human health and the environment, are proposed. In Russian legislation, it is necessary to legalize the concepts of “risk assessment”, “risk factors”, as well as to determine the procedure for assessing the potentially and really harmful effects of GMOs and other results of the use of genetic and biotechnologies on human health and the environment.
One of the most urgent areas of Russian health care is the organization of medical care in the new socio-economic conditions, aimed at providing affordable high-quality and safe medical care to the population, therefore, a new approach to the formation of control over both the quality of medical care and its safety is of particular interest. At all stages of the treatment and diagnostic process, serious mistakes can be made that can have a negative impact on the life and health of patients.
The article discusses the methodological aspects of assessing the quality of medical care at all stages of the treatment and diagnostic process. Requirements for the formation of an expert opinion, which is prepared based on the results of the examination of the quality of medical care, have been formulated. In order to effectively manage the quality of medical care, the author proposes the creation of a digital “smart” system for monitoring defects in medical care.
Based on the concept adopted by the Russian legislator in the field of bioethics, the articleanalyzes aspects of the formation of moral and ethical regulations as a subject of legal regulation, a historical review of the features of the perception by the individual and society of ethical norms as criteria for self-restraint of the possibility of choosing options for lawful or unlawful behavioris given. The transformation of law from the age of enlightenment to the era of return to ethical institutions is shown both in the historical periods of the outgoing era and in the examples of negative law-making of contemporaries, in order to leave the norms of ethics outside the national order.
The traditional explanation of the dominance of such an approach to the legal regulation of ethical institutions is reduced to the absence of objects of legal support due to the fact that ethics is not a legal, but a moral one. De facto ethical norms are introduced into the modern legal order of the Russian Federation at the level of law enforcement activities, for example, through the adoption of Codes of Professional Ethics. The expediency of formation in Russia of the National Council on Bioethics and Biosafety is substantiated.
The article analyzes the correlation between the development of genetic science and bioethics issues. In the context of the rapid and steady development of genetic engineering and biomedicine, there is a lag in legal research in this area. Determining the vector of development of legal regulation of gene therapy and gene doping is currently one of the most important issues of modern science, which needs to be resolved from a legal and ethical point of view. In regulatory legal acts in the field of international sports and at the national level, a ban on the use of gene doping has been established, as well as responsibility for its use is provided. However, the measures taken are not enough.
The article considers some existing problematic aspects of the correlation between the development of genetic science and bioethics and suggests ways to solve them. Thus, it is proposed to build a system of principles for preventing and countering the use of the gene doping method and to differentiate the concepts of gene therapy and gene doping in order to comply with the principles of Olympism and preserve the health of future generations.
VECTOR OF LEGAL SCIENCE Medicine intellectual activities regulation
The author analyzes the legal means of protecting the rights to the results of intellectual activity through the TRIPS agreement and its impact on the development of international business in the field of healthcare. Attention is paid to the national patent policies of different legal orders, exploring the theoretical differences in the policies of different countries. It also addresses key domestic implementation policy issues as the new rules move from the international to the national level. Finally, it examines the implications of TRIPS for managing innovation in ICT-based industries, including pharmaceuticals, and where ICT has enabled global value chains, where the speed and distributed nature of innovation makes intellectual outcomes both less efficient and more necessary
VECTOR OF LEGAL SCIENCE Patient health law protection
The development of medicine in Russia is facing problems associated with risks in the activities of medical professionals, primarily with “medical errors” and responsibility for their commission. In addition, the number of conflict situations between doctors and patients has significantly increased. Medical activity is currently insufficiently protected, the confidence of doctors in the correctness and expediency of providing medical care has significantly decreased. There are many cases when doctors, fearing possible criminal prosecution, leave the profession. One of the solutions to these problems is the real consolidation at the legislative level of the right of each individual doctor (as an individual, and not a medical organization) to insure their professional liability. In the article, with the statistics of the investigation of iatrogenic crimes, an attempt is made to analyze the current normative acts regulating the issue under consideration, as well as existing initiatives to improve legislation in this area.
The prospects of the impact of clinical recommendations of medical professional non-profit organizations on the legal regulation of labor of medical workers in the aspect of implementation of the novels of the Federal law dated 25.12.2018 № 489-FZ “On amendments to article 40 of the Federal law ‘On compulsory medical insurance in the Russian Federation’ and Federal law ‘About bases of health protection of citizens in the Russian Federation’ on clinical recommendations.” are analyzed in the article. The purpose of the article is to develop recommendations for solving problems in this area. These problems can be classified into problems that will arise from January 1, 2022 and those that already exist at the present time, but from 2022 will acquire a new meaning due to the actual recognition of clinical recommendations by sources of labour law.
The Ministry of Health of the Russian Federation at the year 2018 has approved a new procedure for plastic surgeons. An administrative claim was filed to the Supreme Court of the Russian Federation, containing arguments about procedural violations during the adoption of a regulatory legal act, as well as challenging some provisions (mandatory requirements), which, in the opinion of the administrative plaintiff, do not contribute to the quality and safety of medical care. The paper presents the modern regulation as well, associated with the enactment of the Federal Law “On mandatory requirements in the Russian Federation”.
CONTEMPORARY ISSUES OF HEALTHCARE LAW
The article discusses some problems of criminalization and lawmaking in the field of countering crimes involving violations of sanitary and epidemiological rules. From the point of view of the legal and technical approach, Part 1 of Article 236 of the Criminal Code of the Russian Federation contains a construction of a complex composition, which can be called «delinquent-material». In such a composition there is both a mass disease (poisoning of people) and the threat of a mass disease (poisoning of people) they are considered not as acts, but as a socially dangerous consequence. In other words, this kind of criminal-legal construction includes, firstly, the violation of the rules itself and, secondly, socially dangerous consequences in the form of mass illness or poisoning of people or creating a real threat of the onset of these consequences. At the same time, violation of sanitary and epidemiological rules without the occurrence of socially dangerous consequences or the threat of such consequences entails administrative responsibility under Articles 6.3 — 6.7 of the Administrative Code of the Russian Federation.
The author notes that an act that creates a real threat to law enforcement facilities provided for in Part 1 of Article 236 of the Criminal Code of the Russian Federation has a lower degree of public danger compared to such actions (inaction) that inadvertently lead to mass illness or poisoning of people. Equalizing the limits of criminal liability for the commission of the two abovementioned torts is a violation of the principle of justice. In this regard, the author of this article proposes in Part 1 of Article 236 of the Criminal Code of the Russian Federation to establish responsibility for violation of sanitary and epidemiological rules if such violation created a threat of mass illness or poisoning of people. In turn, criminal liability for violation of sanitary and epidemiological rules, which inadvertently caused mass illness or poisoning of people, should be established in Part 2 of Article 236 of the Criminal Code of the Russian Federation, which provides for a more severe punishment.
TRIBUNE FOR YOUNG SCIENTIST
The sphere of social and labor rights has undergone a large-scale transformation due to the COVID-19 pandemic and related restrictive measures. Almost all enterprises and organizations during the period of restrictive measures were forced to switch to a remote (remote) mode of operation. Some, and sometimes all, employees of organizations were forced to perform their labor function, stipulated by an employment contract, at home.
At the same time, before the introduction of the above-mentioned forced measures and subsequent amendments to the labor legislation regarding the regulation of the work of “homeworkers”, there were no provisions in the domestic labor legislation that would allow establishing legal regulation of the emergence of this kind of relationship between an employee and an employer.
In December 2020, the Federal Law “On Amendments to the Labor Code of the Russian Federation regarding the regulation of remote (remote) work and temporary transfer of an employee to remote (remote) work on the initiative of the employer in exceptional cases” was adopted.
This article is devoted to a conceptual review of the amendments to the Labor Code of the Russian Federation adopted in 2020, aimed at establishing the regulation of remote (remote) work, as well as the procedure for temporary transfer of an employee to remote (remote) work on the initiative of the employer in strictly exceptional cases.
The article is devoted to the consideration of the issue of civil law regulation of the donation of human reproductive cells in order to substantiate the fundamental possibility of classifying them as separate objects of civil rights by generalizing the practice of foreign and domestic regulation of property and obligation relations arising from the donation and use of human gametes. With the development of new technologies, the commercialization of the field of assisted reproductive technologies, the development of the surrogacy market, the question of the turnover of such objects as human reproductive cells will be quite acute. According to the results of the study, questions are raised for further development in the legal doctrine, as well as the formation of legislation in the field of turnover of human gametes (reproductive) cells.
The article is devoted to the study of problems related to the implementation of social support measures for healthcare workers in the context of the development of the COVID-19 pandemic and its consequences. In order to assess the current system of social support measures for medical workers, the author turns to a retrospective analysis of social support measures contained in the previously existing legislation. From the author’s point of view, today the most effective mechanism is the measures of material incentives taken, carried out in the form of payments.
Attention is drawn to the lack of unified approaches to the implementation of incentive measures in practice, in particular, in the constituent entities of the Federation. The author emphasizes the imperfection of the current system of compulsory medical insurance and the importance of introducing a regime of “special regulation of health protection”. A positive assessment of the financial budgeting system is given, with the help of which it was possible to launch the mechanism of “payments to medical workers during the COVID-19 pandemic” in a timely manner.
DIGEST OF THE FACULTY ACTIVITIES
LAW IN HISTORICAL REFRACTION. Legal Monuments
LAW IN HISTORICAL REFRACTION. Legal heritage
POST SCRIPTUM
ISSN 2782-6163 (Online)