A WORD TO THE READERS
KUTAFIN UNIVERSITY CHRONICLE
EXPERT OPINION
Examples of modern research conducted within the framework of the concept of human improvement with the use of artificial intelligence technologies, genomics, nanotechnology and robotics to improve the functional characteristics of the human body are considered. It is shown that the creation of bioengineering systems «man-machine» can be considered as a supertechnology of the XXI century, which is capable of influencing the entire course of human history, the biosphere, and the process of its development and application may turn out to be a new area of confrontation, the beginning of a «supernova» arms race. In connection with the above, prospective and applied research in this area should be considered in the context of the national security strategy. Along with the work on modeling, creation and application of individual bioengineering systems «man-machine», it is necessary to intensify the development of legal, bioethical and other norms and rules that ensure both technological development (In a given corridor of possibilities) and a high level of safety (by type) of new technologies and developments.
VECTOR OF LEGAL SCIENCE. Topical issues of medical law
State strategic and regulatory documents in healthcare use the terms “medicines availability” and “accessibility of medical devices”. However, there are neither any definitions of these term, nor there are specific details in those documents. Currently, the issue is especially relevant when legal mechanisms of compulsory licensing and the use of patents without the consent of patent holders for national security benefits need to be straightened.
The article discusses the need for deeper understanding of the terms in the Russian legal system. Based on comprehensive analyses, the basic criteria, characterizing the availability of medical goods are highlighted along with the expediency of taking into account these criteria with possible limitations of patent holders’ exclusive rights in respect of medicines and medical devices
Thus, taking into account the specification of physical and economic accessibility criteria, as well as other identified parameters proposed for discussion of the terms “medicines availability” and “accessibility of medical devices” by the expert community.
Based on a comprehensive analysis of theoretical research, regulatory regulation, as well as the established judicial practice in the field of artificial termination of pregnancy, recommendations are made to improve legislation in order to eliminate existing contradictions. In particular, it is proposed to take into account the opinion of the spouse when deciding on an artificial abortion. In order to minimize individual security threats associated with the widespread practice of abortion, it is proposed to take decisions involving the application of legal, socio-economic measures, as well as preventive measures. Attention is paid to the issue of the legal status of the embryo. It is proposed to consolidate at the legislative level the right to life before birth, and to exclude contradictions in determining the moment of its occurrence from a legal point of view, to consider the moment of official confirmation of pregnancy by medical diagnostic methods as the beginning of life.
In recent years, the nationally oriented economic and social policy of the state has been actively implemented. Attempts are being made to implement certain provisions of the country’s spatial development policy, as well as demographic policy. However, the successes of the conditionally “social” block of the implemented policy are very modest, in connection with which new concepts, strategies and other documents are being discussed, during the adoption and implementation of which noticeable shifts in the field of policies implemented by the state should be visible. The author believes that real changes in the field of demography will become possible only with the implementation of a system of economic and social measures in conjunction with the implemented policy of economic and spatial development. Solving demographic problems in Russia at this stage (segment) of historical development is difficult without solving the main economic and infrastructural problems faced by young families.
As a set of legal norms and social institutions, biopolitics did not always imply the dominance of ethical principles as its own basic element. Based on the comparative analysis of the history of the formation of legal approaches to the content of biopolitics in the period of its emergence, the author comes to the conclusion about the transformation of the concept of biopolitics in the XXI century, associated with the inclusion of a basic ethical component in it. Regulation of relations based on a combination of formal legal imperatives and dispositions with ethical institutions generates not only standards of behavior of their participants, conforming to the autonomy of the will with the presumptions of reasonableness and good faith, but also formulates requirements for representatives of the legislative branch aimed at the inadmissibility of the adoption of legislative acts with a non-legal nature, since any future attempts to comply with them are illegal in themselves.
The purpose of this article is to study biopharmaceutical innovation ecosystems through the prism of the results of intellectual activity and objects of civil and business turnover. In doing so, this work aims to answer the following research question: which stakeholders are needed for innovation systems in the biopharmaceutical industry and what is their main role in creating intellectual property. The research strategy was developed in accordance with the grounded theory methodology. The author makes an attempt to prove that biopharmaceutical innovation ecosystems consist of a multi-level set of key stakeholders. In addition, taking a holistic view of biopharma innovation ecosystems, the study traces the dynamics of biopharma innovation ecosystems through a driving force analysis. This article presents an attempt to deeply analyze biopharmaceutical innovation ecosystems from a holistic perspective, including regulatory issues. The conclusions made in the article can be considered an important addition to biopharmaceutical innovations around the world.
VECTOR OF LEGAL SCIENCE. Modern problems of public health protection
The article analyzes the right of citizens to an effective assessment of the quality of medical care and the prospects for the use of standards for the provision of medical care, it is noted that they can serve as a tool for determining the quality of medical care. In this article, the purpose of the study is to determine effective methods for identifying the level of medical care in modern conditions, and the tasks are: to determine the criteria for assessing the quality of such care and identifying their official approval, as well as what are the methodological recommendations for the provision of medical care in the Russian Federation and whether it is possible to retreat in the interests of the patient. The article uses generally accepted methods, such as: analysis, synthesis, generalization, as well as private scientific research methods: comparative legal, dogmatic legal method of interpreting the law.
The problem of determining the legal nature of the standards for the provision of medical care, their impact on the assessment of the quality and impeccability of their content, how in the future the availability of standards for the provision of medical care will affect the assessment of the behavior of medical personnel in court, and what to use in the absence of a standard for a specific disease are described.
It is concluded that the standards are an effective tool in assessing the quality of medical care and allow the realization of the rights of a citizen to protect his health, but they are not a guarantee of the success of the treatment and diagnostic process in a particular patient, which requires changes in the legislation to ensure the flexibility of their application, taking into account constitutional law citizens for health care.
The article analyzes the issues of risk distribution of failure to achieve results in the provision of medical services and concludes that the distribution of risks falls on the customer of such a service. The beneficial effect of the medical service is absorbed by the patient in its process. Despite the wording of the legislation on the protection of citizens’ health, quality assessment issues are solved not through the prism of determining the degree of achievement of any result, but through the ratio of performed actions (medical manipulations) in comparison with the prescriptions of the standard of medical care. The authors believe that the medical service itself never has a materialized result, the intangible result is also not guaranteed by the service provider, but only the proper fulfillment of the terms of the contract by him. It is revealed that the medical service does not have a materialized result, and the objects that are used in the process of medical manipulations arise from contractual relations and are used as things in the process of providing a medical service. It is concluded that such things become part of human tissues and organs as a result of their implantation and lose the properties of things, becoming an integral component of his body. The medical organization guarantees the proper performance of the service, which ensures a balance of interests of the participants in legal relations for the provision of medical services, in which each party is obliged to fulfill the terms of the contract properly.
The article is devoted to the study of such a phenomenon as medical denialism and legal mechanisms to overcome it. The mass nature of the movements of antivaxers, HIV and covid denialism indicates the relevance of this problem in our country, and therefore it is important to investigate the reasons underlying medical denial. No less relevant is the question of the effectiveness of legal influence on these processes: can legal imperatives properly influence people’s behavior in relation to their health? Or should the state involve other social regulators to counter the destructive manifestations of medical denialism? The search for answers to these questions involves the use of not only legal tools, but also the involvement of an arsenal of other sciences — medicine, psychology, philosophy.
The concept of human rights is a dynamic legal phenomenon. The main feature of all three generations of rights is that they are a powerful constitutional and moral-legal foundation for the development of the last fourth generation of rights. Traditionally, the fourth generation of rights includes somatic, reproductive and informational rights. The article substantiates the innovative idea of identifying an independent category of rights — biogenetic rights. The author for the first time in the scientific literature uses the term “biogenetic rights”, offers the definition and content of a new category of rights. The main conclusion of the study is that the generation of biogenetic rights should be aimed at protecting the human genome, genetic information, ensuring the biosecurity of a person, society, state and mankind.
The article proposes an analysis of modern digital tools in the field of public health. The expediency of improving the experimental legal regime in the field of digital innovations is substantiated. The main reasons for the technological breakthrough in the field of digital innovations in medicine are investigated. An assessment is given of possible options for further technological development of the healthcare sector in the direction of “artificial intelligence”. At the same time, specific mechanisms for the legal regulation of technological solutions introduced into practice are proposed. A special place is given to strategic planning documents that determine and justify, from the point of view of law, the course towards the digital transformation of the healthcare sector. Particular attention is paid to the issue of transition to a new proactive model of medical care using artificial intelligence systems. At the same time, the lack of legal regulation of issues of legal liability in the case of the use of artificial intelligence systems and robotics is taken into account.
VECTOR OF LEGAL SCIENCE. Foreign experience
The article summarizes the views of legal scientists and medical scientists engaged in research in the field of public health. From the standpoint of the theory of medical law, legislative acts are analyzed that have led to significant achievements of the healthcare system of the Federal Republic of Brazil, which is a member of the BRICS and whose experience (legal and organizational) is of interest to specialists in the field of healthcare organization of other member countries of the international organization. The Brazilian health care system is not only in a stable legal field, but also in the first places in the ranking of world health systems. In this regard, experts study the experience of Brazil as a country with vivid geographical, social and economic contrasts, especially in the field of public health. The State pays primary attention to the legal issues of the organization of medical care and places healthcare in the priorities of national policy. A Unified healthcare system has been created and is functioning within the framework of the State healthcare system. Medical services provided in accordance with this system are free of charge and cover all citizens of the country regardless of socioeconomic status and territorial location of residence.
The article discusses the features of the healthcare system in India. Medical care is based on a number of regulatory legal acts that have defined the federal structure of the healthcare system and the rules of financing. National laws define the principles of healthcare organization in order to provide timely quality medical care to the entire population of the State. The peculiarities of Indian healthcare is the fact that society is divided on many grounds, that is, into religion, castes, races, skin color and political parties. These features lead to health inequalities. The Constitution of India establishes that human rights relating to life, freedom, equality and dignity of the individual are guaranteed by the Constitution itself, International Covenants and are subject to enforcement by the courts of India. These provisions triggered the creation of new executive bodies in the field of health: the National Human Rights Commission, as well as Human Rights Commissions in all states and courts. According to international experts, India’s medical innovation activity is rated as one of the most progressive forms (creativity and efficiency) in global healthcare. Such a result is not accidental, since India’s role in global health is based on an adequate domestic national medical policy.
REVIEWS
SCIENTIFIC RESEARCH
The article is devoted to the analysis of the provisions of Draft Law no. 275599-8 of the new federal law on employment. The focus of the research is on the effectiveness and procedural provisions of the activities of Russian employment services, some foreign models of effective activities of state employment services.
Using the author’s approach to solving employment problems, which remains relevant, justified in his doctoral dissertation in 2006, the author assesses the conceptual approach of draft law no. 275599-8 as excessively conservative, requiring adjustments in terms of strengthening state integrated regulation, wider use of new non-traditional approaches in regulation, in particular — the inclusion in the draft law of the main procedural provisions of the modernized standards of the activity of the employment service bodies, which are already used in the practice of a number of employment centers. The fundamental contradictions of the analyzed draft law are revealed, and based on the results of the analysis, ways to improve employment legislation are proposed.
TRIBUNE FOR YOUNG SCIENTIST
This article analyzes the historical development of medical experiments and biomedical research, as well as their subsequent regulatory consolidation. Medical experiments originate from the I century BC, gradually transforming into biomedical research, taking into account the progressive development of science and the emergence of new and emerging technologies. The article presents various stages of legal regulation of research both in the Russian Federation and abroad. Much attention is paid to the legal regulation of genomic research as a modern type of biomedical research. The author comes to the conclusion that the legal regulation of medical experiments and biomedical research has a long history, however, at the present stage, legislation mainly regulates certain areas, and there is also no general regulatory approach to the achievements of modern biomedical technologies.
In this article, the author considers the institution of examination in the criminal process of Russia, compares it with a medical examination and a forensic medical examination. The author, based on law enforcement experience, court decisions and the results of a survey of employees of the investigating authorities, analyzed the practice of using the institution of examination. In addition, the author considered the evidentiary value of the results of the examination and drew attention to the problem of non-application of this investigative action in law enforcement practice.
OFFICE EVENTS DIGEST
BOOKSHELF OF THE DEPARTMENT
LAW IN HISTORICAL REFRACTION. Legal Monuments
LAW IN HISTORICAL REFRACTION. Scientific Legacy
POST SCRIPTUM
ISSN 2782-6163 (Online)