Orphan medications became a significant share of drug expenditures in every country. The high cost of therapy is caused by the low prevalence of diseases and the need to compensate the investment of producers in long-term development and registration procedures. The article highlights the main stages of the formation of legislation regulating the circulation of orphan medicines in the United States, covering state guarantees for the development of «orphan medicines», and imperfections of the existing system which influence the cost and availability of medicines. On the example of the EU, the author examines the unified approaches of EU countries to determining the orphan status of medicines, which is especially relevant in the context of convergence and harmonization of national legal systems regulating the circulation of medicines.

The purpose of this article is to analyze various approaches to regulating orphan medicinal products in order to determine the most effective practices. The author identifies the main barriers in the provision of medicines to patients with orphan diseases in the Russian Federation, analyzes the main directions of the development of the drug supply system and outlines possible directions for expanding access to necessary treatment methods.

At the present stage of formation and progressive development of the socially-oriented policy of the Russian state and developed civil society, the possibility of using modern genomic technologies, genodiagnostics and gene therapy in medical practice becomes particularly relevant in order to ensure the physical and mental health of the population and protect the rights of citizens in the field of medicine, effective treatment of patients with genetic and other diseases. The practice of implementing such developments is aimed at implementing the rights of a citizen of the Russian Federation in the field of health care, genetic «improvement» of the human body for medical purposes.

The article analyzes some features of legal regulation and the possibility of using modern biomedical technologies, genodiagnostics and gene therapy in medical practice in order to ensure the physical and mental health of the population, effective treatment of severe diseases.

Biology and biotechnology are developing at an active pace. In many ways, the achievements of genetics contributed to this. One of the areas of biology is synthetic biology, i.e. biology, which is based on work with the genome, and not only by «editing» the existing one (deleting and (or) replacing its individual fragment), but by synthesis, by artificially obtaining another genome or its fragment that performs the necessary, predetermined functions. Synthetic biology opens up great opportunities for medicine, veterinary medicine, agriculture and other branches and fields of bioeconomics. At the same time, the latest synthetic biology technologies can lead to serious changes not only in those areas of the economy where they can be successfully used, but also in society and in the environment. The article attempts to comprehend the phenomenon of the «synthetic» genome and new objects and products created with its use.

The article is devoted to biological threats and ensuring biosafety in Russia. Special attention is given to the relevance of this work. The article contains such sections as introduction, biological threats, ensuring biological safety and conclusion. In accordance with Presidential Decree No. 97, the characteristics of the most significant infectious agents that can potentially be used as a biological weapon are given. At the same time, the issue of the rapid spread of antibiotic resistance and the introduction of genetically modified objects into widespread practice is being considered. The necessity of improving the regulatory framework and the biosafety system as a whole is substantiated.

Based on the published data on the epidemiological situation in the Russian Federation as of the end of March 2020, the article analyzes the need for a single integrated mechanism for ensuring biological safety state.

In the Russian Federation, the basic principles of protecting public health are fixed at a constitutional level, and, accordingly, when providing medical care to a person, their constitutional rights are affected, which confirms the importance of the scope of circulation of medical devices. One of the main problems in providing citizens with quality and safe medical products is the imperfection of the regulatory framework in this area, including the lack of a separate federal law. The article is devoted to the problems of legal regulation in the field of circulation of medical devices. The author analyzes the level of legal regulation of the sphere of circulation of medical devices, discloses the legislative regulation of the mechanism of circulation of medical devices, and also draws attention to the existing gaps in the legislation in this area, suggests ways to solve them.

The article offers an analysis of the instruments of public control, namely the conduct of public audits, public monitoring and public hearings, allows for the accumulation of a large amount of information for subsequent analysis, which is not always available to government bodies. The basis for public control measures is the identification of a significant problem by representatives of public organizations (patient organizations, medical associations, etc.). In a significant number of cases the results of public control may lead to the cheerful adoption of measures. The analysis of the activities of the department of the Council for the Protection of Patients' Rights under the Territorial Authority of the Federal Service for Supervision of Health Care in Moscow and the Moscow Region was performed from April 1, 2018 to December 31, 2019, for which 480 public control measures were carried out.

Genetic information does not fully correspond to the concept of personal data. It can relate not only to a specific person, but also to his “biological family”. Their interests do not take into account the legislation on personal data.

The state genetic engineering policy should be based on the next principles: the freedom of scientific research, the protection of human dignity and the prohibition of discrimination. The state must limit the freedom to use genetic information, to fix in the law the conditions for its use, identify individuals who can process genetic information and organizational and legal genetic data security tools. In Russia, there is no comprehensive legal regulation of genetic information protection. It is necessary to adopt the law «On genetic information».

The article is devoted to the description of the current situation in the sphere of countering crimes related to causing harm to life and health in the provision of medical care. There is a lack of official statistical reporting on crimes committed by medical professionals in the course of their professional activities. The article analyzes the articles of the Criminal code of the Russian Federation that currently involve medical workers in the case of a careless crime involving harm to the life and health of a patient. The author analyzes the sanctions of these articles. A study of the proposals of the Investigative Committee of the Russian Federation to amend the criminal code of the Russian Federation and include new elements of crimes that provide criminal liability for improper provision of medical care (medical services)" and conceal violations of medical care. The possibility of a positive preventive impact of the sanctions of the new articles is noted, but the emphasis is also placed on the impossibility of radically affecting the growth of this type of crime only using the means of criminal legal influence.

This article is devoted to the consideration of issues related to the legal mechanisms for stimulating the development of innovative technologies in the healthcare sector. In the course of the study, the features of the functioning of innovative infrastructure in the health sector in a number of foreign countries (USA, France, Canada, England) were highlighted. Four leading areas of stimulation of innovative development in medicine of foreign countries are identified: budget financing of science-intensive research; appropriate legal guarantees for the comfortable conduct of innovative research and the unhindered implementation of the results in the practice of medical organizations; modernization and re-equipment of research centers and laboratories; creation of territories with innovative infrastructure. It is concluded that the absence of clearly formulated by the domestic legislator directions for stimulating innovations and mechanisms for their implementation in practical medicine significantly slows down the processes of practical use of the country’s innovative potential. In this connection, the adaptation of the best foreign practices to stimulate the innovative development of medicine to the realities of Russian reality is an urgent necessity of the present.

The author examines the legal rules governing the relationship of gene diagnostics, which can be mandatory and optional for the use of certain legal relations. It is noted that the results obtained during the gene diagnostics can not always be used freely and bring benefits to those who conducted such a study. The exception is the Convention on Biological Diversity, in which most of its provisions on the beneficial use of research results are not binding. All other provisions analyzed, such as the Helsinki Declaration, the International Ethical Guidelines for Biomedical Research, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Universal Declaration on Bioethics, are not binding on them. The author notes that in most of the world’s law and order, the above Conventions form part of their legal system. The author emphasizes the importance of genetic diagnostics as an object of intellectual property and the need for its legal protection (TRIPS). It is concluded that at the global level, the issue of the commercialization of human biological resources remains unresolved and controversial.

The article deals with topical issues of the Unified state system of prevention and emergency response in the context of a coronavirus pandemic. Legal aspects of possible reform of state activities for the protection of the population and territories in emergency situations are studied. Based on the analysis of recent changes in legislation in this area, the authors substantiate proposals for improving the protection of the population and territories in emergency situations, as well as expanding the functions of the security Council of the Russian Federation.

At the moment, the business sector uses various directions to increase its own potential. The use of gene therapy and gene diagnostics, is no exception, is actively used in the form of innovative types of entrepreneurial activity. This article discusses the main entrepreneurial projects in the field of gene diagnostics, the use of genetic testing, its role in the future development of entrepreneurship in the country and the world. This innovative type of entrepreneurial activity is being improved through the introduction of certain types of services and research.