Journal articles on the topic 'Pharmaceutical biotechnology – Law and legislation'

After legal enaltment in the pharmaceutical profession appear two intimately related concepts: the pharmaceutical law andt the pharmaceutical legislation that we should define and analyze. On the one hand, the pharmaceutical law is a heterogeneous group of dispositions regulating directly or indirectly the pharmaceutical activity. It cannot be considered an independent branch of the law, but it is possible for practical effects to order systematically the legal regulations. Such is the source of a new branch inside the sanitary law, the pharmaceutical legislation, that every pharmacies most know in applied to his scientific-professional activity which evolution is vertiginous. This paper will study this concept. From the beginning this study requires the most appropriate methodological tools. The most important one for investigation must be the desire to mark out the treated topics guided by the necessary documentation. The use methodology is the usually followed in the works of pharmaceutical legislation where the primary source is found in the diverse official bulletins publishing the legal disposition and the critical literature of the topics.

The right of a person to access medicines is derived from the right to health. At the time of the establishment of fundamental human rights, the issue of lack of access to medical supplies was not considered a violation of human rights. The spread of pandemics has led to the gradual recognition of the right of access to medicines. The TRIPS agreement fundamentally reformatted the discussion on access to medicines. Prior to the TRIPS Agreement, states had considerable independence in the formation and implementation of state policy in the field of intellectual property. TRIPS obliges countries to provide pharmaceutical patents. The growing influence of the international patent system has aroused widespread interest and concern about the impact on access to medicines. The Doha Declaration on the TRIPS Agreement defines the importance of the implementation and interpretation of the Agreement in the most favorable way for the protection of public health by making available to the public existing medicines and creating conditions for the production of new ones. Ukraine is on the way to creating its own legislation in the field of intellectual property. Art. 219 of the Association Agreement between Ukraine and the European Union contains provisions according to which the parties recognize the importance of the Declaration on the TRIPS Agreement in the field of health care. Positive changes in the field of intellectual property include the provisions of the Law of Ukraine «On Amendments to Certain Legislative Acts of Ukraine on the Reform of Patent Legislation» № 816-IX as of 21.07.2020. This law limited the range of objects to be patented. The implementation of these legislative changes is impossible without a proper methodology for the examination of novelty. Reforming the national system of intellectual property protection has created good preconditions for the formation of a civilized pharmaceutical market in Ukraine. Among the areas of legislation in Ukraine, there is an urgent need to form an institution of compulsory licensing. A separate area is the introduction of the pre-grant and post-grant procedures of the opposition. An important area of legislative work is the formation of a favorable domestic policy for innovation and invention in the field of medicine and biotechnology.

Background:The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.Methods:Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the “Balduzzi Law”.Results:The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and “good medical practice” while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient.Conclusion:However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled “Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers”.

The author, considering the possibility of the emergence of a new branch of law in the future - pharmaceutical law, focuses on the complexity of regulating the sphere of turnover of medicines, at the same time pointing to this as the main reason for the uncertainty of the legislator in matters of the correctness of the choice of the object and subject of legal regulation. The author, citing examples from practice, draws attention to the fact that pharmaceutical activity is gradually becoming the object of regulatory regulation of various legal institutions, where the turnover of medicines, as well as medicines and other products containing raw materials of a medicinal nature, can be subject not only to the rules of civil turnover, as well as other special acts, but also to the norms of criminal law. The purpose of the study: To analyze the criminal legislation of the Russian Federation, including articles of the Criminal Code that establish responsibility for crimes in the field of pharmaceutical criminal law. Methodology and methods: the article uses both general scientific methods of analysis, synthesis, deduction, induction, and the method of interpretation of legal norms, which together make it possible to more effectively analyze the institutions of criminal law and determine the directions of development of the norms of pharmaceutical criminal law. Conclusions: as a result of the study, the author consistently substantiated the conclusion that the scope of application of criminal legislation in the control of pharmaceutical activities is expanding, at the same time, frequent violation of established prohibitions and regulations in the turnover of medicines suggests that the dialectical component of this issue is in an active phase of development, which indicates the inevitability (regularity and expediency) of the separation of a group of norms into a relatively autonomous group, which may be called pharmaceutical criminal law.

Medicines and the professional activity of the pharmacists are the subject of study of Pharmaceutical Law and Pharmaceutical Legislation. In this paper, on the one hand, the definition of these disciplines is examined, as well as their field of study, evolution and sources. On the other hand, the development of Pharmaceutical Legislation in the European Union is analysed in three clearly differentiated periods and related to different juridic enactments of generations of norms that affect medicines. Special attention has been paid to the so–called third generation standards, as the regulatory developments at European Union level and national level have been depened in the last three decades. Finally, those areas of the pharmaceutical sector that could have a regulatory development in the coming years are detailed.

This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990–2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justice, economic development, labor law, health and safety, privacy, and property rights). This analysis seeks to answer three questions regarding biotechnology legislation at the state level: who is acting (policy adoption), when is policy adopted (policy timing), and what is policy doing (policy content). Theoretical concerns examine state ideology (conservative or liberal), policy type (economic or moral), and the role of external events (federal law, news events, etc.) on state policy adoption. Findings suggest ideological patterns in adoption, timing, and content of biotech policy. Findings also suggest economic policies tend to be more uniform in content than moral policies, and findings also document a clear link between federal policy development, external events, and state policy response.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

The aim. To find out the content and essence of the legal liability grounds, to determine the main features of each element. Materials and methods. Synthesis, analysis and comparative law methods were used in the course of the study. Results. The grounds for legal liability in the pharmaceutical field are: 1) the fact of committing an act, defined as an offence by the relevant legislation, i.e. the factual basis; 2) the existence of a legal rule that prohibits such behavior and establishes appropriate sanctions, i.e. the regulatory basis; 3) lack of grounds for release from liability; 4) the existence of a law enforcement act, a written decision of the competent authority in which the person is found guilty and assigned the type and measure of punishment, i.e. the procedural basis. The analysis of the relevant regulatory framework shows some inconsistencies in the legislation governing the pharmaceutical sector in the context of legal liability. Thus, the cited articles of Fundamentals and the Law of Ukraine “On Medicinal Products” presume different types of legal liability for violations of the sectoral legislation. The fact is that Article 80 of the Fundamentals does not presume disciplinary liability, which, in our opinion, may have quite unpleasant precedents. In order to increase the effectiveness of the legal liability mechanism, we consider it appropriate to amend Article 80 of the Fundamentals. Conclusions. The grounds for legal responsibility in the pharmaceutical sphere correspond to the generally accepted approaches to their classification, and also have branch-specific features. In order to bring a violator of pharmaceutical legislation to justice, it is necessary to have several elements and only their combination determines the legal responsibility in the pharmaceutical field as possible and appropriate.

The aim: Scientific substantiation of the state and tendencies of development at the present stage of the legislation of the European Union and Ukrainian legislation on quality assurance of medicines. Materials and methods: Using the biblio-semantic, systematic-review, analytical, formal-legal and comparative-law methods, the individual regulatory sources of pharmaceutical legislation of the EU and Ukraine were studied. Conclusions: The paper identifies that pharmaceutical legislation of the EU and Ukraine on quality assurance of medicines at the present stage of their development have common features, which include the number, disorder of existing legal acts, which creates conflicts between them and the potential for gaps in regulation. The main trend in the development of this legislation in the EU and Ukraine is the disparity of legal acts and the lack of significant legislative efforts to codify them.

The article is devoted to the problems of legal regulation of pharmaceutical activities. The main contradictions of legislation in the approaches to the definition of the concepts of “pharmaceutical organization”, “subject of pharmaceutical activities”, “pharmacy organization”, “type of pharmacy organization” are considered. The problem of uncertainty in the status of a pharmacy organization, an individual entrepreneur with a pharmaceutical license has been identified. The need to develop an unified terminology for the types of pharmacy organizations, indicating their differences according to criteria such as functional purpose and structural features, is indicated. It was proposed to amend the Federal Law-61 taking into account the provisions of Federal Law-323, a new order “On the approval of the types of pharmaceutical organizations.

А number of factors influence the qualification of relations as consumer relations, however, neither a scientific literature nor law enforcement practice has formed a common list of signs defining the relationship to the subject of regulation of consumer protection legislation. The main purpose of the article is to identify signs that qualify the relationship as consumer. Achieving the goal of the article is carried out by solving the following tasks: determining the influence of the subject composition of relations, the nature of their activities, as well as other signs on the qualification of relations in order to apply legislation on consumer protection. The article was prepared using general scientific methods (systemic, logical) and special legal methods (comparative legal, formal legal). The author comes to the conclusion that for the proper qualification of public relations in order to apply legislation on the protection of consumer rights, it is necessary to take into account both the subject composition and the purpose of purchasing goods. The formal affiliation of a person to a particular category of entities cannot definitely indicate the goals of a person entering into a relationship. In particular, an individual entrepreneur has a dual status, being, on the one hand, a citizen, and on the other, a subject of entrepreneurial activity. The article also concluded that when determining the purpose of acquiring a product (work, service), it is necessary to take into account both direct signs expressed in the nature of the person's activity and indirect ones determined by the quantity of the purchased goods and its technical and functional characteristics. To assess indirect features, the author suggests referring to the category of «average person» formed in the general theory of law.

This section aims to update readers on decisions related to marketing products of modern biotechnology (e.g., GMOs, animal clones) at EU level and on national measures concerning their production. Special attention is devoted to problems of competence between Member States and the EU in regulating biotechnology issues; the institutional dynamics of decision making regarding products derived from modern biotechnology; the relationship between the EFSA and the EU institutions on green biotech-related issues; the evolution of EU regulatory framework and of national attitudes towards the risks and benefits of biotechnology derived products and their production. This section will also delve into the interaction between the EU legislation and WTO law regarding advances in the application of biotechnology within the agri-food value chain.

Problem statement. The main issues that exist in the management of strains of particularly dangerous microorganisms are primarily related to the weakening of state supervision and control. Surprisingly, nowadays, there is no single official register of owners of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Some biological objects are found, even in private collections. There are no permitting procedures for handling such facilities and sanctions for violating them. That is why it is not surprising that the Prosecutor General’s Office has announced that the head of the State Research and Control Institute of Biotechnology and Microorganism Strains has identified dangerous virus strains that are known as infectious animal pathogens and can spread rapidly on a large scale across national borders. Dual-use studies should be supervised to address the risks arising from the development of biomedical sciences. Continuous monitoring and verification of scientific and technological advances sensitive from the point of view of security allow to minimize the possibility of the adoption of biological and toxic weapons and other risks. Analysis of recent sources and publications. Theoretical issues of legal regulation of activities in the field of circulation of certain groups of drugs containing strains of microorganisms, in particular in vaccination, attract the attention of many researchers. They were studied, in particular by: R.A. Maidanyk, I.Ya. Senyuta, etc. However, the peculiarities of activities in the field of particularly dangerous microorganisms’ strains treatment have been left without due attention of researchers, including specialists in medical law. Formulating Goals. The aim of the work is to study the state of relations in the field of especially dangerous microorganisms’ strains treatment legal regulation in Ukraine, analysis of the current legislation of Ukraine and the practice of its application in this area. There have been used scientific publications of leading experts and current Ukrainian legislation. The research is based on an organic combination of general scientific and special legal research methods. Presenting main material. The main sources of biological threats are: 1) epidemics and outbreaks of infectious human diseases; 2) epizootics (high incidence among animals); 3) epitophytia (spread of infectious plant disease in large areas); 4) accidents at biologically dangerous objects; 5) natural reservoirs of pathogenic microorganisms; 6) transboundary transfer of pathogenic microorganisms, representatives of flora and fauna, dangerous for ecological systems; 7) sabotage at biologically dangerous objects; 8) biological terrorism; 9) the use of biological weapons by the state. It should be noted that the regulatory framework in the field of particularly dangerous microorganisms’ strains treatment in the context of biosafety in Ukraine is fragmentary. Although the list of laws and other regulations governing biosafety and/or biosecurity in Ukraine is impressive. Nowadays, the use of strains of microorganisms is gaining popularity, in particular in agriculture, because they can be used for the needs of veterinary medicine and for the production of certain foods such as yogurt, kefir etc. Therefore, in addition to the basic law, regulation of the use of strains and protection of rights to them is regulated by other acts, in particular the Law of Ukraine “On protection of rights to inventions and utility models”. Namely, in accordance with Part 2 of Art. 6 strains of microorganisms that have been bred or would be bred shall be considered as the objects of the invention. It follows that the owner who invented the strain must certify the authorship and the right to obtain a patent or declaratory patent. However, this procedure, unlike others, is complicated. After all, to obtain a full patent, you need to conduct an appropriate qualification examination, which would establish whether the strain meets the conditions of patentability. Also, in addition to filing an application for the invention of a utility model and obtaining a patent, in accordance with the Law of Ukraine “On Veterinary Medicine” when registering a domestic veterinary immunobiological agent, the applicant must deposit strains of microorganisms in a special collection – depository. There are currently three national depositories in Ukraine, each of which specializes in a specific type: non-pathogenic strains; pathogenic to humans; pathogenic to animals. The procedure of depositing strains of microorganisms is carried out in accordance with the Instruction on the procedure of depositing strains of microorganisms in Ukraine for the purpose of patent procedure, approved by the order № 106/115 of the State Patent and the National Academy of Sciences of Ukraine of 26.06.1995. Moreover, in accordance with the Regulations on the National Center for Microorganism Strains and the procedure for depositing microorganism strains, approved by the Cabinet of Ministers of Ukraine regulation № 637 of 07.05.1998, deposit of microorganism strains in Ukraine is carried out by the National Center for Microorganism Strains. Its task is to preserve the production and control of strains of microorganisms, maintain biotechnological indicators, control the state of their population, as well as the preparation of new strains. It is necessary to pay attention to the decision of the National Security and Defense Council of Ukraine “On Biosafety of Ukraine”, which states that at the moment there is an increase in the negative impact of various biological factors on the population, which may lead to threats of biological origin. The reasons for such plural regulation are: 1) the lack of a program on biosafety and prevention of biological terrorism, no national system of counteraction to possible biothreats; 2) no automated and integrated data banks on possible threats of biological and chemical origin. Funding and logistics for laboratories also remain unsatisfactory. Also, the state supervision and control in the field of biosafety is weakened, namely when the owner of high-risk facilities changes or when there is a risk of unauthorized access to laboratories due to imperfect protection of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases, which in turn can lead to the leakage of pathogenic microorganisms into the environment and cause mass infectious disease. In addition, there is a legal gap in the legislation of Ukraine regarding the location and control of viral and biological laboratories by foreign states. However, in almost all European countries, as well as in the United States, domestic law prohibits the placement of such laboratories in these countries, because they are potentially dangerous to the population. The danger behind viral and biological laboratories, even with the strictest observance of all necessary safety rules, is extremely great, because the pathogenic microorganisms of human and animal origin in them are considered potential agents of biological weapons. Although Ukraine ratified the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction of 10 April, 1972, an agreement was signed in 2005 between the US Department of Defense and the Ministry of Health of Ukraine (expired on 31.05.2013) regarding cooperation in the field of prevention of the spread of technologies, pathogens and knowledge that can be used in the development of biological weapons and the US Department of Defense has begun construction of its objects on the territory of our country. At the same time, microbiological laboratories and production facilities are considered to be areas of the highest biological risk. Infecting of persons while working with microorganisms in laboratories is noted throughout the existence of microbiology and is considered as an indisputable confirmation of occupational hazards. In general, there is a wide variety of ways of potential attacks involving bio-toxic weapons and there are several ways to assimilate biotechnologies with their transformation into weapons due to: 1) use of various agents (e.g., bacteria, viruses, fungi, toxins, bioregulators); 2) use against various aims (humans, animals and plants); 3) different scales of application (tactical, strategic); 4) use for various purposes (open or covert war, murder, terrorism or criminal activity). Probably because of this, in 2012 the WHO adopted the Framework Strategy for Laboratory Biorisk Management for 2012-2016, aimed at creating sustainable global, regional and national plans for biological risk management in laboratories. It recognizes that “In accordance with the International Health Regulations (IHR (2005), all participating countries have made a legal commitment to evaluate, develop and maintain their national key oversight, evaluation and response functions”. Conclusions. The current state of legal regulation of relations in the field of strain management requires, given the intersectoral nature of the issue, consideration of the creation of a single intersectoral body for the supervision of hazardous biological objects. Such a body may not only be a licensing body, but also responsible for the introduction of a register of owners of hazardous biological objects that are not economic entities (for example, individual owners of collections of such biological objects). In this paper, it is impractical to consider the circulation of products with GMOs, on the one hand, this issue is perfectly regulated in other special regulations, on the other hand, today there is an issue concerning the treatment of dangerous strains of pathogenic viruses, bacteria and other microorganisms and toxins, as well as poisons of animal and plant origin. For entities engaged in economic activities with pathogenic microorganisms and strains of dangerous infectious diseases, it is advisable to introduce licensing of this type of activity, which requires further development of a bylaw on licensing conditions. For other persons who are the owners of such biological objects and who are not engaged in economic activities, it is necessary to introduce other forms of permit, including special requirements for their handling and storage conditions. The next important bylaw should be the Regulations on the state register of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Particular attention should be paid to the disposal of hazardous biological objects. Nowadays, for example, there is no effective system for the disposal of vaccines and other immunobiological drugs that have expired (for reference, the shelf life of the flu vaccine is 7-8 months). The cost of recycling is not always profitable for pharmaceutical operators. There are cases when such drugs are falsified by replacing the expiration date, which adversely affect the health of patients. In this context, it can also be mentioned the fact of importing humanitarian aid in Ukraine in the form of a vaccine against measles and rubella (from the Ukrainian diaspora in Canada). The storage temperature of this vaccine was up to minus 48 degrees. After importation into the customs territory of Ukraine, given the shortcomings of customs legislation and the lack of effective control, the temperature regime was not observed. However, the Ministry of Health still carried out compulsory vaccination of children (there were cases of deteriorating health), which is not only negative for the health of children, but also for the very idea of vaccination. In this case, the Ministry of Health, given the interest, was not able to make the right and lawful decision. This is why an independent intersectoral body of state control (supervision) is needed.

The article analyzes the provisions of the Code of the Republic of Kazakhstan «On Health of people and healthcare system» dated July 7, 2020, as well as several departmental regulatory acts regulating the labor of medical and pharmaceutical workers, which were adopted in compliance with this Code. Chapter 30 «The status of medical and pharmaceutical workers» of this Code identifies gaps in the status, rights, duties, and social guarantees of this category of workers and offers specific measures to eliminate them. The Labor Code of the Republic of Kazakhstan dated November 23, 2015, is not included in the scope of the analyzed legislation due to the absence of norms on the labor of medical and pharmaceutical workers in it. The article also covers the need to adopt a new law of the Republic of Kazakhstan «On the status of medical and pharmaceutical workers». It shows the defects of departmental regulatory acts on the provision of remote medical services, the rules for certification of health managers, personnel accounting, incentives, differentiated surcharges, and salary allowances for employees of health care subjects, which arose because of the conscientious delusion of developers, timely elimination of which will have a positive impact on law-making practice.

The prescription of a specific drug to treat a patient is influenced by the patient’s medical condition, the prescriber’s medical knowledge, and the pharmaceutical industry’s influence on the prescriber. This paper describes the different areas of interaction and cooperation between the prescriber and the pharmaceutical industry. This relationship is discussed in light of the requirements of the Federal law of the Russian Federation regarding the restrictions imposed on the prescribers. Problems of application of the standards of the law are discussed and ways of elimination of gaps of the legislation are offered.

Developing biotechnologies have an impact not only on technical, technological and other economic processes, but also on industries and sectors of the economy, public relations, and change the prevailing stereotypes of behavior and habits. In this regard, new sprouts of an innovative economy, and the changing social sphere, the psychology of individual groups and communities determine the need for a unified balanced biopolitics. This policy manifests itself in the provisions of the rule of law and legislation, strategic planning documents, and in law enforcement. Due to the nontriviality of technologies, their great potential opportunities, as well as challenges, risks and threats for the population, society, biopolitics is becoming an important factor in the policy pursued in general. The author proves the need for systemic and comprehensive regulation of biotechnologies allowed for use, taking into account their biological and other types of safety, contribution (positive effects) to the developing bioeconomy and development of society. In connection with the above, the concept of the four "bio" (biotechnology — biosafety — bioeconomics — biopolitics) is proposed, which requires the development of law and legislation based on modern trends in the development of technology, economy, society and the state.

The aim of the work – is to study the conceptual and categorical apparatus of the legislation of Ukraine, which determines the legal responsibility in pharmaceutical activities. Materials and methods. The study is based on a number of legislative terms and case law in cases of prosecuting violators of pharmaceutical legislation. During the work, we used methods of information retrieval, analysis, systematization, and generalization. Results. It is established that pharmaceutical activity is one of the branches in the field of health care, which is carried out by conducting licensed economic activities by economic entities and professional activities by non-economic entities – pharmaceutical workers. The complex nature of such activities determines the establishment by the state at the legislative level of various types of legal liability: criminal, administrative, civil, and disciplinary. Conclusions. Legal responsibility in pharmaceutical activity is characterized by a certain terminological inconsistency and unsystematic nature, which is manifested in the lack of disclosure of the meanings of such terms as pharmaceutical activity (its types and directions), pharmaceutical care, pharmaceutical service; subject of pharmaceutical activity (with the separation of categories of persons with appropriate legal status). The conceptual and categorical apparatus of legislation governing pharmaceutical activities needs urgent unification, as the imbalance of legislative terminology results in inadequacy and inconsistency both in the conceptual sense of the institution of legal responsibility and in bringing participants of pharmaceutical activity to legal responsibility for relevant offenses.

The phenomenon and development of modern digital technologies put imprint on almost all life spheres, including sports. Over the past years, there have been a rapid development of a new sport and a new direction of the sports business, i. e., esports, which, unlike traditional sports, is causally relating to information and telecommunication technologies and intellectual property. The Regulations on esports adopted in 2020 by the Ministry of Sports of the Russian Federation, expanded the concept of sport by officially recognizing esports as an independent sport. Today, esports is a fast-growing high-tech industry with an ever-growing global audience and a significant number of computer companies and stakeholders involved, which are usually in fierce competition with each other. Nevertheless, despite rapid transformation into the mainstream, this industry is faced with both traditional criminal law concerns and specific inherent to esports problems, which can hinder its potential growth. All the aforesaid suggests that the boundaries of sport are constantly expanding likewise the legal relations regulated in the digital era by criminal legislation, as well as the related law enforcement issues. At the same time, it must be acknowledged that the current legislation is imperfect, and the issues of countering illegal methods of influencing the results of computer sports competitions and electronic doping, fraud and corruption, as well as criminal protection of copyright and related rights, problems of the ratio of criminal and non-criminal in esports are understudied by experts.

Abstract The present work is aimed to answer a very interesting and sensitive legal issue in the Romanian pharmaceutical field. This issues regard mainly the existence of coordination or contradiction between Romanian (i.e. Romanian Pharmacy Law no. 266/20081) and European legislation (art 34 TFEU2) in respect of the delivery of the online sale of OTC medicine only from pharmaceutical units.

The article addresses the issue of classifying a limited civil circulation thing as a medicine that is defined by a set of attributes including generic ones. After the adoption of the first specialized law — Federal law “On Medicines” N 86-FZ dated 22.06.1998 legal standards for different law branches where medicine is a law object have been formulated. This explains the relevance of this research and its practical applicability in further development of legislative initiatives and regulatory practices. The correctness of medicine definition in the Russian legislation can be determined by the comparison of laws of the leading countries on the international pharmaceutical market — USA, Japan and Germany. Providing a certain degree of succession from German legislation, the term medicine and its attributes as they are defined in the Federal law “On Circulation of Medicines” № 61-FZ dated 12.04.2010 and used herein, in general demonstrate the same approach as in the countries mentioned above, which allows to conclude that the Russian legislation has been developing not independently but rather in the context of previous and ongoing studies of Russian researches and scholars from Anglo-American and Romano-Germanic legal systems. The article addresses controversial issues of drug circulation and challenging practical aspects, namely distinguishing medicines from related by application chemical substances, biologically active additives, medical devices and perfume and beauty products.

The article presents the results of a study of the legal basis for the labor activity of medical and pharmaceutical workers in some states that are members of the Organization for Economic Cooperation and Development (hereinafter - OECD). The author provides general features and specifics of labor regulation models in the healthcare sector. The article analyzes legislation and law enforcement. Thus, the European (continental) and Anglo-American models stand out, which differ in the direction of regulation. The first model is distinguished by the social orientation of labor regulation and public law regulation of disciplinary liability issues through quasi-state bodies of control and supervision. Whereas the second model provides for more autonomy to the parties to labor relations in establishing working conditions and private law regulation of disciplinary liability issues through self-regulatory professional organizations. The second model is more flexible, allowing more freedom to build labor relations with medical and pharmaceutical personnel, contributing to the development of the market for medical services and the efficiency of the health care system. The article substantiates the need for the reception of individual institutions and norms of labor and medical law of the states in question in the legislation of the Republic of Kazakhstan. In particular, there is a need for an independent law regulating the legal status of medical and pharmaceutical workers by analogy with foreign laws on the regulation of medical professions, in order to differentiate the norms that establish the specifics of the application of disciplinary measures, compliance with professional ethics and quality standards.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive. For some stakeholders, including patient groups and representatives of regulated industries, the Act represented a major leap forward in pharmaceutical innovation, human subjects protections, and numerous other provisions. For other observers, this legislation was characterized as a major rollback in important regulations, which would leave patients worse off and the payers holding the bag. The one element of the Act that was relatively uncontroversial covered a number of provisions related to addressing the opioid crisis.This was by design. Provisions related to this issue were not part of the original legislation and were added to win over additional members of Congress who needed to be brought along to support the legislation. Many of the statute's provisions were intertwined with the Comprehensive Addiction Recovery Act (“CARA”) passed previously, but that legislation was stripped of much of its funding for opioid crisis response.

The evolution of pharmaceutical administration in PolandProduction and marketing of medicinal products are of interest to the legislature for many years. Already in 1919, they entered into force on the first rules governing the matter indicated. The basic health law was the first piece of legislation to regulate the issue of the pharmaceutical market. The legislator only in 1939 passed a new law in this area, which for several years was in force between 40 and 50. Only later came into force a new law on pharmaceuticals and drugs and sanitary articles, which was much more extensive than previously applicable. Due to the political changes legislature has decided to re-regulate the matter of trade in medicinal products. The next act was even more extensive regulation than the last. Currently, since 2001 the issue of the production and marketing of medicinal products has been regulated in the Law pharmaceuticals. Out of all these acts is the most detailed spite of the narrower scope of the legislation. It reflects a trend towards more study, a matter of regulating the production and marketing of medicinal products, as well as increasingly sophisticated system of supervision and control in this area.

The article researches the legal issues of protection from various forms of distant psychological violence arising in electronic communication. The study aims to assess the public danger of cyber-bullying, cyber-stalking and cyber-harassment among potential and real victims in order to develop recommendations for improvement of domestic legislature. The main results of the study have been obtained by surveying 207 individuals and by means of comparative review of domestic and foreign law. The results indicate that distant violence does take place, but its assessment by legislators and the public is highly controversial. Cyber-harassment is commonly seen as a more dangerous phenomenon than cyber-bullying or cyber-stalking, which raises a question of its criminalization in the law. This necessitates a correct definition of sexual harassment in distant form as there are risks of either intruding into the field of socially acceptable behavior or overlooking the socially unacceptable ones.

The relative independence of railway legislation to a certain extent hinders the applicability of the principles of civil law to the carriage of cargo. This threatens the unity of the legal regulation of property relations. One of the fundamental provisions limiting the freedom of contract in the interests of the economic system as a whole is the recognition of the public nature of business contracts. The public nature of the contract (compulsory contract) of carriage should prevent the arbitrariness of the carrier’s actions and ensure fairness in the provision of transport services. To what extent does the sectoral legislation comply with the principles of civil law? Is the importance of the rules on public contract (compulsory contract) in a special legal regime not diminished? The main task is to assess the degree of compliance of the provisions of the railway transport legislation with the rules on the public contract (compulsory contract). Particular tasks are: to establish the formal inconsistency of industry norms on cargo transportation with civil legislation; to identify contradictions in the procedure for concluding and conditions for the contract of railway cargo transportation to the idea of a public contract (compulsory contract); to prove the need for changes in the design of auxiliary transport contracts from the position of publicity of the contract (compulsory contract) of carriage. The tasks set are solved on the basis of a critical understanding of the norms of civil and railway transport legislation. Methods of comparative jurisprudence were used to prepare the source material for this study. The work is primarily of the nature of a theoretical search, contractual and law enforcement practice was studied at the initial stage of data analysis in order to best understand the essence of the regulations. Based on the conducted research, it should be stated that the implementation of the rules on the public contract(compulsory contract) requires a direct indication in the railway transport legislation. The agreement on the terms and procedure for concluding a cargo transportation contract, especially the procedure for accepting an application for transportation, does not take into account, and in some cases directly contradicts the principles of civil legislation. The system of auxiliary transport contracts creates conditions for a significant restriction of the rights and interests of cargo owners. Based on theoretical conclusions, the paper formulates proposals aimed at improving the current legislation.

The article examines the background of legislative consolidation and the main problems of the introduction by pharmaceutical companies of a new legal institution for the prevention of violations of antimonopoly legislation — antimonopoly compliance, introduced by Federal Law No. 33-FL of March 1, 2020.The definition of the concept and a brief description of the current state and trends in the development of the pharmaceutical industry in connection with the relations of competition are given.The necessity of introducing antimonopoly compliance by pharmaceutical companies as a relatively independent part of pharmaceutical compliance as the most general (universal) tool for self-prevention of any offenses by the company itself and all its employees in connection with official activities is substantiated.The main antimonopoly risks associated with the implementation of pharmaceutical companies’ economic activities are named. Typical examples of violations of antimonopoly legislation by pharmaceutical companies are considered.The results of a sample survey of pharmaceutical industry representatives conducted by the author on their attitude to the introduction of antimonopoly compliance are presented.Proposals have been formulated to amend the Code of Administrative Offences of the Russian Federation in order to create additional incentives for the implementation of antimonopoly compliance.

The Medicaid Prudent Pharmaceutical Purchasing Bill is designed to improve Medicaid patients' access to medications in return for signed rebate agreements from pharmaceutical manufacturers. The legislation also recognizes and attempts to develop the potential clinical role of pharmacy through mandates for drug utilization review, patient counseling, and electronic claims processing for Medicaid patients. Managed care pharmacy has a distinct advantage in the achievement of these clinical roles; it has already implemented drug utilization review and has electronic claims capabilities. This article reviews the legislation and describes the potential impact of the law on managed care pharmacy practice. The government is a major player in terms of setting health policy and trends in this country, and managed care pharmacy departments should be keenly aware of the legislative impact on overall future pharmacy trends. The potential exists for other government agencies and eventually the private sector to require and reimburse for provisions similar to those described in the Medicaid legislation. Managed care pharmacists should take a special interest in ensuring that the demonstration projects and studies mandated by the legislation show positive documentation of pharmacists' intervention so that eventually pharmacists will be properly compensated for such services in the public and private sectors.

In the context of the COVID-19 pandemic, the burden on the sphere of health care, pharmacy, finance, economy, industry, and law enforcement are increasing. The level of the state system regarding the effectiveness of the criminal and legal struggle against the illegal circulation of narcotics (narcotic drugs and psychotropic substances) and their abuse by improving the legislation and normative legal acts of Ukraine in the conditions of the pandemic on the basis of forensic pharmacy, drug technology, the organization of the pharmaceutical case, medical and pharmaceutical law. Scientific information sources were studied, taking into account the recommendations of the WHO and the Cochrane Society for PICO from 25 disciplines that have interdisciplinary connections. The forensic and pharmaceutical practice in criminal proceedings regarding the illegal circulation of psychoactive substance of various classification and legal groups were analyzed. Proven that the abuse and uncontrolled intake of psychoactive substances causes manifestations of a person's hidden predisposition to mental illnesses according to the ICD-11 codes. The forensic and pharmaceutical characteristics of the "drug business" market were summarized according to the data of law enforcement agencies. The provisions of the State Policy Strategy on Drugs in Ukraine were analyzed. Normative proposals for improving the legislation on measures to counter the illegal circulation of narcotic drugs, psychotropic substances and precursors and their abuse in order to protect the rights and freedoms, life and health of drug addicts were presented.

<p>The work is aimed at identifying the prerequisites for the formation of legal nihilism among prosecutors. The correlation of legal and actual models of the prosecutor's activity in criminal proceedings from the position of influence on legal consciousness of prosecutors was carried out. To achieve the purpose of the research the authors conducted an analysis of the current legislation, law enforcement practice, information posted on the official websites of the investigation and prosecution bodies, as well as a cross-sectional survey by questioning participants in criminal proceedings. The results allow us to speak about the presence of legal nihilism of prosecutors in the conditions of inability to fully perform their functions, based on the current legislation. In modern conditions, prosecutors are forced to violate the law or distort the practice of its application in order to solve the tasks assigned to them by the same law, which indicates not the professional unsuitability of prosecutors, but the inconsistency and illogic of the current legislation, the shortcomings of which prosecutors are forced to compensate with the manifestations of legal nihilism.</p>

In this paper, we discuss the implications of the recent Intellectual Property Right (IPR) enforcement in the European Union (EU) as a potential factor affecting agrifood biotechnology industry stagnation. After presenting a theoretical framework justifying patents, we describe some controversial questions in the European patent protection related to: a) the distinction between discovery and invention and; b) the morality and ordre public exception to the patentability. Although we provide some evidence about the reduction in importance of agrifood activities compared to that of pharmaceutical areas of application, we conclude that differences between EU and other developed countries IPR legislations are not the principal regulatory controversial factor affecting activities in the agrifood biotechnology sector.

The article on the guidelines for the development of social legislation of the Russian Federation predicts a rapid and accelerated development of this block of Russian law system.Among the largescale trends typical for social legislation the author includes: expanding of the scope of regulation (juridification) and the corresponding expansion of legal regulations, differentiation of social legislation on the new brunches (in particular, immigration legislation), the formation of new sub-brunches within the existing ones (for instance, labor relations in the public service) and institutions (biotechnology and so on). The article discusses some “growth problems” of social legislation: the tendency of commercialization of the sphere leads to a decrease of the quality of services, the weakening of safeguards for the most vulnerable categories of citizens (for example, cancellation of the rules on prior consent of the guardianship authorities to carry out transactions with premises where childrenlive, led to a decline of living conditions of many minors of the Russian Federation). As a result the very content of constitutional rights is expressly questioned. At the same time it is underlined that the positive aspect of social legislation juridificationis the appearance of new obligations of the state in the social sphere. To overcome the existing problems and to prevent new onesit is proposed to strengthen the role of science in determining the broad guidelines of development of social legislation in the systematization of social legislation, unification of regional legislation in the social sphere, preventing the rejection of statutory approach in the formation of the secondary legislation, reduction of by-law regulation, strengthening the greater coherence of other branches of Russian legislation with the norms of social legislation. Optimization of legislative regulation through the adoption of the Federal Law “On Normative Legal Acts” will contribute to the elimination of many defects of social legislation and greater stability of legislation of the Russian Federation in the whole.

On the basis of the concepts used in the legislation on the circulation of medicines (including the relevant provisions on licensing) the paper distinguishes between two licensed activities: drug production and pharmaceutical activities. The concepts of “manufacturing” and “production”, “vacation” and “sale” are related within the framework of the norms of the Federal Law dated April 12, 2010 No. 61-FZ “On Circulation of Medicines”, taking into account the need to separate economic activities according to the Russian Standard Industrial Classification of Economic Activities (OKVED 2) OK 029-2014. There are examples from judicial practice that consider cases when obtaining a license for pharmaceutical activity is not required (taking into account the objectives of the activity, as well as the list of entities established in the law that need to obtain a license for pharmaceutical activity). The problem of a significantly wider use of the concept of “pharmaceutical activity” in various special and scientific literature as compared with the definition set by the legislator is touched upon.

The article examines the features of the legal status of pharmaceutical workers and determines the place of pharmaceutical activity in the field of health care. Pharmaceutical workers are considered as a separate category of health workers, along with medical workers and workers working in the field of rehabilitation. The qualification requirements to pharmaceutical workers fixed by the legislation depending on the sphere and type of pharmaceutical activity are determined. Pharmaceutical workers include professionals and specialists who work on the basis of an employment contract in the field of production, wholesale (retail) and import of medicines and meet the licensing and other regulatory requirements governing the organization and operation of pharmaceutical activities. Some licensing conditions for the implementation of various types of pharmaceutical activities and the relationship of their standards with other regulations are investigated. The need to improve the current legislation in the field of regulation of pharmaceutical relations and the development of effective legal mechanisms to ensure effective control over such activities is pointed out. It is necessary to adopt a special law on pharmaceutical activities; legislative definition of pharmaceutical activity with its main features; legislative definition of all main types of pharmaceutical activity, conditions of its implementation and subjects; detailed regulation of the legal and labor status of pharmaceutical workers. Particular attention and control should be paid to determining the qualifications of pharmaceutical workers, supporting their continuing professional education and establishing quality control over the quality of their work.

The article is devoted to the analysis of the legislative regulation and the practice of applying penalties related to the restriction of the labor rights of minors. The goal is to identify the problems existing in theory and law enforcement practice, to propose ways to solve them. The frequency of the election of compulsory and correctional labor to adult and juvenile criminals is compared. The shortcomings of the legislative regulation of penalties related to the restriction of the working capacity of minors are indicated, the difficulties faced by the law enforcement officer in choosing these types of penalties are noted. Based on the analysis, conclusions are drawn on the need to improve the existing criminal legislation, and proposals are made to amend the relevant legislation.

This article is devoted to the study of the historical experience of regulating pre-contractual legal relations. The main focus is on the development of preliminary contract legislation. At the same time, problems are posed related to possible ways of further development of legislation on a preliminary contract. The purpose of the article is to study the current legal regulation of legal relations complicated by a preliminary agreement, and to propose scientific ideas aimed at improving the Civil Code of the Russian Federation in the part related to the preliminary agreement. The article was written with the active use of general scientific methods and special legal methods. When writing the article, the methods of formal logic and the general dialectical method and methods of interpretation of legal texts were used. In this article, conclusions are drawn about the need for a general design of a preliminary contract, uniting elements of all existing structures that ensure the organization of future contractual relations. In addition, this article draws conclusions about the introduction of special restrictions on freedom of contract when concluding a preliminary contract. The author expressed the idea of fixing such a legal consequence in case of violation of a preliminary contract, as the recognition of legal consequences as having occurred.

The article is devoted to the analysis of the latest innovations in the legislation on veterinary medicine, namely the regulation of the production, distribution and use of veterinary medicines. The adoption of the new Law of Ukraine “On Veterinary Medicine” is caused by the need to approximate the relevant national legislation with the legislation of the European Union to fulfill Ukraine’s international obligations under the Association Agreement. This law reflects the latest trends in the development of legislation on veterinary medicinal products in the European Union. The article pays attention to the strengthening of state regulation of production and distribution of veterinary medicines, in particular the introduction of licensing of imports, wholesale and retail sales of these medicines in Ukraine, due to the need to combat counterfeiting and veterinary medicinal products of dubious quality. It is also noted that the changes in the procedure of state registration of veterinary medicines provided by this law will on the one hand reduce the administrative burden on business due to the transition to indefinite state registration of veterinary drugs, and on the other hand new requirements for the registration dossier will improve the safety, quality and efficacy of veterinary medicinal products. New requirements for the use of antibiotics are analyzed. Attention is drawn to the fact that along with the regulation of the use of antibiotics in animal husbandry, it is also necessary to regulate in more detail the issues of control of the circulation of active substances (active pharmaceutical ingredients). The article also deals with the mechanism of veterinary pharmacovigilance, which is new for Ukraine. At the same time, it is necessary to study the practical experience of implementing the European model of pharmaco to improve the relevant legislation in Ukraine.

Facing the problem of matching growth and status, starting work, starting work, starting work, starting work, starting work, starting work, starting work, and the United Arab Emirates. This harmonization - by approving a set of exceptions of this nature has some of the effects and the secret idea behind it. As we see him, he relied on the idea of ​​public order in order to set some exceptions related to the inventions themselves by excluding some of them from the requirement to obtain a patent certificate, which is stipulated in Article 6 of the Law on the Organization and Protection of Industrial Property, and he also made exceptions related to the rights established for the inventor, which are It gives him the power to monopolize and dominate the invention if the inventor has what is in conflict with the objectives of scientific research, which is stipulated in Article 19 of the aforementioned law, and we see that the UAE legislator has organized the idea of ​​compulsory licensing contracts for pharmaceutical products in accordance with the interests of both the licensee and the licensee. Both. Research problem: considering that the pharmaceutical industry in the UAE is a strategic industry, and because of the fluctuation of drug prices in the global and local market. Therefore, the problem of this research will focus not on the extent to which the pharmaceutical industry in the Emirates can activate its role in the UAE national economy in light of the UAE pharmaceutical legislation, and whether these legislations were able to create a balance between secrecy in the pharmaceutical industry and scientific progress in this industry. research assumes: 1- There is no relationship between advances in the pharmaceutical industry in the UAE and the confidentiality imposed by the TRIPS Agreement. 2- The UAE’s accession to the TRIPS Agreement had a negative impact on the pharmaceutical industry. 3- The Emirati legislator was able to create a consensus between commitment to confidentiality and the manufacture of medicines. research aims: 1- Introducing confidentiality in the pharmaceutical industry. 2- Identifying the main obstacles to the pharmaceutical industry in the UAE. 3- Developing proposals to activate the role of local legislation to create a balance between confidentiality and the pharmaceutical industry. research importance: The importance of the research lies in focusing on the balance between confidentiality and the local pharmaceutical industry to have a developmental role. Thus, we will try to reveal the state of the pharmaceutical industry in the UAE. And how to stimulate the pharmaceutical industry through national legislation Research methodology: The researcher will rely on a descriptive approach to analyze and characterize the special industrial reality in medicine in the UAE and analyze private legislation Based on the foregoing, and in order to understand the position of the Emirati legislator on the idea of ​​secrecy in the pharmaceutical industries more, this requirement must be divided into two studies. In the first, we review the concept of confidentiality in the pharmaceutical industries. Second: the concerted attempts to mitigate the negative effects of confidentiality in the pharmaceutical industries.