Legal principles of public administration for the invention of innovative medicines: European experience

2021 ◽  
Author(s):  
Stanislav Vasyliev
Keyword(s):  
European Union ◽  
Public Administration ◽  
Financial Support ◽  
Legal Regulation ◽  
The State ◽  
The European Union ◽  
State Service ◽  
European Legislation ◽  
European Experience ◽  
The Creation

Formulation of the problem. The creation of innovative medicines is the key to increasing the competitiveness of the pharmaceutical sector of Ukraine’s economy. Going through European integration requires bringing Ukrainian legislation, which regulates various sectors of the economy, in line with European legislation. The study of the European experience of legal regulation of medicines development is characterized by relevance. The state of the problem research. Problems of innovative activity in the field of medicines creation are investigated in scientific works of such Ukrainian scientists as V. M. Pashkov, S. V. Glibko, Yu. V. Heorgievsky, O. G. Alekseev, and T. A. Kolyada. European authors who have studied scientific activity problems in pharmacy are Philip A. Hines, Rosanne Janssens, Rosa Gonzalez-Quevedo, Ralf Arno Wess, and Constantinos Ziogas, Ivana Silvia. The purpose of the study is to develop proposals for amendments to Ukrainian legislation governing public administration in the sphere of medicines creation, taking into account the European experience. Presenting main material. State regulation of the creation of innovative medicines in Ukraine and the European Union is carried out in the following areas. The first is the creation and financial support of research institutions that develop innovative medicines. Second, the identification of research that needs public financial support on a competitive basis. Public administration bodies shall establish the procedure for registration of medicinal products or obtaining a trade license for placing a medicinal product on the market. Legislation and bylaws define the conditions for licensing the production of medicines. The differences in the legal regulation of the creation of medicines under Ukrainian and European legislation are as follows. First, in the European Union, licenses for marketing medicines are issued by the European Medicines Agency. At the same time, in Ukraine, the registration of medicines is entrusted to the Ministry of Health of Ukraine. Secondly, in the European Union, licenses for medicines production are issued by the national authorities of the EU member states. At the same time, the issuance of such licenses in Ukraine belongs to the competence of the State Service for Medicines Trafficking and Drug Control. Conclusions and prospects for further research. The implementation of European legislation governing the development of medicines may consist of further amendments to Ukrainian legislation in the field of circulation of medicines. Firstly, to consolidate the medicines registration function to the State Service for Medicines Trafficking and Drug Control of Ukraine. Secondly, to define one of the service’s tasks as providing advice to medicines developers on clinical and preclinical trials and medicines registration. It is also necessary to assess the environmental risk due to the use of a new medicinal product during its registration.

scholarly journals Theoretical and Applied Aspects of Public Governance in the Field of Tourism in the Conditions of Adaptation to EU Standards

2021 ◽  
pp. 113-119
Author(s):  
Nataliia HRABAR ◽  
Nelli LEONENKO
Keyword(s):  
European Union ◽  
Public Administration ◽  
Rule Of Law ◽  
National Level ◽  
State Regulation ◽  
The State ◽  
Market Model ◽  
The European Union ◽  
The Rule Of Law ◽  
State Management

The article is devoted to the study of public administration in the field of tourism in terms of adaptation to the standards of the European Union. Emphasis placed on the fact that the state of domestic policy in the field of tourism does not meet modern world standards of industry management at the state level. In connection with the transition from a planned to a market model of state development in the last two decades, there have been clear problems that prevent the full use of the tourist and recreational potential of Ukraine. On the one hand, the underdevelopment of domestic tourism correlates with the general problems of political, social and economic nature inherent in developing countries at a certain stage of their development. On the other hand — the lack of the necessary methodological framework and lack of methodological developments for state regulation of tourism correlates with the impossibility of practical application of tourism laws, tourism development programs and the formation of tourism regulation structures at the national level, which directly and indirectly affect the adaptation of Ukrainian legislation and state-management activities in accordance with the standards of the European Union. Based on the results of doctrinal and comprehensive research, it concluded that in the context of promoting the gradual convergence of domestic and European public administration environment, strengthening economic and trade relations that will lead to Ukraine’s gradual integration into the EU internal market, expanding cooperation based on the rule of law and respect for the rule of law. Human rights and fundamental freedoms, the sphere of tourism occupies one of the key aspects not only at the national level but also at the international level. At the same time, in the context of adaptation of domestic legislation and public administration to EU standards, it is advisable to develop a methodology and action plan aimed at implementing the holistic guidelines and principles enshrined at the European level.

Comparative Analysis of Foundations of Legal Regulation of Criminal Liability for Organ Trafficking in the Russian Federation, Kazakhstan, and the European Union

2020 ◽  
Vol 11 (4) ◽  
pp. 1405
Author(s):  
Anna V. SEREBRENNIKOVA ◽  
Tatjana F. MINYASEVA ◽  
Nagima S. KALA ◽  
Alexei A. MALINOVSKY ◽  
Victoria M. MALINOVSKAYA ◽  
...  
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Russian Federation ◽  
Criminal Liability ◽  
National Level ◽  
Legal Regulation ◽  
The European Union ◽  
Organ Trafficking ◽  
The Russian Federation ◽  
The Creation

Currently, organ trafficking occupies a leading position among transnational organized criminal groups due to the high demand for illegal services and the relatively low rates of detection of illegal actions by law enforcement agencies. In this context, the purpose of the paper was to conduct a comparative analysis of the foundations of the legal regulation of criminal liability for organ trafficking and trafficking in the Russian Federation, Kazakhstan, and the European Union to form scientifically substantiated conclusions and suggestions for improving existing national legislation. To achieve this purpose, general scientific and special methods were used. The study also uncovers vectors and substantiates the feasibility of implementing EU legislation in the field of organ trafficking and trafficking in the criminal legislation of the Russian Federation and Kazakhstan, predicts the prospects for improving legal regulation on the subject matter and outlined the priority actions of legislative bodies. At the same time, promising areas of research in this matter are the issues of punishability of such acts and the appointment of the appropriate punishment. Furthermore, the creation of a highly regulated transplantation system at the national level was proposed, which is to be managed by a national transplantation authority with broad oversight powers. The creation of such a centralised competent authority will ensure the implementation of the scope of measures that would effectively reduce the risk of organ trafficking and trafficking and protect potential victims.

scholarly journals THE CONCEPT AND CONTENT OF PUBLIC ADMINISTRATION PROCEDURES IN THE FIELD OF INTELLECTUAL PROPERTY IN THE COUNTRIES OF THE EUROPEAN UNION

2021 ◽  
Vol 1 (2) ◽  
Author(s):  
Pavlo V. Makushev ◽  
◽  
Andriy V. Khrid�chkin ◽  
Keyword(s):  
European Union ◽  
Intellectual Property ◽  
Property Rights ◽  
Public Administration ◽  
Intellectual Property Rights ◽  
Case Law ◽  
Legal Regulation ◽  
The European Union ◽  
Goods And Services ◽  
Court Of Justice

The article considers the features of public administration in the field of intellectual property and the conceptual basis for the formation of its procedures in the European Union. The conceptual bases of formation and development of procedures of public administration in the field of intellectual property in the countries of the European Union are opened. The pluralism of approaches to the definition of public administration procedures in the field of intellectual property in the countries of the European Union is analyzed. The normative-legal base of procedures of public administration in the field of intellectual property in the countries of the European Union is given. The acts of the Court of Justice of the European Communities on public administration in the field of intellectual property are analyzed. It is proved that the formation of European private law is due to the purpose of creating and functioning of a common market. It is established that in the national legal systems of European countries the regulation of public relations in the field of intellectual property is given considerable attention. The process of improving the procedures of public administration in the field of intellectual property in the European Union is analyzed and the legal framework of this process is given. A feature of European Union law is to strengthen the protection of intellectual property rights through two main mechanisms: harmonization of legislation of member states of the European Union and the introduction of European Union protection documents for various intellectual property. Thus, other partner countries of the European Union, in addition to measures to approximate legislation, may decide on the signing of agreements on entry into the regional European system of protection of certain intellectual property. The member states of the European Union pursue a coherent policy in the field of legal protection and use of intellectual property. Guided by the principle of free movement of goods and services, they focus their efforts primarily on the unification and harmonization of legislation in the field of intellectual property and prevention of the use of intellectual property rights in unfair competition. Within the European Union, a system of direct regulation of the processes of unification and harmonization of legislation in the field of intellectual property, which is especially characteristic of the field of copyright and related rights. The Court of Justice of the European Communities plays a significant role in the unification and harmonization of the legal regulation of relations in the field of intellectual property. In the absence of appropriate harmonization of national legislation in the field of intellectual property with the principles of free movement of goods and services, as well as freedom of competition, proclaimed by the European Union, the importance of the case law of the European Court of Justice is difficult to overestimate. The beginning of unification and harmonization activities in the field of intellectual property protection is preceded by a stage of case law enforcement practice, which allows to identify existing gaps in legal regulation and solve relevant problems. At present, it is a question of the existence of a special system of intellectual property rights of the European Union, formed in its general features, built on principles different from the traditional national ones, with a special subject of regulation. At the same time, this system is a new legal phenomenon that is developing quite dynamically and rapidly along with national and international legal systems. The legal regulation of intellectual property relations in the European Union aims to ensure a high level of protection of these rights, as they are the legal basis for the protection of the results of creative activity. The conclusion about the urgency of research of problems of public administration in the field of intellectual property in the countries of the European Union is made.

scholarly journals The features of the contractual form of protection of subjective intellectual property rights for a cinematographic work under the laws of Ukraine and the countries of the European Union

2020 ◽  
pp. 323-328
Author(s):  
Kateryna Poturai
Keyword(s):  
European Union ◽  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Legal Regulation ◽  
General Concept ◽  
The European Union ◽  
Modern Development ◽  
The Creation ◽  
Civil Contract

The article reveals the features of the contractual form of subjective intellectual property rights to a cinematographic work underthe laws of Ukraine and the European Union as the main form of protection of cinematographic works.The author emphasizes that in modern development of copyright relations, civil law has abandoned the legislative consolidationof the concept of copyright agreement, yet only lists and discloses the sense of its types.Thus, at the legislative and theoretical level, the problem of classifying a copyright agreement on the creation of a cinematogra -phic work as an agreement on the alienation of exclusive rights or a license agreement still remains unresolved. At the present stage,the legal regulation of the creation and use of films is further complicated by the fact that many film studios instead of copyright agreementsenter into refit contracts on the creation of films.The author draws attention to the fact that the French legal doctrine does not see any difference between the subject of the contractand the content of the obligation and uses such concepts as synonyms. The French legislator does not give a general concept, whichwould reveal the main features of the copyright agreement. However, the provisions of the French Intellectual Property Code directlyindicate the possibility of assignment of the author’s property rights (succession in a certain part of copyright) on the basis of the cont -ract. In the French literature and in the practice of courts it is unanimously recognized that from the point of view of general civil lawthe assignment of exclusive property copyrights is in principle a civil contract of sale of property, in turn a license is a civil contract ofproperty lease.The author also emphasizes that there is a necessity to regulate the conclusion of copyright agreements with all subjects of a cinematographicwork, which may have intellectual property rights in connection with the creation of such a work.

Dopady na státní rozpočet v souvislosti s aplikací finančních oprav u evropských dotací

2021 ◽  
pp. 144-163
Author(s):  
Andrea Vuongová
Keyword(s):  
European Union ◽  
National Level ◽  
The State ◽  
The European Union ◽  
State Budget ◽  
European Legislation ◽  
Intended Purpose

As part of the protection of the European Union budget, European legislation sets out corrective mechanisms in cases where the funds provided have not been used in accordance with the intended purpose and rules. At the national level, there are a number of ways, as well as a number of obstacles, to returning funds to which a financial correction has been applied back to the state budget. The institute of budgetary discipline breach plays a key function for the return of unjustly used funds to the state budget. There is a difference between the funds that have not been reimbursed from the European Union due to the application of the correction and the funds recovered at the national level, this difference is a burden for the state budget. This paper will describe the circumstances of this difference, its causes and possible solutions.

POSSIBILITIES OF IMPROVEMENT THE PREPAREDNESS OF OFFICERS OF THE BORDER CONTROL AND IMMIGRATION CONTROL STRUCTURAL UNITS OF THE STATE BORDER GUARD FOR SCHENGEN EVALUATION ON-SITE VISITS

2016 ◽  
Vol 1 (6) ◽  
pp. 14 ◽  
Author(s):  
Iluta Arbidāne ◽  
Jekaterina Kuprijanova ◽  
Juris Garjāns ◽  
Viktorija Pokule
Keyword(s):  
European Union ◽  
Scientific Information ◽  
Present Situation ◽  
Legal Regulation ◽  
The State ◽  
General Context ◽  
Border Control ◽  
The European Union ◽  
Structural Units ◽  
Immigration Control

The aim of the research is evaluation of the present situation in Latvia concerning the preparedness of officers of the border control and immigration control structural units of the State Border Guard for Schengen evaluation on-site visits, examination of its legal regulation and practical aspects. In the research the scientific information about the Schengen evaluation historical development is summarised, its principles and mechanisms are reviewed, as well as its significance in the state border security is defined. The topicality of the theme is defined by the fact that in Latvia the regular Schengen acquis application evaluation started in July 2012 and it completed in May 2013. In practice the Member States’ evaluations are implemented on the basis of multiannual and annual evaluation programme. The next planned evaluation is foreseen in 2018. The new evaluation mechanism gave the possibility of organisation of unannounced evaluation on-site visits aiming at getting clearer picture of the present situation and working out recommendations for further actions to remedy any deficiencies in the external border control. It is obvious that the largest responsibility in Schengen acquis application enters the scope of competences of the institutions subordinate to the Ministry of the Interior, namely, the State Police and the State Border Guard. The issues of the research indicate how important and necessary is the complex approach to ensuring of Schengen evaluation on-site visits – both announced and unannounced – implementing the integrated border management in the general context of the European Union and contributing to the common state security in the European Union. In the research it was concluded that the State Border Guard implements a range of actions in accordance with its competence in the field in question, thus ensuring realisation of requirements on the corresponding level.  

scholarly journals Some Features of the Development of Legal Regulation of Ensuring the Border Security of the Member States of the European Union

2021 ◽  
Vol 4 ◽  
pp. 12-16
Author(s):  
Vladimir V. Kudinov ◽  
◽  
Elena G. Mukhina ◽  
Keyword(s):  
European Union ◽  
Legal Regulation ◽  
The State ◽  
Coast Guard ◽  
Border Security ◽  
The European Union ◽  
Member States

The article examines the peculiarities of the development of legal regulation of ensuring the border security of the Member States of the European Union on the external and internal sections of the state border; highlights the main forms of interaction and powers of the European Border and Coast Guard Service (hereinafter the Agency, Frontex, ESSPO) in the area under consideration; shows the main problems in ensuring the border security of the European Union.

scholarly journals Agricultural production of genetically modified products as a means of ensuring food security: European experience in legal regulation

2020 ◽  
pp. 42-53
Author(s):  
Tatiana Vladimirovna Rednikova
Keyword(s):  
European Union ◽  
Agricultural Production ◽  
Crop Production ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Legal Regulation ◽  
Scientific Data ◽  
The European Union ◽  
Commercial Use ◽  
European Experience

The article deals with the issues of legal regulation of the use of genetically modified organisms in the process of agricultural production in the European Union.The solution to the problems of agricultural production intensification is primarily possible through the use of new modern intensive technologies of crop production, animal husbandry and fisheries, which are also developed on the basis of the latest achievements of the biotechnological industry. One of the directions of intensification of agricultural production is the use of genetically modified crops, which allows increasing the profitability of growing plants, ensuring their increased resistance to negative climatic conditions, pathogens of infectious diseases, etc. The possibility of using such technologies is related to the need to assess their potential risk to the environment and human health.For almost 20 years, the European Union has had a fairly developed system of regulations governing various aspects of the use of genetically modified organisms in agriculture. However, their commercial use in the European Union for various reasons (complexity of administration, negative attitude in society, etc.) has not become widespread over time, and in most member States has now been banned. Taking into account the European experience, the author concludes that it is necessary to use other methods to intensify agricultural production, and the ban on the commercial use of genetically modified organisms in food production is justified due to insufficient scientific data on their safety for human health and the environment

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