scholarly journals Legal differentiation in the case of domestic legislative default in the field of intellectual property for medicines

2020 ◽  
pp. 311-318
Author(s):  
Iuliia Vishar
Keyword(s):  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Legal Regulation ◽  
Pharmaceutical Products ◽  
The State ◽  
Regulatory Framework ◽  
Pharmaceutical Market ◽  
Unfair Competition ◽  
Definition Of ◽  
The Impact

Within the framework of this article, it is pointed out the importance of legal order in the created domestic regulatory and legalframework of intellectual property for medicines on the basis of international legislation, implemented by approximating national le -gislation to the norms of the European Community law in this area. The disadvantages of the standard approaches of Ukrainian lawmakingin the intellectual pharmaceutical industry to the transformation of legal experience in the pharmaceutical industry of the EuropeanCommunity, which give rise to the domestic legislative default, are presented.Impartially considered the impact of the lack of clarity of the current legislation on intellectual property in pharmaceuticals onthe formation of legally defective, with protective and protective helplessness, intellectual property objects for medicines, which are amanifestation of the legal incompetence of national legislators.The negligent attitude of domestic legislators to the uncertainty in the content of the above changes to the laws that have a directimpact on the definition of the concepts of intellectual property objects for medicines, forms a deformed regulatory and legal basis forpatenting in this area – the ground for possible violations in the form of patent trolling, counterfeit pharmaceutical products, corruptionschemes in medicine, unfair competition, falsification of drugs, and the like, where, first of all, the safety, quality and effectiveness ofdrugs are leveled.The importance of legal differentiation and the need for legal sorting, the renewal of the national legal system to consolidate thesystem of legal regulation of the intellectual pharmaceutical industry by increasing the transparency of the pharmaceutical market andthe responsibility of its participants are noted.Indicated on the negligent attitude of domestic lawmakers to the uncertain classification of inventions in pharmaceuticals, which,like the above definitions of the concepts of intellectual property for medicines, forms a deformed regulatory framework for patentingin this area – the basis for possible offenses in the form of patent trolling, counterfeit pharmaceutical products, corruption schemes inmedicine, unfair competition, falsification of drugs, etc., where, first of all First, the level of safety is leveled, as are the spines andeffectiveness of drugs. At the same time, it should be noted that the lack of results of proper judicial practice in the field of intellectualproperty for medicinal products is an indicator of non-functioning legislative mechanisms for the transformation of the European legalsystem into a national regulatory framework. The importance and necessity of restoring ecological pharmacies to consolidate the system of legal regulation of the intellectualpharmaceutical industry by increasing the transparency of the pharmaceutical market and the responsibility of its participants is indicated.In our opinion, the legislation in this priority for the state strategy area should be reviewed to eliminate recurrences and contradictionsbased on the implemented system of monitoring, competent legal analytics and control of compliance of Ukrainian legislationwith EU legislation. In turn, a well-functioning, fully documented pharmaceutical quality system must be developed that should includeGood Manufacturing Practices (GMPs) with quality control and risk management for quality at the stage of intelligent product creation.Thus, the underestimated pharmacy business, where extracorporeal medicines created in the conditions of individual production(manufacturing) with ensuring compliance with their purpose, the requirements of regulatory (analytical, technical, technological) do -cu ments, the State Pharmacopeia of Ukraine, and exclusion of risks for patients, may unreasonably have features patentability, basedon international experience, as a manifestation of relevant medicine.

scholarly journals On legislative interoperability in civil law protection of intellectual property rights for medicinal products

1970 ◽  
pp. 254-262
Author(s):  
Iuliia Vishar
Keyword(s):  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Medicinal Product ◽  
European Community ◽  
Legal Regulation ◽  
The State ◽  
Regulatory Framework ◽  
Medicinal Products ◽  
National Legislation ◽  
Independent Expert

In the framework of this article, attention is drawn to the importance of legal ordering in the created domestic regulatory framework of intellectual property for medicines on the basis of international law, implemented by approximating national legislation to the norms of the European Community law system in this area. The shortcomings of the standard approaches of Ukrainian lawmaking in the intellectual pharmaceutical industry to the transformation of legal experience in the pharmaceutical industry of the European Community, generating domestic legislative eclecticism, are presented. The effect of omitting the clarity of the definitions of the basic concepts in the regulatory legal acts of the national legislation, namely: «homeopathic medicines», «confidential registration information», «independent expert», «reference medicinal product», «original (innovative ionic preparation)», «unlawful use of natural information on the safety and efficacy of a medicinal product», «a similar biological preparation (biosimilar)», on intellectual property in the pharmaceutical industry on the education of legally inferior, with protective and protective helplessness, intellectual property objects for medicines, which is a manifestation of the legal incompetence of national legislators. Indicated on the negligent attitude of domestic lawmakers to the uncertain classification of inventions in pharmaceuticals, which, like the above definitions of the concepts of intellectual property for medicines, forms a deformed regulatory framework for patenting in this area - the basis for possible offenses in the form of patent trolling, counterfeit pharmaceutical products, corruption schemes in medicine, unfair competition, falsification of drugs, etc., where, first of all First, the level of safety is leveled, as are the spines and effectiveness of drugs. At the same time, it should be noted that the lack of results of proper judicial practice in the field of intellectual property for medicinal products is an indicator of non-functioning legislative mechanisms for the transformation of the European legal system into a national regulatory framework. The importance and necessity of restoring ecological pharmacies to consolidate the system of legal regulation of the intellectual pharmaceutical industry by increasing the transparency of the pharmaceutical market and the responsibility of its participants is indicated. In our opinion, the legislation in this priority for the state strategy area should be reviewed to eliminate recurrences and contradictions based on the implemented system of monitoring, competent legal analytics and control of compliance of Ukrainian legislation with EU legislation. In turn, a well-functioning, fully documented pharmaceutical quality system must be developed that should include Good Manufacturing Practices (GMPs) with quality control and risk management for quality at the stage of intelligent product creation. Thus, the underestimated pharmacy business, where extracorporeal medicines created in the conditions of individual production (manufacturing) with ensuring compliance with their purpose, the requirements of regulatory (analytical, technical, technological) documents, the State Pharmacopeia of Ukraine, and exclusion of risks for patients, may unreasonably have features patentability, based on international experience, as a manifestation of relevant medicine.

scholarly journals REGULATORY MECHANISMS OF UKRAINIAN PHARMACEUTICAL MARKET COMPETITIVENESS IN THE CONTEXT OF EUROPEAN INTEGRATION

2020 ◽  
Vol 1 (3) ◽  
pp. 1-8
Author(s):  
Iryna Budnikevych ◽  
Vadym Honchar
Keyword(s):  
Foreign Trade ◽  
Pharmaceutical Products ◽  
The State ◽  
Pharmaceutical Market ◽  
Trade Regulation ◽  
Pharmaceutical Markets ◽  
Medical Supplies ◽  
Regulation Mechanisms ◽  
Definition Of ◽  
The Eu

The purpose of the paper is to summarize and present the differences in the competitive environment of the European Union (EU) and Ukrainian pharmaceutical markets. The method of longitudinal study allowed to detect the patterns of changes and correlations for pharmaceutical products exports and imports volumes over twenty years (2001-2020). Methodology. The research is based on the definition of the pharmaceutical market as a complex socio-economic institution that fulfills the function of pricing medical products and utilizes them to ensure health care functioning. It indicates the population’s wellbeing and requires ongoing maintenance based on needs agreement of households, economic entities, and the state. The quantitative research is based on export-to-import coverage ratio calculations with the identification of pharmaceutical products fraction in the total volume of foreign trade, including the one with the EU. The results of the paper consist in the evaluation of the competitive environment of the European Union’s pharmaceutical market and statistical assessment of Ukrainian foreign trade of pharmaceutical products. They also include the definition of the European integration influence over the Ukrainian pharmaceutical market and well-reasoned recommendations about the application of the state and trade regulation mechanisms. In the paper, we defined the distinctive features of the European countries’ pharmaceutical markets and outlined their main characteristics that have connections to the transnational corporation’s activities, common market, and high concentration. Statistical data collected over 20 years indicated the dynamic development of the Ukrainian pharmaceutical market, despite its small-scale contribution to the foreign trade turnover. The dependence of Ukraine on the foreign supplies of drugs and medications is illustrated by the multiple excesses of imports over exports, especially in the trade relationships with the EU. The EU countries are the leading importers of pharmaceutical products to the Ukrainian market. However, the share of medical supplies exports from Ukraine to the EU countries is negligible. Their key exporters are post-Soviet and developing countries. The growth in Ukraine’s export potential is inextricably linked to the expansion of the competitiveness of domestic medical supplies. Practical implications consist in the development of recommendations concerning the GMP and GDP demands realization, domestic manufacturers cooperation with the leading foreign pharmaceutical companies, the penetration of transnational companies into the Ukrainian domestic pharmaceutical market based on imports of innovative technologies, the improvement of the marketing management of the pharmaceutical products exporting. The priority factor in the growth of the competitiveness of the Ukrainian pharmaceutical market is a successful combination of state and trade regulation mechanisms. The objects of these factors are the pricing policy for material resources and finished products, the introduction of innovations, tax exemptions, and export-import quotas implementation. They also include the establishment of traffic rates that depend on the market saturation with socially significant medical supplies, budget support of the prioritized subsectors of the pharmaceutical industry, and patent protection. The expected results concern the decrease in the dependence of the Ukrainian pharmaceutical market on the foreign distribution of the raw materials and finished products and strengthening the positions of the Ukrainian manufacturers in foreign markets. Value/originality. We evaluated the competitiveness of the national pharmaceutical market based on the criteria of foreign trade performance and detected the priorities of its growth, taking into consideration the synthesis of the state and trade regulation mechanisms.

Prospects for the development of Russian pharmaceutical products in the process of forming the single market of the Eurasian Economic Union

2018 ◽  
Vol 35 (4) ◽  
pp. 3-10
Author(s):  
V. L. Abramov
Keyword(s):  
Pharmaceutical Industry ◽  
Economic Integration ◽  
Pharmaceutical Products ◽  
Single Market ◽  
The State ◽  
Pharmaceutical Market ◽  
Member States ◽  
Economic Space ◽  
Eurasian Economic Union ◽  
Economic Union

The article analyzes the state and dynamics of the development of the Russian pharmaceutical industry. There is given an assessment of the state and trends of exports of its products to the member states of the Eurasian Economic Union, as well as the countries of the post-Soviet economic space. Opportunities and prospects for the development of the Russian pharmaceutical industry in the process of formation of the single market of the EEU, the use of regional economic integration opportunities are substantiated. Proposals have been formulated to increase the export potential and international competitiveness of the Russian pharmaceutical industry, to develop integration processes of forming a single pharmaceutical market for the member states of the EEU.

scholarly journals State national security policy and intellectual property issues

2021 ◽  
pp. 19-33
Author(s):  
Oleksandr Zaikivskyi ◽  
Oleksandr Onistrat
Keyword(s):  
Intellectual Property ◽  
National Security ◽  
State Policy ◽  
Security Policy ◽  
The State ◽  
Destabilizing Factors ◽  
Definition Of ◽  
Political Economic ◽  
The Impact ◽  
Further Development

Keywords: state policy, national security, intellectual property National security (“NS”) of Ukraine is achieved through a balancedstate policy in accordance with accepted doctrines, strategies, concepts and programsin such areas as political, economic, social, military, environmental, scientific andtechnological, information, etc.However, many theoretical and practical issues concerning the definition of thecontent, challenges, tasks and mechanisms of implementation of effective functions ofpublic policy and management decisions for the further development of social processesstill remain insufficiently studied. Therefore, the main tasks of the NS system subjectsare constant monitoring of the impact on NS of processes taking place in variousfields (including intellectual property), forecasting, identifying and assessing possiblethreats, destabilizing factors and conflicts, their causes and occurrence consequences.In particular, the impact on NS (especially on defence capabilities) of the significantdevelopment of intellectual property and the full use of intellectual property rights isnot taken into account at all.State NS policy should include measures to prevent the emergence and neutralizationof sources of threats to NS under the influence of the development of intellectualproperty.Theoretical aspects of the state policy of National Security and Defence of Ukraine(“NSDU”) development are considered. The necessity of current problems definition inthis sphere and the inclusion of intellectual property questions in these processes isinvestigated. It is determined that the effective implementation of the state NS policyis impossible without a comprehensive analysis of intellectual property issues impacton the sphere of the NSDU. The importance of further research on the development ofa unified approach to improving the protection of intellectual property and its determinationas a component of NSDU, the development of appropriate recommendationsto address issues of intellectual property in this area and to neutralize sources ofthreats under the influence of intellectual property in the structure of NSDU.

scholarly journals Protection of genomic research data as the objects of intellectual property

2020 ◽  
pp. 167-178
Author(s):  
Olesia Valer'evna Belaia
Keyword(s):  
Intellectual Property ◽  
Civil Law ◽  
Legal Protection ◽  
Legal Regulation ◽  
Trade Secret ◽  
Pharmaceutical Products ◽  
Research Data ◽  
Genomic Research ◽  
Intellectual Activity ◽  
Definition Of

The object of this research is the determination of legal nature of genomic research data and their role among the objects of civil law. The subject of this research is the data of preclinical and clinical studies of pharmaceutical products, mostly those that contain biomaterial and biomedical cell products. The author underlines the problem of the absence of due legal regulation of genomic research data as the objects of law within Russian legislation, as well as protection of their rightsholders from anticompetitive use. The author reveals the possibility of recognizing genomic research data as the results of intellectual activity that are subject to legal protection as objects of intellectual property, as well as the need to enshrine them in the provisions of the Part 4 of the Civil Code of the Russian Federation. The main conclusion consists in the substantiation of the need for protection of genomic research data as the objects of civil law. Arguments are adduced on the potential reference of genomic research as the results of intellectual activity to the objects of intellectual property. The list of data that may comprise trade secret is subjected to critical analysis. The author proposes the original classification of the results of intellectual activity as the objects of intellectual property from the perspective of the presence of creative beginning as directly invented by human, and indirectly reflecting the result of human activity. The conclusion is formulated on the independent nature of the results of genomic research as the objects of intellectual property in the form of the results of intellectual activity. The author underlines the need for protecting genomic research data as a variety of results of such tests as the know-how, as well as corresponding revision of legal definition of trade secret captured in civil legislation.

PERTANGGUNGJAWABAN KERUGIAN NEGARA DALAM PENGELOLAAN KEUANGAN DAERAH

EDUKASI ◽  
2018 ◽  
Vol 16 (1) ◽  
Author(s):  
Hendra Karianga
Keyword(s):  
Financial Management ◽  
Criminal Liability ◽  
The State ◽  
Legal Proceedings ◽  
Regional Finance ◽  
Regional Budget ◽  
State Finance ◽  
Budget Policy ◽  
Definition Of ◽  
The Impact

Sources of revenue and expenditure of APBD (regional budget) can be allocated to finance the compulsory affairs and optional affairs in the form of programs and activities related to the improvement of public services, job creation, poverty alleviation, improvement of environmental quality, and regional economic growth. The implications of these policies is the need for funds to finance the implementation of the functions, that have become regional authority, is also increasing. In practice, regional financial management still poses a complicated issue because the regional head are reluctant to release pro-people regional budget policy, even implication of regional autonomy is likely to give birth to little kings in region causing losses to state finance and most end up in legal proceedings. This paper discusses the loss of state finance and forms of liability for losses to the state finance. The result of the study can be concluded firstly,  there are still many differences in giving meaning and definition of the loss of state finace and no standard definition of state losses, can cause difficulties. The difficulty there is in an effort to determine the amount of the state finance losses. The calculation of state/regions losses that occur today is simply assessing the suitability of the size of the budget and expenditure without considering profits earned by the community and the impact of the use of budget to the community. Secondly, the liability for losses to the state finance is the fulfillment of the consequences for a person to give or to do something in the regional financial management by giving birth to three forms of liability, namely the Criminal liability, Civil liability, and Administrative liability.Keywords: state finance losses, liability, regional finance.

FEATURES OF THE STRUCTURE AND SUBJECTIVE COMPOSITION OF CONTRACTUAL RELATIONS WITH THE PARTICIPATION OF JSC «SCIENTIFIC AND PRODUCTION CORPORATION «PRECISION INSTRUMENTATION SYSTEMS»

2020 ◽  
Vol 1 (6) ◽  
pp. 42-46
Author(s):  
S.V. DOROZHINSKY ◽  
Keyword(s):  
Public Procurement ◽  
Legal Regulation ◽  
The State ◽  
Regulatory Framework ◽  
Contractual Relations ◽  
Procurement System ◽  
State Defense

The article discusses the features of procurement in the framework of the state defense order by conducting trade procedures. The analysis shows that the regulatory framework for state defense orders includes both general acts for the entire public procurement system and special acts regulating relations specifically in the field of defense orders. The features of legal regulation in this sphere are determined, first of all, by the defense order specifics, but, primarily, this sphere as a whole is subject to the rules of legal regulation common to the sphere of public procurement.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

Features of the legal status of subjects of Civil Law

2021 ◽  
Vol 28 (2) ◽  
pp. 181-188
Author(s):  
Iryna I. Banasevych ◽  
Ruslana M. Heints ◽  
Mariia V. Lohvinova ◽  
Oksana S. Oliinyk
Keyword(s):  
Legal Status ◽  
Civil Law ◽  
Historical Analysis ◽  
Legal Regulation ◽  
The State ◽  
Roman Law ◽  
Historical Method ◽  
Legal Method ◽  
Definition Of ◽  
Legal Entities

Theoretical and applied research of the features of the legal status of the subjects of civil law remains debatable today. Doctrinal and legislative analysis of this subject points to unresolved issues in this area. In particular, the provision on defining the state as a party to civil law remains controversial. There is no consensus on the definition of individuals and legal entities as subjects of civil law among scholars. Furthermore, the legal regulation of certain types of entities is somewhat unsystematic and chaotic. This is largely due to the insufficient development of theoretical issues related to the subjects of civil law. The above issues determine the relevance of the study of the features of the legal status of subjects of civil law. The purpose of the study is to investigate the features of the legal status of subjects of civil law based on doctrinal and legislative analysis. The study is based on a systematic approach, which lies in studying a complex system of relationships between subjects of civil law. Furthermore, the study is based on the laws and principles of dialectics, which contribute to the study of the legal status of the subjects of civil law. Systemic and structural-functional analysis was used to comprehensively describe the legal status of subjects of civil law. The historical method contributed to the study of the evolution of research on the subjects of civil law. The formal legal method helped identify the special features of the provisions of regulations concerning the subjects of civil law. With the help of the comparative legal method, the study analysed the provisions of the Civil Code of Ukraine in terms of regulation of subjects of civil law and such regulation was compared with other countries. The study defined the concepts and types of subjects of civil law and considered the features of the legal status of individuals, legal entities, as well as the state as a special participant of civil law. Special attention was paid to the historical analysis of the development of approaches to the definition of subjects of law, starting with Roman law

scholarly journals Legal regulation of legal relations in the field of land accounting

2019 ◽  
Author(s):  
D. Kondratenko
Keyword(s):  
Public Relations ◽  
Local Governments ◽  
Legal Regulation ◽  
The State ◽  
Main Body ◽  
Public Authorities ◽  
Registration System ◽  
Land Registration ◽  
Land Relations ◽  
Definition Of

Problem setting. The article analyzes the issue of legal relations in the field of land accounting. The legal nature of public relations in this area has been clarified. The accounting of the quantity and quality of land is investigated. The author’s definition of legal relations in the field of land accounting is provided. The circle of subjects of these legal relations is outlined. Analysis of recent researches and publications. To date, in the scientific literature there is no comprehensive study of the legal regulation of legal relations in the field of land accounting. There are only developments devoted to certain issues of land law science. Target of research. The study of the legal regulation of legal relations arising in the field of land accounting, the allocation of subjects of these legal relations. Article’s main body Justification of the appropriateness of obtaining, systematizing all the resources available on the land plot, determining the size, quality status and distribution of the land fund, providing the necessary data about the land, studying the legal relations arising on this occasion. The basis of the land registration and registration system in Ukraine is the State Land Cadastre. It reflects the subjective information on land, which accumulates as a result of land accounting. Such information is necessary primarily for the implementation of state control over the use, reproduction and protection of land. Only a legally regulated and wellmaintained process of conducting accounting and registration activities in the field of land relations can become the key to the introduction and functioning of a transparent mechanism for the circulation of land in market conditions and an effective mechanism for managing them. In this aspect, it is important to note that it is necessary to distinguish land accounting in the proper sense and land rights accounting (as a broader category compared to the first). In the context of the land registration reform and the further process of improving the State Land Cadastre, it is necessary to talk about the formation of land information relations. Conclusions and prospects for the development. Land accounting relationships are public relations that arise in connection with the activities of public authorities and local governments, which are endowed with appropriate powers to take measures to obtain, systematize and analyze information on the quantity, territorial location and use of land. The subjects of these legal relationships are landowners and land users, the state, state authorities and local selfgovernments, who are vested with the respective powers.

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