scholarly journals Legal Basis of State Support for Creating Innovative Medicinal Products

2021 ◽  
Vol 81 (2) ◽  
pp. 21-26
Author(s):  
S. V. Vasyliev
Keyword(s):  
Pharmaceutical Industry ◽  
Scientific Research ◽  
Legal Regulation ◽  
The State ◽  
Medicinal Products ◽  
State Support ◽  
Public And Private ◽  
Development Fund ◽  
Private Partnership ◽  
The Creation

The study is focused on the legal regulation of state support for the creation of innovative medicinal products. Establishment of the measures of state support for scientific research for creating innovative medicinal products within legislative acts and by-laws should help to increase the competitiveness of the pharmaceutical industry in Ukraine. The government declares the provision of support for scientific research in the field of creating innovative medicinal products. The legislation establishes the conditions for registering an innovative project, provides the maintenance of the Register of scientific institutions that received the state support. A detailed characteristic of the existing means of the state support for scientific research in the pharmaceutical industry is provided. The state supports innovations by establishing tax incentives for research institutions and providing funding for some innovative projects. Support for innovations is carried out by the State Innovative Financial and Credit Institution, the National Research Fund of Ukraine and the Innovation Development Fund. Funding for the creation of innovative medicinal products can be realized through public and private partnership. The scholars have declared their propositions regarding the introduction of specific measures of the state support for innovations in the field of creating new medicinal products. It has been offered to amend the current legislation on the issues of state funding of scientific research in the sphere of developing new medicinal products. It is necessary to delineate the competence of various funds for promoting innovations in relation to supporting innovations in the field of pharmacia. It is important that the law should provide the procedure and conditions for supporting public and private partnership projects at the expenses of funds for promoting innovations.

Investment legislation of Ukraine and national investment security

2019 ◽  
pp. 13-19
Author(s):  
V. Kudriavtseva
Keyword(s):  
Scientific Research ◽  
Economic Security ◽  
State Regulation ◽  
The State ◽  
Investment Policy ◽  
State Support ◽  
Investment Activity ◽  
Economic Relations ◽  
The Creation ◽  
National Investment

Problem setting. This article deals with the problems of forming the legislative mechanism of creation and state support of the legal investment order, which should ensure the functioning of the investment market in the mode of observance of the principle of freedom of investment activity and at the same time real providing the national economy with investments in the necessary quantitative and qualitative parameters for the expanded reproduction of competitive socially-based production, without the use of excessive enforcement mechanisms labor, intellectual, financial and natural resources of the country and ensure the state of investment security. Analysis of scientific research. It is significant that public procurement has been the subject of scientific research by experts in commercial law: D.V. Zadikhaylo, V.K. Mamutov, O.P. Podserkovniy, V.A. Ustimenko, V.S. Shcherbinа, etc. The purpose of this scientific article is to identify the key problems of the formation of the legislative mechanism for the creation and state support of the legal investment order, which should ensure the functioning of the investment market and ensure the state of investment security. Article’s main body. The concept of national investment security, which is part of the national economic security of the country as a whole, is to systematically prevent the threat of a critical shortage of investment resources through the creation and state support of an appropriate legal investment order. The lack of a clear and systematic definition in the legislation of Ukraine of the legal mechanism of state regulation of economic relations, including investment, is a disadvantage, which frankly reduces the state’s ability to effectively influence economic processes and, consequently, its ability to fulfill its functional responsibilities in the sphere of economy. The investment component is a special subsystem of economic security that creates prerequisites for the best use of socio-economic relations in the development and scientific and technical restoration of productive forces of society through active investment activity. In studying the structure of the investment component we propose to take into account: inclusion of the investment component in the system of economic security of Ukraine; differentiation of the investment component by different levels of economy (country, region, industry, enterprise); the property of synergism, that is, the investment component of the economic security of the country is not a mere set of investment components of the economic security of regions and enterprises; formation of an investment component under the influence of many objective factors; the occurrence of various risks as a result of appropriate conditions. Conclusions and prospects for development. That’s why there is a need to develop and substantiate a system of initial concepts related to the economic and legal support of the implementation of the investment policy of the state: the investment market, the investment policy of the state, the legal investment policy of the state, the legislative investment policy of the state, the mechanism of formation of the legal investment policy, investment order and national investment security, etc.

scholarly journals State private partnership as a public policy tool under decentralization of power in Ukraine

2020 ◽  
Vol 8 (6) ◽  
pp. 192-203
Author(s):  
Тetiana Sokolska ◽  
Viktoriia Panasiuk ◽  
Svitlana Polishchuk ◽  
Bohdan Osypenko
Keyword(s):  
Public Policy ◽  
Institutional Support ◽  
Legal Regulation ◽  
Economic Benefits ◽  
Policy Formation ◽  
The State ◽  
Sustainable Rural Development ◽  
Public Authorities ◽  
Public And Private ◽  
Private Partnership

The article considers the issue of public policy formation in terms of state private partnership development as the most efficient form of interaction between public authorities, private business and science implemented on the principles of equality.The study defines the essence of the concept of ‘state private partnership (SPP), its purpose, forms, areas of implementation and characteristics from the standpoint of institutional theory and identifies the benefits of state private partnership. The partnership comprises the possibility of attracting additional financial resources that can be used for community development, the possibility to restore infrastructure, to receive quality services and socio-economic benefits and additional jobs; business and the state share the risks.The study investigates the state of public and private partnership realization in Ukraine and the leading countries and defines risks for public authorities and the private investor as well as factors constraining this process in Ukraine. These include imperfect regulatory and institutional support, lack of political will; lack of standard, simple and transparent tender procedures for SPP projects and defined priority areas for their implementation, unstable legislation on attracting foreign direct investment.The study examines the current state of legal regulation state private partnership in Ukraine and justifies the need to improve the institutional support of this process in terms of forming public policy to involve regional higher education institutions into examination of innovative projects and the staff training.The expediency of introduction of state private partnership relations as a form of cooperation between public administration bodies and private economic entities for the purpose of sustainable rural development in the conditions of decentralization of power is substantiated. In order to ensure the effective implementation of state private partnership projects, public authorities should pay attention to creating a number of mandatory general prerequisites and ensure a proper examination of documents provided by potential private partners to make sure they show the real situation through involving scientists in this process.

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.

Use of the public-and-private partnership agreements in the conditions of imperfection of legal regulations in the Russian Federation

2021 ◽  
pp. 55-62
Author(s):  
I. S. Polyakova
Keyword(s):  
Russian Federation ◽  
Legal Regulation ◽  
Controversial Issues ◽  
Legal Regulations ◽  
Infrastructure Projects ◽  
Public And Private ◽  
Private Partnership ◽  
The Public ◽  
Private Investments ◽  
The Russian Federation

The objective of this research is to consider some controversial issues of the development of public-and-private partnership (and concession agreements as its most common form) in Russia. Some complaints made by Federal Antimonopoly Service of the Russian Federation to some infrastructure projects are reviewed. The author studied dynamics of private investments into infrastructure projects in the conditions of imperfect legal regulation. The assessment of the validity of the position of Federal Antimonopoly Service is given. It is predicted whether the legislative collisions will prevent the growth of private investments into infrastructure. Recommendations on the development of the mechanism of public-and-private partnership with the observance of antimonopoly regulation, as well as recommendation on the improvement of the legislation in this area are developed. The results of the research can be used by both private participants of public-and-private partnership and the federal, regional and municipal authorities, and also by legislators working on the improvement of the legislative regulation in this area.

scholarly journals RELAÇÃO PÚBLICO-PRIVADO NA EDUCAÇÃO BÁSICA: a democratização da educação?

2017 ◽  
Author(s):  
Vera Maria Vidal Peroni
Keyword(s):  
Public Education ◽  
Educational Policy ◽  
Public Private Partnership ◽  
The State ◽  
Social Rights ◽  
Public And Private ◽  
Private Partnership ◽  
Role Of The State ◽  
Brazilian Case

O artigo trata das redefinições no papel do Estado, que reorganizam as fronteiras entre o público e privado e materializam-se das mais diferentes formas na educação básica pública, e suas implicações para o processo de democratização da educação. No caso brasileiro, muito lutamos no período de abertura política pela democratização com direitos sociais materializados em políticas. Mas, ao mesmo tempo em que avançamos nos direitos conquistados, também foi naturalizado que o Estado não seria mais o principal executor.Palavras-chave: parceria público-privada em educação; política educacional; democratização da educação.The article deals with the redefinitions of the role of the state, which reorganize the boundaries between public and private that materialize in many different forms in basic public education, and their implications for the process of democratization of education. In the Brazilian case, we have struggled so hard since the so-called ‘opening period’ of political democratization with social rights materialized in public policies. However, while we have advanced in the conquered rights, at the same time the idea of the State as the main provider no longer prevails.Keywords: public-private partnership in education; educational policy; democratization of education

scholarly journals Priority-partnership approach as a mechanism for encouraging investment activities at the railway transport

2019 ◽  
Vol 67 ◽  
pp. 04014
Author(s):  
Oleg Vasyliev ◽  
Volodymyr Volokhov ◽  
Inna Volokhova ◽  
Olena Lukianova ◽  
Hanna Zhovtiak
Keyword(s):  
Global Economy ◽  
Structural Changes ◽  
Public Private Partnership ◽  
The State ◽  
Railway Transport ◽  
Public And Private ◽  
Private Partnership ◽  
The Public ◽  
Modern Economic ◽  
Partnership Approach

Modern economic conditions and the integration of the national economy into the global economy require structural changes and a search for a new model of relationship between the public and private sectors. The relevance of this article is determined by the fact that the existing scientific concepts have not formed a general understanding of the theoretical aspects for the implementation of public-private partnership at the railway transport, have not established development priorities and tasks of the state in the implementation of the mechanism of public-private partnership at the railway transport. Realization of the projects capable of maintaining implementation of the development priorities of the railway industry requires significant investments of private business and financial, organizational and legal support of the state. The authors substantiate the necessity of using public-private partnership at the railway transport of Ukraine for solving the most urgent current problem – renewal of the material and technical resources and bringing them in line with the requirements of the leading European countries. The proposed priority-partnership approach and the obtained results open up new opportunities for further research into the solution of the problem regarding the implementation of public-private partnership at the railway transport.

scholarly journals Public-and-private partnership development under conditions of the imperfect legal regulation

2019 ◽  
Vol 110 ◽  
pp. 02162
Author(s):  
Irina Polyakova ◽  
Elena Vasilyeva
Keyword(s):  
Russian Federation ◽  
Legal Regulation ◽  
Controversial Issues ◽  
Infrastructure Projects ◽  
Public And Private ◽  
Private Partnership ◽  
Partnership Development ◽  
Private Investments ◽  
Legislative Regulation ◽  
The Russian Federation

The objective of this research is to consider some controversial issues of the development of public-and-private partnership (and concession agreements as its most common form) in Russia. Some complaints made by arising from Federal Antimonopoly Service of the Russian Federation to some infrastructure projects are reviewed. The authors studied dynamics of private investments into infrastructure projects in the conditions of imperfect legal regulation. The assessment of the validity of the position of Federal Antimonopoly Service is given. It is predicted whether the legislative collisions will prevent the growth of private investments into infrastructure. Recommendations on the development of the mechanism of public-and-private partnership with the observance of antimonopoly regulation, as well as recommendation on the improvement of the legislation in this area are developed. The results of the research can be used by both private participants of public-and-private partnership and the federal, regional and municipal authorities, and also by legislators working on the improvement of the legislative regulation in this area.

scholarly journals PUBLIC-PRIVATE PARTNERSHIP AS AN INSTRUMENT OF STATE INVESTMENT POLICY: ECONOMIC MODELS AND LEGAL REGULATION

2021 ◽  
Vol 4 (27) ◽  
pp. 28-34
Author(s):  
V.A. Kulikov ◽  
◽  
Keyword(s):  
Great Britain ◽  
Legal Regulation ◽  
The State ◽  
Investment Policy ◽  
Financial Policy ◽  
Private Partnership ◽  
Foreign Countries ◽  
The Russian Federation ◽  
State Investment ◽  
Legal Forms

The article presents the organizational and legal characteristics of public-private part-nership as one of the effective instruments of state financial policy. The origin of the PPP institute in foreign countries is considered: Great Britain, USA, etc. The branches of law regulating PPP in the Russian Federation are characterized. The advantages of PPP for the state and business are described: reducing the burden on the budget, access to state assets, synergy of the administrative resource of the state and the innovative po-tential of business, etc. The PPP models are characterized: ВОТ, DBOT, BOOT, etc., as well as organizational and legal forms of PPP implementation: concession, life cycle partnership, etc.

scholarly journals Delegation of State Powers to Local Self-Government Bodies: Foreign Experience and Ukrainian Realities

2019 ◽  
Vol 9 (3) ◽  
pp. 262-285
Author(s):  
Svitlana Serohina ◽  
Iryna Bodrova ◽  
Anna Novak
Keyword(s):  
Local Governments ◽  
Comparative Research ◽  
Scientific Research ◽  
Legal Regulation ◽  
The State ◽  
Logical Analysis ◽  
Foreign Experience ◽  
Depth Analysis ◽  
European Standards ◽  
Delegation Of Powers

AbstractThis article is devoted to the study of the problems of the delegation of state powers to local self-government bodies. The paper reveals the pluralism of approaches to the organization of models of such interaction in the countries where various doctrines of the organization and functioning of local self-government prevail (the state-oriented doctrine, the community-oriented doctrine, and the doctrine of municipal dualism). Using the example of various European states (grouped on the basis of the prevailing doctrines presented above for convenience), we reveal specific schemes for the legal regulation of interaction within such relations, their positive features, and drawbacks. The obtained data presented in a compressed form in the paper also features an in-depth analysis of the constitutional and legal regulation of the delegation of state powers to local governments in Ukraine. An important element of the novelty of the study was the projection of modern Ukrainian problems in the field of delegated powers through the prism of the existing European systems and relevant experience, thereby complementing this study with a comparative dimension.Conclusions made by the authors feature a set of recommendations based on the conducted comparative research and on formal and logical analysis of compliance of the domestic model of the delegation of powers with the provisions of the European Charter of Local Self-Government. Taking into account the fact that European standards in the sphere of the delegation of powers (depends on the adoption of amendments to the Constitution of Ukraine and the Law ‘On delegation of separate powers of executive authorities to local self-government bodies’) are not yet implemented in Ukraine, we believe that this research will not only be useful in the context of theoretical and scientific research of the issue but also has the potential to contribute to the development and implementation of relevant legislation.

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