National security: health care, pandemic (COVID-19) and the global trade in counterfeit pharmaceuticals (part 2)

2021 ◽  
pp. 52-62
Author(s):  
H. O. Androshchuk
Keyword(s):  
Intellectual Property ◽  
National Security ◽  
Poverty Line ◽  
Third Wave ◽  
Legal Analysis ◽  
Management Measures ◽  
Timely Response ◽  
Counterfeit Pharmaceuticals ◽  
The Impact ◽  
The Eu

Ukraine’s healthcare system faces unprecedented national security challenges in the third wave of the COVID-19 pandemic. A particularly acute issue is countering counterfeit pharmaceuticals, preventing drug shortages, joining efforts of the authorities and national manufacturers of drugs and medical supplies. According to the UN, more than 60 % of the population lives below the poverty line in Ukraine. Timely response to these challenges and taking preventive measures will save lives, minimize the volume and consequences of the pandemic. The paper provides an economic and legal analysis, trends, risks and threats to national security of the state and health protection during a pandemic, in order to protect intellectual property rights, adequate coordination of actions at the national and international levels. The impact of counterfeiting on the criminal landscape in the EU, and also business and economy, is shown based on the analysis of studies by the OECD, the EU Intellectual Property Office (EUIPO) and Europol. The foundations of anti-counterfeiting management, measures to implement a standard anti-counterfeiting strategy are proposed.

National security: health care, pandemic (COVID-­19) and the global trade in counterfeit pharmaceuticals (Part 1)

2021 ◽  
pp. 52-61
Author(s):  
H. O. Androshchuk
Keyword(s):  
Intellectual Property ◽  
National Security ◽  
Poverty Line ◽  
Third Wave ◽  
Legal Analysis ◽  
Management Measures ◽  
Timely Response ◽  
Counterfeit Pharmaceuticals ◽  
The Impact ◽  
The Eu

Ukraine’s healthcare system faces unprecedented national security challenges in the third wave of the COVID-19 pandemic. A particularly acute issue is countering counterfeit pharmaceuticals, preventing drug shortages, joining efforts of the authorities and national manufacturers of drugs and medicines. According to the UN in Ukraine more than 60% of the population lives below the poverty line. Timely response to these challenges and taking preventive measures will save lives, minimize the volume and consequences of the pandemic. The work provides an economic and legal analysis, trends, risks and threats to the national security of the state and health protection during a pandemic, in order to protect intellectual property rights, adequate coordination of actions at the national and international levels. Based on the analysis of studies by the OECD, the EU Intellectual Property Office (EUIPO) and Europol shows the impact of counterfeiting on business and the economy, the criminal landscape in the EU. The basics of the anti-counterfeiting management, measures to implement a standard anti-counterfeiting strategy are proposed.

The European framework for intellectual property rights for biological medicines

2021 ◽  
Vol 10 (4) ◽  
pp. 172-183
Author(s):  
Josette Sciberras ◽  
Raymond Zammit ◽  
Patricia Vella Bonanno
Keyword(s):  
Intellectual Property ◽  
Market Access ◽  
Access To Medicines ◽  
Marketing Authorization ◽  
Joint Procurement ◽  
Europe 2020 ◽  
Increasing Trend ◽  
Biological Market ◽  
The Impact ◽  
The Eu

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

scholarly journals Impact of a simultaneous reduction in fishing subsidies and introduction of efficient management of rents: the case of the Northwest Spanish fleet

2017 ◽  
Vol 31 ◽  
pp. 1 ◽  
Author(s):  
Eugenia Merayo ◽  
Staffan Waldo ◽  
Max Nielsen
Keyword(s):  
Fishing Effort ◽  
Simultaneous Reduction ◽  
Effort Level ◽  
Efficient Management ◽  
Management Measures ◽  
Management Scheme ◽  
Fishing Sector ◽  
The Impact ◽  
The Eu

Subsidies to the fishing sector have long been criticized for fueling over-fishing, and a reduction in subsidies is currently on the agenda in the negotiations within the World Trade Organization (WTO). This article analyzes the role of subsidies and other management measures for Spain, one of the largest fishing nations within the EU. A static bio-economic model is used to analyze the effect of simultaneous elimination of subsidies and introduction of an economically efficient management system for the Northwest Spanish fleet. It is concluded that improvements in management would bring substantial rents to the industry, up to €164 million, irrespective of subsidy level, but also a reduction in fishing effort of almost 60%. Under a management scheme that maximizes economic rents, elimination of subsidies in the fishery would increase social welfare, induced by a decrease in the equilibrium fishing effort level. However, the impact of subsidies under this scheme is limited.

scholarly journals The data science tools for research of emigration processes in Ukraine

2020 ◽  
Vol 18 (1) ◽  
pp. 70-81 ◽  
Author(s):  
Andrii Roskladka ◽  
Nataliia Roskladka ◽  
Anatolii Karpuk ◽  
Andriy Stavytskyy ◽  
Ganna Kharlamova
Keyword(s):  
Data Science ◽  
Accurate Method ◽  
Impact Factors ◽  
Third Wave ◽  
Host Countries ◽  
Economic State ◽  
Research Gap ◽  
The Impact ◽  
Further Development ◽  
The Eu

The process of world globalization, labor, and academic mobility, the visa-free regime with the EU countries have caused a significant revival of migration processes in Ukraine. However, there is still the research gap in the most informative, and, at the same time, accurate method of the assessment and forecasting of the migration flows. Thus, the object of research is migration processes (mostly emphasizing the emigration flows). The motives, causes of emigration processes, and their relationship with the economic state were analyzed. The impact factors of external labor migration on the economy of the host countries were revealed, particularly the negative and positive impacts of emigration on the socio-economic situation in Ukraine and the migration attitude of Ukrainians were assessed.The main result of study is further development of the econometric model for forecasting the number of emigrants from Ukraine to other countries in the nearest future. The model considers the factors of minimum wage lavel in Ukraine, the number of open vacancies in the countries of Eastern Europe, and the level of competition for jobs. According to the results of forecasting based on Maple computer algebra system and Microsoft Power BI analytical platform, by the end of 2019, the number of emigrants from Ukraine supposed to be the largest in the last four years and to reach the estimates in the range from 2,444 to 2,550 million people, which may indicate a new third wave of emigration processes.

scholarly journals Recent Evolution of Intellectual Property Enforcement in Georgia

2020 ◽  
Vol 10 (2) ◽  
pp. 42-56
Author(s):  
Tamar Taliashvili ◽  
Irakli Shamatava
Keyword(s):  
Intellectual Property ◽  
The Novel ◽  
New Wave ◽  
Association Agreement ◽  
Legal Nature ◽  
Harmonization Process ◽  
Enforcement Mechanisms ◽  
Exclusive Right ◽  
The Impact ◽  
The Eu

Abstract The article elaborates on the topic of the new wave of evolution of the protection of intellectual property in Georgia inspired by signing the Eu–Georgia Association Agreement, (AA—the Association Agreement between Georgia and the Eu and the nuclear Energy Association of Europe and its Member States). The harmonization process is an impressive field of law on its own. The article deals only with particular issues, such as the role and critical characteristics of the harmonization of intellectual property protection and enforcement mechanisms in Georgia. In this context, the article examines the legal nature of the amendments to the Civil procedure Code of Georgia (GCpC), in particular, a new chapter of enforcement regulations, that has been introduced to the GCPC—‘Specificities in proceedings of the infringement of exclusive right of intellectual property’. The article is predicated upon the allegation that the new legal introductions are merely of a formal character, while the enforcement mechanisms and remedies, as a significant part of Georgian civil legislation, had already been in place and Georgia had ratified major international intellectual property agreements. The article deals with the legal problem of the application of the intellectual property enforcement amendments by the judiciary and measures the practical impact. The hypothesis of the analysis is to consider whether further developments are necessary to contribute to a consistent approach to the adjudication of intellectual property enforcement disputes in Georgian courts and to promote the efficient implementation of the novel intellectual property enforcement mechanisms into the Georgian legal system. The analysis of the characteristics of the impact of harmonization on intellectual property as of intangible rights proves to have wide-ranging benefits for the holders of intellectual property in Georgia or elsewhere in Europe.

‘SEIZING’ PHARMACEUTICALS IN TRANSIT: ANALYSING THE WTO DISPUTE THAT WASN'T

2012 ◽  
Vol 61 (2) ◽  
pp. 389-426 ◽  
Author(s):  
Bryan Mercurio
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Dispute Settlement ◽  
Trade Agreement ◽  
Pharmaceutical Products ◽  
Legal Analysis ◽  
The European Union ◽  
In Transit ◽  
The Eu

AbstractSeveral recent detentions of generic pharmaceutical products transiting through the European Union (EU) for suspected infringements of intellectual property rights raised serious concerns for public health advocates and threatened to expose systemic problems existing in the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The detentions not only garnered international attention, but India and Brazil formally began WTO dispute settlement proceedings against the EU. The parties recently reached a mutually agreed solution to the matter and the proceedings have been halted, leaving unanswered the complex legal and technical questions raised by the detentions of pharmaceuticals in transit. Despite a solution being reached in this dispute, the matter will undoubtedly resurface in the near future for a number of reasons. For instance, the EU is attempting to export its laws to its trading partners through the negotiation of free trade agreements and in other forums such as the recently concluded Anti-Counterfeiting Trade Agreement which increases the likelihood that similar detentions will occur at some point in the future. Moreover, recent trends in international intellectual property law indicate a move towards increased protection and enforcement in at least the short and medium term. The issue therefore offers the opportunity for rich legal analysis into an underexplored, yet increasingly important, aspect of WTO law.

Local border traffic as a liberalization of the Schengen legal regime in the regional dimension with particular regard to the EU-Ukraine border

2020 ◽  
Vol 18 (1) ◽  
pp. 161-176
Author(s):  
Anna Szachoń-Pszenny
Keyword(s):  
Legal Analysis ◽  
The European Union ◽  
Legal Regime ◽  
Eastern Border ◽  
The Subject ◽  
Free Movement Of Persons ◽  
The Impact ◽  
Cross Border Cooperation ◽  
The Eu

Local border traffic has a legal basis in the Schengen acquis and is related to the EU’s free movement of persons, which, subject to certain conditions, is also available to third-country nationals. The subject of the article is the legal analysis of the Schengen regime in the context of cross-border cooperation with selected third countries on the external eastern border. The research thesis is proving that local border traffic is an exception to the Schengen regime and at the same time defines the regional dimension of the Schengen area. These analyses will be based on the practical context, which is the operation of the local border traffic on the example of the external eastern border of the European Union, particularly the EU-Ukraine border, which is also the external border of the EU and the Schengen area. In this context, the impact of the liberalized Schengen regime on the movement of people across the EU-Ukraine external border will be examined, which will indicate its phased nature with particular emphasis on the role of local border traffic as a transition phase between visa and visa-free traffic. The article uses comparative statistical data on both forms of liberalization of the Schengen legal regime on the border with Ukraine. At the same time, considering the local border traffic on the EU-Ukraine border, it is worth putting forward a thesis that the local border traffic is increasingly being replaced by visa-free travel. In addition, the LBT became the first step to introduce a visa-free regime, which is further liberalization of the Schengen regime.

scholarly journals Intellectual property and transmedia informative products: A comparative, transnational legal analysis

Hipertext.net ◽  
2020 ◽  
pp. 31-39
Author(s):  
Javier Díaz Noci
Keyword(s):  
Intellectual Property ◽  
The United States ◽  
Point Of View ◽  
Legal Analysis ◽  
Usual Practice ◽  
The United Kingdom ◽  
General Terms ◽  
Legal Implications ◽  
Copyright Laws ◽  
The Impact

Transmedia products are becoming a usual practice in media, and they incorporate both professional contributions and user-generated contents. From this point of view, we propose a legal, comparative and transnational approach to the legal implications of copyright laws to transmedia products. We focus on news items and informative products. Participative or citizen journalism, fan fictions, which appeared in several media, has developed the so called transmedia narratives, and the law necessarily faces some problems derived from their particularities. Since the international trend of copyright is rather aligned with a strong approach which presumes that authors should be remunerated, or receive any compensation, for the successive exploitations of their works, we explain which is the impact of copyright (and, in general terms, intellectual property) in the distribution of both moral and exploitation rights, and more specifically transformation rights and derivative works. The legal trends towards digital single market in Europe, copyright law reforms in the United States and the particular situation of the United Kingdom in this respect will be considered.

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.

ROLE AND PLACE OF ECONOMIC SECURITY IN THE SYSTEM OF STATE REGULATION PROVIDING FOR NATIONAL SECURITY OF UKRAINE

2018 ◽  
Vol 1 (12) ◽  
pp. 15-28
Author(s):  
Lyudmila Nikolayevna Akimova
Keyword(s):  
National Security ◽  
Economic Security ◽  
State Regulation ◽  
Eu Member States ◽  
Social Standards ◽  
State Administration ◽  
Administrative Units ◽  
The Impact ◽  
The Eu

The essence of such concepts as “national security”, “economic security” is disclosed; the components of the national and economic security of Ukraine are defined; mechanisms of public administration economic security; the main indicators of economic security are described; detected threats that affect economic security; Recommendations are developed to improve the effectiveness of implemented measures to minimize existing threats. It is determined that at present state administration of the subjects of ensuring national security taking into account real and potential threats should be directed to the improvement of the organizational structure of the management of the subjects of ensuring national security, namely: clarification of the functions of ministries and other central executive bodies, elimination of surplus administrative units, simplification and relatively cheaper control of the management apparatus, taking into account the assessment of the impact of information networks on the management of entities with bezpechennya national security in a single information space. Having considered the components of national security, it was concluded that the most important in the overall system of national security is economic security, since it is the material basis of national sovereignty, which determines the real possibilities for securing other types of security. It is noted that the main content of economic reforms in Ukraine is the creation of conditions for overcoming poverty and excessive property stratification in society, bringing social standards closer to the level of the states of Central and Eastern Europe — the EU member states, achieving the economic criteria necessary for Ukraine to become a member of the EU. According to the adopted “Strategy of National Security of Ukraine”, the main condition for a new quality of economic growth is the provision of economic security.

Sign in / Sign up

Export Citation Format

Share Document