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.

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.

scholarly journals Can the implementation of the Europe 2020 Strategy goals be efficient? The challenge for achieving social equality in the European Union

Equilibrium ◽  
2017 ◽  
Vol 12 (3) ◽  
Author(s):  
Michaela Stanickova
Keyword(s):  
European Union ◽  
Income Inequality ◽  
Labour Market ◽  
Social Inequality ◽  
The European Union ◽  
Social Equality ◽  
Europe 2020 ◽  
Europe 2020 Strategy ◽  
The Impact ◽  
The Eu

Research background: Economic crisis hit all the European Union Member States hard, with the impact of crisis varying considerably. The low growth performance in the EU has increased concerns regarding an increasing wage dispersion, income inequality at large, and social exclusion in line with poverty. Inequality should be seen as a cornerstone of both sustainable and inclusive growth under the Europe 2020 Strategy. Social inequality in the EU is a real problem, which hampers sustainable economic growth. Purpose of the article: The purpose of this study is to introduce evaluation of social development convergence and divergence trends between the EU Member States in the context of the Europe 2020 Strategy. The study gives an outline of the issues of the labour market and income disparities and poverty. Policymakers must be clear about what social objectives they are aiming to achieve, therefore special attention is paid to headline national goals of the Europe 2020 Strategy. Methods: The main task of this study is to assess social dimension and inequalities problems in the EU27 by applying Data Envelopment Analysis method, resp. time-series dynamic efficiency analysis in the form of output-oriented Malmquist Productivity Index. This study contains changes of key social equality indicators related to the Europe 2020 Strategy and compares objectives and general outlines of period 2010-2015, as well as the impact on national economics and living conditions. Findings & value added: Results contain elements of typology premises of the EU28 and point to a large diversity in inequality patterns, as the Author observes both increases and decreases in inequality at the EU level. Recent changes in social inequality have been associated with the business cycle, particularly with the accessibility of the labour market and, of course, with income inequality. Additionally, the development challenges are discussed for improvement of the socioeconomic well-being of the EU and to avoid social disparities.

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.

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.

scholarly journals THE IMPACT OF TRIPS AGREEMENT ON ACCESS TO MEDICINES IN DEVELOPING COUNTRIES: LEGAL CHALLENGES FACED BY THE PHARMACEUTICAL INDUSTRY PARTICULARLY IN INDIA

2012 ◽  
Author(s):  
Kamini Shanmugaiah
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Legal Challenges ◽  
The Impact

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal

scholarly journals Brexit: Australian Perspectives on International Trade and Customs Operations

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Roberto Bergami
Keyword(s):  
International Trade ◽  
Market Access ◽  
Economic Interdependence ◽  
The Many ◽  
The Uk ◽  
The Impact ◽  
The Eu

The decision made by a slight majority of voters in the UK to leave the EU, based on a non-binding referendum, sent initial shockwaves across the globe. The separation of the UK from the EU is still a process in the making, as there is no certainty about the negotiation approach the UK or the EU will adopt on the terms of the so called Brexit. This paper seeks to outline the major aspects of market access for the international trade of goods between the UK and the EU and the impact and opportunities for Australia, noting the comparatively greater importance of the EU 27 to Australia. The paper concludes that the economic interdependence between the UK and the EU warrants a win-win solution, despite the many as yet unknown challenges that lie ahead.

scholarly journals Znacaj porekla proizvoda u evropskim sporazumima o trgovini

2003 ◽  
Vol 44 (157) ◽  
pp. 61-83
Author(s):  
Radovan Kovacevic
Keyword(s):  
Free Trade ◽  
Market Access ◽  
Trade Agreements ◽  
Preferential Trade Agreements ◽  
Rules Of Origin ◽  
Preferential Trade ◽  
The Balkans ◽  
Policy Objectives ◽  
The Impact ◽  
The Eu

The key element of the EU's free trade and preferential trade agreements is the extent to which they deliver improved market access and thus contribute to the EU's foreign policy objectives towards developing countries and neighbouring countries in Europe, including the countries of the Balkans. The previous preferential trade schemes have been ineffective in delivering improved access to the EU market. The main reason for this is probably very restrictive rules of origin that the EU imposes, coupled with the costs of proving consistency with these rules. If the EU wants the 'Everything but Arms' agreement and free trade agreements with countries in the Balkans to generate substantial improvements in access to the EU market for products from these countries, then it will have to reconsider the current rules of origin and implement less restrictive rules backed upon by a careful safeguards policy. Governments apply rules to distinguish between foreign and domestic products and to define the foreign origin of a product where some imports receive preferential treatment. The purpose of this paper is to focus on the issue of the rules of origin, and on the "cummulation" of such rules within the EU preferential trade agreements. It does this, firstly, through detailing rules of origin, secondly, by providing a conceptual discussion of the impact of (the cummulation of) rules of origin, and thirdly, by exploring characteristics of preferential trade agreements.

scholarly journals Territorial Cohesion and the Pandemic in Romania

2021 ◽  
Vol 31 (4) ◽  
pp. 54-69
Author(s):  
Marioara Iordan ◽  
Ion Ghizdeanu ◽  
Alexandra Patricia Braica
Keyword(s):  
Cohesion Policy ◽  
General Validity ◽  
Health Crisis ◽  
Real Convergence ◽  
Europe 2020 ◽  
Europe 2020 Strategy ◽  
Territorial Cohesion ◽  
The Impact ◽  
Global Strategies ◽  
The Eu

Abstract Convergence and economic and social cohesion remain priorities for the EU, beyond failures to achieve the objectives of the ‘Europe 2020’ strategy. Convergence and territorial cohesion, as a prerequisite for sustainable and durable development, have been the fundamental objectives that generated and developed the strategic planning in the EU, including through the two global strategies, ‘Lisbon’ and ‘Europe 2020’. The sustainability of these processes, even in periods of high economic growth, is questionable since real national convergence is based in many countries, including Romania, on large and widening divergences between regions and counties. In recent years, Romania has seen one of the most enhanced improvements in convergence compared to the EU average, from 60% in 2016 to 69% of the European average in 2019 respectively. During the same period, disparities between regions and counties have deepened. More than 10 years after EU accession and participation in the Community cohesion policy, there is still a third of the counties with less than 70% of the national average of gross domestic product per capita. The health crisis has deeply affected economic activity, but in a differentiated way, depending on the specific territorial economic structures. As a result, the objective of improved and sustainable real convergence, by bringing regions and counties closer together in terms of their level of development, is receding. The economic situation in the counties in 2020 indirectly provides support for assessing the impact of the pandemic on the territorial cohesion process. The implicit conclusion revealed by the latest statistical data is that the level of development has been the support for better resilience to the health crisis. Although the restrictions on international movement and the closure of tourist and industrial capacities have had general validity, the counties with a higher degree of disparity have been more affected.

scholarly journals Measuring and comparing the water activity and salt content in Parenica cheeses made by traditional and industrial technology

2020 ◽  
pp. 291-301
Keyword(s):  
Water Activity ◽  
Salt Content ◽  
Industrial Technology ◽  
Trade Name ◽  
Activity Measurements ◽  
Increasing Trend ◽  
Lower Variability ◽  
Small Producers ◽  
The Impact ◽  
The Eu

Background. Slovenská Parenica is one of the most traditional and ever-popular sheep´s milk cheese specialities. This cheese has been registered as a geographical indication (PGI) in the EU. Parenica cheese is produced also from cow´s milk, but without the trade name “Slovenská/Slovak”. Objective. The aim of our research was was statistical reporting and results visualization of water activity analysis and salt content in cow´s milk Parenica cheeses from 8 small and medium-sized Slovak dairy producers. Material and method. A total of 320 samples of smoked and non-smoked Parenica cheeses made from cow´s milk using traditional and industrial technology were examined during the 10-month period. Each cheese was analysed immediately after sampling (A) and subsequently after 7 days of storing at 4°C (B). The salt content was measured on the Chloride analyser M 926 and the water activity on the Fast-Lab meter. Due to the hierarchical design of the experiment, the linear mixed models via the R statistical environment to compare the differences in the water activity and salt content were used. Results. Statistical reporting and visualization of water activity measurements showed significant differences between samples A and B ( p = 0.0129) and between kinds of Parenica cheese ( p = 0.0196). The value of water activity ranged from 0.908 to 0.975 (A) with the increasing trend after storing in both kinds of Parenica cheese. The impact of dairy producer type was not significant. The higher content of NaCl was found in fresh Parenica cheese from small farms (nonsmoked: 2.51 ±1.12 g/100 g, smoked: 1.97 ±0.89 g/100 g). The average salt content in cheeses from industrial dairies was 1.65 ±0.34 g/100 g (non-smoked) and 1.96 ±0.43 g/100 g (smoked). Results showed lower variability of salt content in cheeses from industrial dairies. Conclusions. It can be concluded that especially the small producers can have probably problem in noncompliance with the technological processes, non-implementation of standardized procedures and underestimation of hygiene regulations.

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