Joint EU Research Articles

HTA228 Can Just Three PICOs be Feasible for Oncology Assessments with the Joint EU HTA Framework, Whilst Considering All 27 Member States Specificities?

HTA228 Can Just Three PICOs be Feasible for Oncology Assessments with the Joint EU HTA Framework, Whilst Considering All 27 Member States Specificities?

ENTRY-EXIT SYSTEM SCOPE, API/PNR CAPABILITY WEAKNESS

The practical recommendations for the application of Advance Passenger Information and Passenger Name Record System (API / PNR) were described in the article with the aim to use such system as a counteracting cross-border threats tool. Biometrics establishes a strong link between a document and its holder only if all electronic security features (signatures) are reviewed. That is the critical point of all system. Many EU countries don’t have Public key infrastructure in place and can’t use the mentioned security functions. There no joint EU system. Only ICAO has a commercial Public key directory, which provides PKI functions to some countries. Specific digital algorithms know and do many things better, like people, and can make a significant improvement. The order of actions for system implementing is proposed. He will be responsible for Risk assessment, Biometric verification accuracy, and Document verification. It is mandatory to improve data management, mostly to cover all fields and flows of data. Improve legislation related to data management for the mentioned purpose and GDPR. Besides, we have to invest more in automatic border control systems infrastructure. It is mandatory to centralize Public Key Infrastructure and Certificates master list management and validation. All measures will increase public security and save innocent lives from cross border crimes.

Beware what lies beneath: Pragmatic policies for reconciling debt and growth

The EU has a plethora of investment needs. However, the scale of the required investments will not be reached if the EU’s financial stability is called into question. This article calls for a set of pragmatic policies which can generate significant economic growth and raise living standards. This growth will be a key ingredient in increasing employment, improving competitiveness and strengthening budgetary sustainability. The associated fiscal space will also contribute significantly to narrowing the investment gap in the next decade and beyond. The article sets out three pillars—stability and governance, growth and fairness, and budgetary accountability—as the key drivers in building a pragmatic economic programme which bridges the gap between fiscal conservatism and future expenditure. It further identifies the need to refocus on the single market as a key economic driver. It also calls for any discussion on further joint EU borrowing programmes to be postponed until funding sources for the existing Recovery Fund are agreed and its overall economic effectiveness can be analysed.

Principles for the Europeanisation of Public Administration

Administrative regimes are no longer isolated phenomena: they are constantly confronted with international influences, which shape the internal structure and system of the states. The cooperation between the European Union and the Member States’ administration is today a kind of convergence in principles. This is what the EU expects from the candidate countries and in the neighbourhood policy. The main question of the study is whether the content of the principles used by the EU is cognisable and consistent. The study covers two policy instruments: the SIGMA project, which is a joint EU–OECD collaboration, and the comparative legal activities of the ReNEUAL. These instruments testify two completely different attitudes: one does not explain the principle but holds it accountable, the other seeks the means to understand its content and the reasons for the differences in interpretations. Both programs have undergone internal development, but while SIGMA has moved away from its administrative procedural roots, ReNEUAL has confirmed it. The paper is another argument in favour of the need for administrative research using the tools of comparative law.

Hazardous properties of mineral and organo-mineral plastic additives and management of hazardous plastics

Many plastic additives are mineral or organo-mineral substances having functions as pigments, heat stabilizers, flame retardants, process adjuvants and the like. Are additivated plastics hazardous when they become waste? Data from the Plastic Additives Initiative, a joint industry and EU effort, was used, along with substance hazard statements from the ECHA website and hazard properties from the waste classification. 20 elements of 91 substances, namely Al, B, Ba, Bi, Cd, Co, Cr, Cu, F, I, Li, Mn, Ni, Pb, Pr, Sb, Sn, Ti, V and Zn were selected, and their additives used in 11 polymers, considered. Of the 91 substances selected, 57 are non-hazardous or are hazardous but used at too low concentration to render the plastic hazardous when it becomes waste. 34 substances (= 37% of 91) are hazardous and make plastics hazardous as waste. These are mainly heat stabilizers (for PVC), or pigments and flame retardants (for all polymers). The sorting of these plastics by the mineral concentration of their additives with online XRF is theoretically achievable. With data from previous papers, 63 additives (= 27% of 233) make plastic hazardous. The brominated flame retardants are the less documented. Only essential use should be encouraged for pigments. Waste management today should focus on turning waste into non-waste, not waste leakage. With occupational safety and health regulations during processing, and with product regulations during its second life, the material should be managed as another hazardous or non-hazardous (virgin) raw material, and given end-of-waste status when it enters the loop.

The UK government’s Northern Ireland policy after Brexit: a retreat to unilateralism and muscular unionism

ABSTRACT Brexit has significantly altered the trajectory of UK government policy towards Northern Ireland. The peace process was implicitly built on a presumption of continued joint EU membership by the UK and Ireland. The EU model of interdependence and cooperation was explicitly stated to be an inspiration by its key architect John Hume. However, the history of British–Irish cooperation over Northern Ireland is long and complex and cannot solely be understood through the lens of Europeanisation. Despite this, the aftermath of the 2016 referendum has seen a retreat by the UK government from a bilateral and consensual approach towards Northern Ireland to unilateralism and a ‘muscular’ unionist ideology. This has affected their governance there, hampering their relationship with local parties and undermining the agreed role of the Irish government. The impact of Brexit on UK government policy towards Northern Ireland has undoubtedly contributed to the destabilisation of the political settlement.

Change to Stay the Same? German European Preference Formation During the COVID-19 Crisis

ABSTRACT In 2020, the German government supported the COVID-19 recovery fund ‘Next Generation EU’, which according to many observers is breaking with the taboo of joint EU debt liability. In this article, we analyse whether this decision marks a programmatic shift towards fiscal integration, taken in isolation by the Chancellor, or whether it can be reconciled with higher-level principles that guided the Chancellor’s previous European policies? Our analysis builds on a synthetic framework combining a multi-level principal-agent account with ideational components. The empirical analysis of Bundestag debates and original public opinion data reveal that the support for ‘Next Generation EU’ neither breaks with the Chancellor’s established ‘conservational-pragmatic’ approach to EU policy-making, nor separates the Chancellor from the preferences of the Bundestag and the public. Content analyses show how the government and its supporting camp in the Bundestag justified the apparent policy shift, underlining a strong agreement towards strengthening the EU in times of an unseen crisis, while at the same time revealing some noteworthy partisan differences.

HPR59 The Pharmaceutical Reimbursement and Access Pathways in the 27 EU Member States: Who Is Ready for Joint EU HTA?

HPR59 The Pharmaceutical Reimbursement and Access Pathways in the 27 EU Member States: Who Is Ready for Joint EU HTA?

Addressing the European Green Deal with Smart Specialization Strategies in the Baltic Sea Region

Despite the extent and importance of the Smart Specialization strategies, achieved in a short cohesion policy period from 2014 to 2020, the evidence on the assessment of their actual effect on the economic development and the mobilization via the Smart Specialization implementation of the regions is still pending. In light of green transformation, accelerated by the European Green Deal, the heart of Smart Specialization strategies of EU regions is to avoid fragmentation and to reach a complementary in reaching the joint EU ambition of climate neutrality by 2050. This article aims to demonstrate how to identify the region-specific (place-based and bottom–up) pathways for green transformation and align them with the European Green Deal-focused Smart Specialization strategies in regions, using moderated co-creation in DPSIR analysis and policy modeling. The findings of this article are based on the moderated experimental experience from the two interconnected projects in the area, i.e., “LARS” and “GRETA”, implemented in the Baltic Sea Region (October 2017 to September 2021). The research proposes how moderated learning and knowledge transfer between matured innovators and young innovators embodies the identification of place-based pathways and help develop political course recommendations for green transformation, thus solving the homogeneity issues of the Smart Specialization strategies.

Стратегічний компас політико-безпекової царини ЄС

The dynamics of international processes show the growth of the security factor, and hence the importance of regional security systems and the interdependence of regional and global organizations of collective security and defense. The creation and development of the Common Security and Defense Policy (CSDP) of the European Union, aimed at achieving the common strategic goals of the Member States in the field of security cooperation, has undergone a path of dynamic and contradictory transformations, reconciling the interests of the Member States with the supranational institutional nature of the EU and its strategic goal. The common security and defense policy is a conceptual component and the core of the EU’s common foreign and security policy. On March 21, 2022, at a meeting in Brussels, the foreign and defense ministers of the 27 EU member states approved a decision to adopt the first-ever joint EU security and defense strategy – the Strategic Security and Defense Compass for the European Union, which protects its citizens. values and interests and promotes international peace and security ”(hereinafter referred to as the Strategic Compass). Structurally, the Strategic Compass is divided into a summary, an introduction, five blocks (modern world, actions, security, investment, partnership), conclusions. The document notes that humanity is living in an era of strategic competition and complex threats to international security, both in the form of hybrid challenges and acts of direct aggression. Particular emphasis is placed on the return of the war in Europe with Russia’s unjustified and unprovoked aggression against Ukraine. The EU is committed to protecting the European security order, sovereignty, territorial integrity and independence of states within internationally recognized borders. Ukraine’s support in resisting Russia’s military aggression is aimed at restoring peace in Europe. In the long run, the Strategic Compass can be one of the important impulses to increase the level and content of cooperation between the European Community and Ukraine as a candidate country for EU membership. At the same time, a stronger and more effective EU as a powerful international player in security and defense will help strengthen global and transatlantic security.

PUBLIC ATTRIBUTION OF CYBERATACS BY EU MEMBER STATES AND THE APPLICATION OF CYBERSANCTIONS BY THE UNION TO CYBERATTACKS THREATENING THE UNION OR ITS MEMBER STATES

The article examines the issue of public attribution of cyberattacks threatening the European Union or its Member States, and effectiveness of the adopted «cyber diplomacy toolbox» within the Framework for a joint EU diplomatic response to malicious cyber activities. Since public attribution of cyberattacks is a sovereign political decision, which differs from legal attribution for the purpose of invoking state responsibility under Articles on State Responsibility for Internationally Wrongful Acts, author defines the rationale behind decisions to attribute or not to attribute cyberattacks to a particular state by examples of the Netherlands and France. While the Netherlands insist on deterrent effect of public attribution, France believes in the effectiveness of attribution provided to the allege wrongdoer by diplomatic channels. In the article, the effectiveness of cybersanctions implemented at Union level against a limited range of cyberattacks threatening the Union or its Member States was also under assessment. Article concludes that imposition of targeted sanctions in conjunction with sectoral sanctions will increase sanctions` purposes to coerce, constrain, and to signal. However, nowadays only targeted sanctions against individuals and legal entities are foreseen by the EU`s decision. At the same time, this fact does not exclude the possible application of sectoral sanctions against the most serious cyberattacks against EU` or its member states` infrastructure. Finally, the article justifies the possibility of using attribution reports prepared by the private sector to include individuals in the sanctions list if the attribution of Member States is based on intelligence that they do not wish to disclose. Moreover, malicious cyberoperations affect not only states`, but also private sector`s, interests. Private IT and cybersecurity companies thus have a chance to prove their ability to produce detailed and reliable reports on attribution of cyberoperations. Author is convinced both centralized (governmental) and decentralized (private) attribution of cyberattacks is necessary for correctness of findings.

Innovation intensity and skills in firms across five European countries

This study attempts to establish the importance of specific formally achieved higher skills for the innovation intensity in firms across a group of European countries. Innovation expenditures are calculated as the ratio to turnover and the main explanatory variable is the proportion of highly skilled employees (tertiary education in ICT-oriented or other fields). The analysis employs official data on innovation activities (Community Innovation Survey) in firms for the period 2004–2010, linked to registers on education and businesses as well as to the Structural Business Statistics including 34,000 observations. Estimation results show a strong significantly positive relationship between the innovation intensity and the proportion of highly ICT skilled employees. Higher skills outside the field of ICT are also important for the innovation activities. Control variables reveal that the innovation intensity significantly increases with joint national and EU funding while the role of firm age varies. The significant and negative link to firm size reveals a lack of advantages of scale, a finding possibly related to the use of a comprehensive measure of innovation activities. There are also indications that industry affiliation is essential for the innovation intensity.

Пандемия коронавируса и перспективы развития оборонно-промышленного комплекса Европейского союза

The article analyzes the impact of the current crisis on the defence policy of the EU countries. Coronavirus has had a negative impact almost on all industries. According to the forecast of International Monetary Fund the growth of the world economy is expected to be at the level of -4.9%. In such conditions where social sphere including medical is going to be the most important one, governments are faced with the problem of relocation of their expenditures. Therefore, the military expenditures probably would suffer cuts like it was during last crises for example financial crisis of 2007-2008. The EU defence industry is also influenced by coronavirus crisis, this was yielded in the downtime and supply dates shifts during lock down. However together with armed forces defence companies were engaged in fight with coronavirus: production of medical and protective equipment, disinfection, transportation and etc. But these efforts cannot be considered as an efficient measure to limit negative impacts of coronavirus crisis on the prospects of defence industry. The following coronavirus crisis consequences for the defence industry can be outlined: stock prices fall, civil aviation crisis, supply chain disturbance and difficulties for small and medium enterprises during lock down. Such effects of course can slow down the development of the defence industry and complicate the operation. However the most crucial one is military expenditures cuts, because such changes put defence industry in the new environment with reduced demand for arms. Defence cuts are also a threat to the joint EU defence industry development programs. The importance of these programs is that their goal is to contribute to the military capability of the EU and these programs could be used for coronavirus crisis consequences overcome. However the budget allocated for these programs was also cut, so their implementation is hampered. But defence companies and their associations are working on the plans to boost the development. The author believes that in such conditions the key point for the successful overcome of coronavirus crisis and further sustained development of the EU defence industry is the joint efforts in this direction. The current level of cooperation between member state in the sphere of defence industry is not enough not only for the overcome of coronavirus crisis, but also for the development even in the standard conditions. Therefore the deepen of the cooperation is required and important like never before. As a result current crisis situation is a chance for the EU defence industry to joint the efforts in the defence sphere and expend integration in defence and security.

Debordering and re-bordering in the refugee crisis: a case of ‘defensive integration’

ABSTRACT We present the reaction of the EU and eight member states to the refugee crisis 2015/16 as a case of ‘defensive integration’. In the absence of a joint EU solution, the member states were left to their own devices and took a series of national measures that varied from one country to the other, depending on their policy heritage, and the combination of problem pressure and political pressure which they were facing. As a result, debordering responses prevailed at first. Only in a second stage a set of national and EU measures aiming at internal and external re-bordering were introduced. At this stage, destination states proved to be the most important drivers of a joint solution, with Germany taking the lead. The overall outcome is an example of ‘defensive integration’, aiming squarely at joint solutions to stop the refugee flow outside the EU but not to manage it inside the EU.

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges.

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

Meteorological factors are associated with asthma prevalence in England

Background/Aim Several exposures contribute to human vitamin D levels including solar irradiation, diet, behaviour and genes. This study was designed to examine meteorological factors that influence the geography of asthma across England, with influence of solar irradiation as primary factor. Methods General practitioner data from 2005 was used to determine the prevalence of asthma in primary care in England. Additional data such as smoking rates and obesity were merged at lower super output level (population ~1000). Meteorological data was obtained from Met Office UK and Joint Research Centre, EU and averages for the period of June 2002 to July 2003 were used. The meteorological data was reprocessed to postcode district level and aggregated to a mean annual measurement. The meteorological data was mapped using ArcMap 10. Associations between climactic factors such as solar irradiation, temperature and humidity and asthma prevalence were tested with a principle component analysis, with spatial auto correlation accounted for. Results Asthma prevalence from GPs in England was 5.9% (95% CI, 5.8-5.9). In the highest UVvitd quartile (2.1-2.5 kJ/m2/day), asthma had an 8% reduction in prevalence compared to the lowest quartile. Similar reductions were found in the higher temperature 0.91 (95% CI, 0.88-94). The opposite was found with relative humidity 1.09 (95% CI 1.05 to 1.12). A combination of high temperature and UVvitd highlighted postcode districts in the South East of England with a climate beneficial to reduced risk asthma, whereas in the North West there was a climate detrimental to asthma with increased risk. Conclusions Weather variables were shown to associate with asthma prevalence in England. Understanding the complex contribution of multiple climatic factors and the relationship with the indoor environment could help to explain the population distribution of asthma.

ПОЛІТИКА ЄС ЩОДО ПРОТИДІЇ ТОРГІВЛІ ЛЮДЬМИ

After the mid-1990s, the EU realized the need to develop a common approach to combating human trafficking. As a result of the increased competence of the relevant EU institutions, as well as the increase of stakeholders’ concerns about its internal security and control of external borders began to grow, which gave push to the unprecedented formation, expansion and consolidation of anti-trafficking policy. Accordingly, a number of legislative and policy instruments have been created for this purpose. Important EU anti-trafficking program activities include the EMPACT program (European Multidisciplinary Platform Against Criminal Threats) (2011-2013) and (2013-2017), which consisted of the joint participation of Member States in multidisciplinary operational actions to combat organized crime involved in trafficking in human beings. Also in 2009, the EU developed the Global Approach to Migration and Mobility, as well as a separate document focused on strengthening the EU’s external influence against human trafficking. A more recent EU migration program in 2015 provided Member States with a comprehensive set of tools to manage migration and combat trafficking in human beings. Important tools in the fight against trafficking in human beings in the EU include Directive 2004/81/EU, which regulates the granting of temporary residence permits to third-country nationals who have been trafficked; Directive 2011/36/EU on preventing and combating trafficking in human beings and protecting its victims; Directive 2012/29/EU, which set additional minimum standards for the rights, support and protection of trafficking victims. In 2012 a joint EU strategy to eradicate trafficking-related crimes was launched for 2012-2016. An appropriate information platform has also been set up, which contains information on legal documents, initiatives, or possible projects and stakeholders dealing with human trafficking. In addition, a funding program has been established to promote quantitative and qualitative research projects, enhance the exchange of valuable knowledge and improve the quality of data collection. We came to the conclusion that institutional mechanism of the European Union in combating with trafficking in human beings is a system of EU bodies that adopt relevant regulations. This institutional mechanism has a rather complex structure, based on the European Parliament, the European Council, the European Commission, the European Anti-Trafficking Coordinator, the EU Expert Group on Trafficking of Human Beings, Europol, Eurojust, the European Judicial Network. The main component of this structure is the European Commission, which makes decisions and takes initiatives in this area. A characteristic feature of the EU’s anti-trafficking policy is not only to ensure respect for human rights of victims of this crime, but also to create appropriate conditions for its rehabilitation, further socialization and prosecution of perpetrators. In sum, the EU treats human trafficking as one of the global problems of our days and is making considerable efforts to combat it.

Strategic autonomy of the European Union: on the way to «European Sovereignty» in defense?

2019 marked 20 years since EU Member States decided to create a joint EU approach to security and defense. The paper raises the question on finding new approaches to provide security and defense in Europe in the current context, as well as the formation of a new paradigm for research on regional security in Europe. Traditional approaches to the study of European integration (neofunctionalism and intergovernmentalism) are of little use for theorizing the development of European defense in conditions of new challenges and threats to national and regional security, as well as transatlantic solidarity violations. The article studies European Strategic Autonomy (ESA), which refers to the ability of the European Union, in conjunction with Member States, to independently determine its own priorities according to which to take decisions and implement them in the fields of foreign policy, security and defense. ESA is not synonymous with independence, nor does it deny membership in military-political alliances, since a more realistic scenario implies positioning itself as a European pillar of NATO. The implementation of the idea of building a "european sovereignty" in the field of security and defense implies that the European Union should take bigger responsibility for its own security, the security of its neighbors, andshould strengthen its role in transatlantic relations without opposing NATO. In order to move from rhetoric to concrete policy steps, the EU needs to develop a plan of measures for political, institutional and industrial action. It means that achieving real autonomy requires time and joint efforts by EU institutions and Member State governments. However, political and institutional autonomy can be built exclusively within the whole Union, while military-industrial autonomy can be initiated and implemented by a group of the most economically and technologically advanced EU Member States.

Labor force participation in Eastern European countries: nonlinear modeling

PurposeThe purpose of this paper is to investigate the behavior peculiarities of the labor force participation in Eastern European countries.Design/methodology/approachThe authors provide the analysis of nonlinearity in dynamics of economic active population and perform the econometric analysis using logistic smooth transition autoregressive models that are flexible and capture various kinds of behavior for different modes. The paper investigates labor markets of six Eastern European countries, Hungary, Bulgaria, Poland, Slovakia, Romania and Croatia that are characterized by lower level of labor force participation rate (LFPR) than average level in EU.FindingsThe results of modeling quantitatively characterize smooth changes in the behavior modes of labor force activity for each country and indicate how population economic activity depends on previous labor market states. The estimated slope parameters that determine the smoothness of transition between regimes show that, in all countries, the labor force participation quite quickly reacts to changes that occurred on the labor market in the past. During recession periods, households of European countries that joint EU last decade in order to prevent the depletion of their total income increased labor supply and showed increased activity in job search.Originality/valueThis paper indicates the nonlinearity and asymmetry in LFPR in transition economies, discovers variety of its dynamics in the different regimes and determines the indicators that cause the change of the population economic activity behavior in each country.

Impact of Trajectories’ Uncertainty in Existing ATC Complexity Methodologies and Metrics for DAC and FCA SESAR Concepts

The most relevant SESAR 2020 solutions dealing with future Capacity Management processes are Dynamic Airspace Configuration (DAC) and Flight Centric ATC (FCA). Both concepts, DAC and FCA, rely on traffic flow complexity assessment. For this reason, complexity assessments processes, methods and metrics, become one of the main constraints to deal with the growing demand and increasing airspace capacity. The aim of this work is to identify the influence of trajectories’ uncertainty in the quality of the predictions of complexity of traffic demand and the effectiveness of Demand Capacity Balance (DCB) airspace management processes, in order to overcome the limitations of existing complexity assessment approaches to support Capacity Management processes in a Trajectory-Based Operations (TBO) environment. This paper presents research conducted within COTTON project, sponsored by the SESAR Joint Undertaking and EU’s Horizon 2020 research and innovation program. The main objective is to deliver innovative solutions to maximize the performance of the Capacity Management procedures based on information in a TBO environment.