EU Authorities Research Articles

How do elite core actors assess trust in national and EU authorities? The varying role of generalised trust at different governmental levels

AbstractIn this paper, we position generalised trust as central to the debate on elites’ assessments of trust in EU multi-level governance. We leverage one of the most influential factors in explaining political trust in single-government studies to understand variations in trust towards political authorities at various levels. Departing from existing studies, we hypothesise the dual nature of generalised trust: while it influences how individuals assess their trust in political authorities, its impact varies depending on different degrees of perceived similarity of these authorities at either the national or the EU level. To test our hypotheses, we conducted an elite vignette experiment involving 567 decision-makers from public and private stakeholders within regulatory regimes in eight countries. The results reveal a significant positive effect of generalised trust on political trust when evaluating a national-level regulatory agency. However, trust assessments of EU-level regulatory agencies appear to be largely unaffected by generalised trust levels. Furthermore, we observed notable differences in trust assessment between private and public stakeholders, reinforcing our argument that similarity and community belonging underlie the influence of generalised trust on political trust. Our study suggests that EU-level political authorities may derive less benefit from high levels of generalised trust, compared to national political authorities. However, in instances where generalised trust is low, political authorities at the EU level have comparatively more opportunities to cultivate trust in them.

Deployment of in-body wearable devices in healthcare and at work: closing the EU regulatory gap

Abstract Background In-body wearable devices can protect workers’ health and safety. Moreover, they might provide data that could be capitalized on in the context of the European Health Data Space (EHDS), which aims at fostering a single market for medical devices and high-risk AI systems. Yet, neither EU legislation nor national law regulates the use of in-body wearables at the workplace and the related data protection and safety issues. This regulatory gap impacts on workers’ rights. Methods The study explores whether the EU regulatory framework used in the healthcare sector for medical devices could fit the in-body wearables’ application in employment. The legal and policy analysis takes the perspective of workers’ rights and discusses the application of a key GDPR principle: lawfulness. The research discusses the potential transformations in the EU health data protection framework that could close the regulatory gap. Results The EU regulatory framework for medical devices (focused on product safety, performance, and quality) is not equipped to address the data protection challenges linked to the use of in-body wearables for occupational health and safety purposes. The GDPR’s principle of lawfulness and the related guidance by EU and national data protection authorities lack clarity on employers’ possibilities to apply in-body wearables for occupational health purposes. Filling the regulatory gap is conducive to appropriate qualification and risk-based classification of in-body wearables, which affect pre- and post-market requirements and impact on data protection. Conclusions a. The EU legislator could use its social policy competence to regulate the use of in-body wearables to protect workers’ health while safeguarding their data. b. EU authorities should clarify whether and how the data collected by in-body wearables at the workplace could be shared and (re)used within the EHDS. c. Further input by data protection authorities is needed to close the regulatory gap. Key messages • The EU should regulate the use of in-body wearables to protect workers’ health and safety. • Health data gathered through the application of in-body wearables at the workplace may be an asset for the EHDS.

Quality evaluation of field safety notices of medical devices, across EU and non-EU countries

Abstract Introduction The EU Medical Device Regulation 2017/745 (MDR; article 87) requires device manufacturers to report to the relevant authorities any serious incident and any corrective action undertaken, through Field Safety Notices (FSN) whose content must be consistent in all Member States. Before MDR, due to the lack of harmonized global standards for reporting, FSNs were published independently by each country with different formats, styles, nomenclatures and languages. This heterogeneity makes it challenging to use such historical data for trend analysis in post-market surveillance (PMS). Purpose 1) To assess the quality of the FSNs issued by EU or non-EU national authorities for analysing historical trends. 2) To group countries based on such quality, and test for differences between EU and non-EU countries. Methods As part of the CORE-MD project coordinated by the ESC, all FSN information publicly available as HTML text (excluding linked PDFs) was retrieved automatically from national authorities’ websites, using the CORE-MD PMS tool [1]. For each FSN, a score was assigned to each field of interest (1 or 2, according to importance for building trends) (see Figure 1), and a Percentage Score (PS) computed as the % of the ratio between the scores’ sum and the maximum possible score (10). Based on PS, FSNs were categorized as Excellent (≥90), Very Good (80≤PS<90), Good (70≤PS<80), Medium (60≤PS<70), or Unqualified (<60). For each country, the distribution of FSN categories was computed. Hierarchical Agglomerative Clustering (HAC) was used to group countries based on their similarities, and differences between EU and non-EU countries were assessed by Mann-Whitney U test. Results 126,405 FSNs published before 31/12/2022 were retrieved and analyzed. The % of FSN in which each field was available is shown by country in Figure 1. Manufacturer and Device were clearly described, but more detailed device information was often absent. The Description, with the reason for publishing the FSN, and the Device Category, allowing nomenclature categorization, were provided only by a few countries. The % of FSNs in each quality category is reported in Figure 2: only Italy provided some FSNs (31%) classified as Excellent. The HAC analysis identified three clusters: "high-quality FSNs" (Czechia, Denmark, Italy, Sweden, the Netherlands, and the USA), "moderate-quality FSNs" (Australia, Canada, Greece, Ireland, Latvia, Slovenia, Spain, and the UK), and "low-quality FSNs" (Croatia, Estonia, France, Germany, Poland, and Portugal). There was no difference between EU and non-EU countries. Conclusions A significant discrepancy was observed in the quality of FSNs retrieved from different countries, highlighting the difficulty in using such data to analyse trends, for example in reports of cardiovascular devices. This study reinforces the need for a global minimum reporting standard, to facilitate more effective PMS.Figure 1Figure 2

Emerging Challenges and New Responses, Building Capabilities to Counter Threats in Cyberspace

Cyberspace phenomena are changing rapidly at international and national levels. Growing threats, new vulnerabilities and protection against them require continuous action at the level of the EU, NATO and national competent authorities and organisations. Adequate protection of critical infrastructure and cyberspace is a vital strategic, operational and technical challenge for the EU, NATO and therefore nations. Cross-border impacts, threat actors and malicious actions require coordination of international and national procedures, mechanisms and cooperation. This article presents the most important phenomena and trends experienced today, as well as EU and NATO initiatives and requirements at the strategic level, illustrating what changes can be expected in cybersecurity.

Permanent Sovereignty vs. International Obligations

This research analyses Indonesia's policies related to downstreaming and restrictions on raw nickel exports that have caused international debate, especially the European Union which complained against Indonesia to the World Trade Organization (WTO) in Dispute Settlement 592 (DS-592). The study explores Indonesia's position as a WTO member that is being questioned for its policy of banning nickel ore exports to the European Union, and examines the DS-592 ruling in relation to the permanent sovereignty debate. This article uses a normative juridical method with doctrinal, comparative, and case approaches. The results show that Indonesia has permanent sovereignty over its nickel ore guaranteed by UN Resolution 1803. Therefore, Indonesia must exercise this sovereignty with due regard to international obligations. Indonesia should learn from China's export regulations as it prioritises export restriction policies rather than export bans. By applying China's approach, Indonesia can prevent the problems that occurred in DS 592. However, a series of nickel downstream policies implemented by Indonesia have violated the provisions of the WTO Agreement. This article also explains that the vacuum of the Appellate Body does not negate the EU's authority to retaliate against Indonesia. This article concludes that Indonesia must implement a policy determining the percentage of downstream nickel ore, as well as nickel ore that will be exported. This conclusion has resulted in the theoretical idea that no sovereignty can be exercised in violation of the country's international obligations. Thus, each country must be able to establish policies that can balance national interests with international obligations. KEYWORDS: Export Restrictions, International Obligations, Nickel Ore, Soverignty, WTO.

Reforms of the Financial System in the European Union –Towards a New Legal-Institutional Order

The combination of the legal documents including the 2021-2027 EU long-term budget, NextGenerationEU, andthe Own Resources Decision (3) (Decision of 14 December 2020 on the system of own resources of the EuropeanUnion, repealing Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of theEuropean Union) has been praised as a groundbreaking achievement and political success of the EU authorities,one whose importance is no lesser than that of the establishment of the EU’s common market. The package hasmarked a powerful turn in EU’s politics, in that it helps move the debts of the countries receiving funds fromNextGenerationEU as well as within National Recovery and Resilience Plans (NRRPs) outside their national budgetarysystems. As is emphasised in a number of EU documents, the increases in EU Member States’ deficits anddebts have been due to the financial and health crisis. However, how or in what ways the new own resources andnew outside-Treaty financial engineering might contribute to the funding and eventual repayment of NextGenerationEUdebt, has not been explained.In parallel, the aforementioned success has given the basis for further action in view of in-EU integration, as expressedin the project to amend EU Treaties. Work on the amendment will continue during the present EuropeanParliament’s term. Analysis of the directions of change in the Treaty provisions covering EU fiscal and monetarypolicies and the gradually remoulded model of EU funding form t he core of this present paper.

A Very European Way Out: Polity Maintenance and the Design of Article 50

Abstract Multilevel polities do not typically facilitate secession, so why did the European Union adopt Article 50? Revisiting formative debates from the 2003 Convention on the Future of Europe, we combine archival research with an original dataset of delegate debates over two levels: the existence and procedural operation of an exit article. This reveals essential new detail on the genealogy of Article 50. We locate this institutional innovation within a Rokkanian–Hirschmanian theoretical framework which treats exit closure as necessary for loyalty and resilience. Further refining this ‘polity’ perspective, we find many participants showed awareness of the potentially disruptive implications of an exit article. Yet, given extant tensions around ‘ever closer union’, a Eurocentric procedural design prevailed as a safety valve, granting EU authorities default control over any exit process. This European logic of ‘controlled opening' offers a potential blueprint for other integrating compound polities and international organizations facing backlashes from member states.

Трансформация партийно-политической системы ЕС накануне евровыборов-2024

The article analyzes the main trends in the transformation of the political party system of the European Union on the eve of the next European Parliament election, which will be held in June 2024. Long-term trends include: a decrease in the popularity of traditional political parties – conservatives, social democrats and liberals – in most EU member states; an increase in electoral support for populist parties in the same countries; an increase in the representation of women in EU authorities; strengthening the pan-European political space, which leads to deepened impact of EU political institutions on the political systems of EU member states, etc. Relatively new trends in the transformation of this system are: growing popularity and influence of Eurosceptic parties both in individual European countries and in the European Union as a whole; political conflict between the EU and its member states – Poland and Hungary which violate European democratic principles, including the rule of law with respect to the rights of citizens and the independence of the judicial branch of government. The author scrutinises the influence of changes in the socio-class structure of European society on these processes, which occur partly owing to a visible reduction in the number of the industrial proletariat. It is noted that the consequences of these changes are the destruction of the boundary between the traditional right and left parties, and the death of many classical ideological categories. The study also presents the forecast of results of the leading pan-European political parties’ participation in the 2024 European election, made by a number of European non-governmental organizations and mainstream media holdings following public opinion polls, as well as their possible impact on the formation of a new composition of the European Parliament and the European Commission.

Architectonics of Reforming Romania and Bulgaria in the Context of Integration into the EU

he article analyses the dynamics of negotiations between Romania and Bulgaria regarding EU membership and reveals their steps on the way to integration and solving the main problematic issues. It has been proven that the new approach of Bucharest, in particular institutional reforms, the creation of a national system for the coordination of European integration and the development of National Programs and Priority Action Plans for the preparation of EU accession, led to the acceleration of the process of preparation for integration and conducting negotiations. It is established that the EU authorities tried to promote the integration of Romania and Bulgaria by modernizing the Accession Partnership in 2002 - 2003 and updating the Road Map in 2000 and 2002, as well as providing and increasing the amount of financial assistance. The European Commission and the European Council, due to the backwardness of Romania and Bulgaria, called on them to step up their efforts, thereby confirming the EU's willingness to provide them with full support. It is substantiated that the adoption of the financial package for the accession of Romania and Bulgaria in February 2004 intensified the negotiations and contributed to the implementation of the most difficult sections of the acquis in 2004. The reporting documents of the Commission on Romania and Bulgaria for 2004 stated that they continued to fulfil the Copenhagen criteria and the probable readiness to membership in three years. It is noted that after making a number of efforts and carrying out forced reforms, the above-mentioned states managed to achieve EU membership in 2007.

Debating Legitimacy and Solidarity in the European Parliament: Patterns of Opposition and Conflict During the Pandemic

AbstractTo cope with the socio‐economic consequences of the Covid‐19 pandemic, the EU has adopted a new approach by launching an instrument aimed at promoting cross‐national solidarity, called Next Generation EU. This could trigger major changes in terms of EU power and authority, calling into question the polity's legitimacy, and the kind of solidarity to be embodied in the European system. As part of the scholarly debate on transnational solidarity, the article focuses on the politicisation of the Covid‐19 crisis within the European Parliament, with a focus on opposition parties. By applying discourse analysis, the article explains how the crisis has acted as a catalyst for framing opposition parties' stances about the relationship between legitimacy and solidarity in the EU polity. Furthermore, the article examines how opposition parties have assessed their competing views on the role of the EU's political system and on future developments in the integration process.

GEOPOLITICAL VIEWS AND GEO-ECONOMIC CONSIDERATIONS ON THE GERMAN STRATEGY AND EU WIDER FRAMEWORK RELATIONS WITH CHINA

On July 13, 2023, the German Government has released the first national strategy related to approaching China in international relations, including from a geo-economic perspective. The text of the German strategy is of significant importance for other EU member states and the EU authorities, as it encloses aspects pertaining to the industrial policy and cyber-security, serving nonetheless as a use-case and / or a model for developing a coherent approach to China, including the perspective of economic diplomacy in the larger context of policy dialogues with China. From a diplomatic stance, China has anchored international relations in the countries of Central and Eastern Europe, some of which being EU members – in 2012, China forged partnerships via the “16+1” Cooperation, later extended after the Dubrovnik Summit to “17+1” by the adhesion of Greece. China looks to consolidate bilateral relations in Europe via a multi-level approach and sectorial-specific coordination (to include trade, energy, financial technologies, forestry, maritime services, etc) and the German strategy complements the projected EU-China comprehensive strategic partnership, rather than to be an alternative to it. In this context, the paper explores the implications of the German strategy towards China from the European viewpoint and analyses its value-added potential to supporting the wider angle of EU international relations towards China. The research hypothesis is that in the current international geopolitical context related to China, the German strategy enhances at the national level the guiding principles of EU approach to managing the relations with China and adds value to EU economic diplomacy instead of duplicating it. The research methodology is focused on a qualitative analysis of documented authentic scientific public resources and synthesis of key aspects from a geopolitical and geo-economical wide angle of Sino-European relations. The conclusions draw on the fact that China acts as an international challenger, on a path to consolidate its international role and the EU and the German strategies towards China support the mitigation of exposures to economic dependencies by de-risking linkages rather than economic de-coupling from “a partner, a competitor and a systemic rival” at the same time, as designated by EU.

Upholding Maritime Migrants’ Rights at the Borders of Europe – J.A. and Others v. Italy

Abstract Countless people have left the African continent seeking to reach European shores via the central Mediterranean Sea route, despite persistent efforts by Italian and EU authorities to counter migratory activities. International and regional human rights judicial bodies have provided some responses to the abuses faced by maritime migrants both at sea and on land throughout the years. In this case note, I analyze the judgment of the European Court of Human Rights in J.A. and Others v. Italy concerning the detention of maritime migrants in the Lampedusa hotspot center. To this end, I first illustrate the facts of the case. Second, I assess each claim made by the applicants in relation to the human rights abuses they suffered: inhuman and degrading treatment, arbitrary detention, and collective expulsion of aliens. I conclude that the judgment constitutes an important development in the Court’s case law upholding maritime migrants’ rights, albeit characterized by a few shortcomings. I also argue that the Court’s position as a human rights judicial body needs to be further strengthened in the future.

Confiscation of assets in the EU – legal or (just) effective?

The European Union is empowered to legislate in criminal matters; the European Parliament and the Council may establish minimum rules, in certain areas, concerning the definitions of criminal offences and sanctions or facilitating cross-border cooperation. However, in the field of asset confiscation, the EU authorities seem to go beyond these competences in their legislative activity. In this paper the author refers to this and other problems of EU legislation in criminal matters: covering up the insufficient competence to legislate with the argument of needing harmonisation, the lack of reliable data that would justify EU legislative activity and the problematic concept of effectiveness in EU legislation.

Newcomers in EU foreign policy: the Committee of the Regions as an EU para-diplomatic actor

ABSTRACT Has the Committee of the Regions (CoR) any role in the EU’s foreign policy? We conceptualize the CoR as an EU para-diplomatic actor, and we explore the evolving and multi-faceted role of the CoR in the European Neighbourhood Policy (ENP) by employing a two-fold approach: first, from an institutional perspective, we examine the role, capacity, and limits of the CoR’s engagement. Second, from a functional dimension, we investigate the added value of the CoR’s initiatives in the ENP and the EU foreign policy more generally. We show that the CoR has managed to expand its room for manoeuvre acting ‘below the radar’ by establishing communication channels and promoting subtle ways of mediation, especially in conflicts of high intensity whereby the EU and national authorities fail to deliver. Our findings contribute to the more comprehensive understanding of both the EU foreign policy and the CoR’s positioning in the EU institutional architecture.

Do Too Many Cooks Spoil the Broth? How EU Law Underenforcement Allows TikTok’s Violations of Minors’ Rights

For some time already, there have been concerns about TikTok’s business practices and their compliance with EU law. Different market investigations found out that TikTok’s Terms of Service do not comply with the Unfair Commercial Practices Directive, the Unfair Contract Terms Directive or the Consumers Rights Directive, and that they also infringe the General Data Protection Regulation and the Audiovisual Media Services Directive. This is particularly problematic considering that many children, a vulnerable category under the applicable law, use TikTok on a daily basis, which intensifies the severity of the infringements. Although the protection of minors is one of the policy objectives of the EU, this article argues that the enforcement structure is deficient. In view of TikTok’s practices infringing EU law, the European Consumer Organization, BEUC, called for an EU-level coordinated action to the European Commission and national authorities to request TikTok to align its practices with EU consumer law under the Consumer Protection Cooperation (CPC) Regulation. However, the developments following BEUC’s call for action revealed that the CPC Regulation is not sufficiently effective. Ultimately, the ongoing problems and the seemingly lenient interpretation and application of the CPC Regulation by EU authorities that allow the continuation of TikTok’s identified abusive and misleading practices provide evidence that the institutional apparatus for an EU-wide action for enforcement of consumer and data protection law is failing to deliver. This article provides a practical account of these developments and argues that “too many cooks spoil the broth”—i.e., that the plethora of rules, organizations, and procedures involved in enforcement paradoxically lead to the ineffectiveness of EU law. The paper takes the reconstruction of TikTok as a blueprint for discussing various options on how the existing enforcement structure of EU law in general, and CPC in particular, could and should be improved in light of the entry into application of the Digital Services Act.

Access to clinical trial dossiers and documents submitted for the marketing authorisation of a medicinal product under the provisions on access to public information

This article is devoted to an analysis of the current regulations on the disclosure of clinical trial documentation of a medicinal product and documents submitted for the marketing authorisation of a medicinal product. Undoubtedly, due to the very high commercial value of the data obtained in the course of a clinical trial, the sponsor of such a clinical trial is interested in the widest possible coverage of its business secrecy. On the other hand, however, it is in the interest of patients and the public's health protection at large to have the widest possible access to this information.This article is devoted to an analysis of the current legal provisions on the conduct of clinical trials on medicinal products for human use and the registration of these products, both at EU and Polish level, as well as regulations on access to public information. In order to better illustrate the scale of information that may be covered by a request for access, the scope of documentation created in the course of conducting a clinical trial is also presented.The article also presents the rulings of the Court of Justice of the European Union concerning the scope of the obligation to provide access to this type of documentation and possible exceptions to the general principle of access to all documents processed by EU or national authorities. The purpose of the article is to juxtapose the interests of patients (the widest possible access to data on clinical trials and registration of medicinal products) with the interests of companies conducting clinical trials and to confront the practice of Polish regulators - the President of the Office for Medicinal Products, Medical Devices and Biocidal Products and the European Medicines Agency - with the case-law of the Court of Justice of the European Union in this respect.

The impact of BLER on the corporate activity in the UE

Motivation: Since the 1970s, there has been recorded a significant scope of the employee representation in corporate governance bodies, as the earlier German solutions have been popularized in many European countries. Since then, there has been a discussion about the impact of this representation on the activities of companies, their economic results, their value, etc. The research conducted on this subject does not provide a clear answer on this topic.Aim: The article aims to determine the impact of board level employee representation (BLER) on the activities of companies. The latest findings in this area, based on the results of empirical research shall be considered. New types of BLER impact on the value of companies in various phases of the business cycle and on preventing tax avoidance shall be presented. The objective of the article is also to provide the governments of particular countries with additional arguments in favour of introducing or expanding the institution of employee representation. In the longer term, these arguments should encourage the EU authorities to try to develop and adopt a directive on this subject, obliging member states to introduce or extend BLER.Results: The controversy over the influence of BLER on the company’s operations has not diminished. However, taking into account the entirety of such an impact (ideological, economic and social results), there has been an increasing number of arguments in favour of a positive assessment of such an impact. They are provided by the latest, extensive empirical research conducted on this subject, covering several dozen countries. They indicate that BLER has a positive effect on the stabilization of the company in times of economic downturn (recession), that it affects the adoption of a long-term development strategy by companies, etc. The research also shows that representation of the employees in boards prevents companies from tax avoidance. Its effectiveness correlates with the scope of such representation.

An Ecosystem for Social Entrepreneurship and Innovation: How the State Integrates Actors for Developing Impact Investing in Portugal

In this article, we explore how an important state intervention in cooperation with many civil society actors led to impact investing field emergence, intending to create favourable conditions for social entrepreneurship and social innovation. Twenty in-depth interviews were conducted in Portugal, with the main players in the field, including private sector, government, NGOs, and EU authorities. The ecosystem formed by these actors is analysed under the institutional theory lens and through an inductive method, leading to a process-based model. The results of our case study show a state struggling to involve private sector in providing resources to the field. On demand side, new entrepreneurs are finding difficulties in meeting legal requirements and answering suppliers’ selection criteria. Intermediaries contribute to reducing complexities, but are fighting to encounter their place in the field. Our evidences further suggest that social entrepreneurship and social innovation could be implemented as socially embedded actions, in response to local demands.

Moderating Globalization: Is There a Role for Antitrust Law? A Comparison of the Relevance of Entry, Expansion and Imports in US and EU Merger Proceedings

This paper attempts to locate the issue of innovation and foreign entry, in particular new entrants from China, in recent US and EU merger decisions. In the first part, the paper examines to what extend US and EU authorities considered foreign entry in recent major merger decisions such as Bayer/Monsanto, Dow/DuPont and ChemChina/Syngenta. The outcome of this short analysis shows that the EU Commission has in recent years begun to accept the argument of foreign entry, in particular from China, as long as the market shares of the merging parties are not too high. The US has not explicitly discussed the question of foreign entry in the above-named decisions. However, in the case Whirlpool/Maytag the US authorities accepted, despite high market shares of the parties, the argument of foreign entry and approved the merger. With regards to innovation, entry into future product markets is not considered favourable to the merging parties by the EU Commission. ‘Innovation competition’ or early ‘pipeline products’ is rather used as an argument to demonstrate that the merging parties hold market power in product markets in the future. Based on the selected case law, the US authorities, by contrast, did recognize entry into future product markets as an argument in favour of the merging parties. In its second part, the paper looks at the pros and cons of forming ‘national champions’ and discusses competition law enforcement in light of the numerous and politically powerful Chinese state-owned enterprises (SOEs). Global competition/antitrust law and policy, foreign entry in merger decisions and China, innovation competition, entry criteria in US/EU mergers, climate change

Big tech’s acquisition challenge to EU merger control

ABSTRACT In recent years, there has been a tidal wave of merger filings involving large digital firms acquiring low turnover but high value start-ups. The vast majority of those transactions have flown under the radar of EU and National Competition Authorities and, among the few which have been reviewed, none has been blocked. Competition scholars wonder whether there has been a systematic bias towards under-enforcement against acquisitions of start-ups by already dominant tech firms. Some Member States are calling for a reform of the EU merger control’s notification system and an adaptation of the substantive test to effectively address cases of potentially predatory acquisitions.