EU Regulatory Framework Research Articles

Future-Proof Regulation against the Test of Time: The Evolution of European Telecommunications Regulation.

Regulation is sometimes designed to be future-proof, so that it can adapt to changing economic and technological realities. The EU (and UK) Regulatory Framework for electronic communications was expressly crafted to be able to adjust to the evolution of the industry. This article considers how well the regime has stood the test of time and, based on this analysis, what lessons can be drawn for regulation more generally. It appears that, by and large, the Framework has effectively accompanied the transformation of telecommunications in Europe. On the other hand, the EU legislature's commitment to future-proof intervention has waned over time. Every new review of the regime has represented a move away from the philosophy and mechanisms conceived to ensure that regulation would adapt seamlessly to industry shifts. This experience suggests that the failure or success of future-proof intervention primarily hinges on the intertemporal consistency of legislatures.

Data risks and security in the financial sector: Adapting to a new environment

Huge increases in data generation and storage volumes in recent years, coupled with technological innovations, are changing the nature of data risks in the financial sector. Several factors determine the nature of data risks: (a) the way technology is used; (b) the profile of financial sector entities and their interconnections; (c) the cyberthreat landscape; and (d) awareness and practices among legitimate users of data. How these factors are evolving in an increasingly complex digital environment is described. To manage the changing data risk profile, the EU regulatory framework is adapting. Key regulatory developments in the financial sector include the Digital Operational Resilience Act (DORA) proposal and the recent advice from the European Supervisory Authorities in relation to digital finance. More broadly, the Digital Services Act and the Digital Markets Act aim to create a safer digital space for EU citizens.

DOSSIER. Citizenship, Property Regimes and Divorce Settlement in the new EU Regulatory Framework

DOSSIER. Citizenship, Property Regimes and Divorce Settlement in the new EU Regulatory Framework

Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force.

Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force.

National Development Banks in Europe – A Contribution to Sustainable Finance

Purpose: The paper explains critical changes to investment funding occurred over the past fifteen years in the European Union and explores the added value that National Development Banks create for sustainable finance. The delivery of the European Green Deal and the recovery from the Covid-19 pandemic require an unprecedented scale of resources. The need to adopt a new sustainable investment approach and adjust the operation of the financial system has become inevitable. Existing research has underlined the role national development banks play in counter-cyclical measures and promotion of the government’s public policy goals. However, their standing in the sustainable finance landscape has enjoyed less attention so far. The paper, therefore, looks at how the remit of the Banks has evolved and assesses their progress and further development needs in relation to promoting sustainable finance. Design/Methodology/Approach: The research has followed a two-phase design. The first phase has included the examination of the operational setting of National Development Banks and their impact on overcoming market failures and improving access to finance. The second phase concentrated on drawing a comparison between the new regulatory requirements, in particular the European Green Deal, the EU Taxonomy Regulation and the functioning of the National Development Banks. The methodology has included a detailed literature review, desk research, data collection and re-assessment of earlier surveys, which has been used for prescriptive comparative analysis and cluster analysis. Findings: The paper concludes that National Development Banks, despite their common goals and mandates, demonstrate important variations in terms of government involvement in strategic direction and decision-making and the Banks’ actual contribution to national policy goals. The outcome confirms the hypothesis that recent changes to the EU strategic and regulatory framework only require minor amendments to the direction of NDB investments. Their original setup and objectives are already in accordance with the new expectations and they invest mostly in economic sectors that the new taxonomy system classifies as sustainable. Practical Implications/ Originality/Value: This is important for the scholarly discourse on the essential conditions for sustainable finance. Meanwhile, the results provide usable guidance for development banks/funding agencies in Europe, too. The paper offers a solid ground for continued explorations of the European financial sector, whereas the recently adopted Digital Finance Package could further widen the agenda of the research direction.

Migration and Asylum Governance in CEE Countries: Between Historical Legacies and the Europeanisation Process

Migration patterns in post-socialist Central and Eastern Europe countries were different when compared to old EU member states. During the period after WWII until 1990, those patterns involved primarily migration to and from other CEE countries (and the Soviet Union). In former Yugoslavia, a less oppressive regime, together with a high demand for workers in Western European countries, opened up space for rather massive labour emigration during 1960s and 1970s. After the collapse of previous regimes and during the transition period in the 1990s, CEE countries experienced an increase in immigration; however, relatively small numbers of immigrants have been arriving from outside Europe. At the same time, under the EU accession requirements, those countries had to quickly develop migration policies and align their legislation with acquis communautaire on migration and border security. The mass migrations in 2015 and 2016 opened a new chapter regarding migration and asylum governance in CEE countries. Some of them, such as Visegrad countries, strongly opposed the EU initiatives in the area of migration and asylum, which influenced their relations with EU institutions but also other member states. The paper aims to explore the relationship between the transition and Europeanisation on one side, and the development of migration and asylum governance on the other side in CEE countries, based on the path-dependency approach. The paper focuses on the question to what extent (post)socialist factors influence national migration and asylum governance and policies which are at the same time governed by the EU regulatory framework. It is debated whether the effectiveness of the transfer of values and norms relating to migration during the accession process has been replaced by a “national turn” after joining the EU.

On the path to the future: mapping the notion of transparency in the EU regulatory framework for AI

ABSTRACT Transparency is the currency of trust. It offers clarity and certainty. This is essential when dealing with intelligent systems which are increasingly making impactful decisions. Such decisions need to be sufficiently explained. With the goal of establishing ‘trustworthy AI’, the European Commission has recently published a legislative proposal for AI. However, there are important gaps in this framework which have not yet been addressed. This article identifies these gaps through a systematic overview of transparency considerations therein. Since transparency is an important means to improve procedural rights, this article argues that the AI Act should contain clear transparency obligations to avoid asymmetries and enable the explainability of automated decisions to those affected by them. The transparency framework in the proposed AI Act leaves open a risk of abuse by companies because their interests do not encompass considerations of AI systems’ ultimate impact on individuals. However, the dangers of keeping transparency as a value without a legal force justify further reflection when regulating AI systems in a way that aims to safeguard opposing interests. To this end, this article proposes inclusive co-regulation instead of self-regulation so that impacted individuals as well as innovators will be empowered to use and trust AI systems.

Latest EU gas and hydrogen initiatives

LATESTEUGASANDHYDROGENINITIATIVES This article discusses the proposals of the European Commission to change the EU regulatory framework governing access to gas networks and formulating the general rules of the internal natural gas market. The approach of the EU institution is new and provides for the inclusion in the relevant framework of provisions that contribute to the formation of a separate market for hydrogen fuel, its supply and transportation. The study of the issue becomes extremely important, in particular, for the Russian side, which exports energy resources to Europe.

Regulatory Acknowledgment of Individual Autonomy in European Digital Legislation: From Meta-Principle to Explicit Protection in the Data Act

Individual autonomy has been explicitly recognized in the European Union’s 2022 Data Act proposal. This article shows that such unprecedented inclusion of autonomy in an EU regulatory framework targeting the digital domain marks a paradigm shift for digital-sector legislation away from mostly tacit recognition of autonomy as a meta-principle to a more aggressive regulatory posture. It contextualizes this nascent development by highlighting the turn towards the protection of mental privacy in recent sector-relevant legislation and investigates the intent and scope of Article 6 of the Data Act proposal in light of an increasing regulatory focus on so-called dark patterns. Keywords: Individual Autonomy | European Digital Legislation | Data Act | Article 6

On the Path to the Future: Mapping the Notion of Transparency in the EU Regulatory Framework for AI

On the Path to the Future: Mapping the Notion of Transparency in the EU Regulatory Framework for AI

Economic Cyber-Espionage in the Visegrád Four Countries: a Hungarian Perspective

Abstract This article explores the regulatory framework of reference of economic cyber-espionage in Europe, with a particular focus on the V4 region (comprising Slovakia, Hungary, Poland and the Czech Republic) and taking Hungary as a case study. Europe Union member states, including the V4 countries, are particularly exposed to economic cyber-espionage, because of the advanced know-how of the companies based therein. Under international law, there exists no uniform approach to the matter; also at the European Union level, the legal framework appears rather fragmented and the same holds true at the national level and within the V4 group, where each country has adopted its own relevant regulation. After a general overview of the relevant international and EU regulatory framework of reference, this article overviews the modus operandi of the V4 and examines its approach to economic cyber-espionage, with a special focus on Hungary as case study. As already remarked at the European and international levels, cybersecurity policies and regulations, including those regarding economic cyber-espionage operations, should be drafted in coordination among states; the V4 group can become a privileged platform of discussion to advance in the regulatory harmonisation of the issues at stake.

An Analysis of the International Law on Waste Statistics

The article contains an analytical review of the regulatory framework in the waste statistics. By summing up documentary evidences (conventions on protection of the population health and environment, objectives and indicators of Sustainable Development Goals, related with waste), it is demonstrated that waste statistics plays important role in identifying waste-specific problems, priority setting in waste management, formulating and implementing policy goals in waste management. 
 It is shown that the waste statistics is collected by various international entities, and reports on waste generated in the process of economic activities are made up using two main classifications: International Standard Industrial Classification of All Economic Activities (ISIC), and Statistical Classification of Economic Activities in the European Community (NACE). The EU practices in the waste statistics are highlighted. The EU approach to waste treatment is based on “waste hierarchy”. In practice, a major part of EU countries collects the data on waste types by the List of Waste. After that, the conformity between the types of waste and EWC-Stat is set using the translation table given in Annex III to the Waste Statistics Regulation. Only several countries collect data by the reliance on EWC-Stat.
 Problems faced by the waste statistics are discussed (inadequate comparability of waste statistics due to different methods and definitions used in the data production; incomplete coverage of waste-specific issues by the official waste statistics), sources of these problems are determined. 
 The analysis demonstrates that the waste statistics is a rather new field in EU, which evidence is the ongoing change in the EU regulatory framework. The countries producing waste data with reference to it or implementing it should do it by taking account for the most recent change. The need for harmonization of national methodologies in the waste statistics is highlighted.

Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions : Comparative regulation framework of off label prescriptions in pediatrics: a review.

Background Off-label uses of medicines are common in pediatrics. The literature reports that at least one-third of children in hospital and up to 90% of newborns in neonatal intensive care units receive off-label prescriptions. Moreover, the lack of data on safety and efficacy in the pediatric population may sometimes increase the risk of adverse drug reactions. Objective This paper aims to (a) map the main gaps in the existing EU and US regulatory frameworks for pediatric drug development and off-label use and (b) propose potential solutions for further discussion. Conclusion The selected jurisdictions aim to limit off-label prescribing, but implementation levels generally seem low, including in pediatric settings. Subject to further research, we propose potential concerted actions and initiatives of international cooperation to fill this gap. In particular, regulators and pediatric societies could strengthen manufacturers' incentives to develop pediatric medicines, pediatricians' information about off-label uses, and patients' and parents' awareness.

DE JURE HARMONIZATION OF FINANCIAL REPORTING FOR LISTED COMPANIES: EVIDENCE FOR SELECTED CEE COUNTRIES

Globalization of business and free flow of capital resulted in strong demand for comparable financial reports worldwide. An important element of achieving de facto harmonization of financial reporting is de jure harmonization, i.e. harmonization of regulatory requirements on the country level. Although more than 100 countries have a requirement for use of IFRS (International Financial Reporting Standards) for listed companies, de facto harmonization is still an ongoing process. De facto harmonization is affected by many influential factors, among which de jure harmonization represents one of the most important factors. For the purpose of the study, the authors developed an index of de jure harmonization (IDJH) based on the EU regulatory framework and evaluated its value for 5 CEE countries (Croatia, Bosnia & Herzegovina, Montenegro, Slovenia and Serbia). Empirical findings reveal significant differences in de jure harmonization, related to the country's status in relation to EU integration processes. Keywords: de jure harmonization, financial reporting, CEE countries

Opportunities and limitations for the introduction of circular economy principles in EU aquaculture based on the regulatory framework

AbstractEU aquaculture produces only a small fraction of the internal demand of aquatic foods, but boosting this activity must be done in compliance with high standards of environmental protection and social benefits, as fostered by the policies on circular economy recently launched by the EU. Nevertheless, the assessment of the environmental sustainability of aquaculture and other food production systems is complex, due to the different tools and approaches available. Moreover, the current EU regulatory framework may be restricting the options to implement some circular solutions. This paper examines the controversies related to the assessment of environmental impacts of aquaculture processes and the different available circular solutions, with a focus on the best options to valorize aquaculture side streams and how current regulatory burdens and gaps should be solved.

PLATFORM TECHNOLOGIES OF FINANCING THE DEVELOPMENT OF THE MARKET OF INNOVATIVE TECHNOLOGIES IN UKRAINE

Topicality. The urgency of the problem of innovation technology development in Ukraine is due to the fact that, despite the high priority and great efforts of Ukraine to develop the innovation technology market, ie digital transformation, innovation and startups, still remain quite low innovation rates, the level of startups, the number of startups and their share in the national economy. From our country the active outflow of highly skilled workforce and the knowledge defining competitiveness of innovative processes and systems, and consequently, potential of development of the market of innovative technologies proceeds. One of the most important factors in this situation is the lack of financial resources in the newly created small innovative business structures (startups). Aim and tasks. The purpose of the article is to identify promising innovative tools for financing small innovative business structures (startups) and study the need for state regulation. Research results. The study allowed to include in the financial component of the business environment investors who support various stages of the life cycle of the innovation project, from the prototype to the initial public offering (IPO); business angels who finance the early stages of an innovation project; sowing funds; crowdfunding communities and platforms; venture funds; banks; institutions providing grants and institutions providing state financial support; large technology companies that finance startups for their own needs. It was found that crowdfunding can be an important area of investing the savings of Ukrainian citizens in startups, because the financial market is almost non-existent, investing in real estate requires large funds, investing in gold is long-term and risky. It was found that, on the one hand, the lack of special regulation of crowdfunding simplifies fundraising, and on the other hand, there are no guarantees for investment, which significantly increases the risks and so risky investing in innovative projects. Therefore, it is necessary to develop and adopt a law that would regulate crowdfunding in Ukraine, which would raise funds for innovative projects under a simplified procedure. The main provisions of this law can be adapted for Ukraine by the provisions of the EU regulation governing crowdfunding platforms, which can be considered as a basis for the development of Ukrainian law, especially in terms of guarantees of investor protection. Conclusion. The study revealed a promising innovative tool for financing small innovative business structures (startups) - crowdfunding (and its kind of crowdfunding). Given that in Ukraine, on the one hand, the lack of special regulation simplifies the collection of financial resources for the implementation of innovative projects, and on the other hand, there are no guarantees for investment, which significantly increases the risks of investing in innovative projects, the EU regulatory framework crowdfunding and proved the need to adapt it to the regulatory framework of Ukraine.

Achieving Blue Growth Post-Weser: a Study of Aquaculture Regulation in the Nordic Region

Abstract This article explores how the conflict between the interests of protecting water quality in the coastal waters of the Baltic Sea from nutrient emissions on one hand, and supporting blue growth in the aquaculture sector on the other, has played out in the Nordic legal systems and industry practice. It does so by reviewing the legal and industrial developments in Sweden, Denmark, Finland and the Åland Islands with a focus on interpretation and application of the common EU regulatory framework, mainly the Water Framework Directive and the ecj Weser ruling, and the response from the aquaculture sector. The study shows that the four studied jurisdictions have taken disparate regulatory approaches in balancing ecological status of waters and blue growth. As a consequence of these legal developments, the aquaculture industry faces difficulty in attaining required permits for their operations in all four jurisdictions and significant uncertainty on how to develop the sector to meet the set growth objectives has arisen.

Regulation of Telecommunications: The Choice Between Market and Regulatory Failures

Abstract
 The paper examines the main regulatory frameworks of the telecommunications industry through the concept of market failure and analyses how and why the policy often leads to undesirable outcomes that might be considered as regulatory failure. The research uses the EU regulatory framework for electronic communications as a base for the analysis of the main policy objectives through the prism of the market failure theory with an eye to the interests of the main market players in the telecommunications markets. About any aspect of regulation allows to find ways to create opportunities for some groups of the industry and stifle activity of others. Despite the theory of market failure provides reasonable justifications for regulation of telecommunications markets, it is possible to argue that many of these problems are mainly the consequence of the policy and could be better solved by market mechanisms. The results of the research allow to look at the problems of telecommunications development and issues of the high level of concentration of the telecommunications markets as regulatory formed problems rather than consequences of the inherited industry’s characteristics.

Perspectives of National Coordinators for Animal Genetic Resources on the European Regional Focal Point: Survey Results

Abstract The European Regional Focal Point for Animal Genetic Resources (ERFP), is the European regional platform of National Coordinators (NCs) supporting management of animal genetic resources (AnGR). To assess the performance of the ERFP platform/network and consider options for its further development, a survey was performed among NCs. Twenty-five NCs responded to the survey on the roles, values and future of the platform. The paper provides an analysis of the results of the survey, including a ERFP SWOT analysis. NCs indicated high value of the support of the ERFP in fulfilling their functions at the national level. They highlighted the well-established network and facilitated communication and collaboration among NCs and other AnGR experts in Europe. The NCs appreciated the efficient organizational structure of the ERFP (Working Groups, Task Forces, Ad hoc Actions), and the well-functioning Secretariat. Indicated weak points included discontinuity of NC positions in some countries, and low levels of activities in some countries. NCs saw new opportunities for ERFP development in the context of the EU policy and regulatory framework related to AnGR management, and in strengthening the role of the Secretariat. No immediate threats were identified, however potential future threats included insufficient financing and lack of continuity. The NCs highly appreciated the substantial progress achieved by the ERFP over the last 20 years.

The Role of Regulatory Agencies in Agenda-Setting Processes: Insights from the Italian Response to the COVID-19 Infodemic.

International organizations such as the WHO have worked to raise awareness of the massive infodemic that accompanied the COVID‐19 outbreak and made it hard for people to find trustworthy sources of information and reliable guidance for their decisions. Our contribution focuses on the Italian case, where the Communications Regulatory Authority (AGCOM) was able to act as first mover in its field so as to strategically frame the problem of disinformation in the absence of a pre‐existing policy intervention. An emerging body of research shows that the activity of formally independent regulators is not necessarily limited to the implementation of delegated regulatory competencies. We discuss the implications of the activity of independent regulators for the fight against disinformation during the COVID‐19 pandemic. We find that as a political actor in its own right, the Italian media regulator claimed control over sectoral expertise in order to shape the crucial first steps of the response to the infodemic.