EU Legislation Research Articles

Implementation of EU legislation into the criminal legislation of Ukraine to ensure criminal legal protection of pharmaceutical activity

The purpose of the article is to determine the specifics of the implementation of EU legislation into the criminal law of Ukraine to ensure the criminal protection of pharmaceutical activity. The methodology includes the author's emphasis on basic international legal guidelines. Directive No. 2001/83/EC of the European Parliament and the Council of the EU on the Community Code on Medicinal Products for Human Use of November 6, 2001 serves as one of the main guidelines here. In the author's opinion, this is important based on the fact that the adopted Law of Ukraine "On Medicinal Products" of July 28, 2022 implemented many provisions of the said Directive, including those that are important for the criminal protection of pharmaceutical activity. The article pays special attention to the issue of determining the "limits" of criminal protection of the circulation of medicinal products, which depend on the specific requirements of Directive 2001/83/EC, which define the concept of "medicinal product" and provide for the limited use of medicinal products, as well as mandatory components circulation of medicinal products (as defined in Article 2 of Directive 2001/83/EC), each of which is related to the state registration procedure and obtaining the necessary permission. The results. Attention is focused on other international legal documents, such as EU Council Directive 85/374/EEC "On the approximation of laws, regulations and administrative provisions of the member states regarding liability for low-quality products" dated July 25, 1985, which contains an independent general declaratory prescription that the "special liability system" created by this Directive is an effective legal means of protecting consumers of pharmaceutical products. Scientific novelty. The author notes that the construction of a "national model" of criminal law protection of pharmaceutical activity must in any case take into account the main international legal standards regarding the "subjects" of pharmaceutical activity and their separate varieties, "accompanying" subjects that ensure the "handling" of pharmaceutical activity products (in particular, accessories, documents), integral components of pharmaceutical products (active substances and excipients, parts and materials), types and varieties of pharmaceutical activity, as well as state regulation of pharmaceutical activity. Practical significance. The results of the research can be used in law-making and law-enforcement activities during the investigation of crimes related to the field of pharmaceutical activity.

Quality indicators artificial intelligence

The ability of some artificial intelligence (AI) systems to autonomously evolve and the sometimes very limited possibilities to comprehend their decision-making processes present new challenges to our legal system. At a European level this has led to reform efforts, of which the proposal for aEuropean AI regulation promises to close regulatory gaps in existing product safety law through cross-sectoral AI-specific safety requirements. Aprerequisite, however, would be that the EU legislator does not only avoid duplications and contradictions with existing safety requirements but also refrains from imposing exaggerated and unattainable demands. If this were to be taken into consideration, the new safety requirements could also be used to specify the undefined standard of care in liability law. Nevertheless, challenges in the context of provability continue to remain unresolved, posing arisk of rendering the legal protection efforts of the aggrieved party ineffective. It remains to be seen whether the EU legislator will address this need for reform with the recently proposed reform of product liability law by the Commission.

Bridging Entrepreneurial Finance in the EU: The New Crowd Funding Regulation

Bridging finance to small and medium enterprises (SMEs) is a must in the sustainable economic development of any country. Access to finance is an essential determinant for business start-ups, development and growth for SMEs. In these years, crowd funding digital platforms have flourished fast as an innovative form of financing for SMEs. Their characteristics allow them to perform SME credit risk assessment better and quicker than traditional financial intermediaries. Compared to banks, for instance, crowd funding digital platforms benefit from minimal capital requirements and a flexible organizational structure that, thanks to the new digital technology, can collect and process information and big data much more quickly. To foster the growth of the crowd funding industry in the EU and ensure investor protection, the legislator introduced the European Crowd funding Service Provider Regulation (ECSPR). The new regulation aims to create a standardized regulatory framework by harmonizing the crowd funding services in the common market and facilitating cross-border operations, enhancing investor protection, promoting transparency and ensuring compliance with the regulatory requirements to increase investor confidence. This article discusses the ECSPR's objectives, requirements and critical provisions. Furthermore, it evaluates the ECSPR's results against the EU legislator's initial intents of fostering the growth of the crowd funding industry and enhancing investors' trust and confidence with protection measures. A balance between these two would be optimal.

Environmental Impact Assessment in the context of armed conflicts

The Environmental Impact Assessment (EIA) is a legal, procedural tool that allows to identify, predict, evaluate and prevent or mitigate the impacts of a planned project on the environment. An inherent element of this process is public participation that shall be assured at all times.
 EIA is regulated by domestic environmental laws of a given county, but an imminent influence on these regulations is exerted by EU EIA Directive (Directive 2011/92/EU text codified) and international conventions, especially the ESPOO Convention.
 EU legislation and international EIA-focused treaties do not determine if armed conflicts affect the EIA procedures and, if the answer is positive, in which way, especially whether the EIA procedure remains required under these exceptional circumstances or it may be postponed until cease of conflict or even omitted.
 For this reason, it was of high importance to determine whether EIA-related obligations set by EU and international laws are suspended or remain valid and in force during armed conflicts.
 The research revealed that the above-mentioned acts do not have provisions that explicitly regulate the effect of armed conflicts on the obligations relating to the EIA procedures. Furthermore, current jurisprudence and doctrine do not provide clear answer on the scope of application of international environmental law during armed conflict. It is often explained by the fact that environmental law is not yet fully formed in that respect and it is still not commonly agreed how it relates to international humanitarian law.
 Based on findings of the research, some conclusions are proposed that aim at providing advise on the application of EIA during armed conflicts and suggestions to supplement discussed bodies of law.
 This article will discuss the main results of the study conducted on this important and very up-to-date subject.

Legal regulation of banks with foreign capital in EU legislation

Ukraine is in negotiations for deep and comprehensive integration with the EU, which involves adapting standards and rules. The regulation of banks with foreign capital plays a crucial role in this process, being a significant aspect for Ukraine as the country aims to deepen its economic ties with the EU. The research aims to identify the distinctive features and patterns that govern the legal regulation of the activities of foreign banks in EU countries. Historical-legal, special-legal, functional, formal-logical, dialectical-materialistic methods, and a systematic approach were employed in the study. The investigation revealed several directives at the EU level focused on regulating foreign investments and ensuring the security of investment processes within the EU’s internal market. The analysis indicated that these directives aim to ensure unity and effectiveness in controlling foreign investments in strategic sectors. They grant member countries the right to take measures to identify and control foreign investments that may pose a threat to security or public order. Additionally, they define obligations regarding information disclosure for foreign investors seeking control over European companies in strategic areas. Furthermore, they regulate financial instruments and services in the EU internal market, including services for foreign investors, and guarantee standards and transparency in operations on EU financial markets. The research concludes that these directives aim to create a unified and secure financial system in the EU, ensuring the protection of strategic sectors from unforeseen external interventions. This study can serve as a valuable tool for government officials, regulators, academics, and financial industry professionals in making informed decisions regarding further reforms and improvements in legislation for banks with foreign capital in the EU

The judgment of the CJEU in Inspektor (Purposes of the processing of personal data – criminal investigations) of 8 December 2022 and the concept of further processing under the Law Enforcement Directive

In the context of criminal law enforcement and cooperation, the fundamental right to the protection of personal data is not complemented by the General Data Protection Regulation (Regulation (EU) 2016/679 – ‘GDPR’), but by the national law implementing Directive (EU) 2016/680 (‘LED’) together with other pieces of EU legislation. The preliminary ruling of the Court of Justice of the European Union in Case C-180/21 Inspektor (Purposes of the Processing of Personal Data – Criminal Investigations) delivered by the Fifth Chamber on 8 December 2022 is the first judgment in which the Court considered the LED beyond its scope of application. It represents an important milestone for data protection law in the area of criminal law enforcement. This paper will provide an analysis of the main findings of the judgment, with particular focus on the concept of “further processing” and a first reflection on the consequences it may have on the work of competent authorities such as public prosecutors.

Food fraud in the European Union

EU legislation does not provide a definition of fraud in the agri-food chain.
 Commission Regulation (EU) 2019/1715 defines a "fraud notification" in IRASFF and therefore indicates the key elements to consider. In this sense, agri-food fraud is "a failure to comply with any suspected intentional action by businesses or natural persons, with the aim of deceiving buyers and obtaining an undue advantage from it, in violation of the rules referred to in Article 1 paragraph (2) of Regulation (EU) 2017/625".

The place and role of the comparative law method within the interpretation of the Court of Justice of the EU

The term „interpretation” was left in shades by The EU Functioning Treaty, but it shows the communication of the content and applicability limits in space and time of that particular legal norm. All the methods used for descovering the content of the legal norms in order to proceed to its practical enforcement is what interpretation is all about. The European Court of Justice of the EU provides the only official interpretation of the European legal norms, using at this extent several ways to accomplish that, such as grammatical interpretation which, most of the time, needs to be completed by the teleological one. The teleological interpretation ensures the fact that the main purpose of the EU legislation is to recourse to the general principles of the EU Law, but also to the interpretation of the secondary law according to the Founding Treaties. In this generous frame of interpretation, the comparative law method applied by the European Court of Justice enables the hand- in -hand relation between this particular method of interpretation and the constitutional traditions common to the member states.

The EU DLT Pilot Regime for Digital Assets [pre-publication

On 23 March 2023, the DLT-Pilot-Regime came into force. It provides market operators the opportunity to offer blockchain-/DLT-based securities trading subject to full EU financial markets regulation. Although this piece of legislation has not attracted as much attention as the Regulation on markets in crypto-assets (MiCAR), the impact of the DLT-Pilot might be signification. In this article, we outline how the EU legislators have identified the shortcomings of current EU market regulation when applied to DLT-based trading, and addressed them one by one. If successful, the DLT-Pilot could become a ‘test kitchen’ for the development of DLT-based securities and crypto-asset trading in the EU. distributed ledger technology, DLT Pilot, financial instrument, MiCAR, regulatory sandbox, settlement system, multilateral trading facility

EU Antitrust Fines and Managerial Liability – A Legal and Economic Analysis

Should companies that have been fined for EU antitrust infringements be allowed to recover such fines from their (former) directors or employees? On the basis of an analysis of the EU Treaty provisions, legislation and case law on antitrust fines, as well as of the economic nature of antitrust infringements and the economic rationale of fines on undertakings/companies, this paper argues that it would appear contrary to EU law to allow undertakings/companies that have been fined by the European Commission or by a national competition authority(NCA) for infringements of Articles 101 and/or 102 TFEU to recover such fines from the companies’ (former) directors or employees, as such recovery would significantly impair the full effectiveness of those fines. EU competition law, antitrust fines, deterrence, corporate liability, management liability, undertakings and companies, directors and employees, recovery of fines, incentives, agency problems

Climate change as a factor enhancing the invasiveness of alien species

Abstract Climate is one of the key factors governing the biological invasions of alien species, thus its change may have significant consequences for the scale of this process. We analyzed the predicted influence of climate change on the invasiveness of alien species in Poland and identified species susceptible to climate change. A total of 60 species of alien plants and 58 animals were assessed through an expert elicitation process. For 79 species climate change was assessed as the factor enhancing the likelihood of introduction, establishment, spread and/or impact in the future. Currently, the majority of these species are not widespread in Poland, and this list includes species totally absent, or present only in cultivation and captivity. Climate change will increase the number of high-risk invasive alien species (IAS) from 38 to 63. Species originating in warmer parts of the world are most susceptible to climate change. The majority of the high-risk IAS are regulated under the EU and Polish legislature. However, no restrictions have been imposed on some of the high-risk IAS. Since climate change will further increase their invasiveness, implementation of legal provisions towards these species is recommended.

The Internal Reporting Procedure for Breaches of Law and the Protection of the Entrepreneur’s Interest

Abstract Directive 2019/1937 comprehensively regulates the issue of reporting violations of the law and the protection of persons making such a report. The EU legislation formulates obligations regarding the establishment of channels and procedures for making internal reports, setting the framework for such a procedure and leaving it to national legislatures to specify it. The Polish legislature took action in this regard by preparing the draft Act of 5 January 2023 on the protection of persons reporting violations of the law. Due to the sensitivity of the matter, the implementation of formal mechanisms for reporting irregularities in the workplace is undoubtedly associated with many challenges. Most often in this context, challenges related to ensuring sufficient whistleblower protection are mentioned. Meanwhile, it also seems necessary when implementing such procedures to notice the challenge of the protection of entrepreneurs’ interests. A number of solutions included in the Polish draft act raise doubts and objections as to the correct implementation of the EU directive.

Cybersecurity in European Financial Institutions: New Grounds for Corporate Governance Reform

Cybersecurity, digital resistance to incidents, errors and cyberattacks attracted the attention of the European Union legislator, initially, from a public policy perspective. Today, cybersecurity concerns are dealt with as a part of EU Internal Market strategies, including those more closely linked to the financial sector. These pages focus on the new EU legislation to achieve Digital Resilience in the financial sector as well as on their impact upon the Corporate Governance of financial institutions. Compliance with corporate duties of cyber-governance, management of cyber risks, testing, continuous improvement, as well as reporting, communication, and transparency shape the new corporate governance landscape of the financial institutions in the European Union. Within and beyond what is already being legislated and proposed, Corporate Governance is called to play a fundamental role in facing the challenges of digital security. Cyber security, digital operational resilience, cyber risk management, financial sector, large ict supported infrastructures, critical ict providers, corporate governance reform, digital corporate governance, board duties, board commissions

The people’s budget? How business interests and fiscal constraints shaped the economic policies of the Italian populist government

Between June 2018 and September 2019, Italy was ruled by a coalition government comprising the far-right League and the anti-establishment Five Star Movement. The government, which was widely referred to as the first populist executive in a major EU member state, alarmed Italian and European elites. In fact, the coalition built its rhetoric on questioning EU legislation, particularly that concerning immigration and, of interest here, fiscal constraints and austerity policies. The executive’s first programmatic document on economic policy, the budgetary plan for 2019, triggered two months of heated negotiations with the European Commission before being approved. Although critical political economists have investigated how the ‘populist’ government furthered neoliberalism in Italy, an analysis of its organic ties with Italian capital is still missing. Our article addresses this gap by investigating, within a critical Global Political Economy perspective, the competing business interests behind the budgetary plan and how they shaped the formulation of the populist government’s economic policies. The analysis of the executive’s economic policies, together with its organic ties with capital, allows us to explain the rise of the populist government and describe its nature as well as its contradictions which explain its limited transformative potential and its inner fragility. The findings highlight the relevance of a critical Global Political Economy perspective for investigating economic and fiscal policy in the era of authoritarian neoliberalism, in particular in assessing the EU structural constraints on economic and fiscal policy but also the agency of domestic capital shaping it.

The freedom to conduct a business as a driver for AI governance

Artificial Intelligence (‘AI’) is associated with several risks that need to be contained and mitigated through an appropriate AI governance framework. However, it is also crucial to take into account the opportunities and societal benefits of AI and to consider and respect businesses as key actors in the context of AI. The freedom to conduct a business is a fundamental right enshrined in Article 16 of the Charter of Fundamental Rights of the European Union. It cannot be considered a diminished or functionalised right, nor are companies necessarily a threat to human rights or an obstacle to the pursuit of human-centred governance of AI. As in any scenario of conflict or collision between fundamental rights and interests, a fair balance must be struck between the subjective positions of different stakeholders. Ensuring respect for the freedom to conduct a business safeguards innovation and the flourishing of new opportunities that ultimately benefit citizens and the public interest. In the European Union legal system, AI governance will be shaped by both the ‘Artificial Intelligence Act’ and novel rules to address liability issues related to AI systems. While its prima facie content is affected by several provisions and obligations, in particular, for providers of high-risk AI systems, the EU legislator does not neglect the freedom to conduct a business. It seeks to provide legal certainty, ensure proportionality and address the special condition of small and medium-sized enterprises and start-ups. However, the rigidity of some provisions and the approach to risk, together with the uncertainty that characterises the normative environment of the AI, leave room for improvement and for further escape valves, with the future application being of particular importance.

Trends in the Digitalisation of Public Administrations – in Light of EU Legislation and Domestic Developments

Purpose: Regulating the parameters of all types of identity – including its elements, authenticity and authenticator, verifiability, and the verification process – requires particular attention. The most critical element here is most likely its presence in the digital sphere. Our main goal is to examine the proposal to amend the eIDAS Regulation to create a framework for a European digital identity.Design/Methodology/Approach: The paper analyses the topic in terms of Union law and the most recent strategic document of the Hungarian governmental decisionmaker, incorporating pertinent scientific findings. The article evaluates the current situation, highlighting foreseeable and potential impacts of the new legislative developments.Findings: The paper presents both the practices established by the eIDAS Regulation as a starting point and the current status of digitalisation in Hungary (primarily in public administration).Practical Implications: Eventually, we will attempt to identify the expected opportunities and advantages, as well as risks and drawbacks, associated with the nascent trend of digitalization of public administration in the EU and Hungary.Originality/Value: Upon establishing a groundwork in this domain, the nature of the amendment and the domestic response (National Digital Citizenship Programme) will be reviewed to assess efforts at both the European and Hungarian levels.
 
 
 

Presumptions of Law Concerning Causality in Environmental Cases: Towards Collective Presumptions of Fact?

Abstract Presumptions of law are an appealing concept to remedy situations of causal uncertainty. In many pieces of EU legislation in various areas such as competition law, AI law and environmental law, presumptions are presented as a solution for plaintiffs that encounter problems regarding causal uncertainty in their compensation claims. Oftentimes, however, insufficient attention is paid to the possible risks of over- and under-compensation, the available alternatives and the functionality of these presumptions. In this article, I argue that a presumption of law fulfils two functions. First, this paper aims to address situations of evidentiary deficiency (individual goal). Second, it aims to facilitate the procedural road to compensation in cases of mass harm (collective goal). A comparative analysis of Belgian, Dutch and French law reveals that there are many ways to shape a presumption and its consequences. In conclusion, I argue that presumptions should always be tailored to a certain case and should attempt to reconcile the collective goal with the individual goal. To that end, policy-makers should aim to create collective presumptions of fact, based on the statistical evidence in a certain mass harm case, as opposed to presumptions of law.

Piloting Bioethanol Production from Source-Separated Food Waste Boosts Technology Readiness

By the end of 2023, biowaste must be completely separated or recycled at source, based on EU legislation. Separate biowaste collection and valorisation for biofuels could play an essential role in the biobased circular economy. In this context, the principal goal of this paper was to demonstrate on a pilot scale the technological solution of bioethanol production via the utilisation of urban source-separated biowaste within the city context of Athens, Greece. More specifically, the main aim was the demonstration of a pilot system for more than 10 consecutive operating cycles with real feedstock—wet; separately collected biowaste. From the 11 pilot trials performed with wet feedstock, the mean starch and cellulose degradation of the pilot trials amounted to 80.69 ± 16.27% and 79.41 ± 10.37%, respectively, while the bioethanol yield was 74.05 ± 6.82%. The latter was comparable to that of more intensive pretreatment methods. Homogenization and shredding, which were applied in this study, stand as promising pretreatment methods for bioethanol production from wet feedstock. Further research is needed to optimize conditions and evaluate scalability. Nevertheless, pilot-scale testing is a crucial step in the deployment of this technology since it serves as a bridge between laboratory research and full-scale implementation, offering a practical and controlled environment to validate and optimize the technology while minimizing risks and uncertainties. Conclusively, this study could stand as a flagship case study for the implementation of circular and sustainable approaches in the management of organic fractions of source-separated municipal waste, showcasing the technical feasibility of the whole value chain from waste collection to final bioethanol product recovery.

Across the spectrum of legality: The market activities of influencers specialized in steroids and other performance and image enhancing drugs

BackgroundLike many other goods and services, performance and image enhancing drugs (PIEDs), and particularly androgenic anabolic steroids (AAS), are increasingly discussed and promoted by social media influencers. Little, however, is known about the influencers specialized in PIEDs and which drugs and services they promote and sell. AimsAgainst this background, the study has been intended to identify prominent influencers specialized in PIEDs, examine the market activities they engage in, and assess the latter's legality. MethodsWe first searched the clean internet to identify prominent PIED influencers. Second, we conducted a six-month-long, non-reactive digital ethnography of the social media accounts of 20 influencers and, via a content analysis, identified the market activities they engage in. Third, we assessed the latter's legality, primarily using the EU legislation as a benchmark. FindingsThe selected influencers are all current or former bodybuilders, predominantly male and from the United States. Many of them have developed a considerable number of followers, in three cases exceeding one million. They engage in various market activities that span the whole spectrum of legality, from legal to illegal, with many activities having an uncertain, but often dubious, legal status. ConclusionsThough they may promote harm reduction for some users, PIED influencers also promote the public acceptance of PIED use beyond the bodybuilding community and enhance access to PIEDs for millions of people. Multifaceted policy interventions are required, aiming at preventing influencers from becoming a major source of information on, and route of access to, PIEDs.

The “New Normal” Terminology

This paper provides a contrastive analysis of COVID-19-related EU legislative texts with emphasis on term variants. The analysis carried out on a parallel corpus consisting of English and Croatian texts has identified multiple examples of variation of predominately multi-word terms at several levels. These include orthographic and grammatical variants, unit shifts and denominative variants creating different meanings. The findings support other contemporary studies into variation within specialized language, highlighting the importance of studying variation to gain understanding about the dynamics of domain knowledge. By focusing on variation in a parallel corpus, conclusions are drawn about the prevalence of variation in a newer EU official language, as opposed to English as the draft text of EU legislation.