EU Legislation Research Articles

Atypical Types of Criminal Offences Encroaching on Pharmaceutical Activity in Acts of Foreign Criminal Legislation

Purpose: To determine the atypical types of criminal offences encroaching on pharmaceutical activity in acts of foreign criminal legislation. Methods: This article is based on systemic analysis and comparative legal methods. Results and Discussion: We chose the way of systematization of atypical types of criminal offences that encroach on pharmaceutical activity in acts of foreign criminal legislation. Criteria for the systematization of atypical types of criminal offences encroaching on pharmaceutical activity are proposed. Implications of the Research: We have identified the impact of the construction of legal norms of atypical types of criminal offences encroaching on pharmaceutical activity in acts of foreign criminal legislation. Identification of atypical types of criminal offenses and their systematization were useful for finding out “damage” of certain fragments of pharmaceutical activity (its mechanism). Originality/value: We were asked the question of identifying the impact of the construction of legal norms of atypical types of criminal offences encroaching on pharmaceutical activity in acts of foreign criminal legislation. The norms of criminal legislation of EU (Germany), USA (the State of New York, the State of California), Brazil, Switzerland, Turkey, Estonia, Georgia, Ukraine, Kazakhstan, Tajikistan, Uzbekistan were used. It was found that their “atypicality” does not mean errors of legal technique in acts of foreign criminal legislation, but is carried out on the basis of normative (blanket) legislation in the field of pharmaceutical activity.

Reframing the Refugee: Jenny Erpenbeck’s Compassionate Politics

Countless polls, studies and surveys conducted prior to and following the 2016 UK Referendum on Membership of the European Union confirmed immigration to be the key emotive issue for not only the British electorate, but several Western European nations. By critiquing key pieces of EU legislation, Go, Went, Gone (2015) by Jenny Erpenbeck offers a humanising, caustic warning of the troubling politicisation of EU and non-EU migration in Germany, suggesting the ways by which literature can destabilise institutional optics of power and counteract myths surrounding the process of racial othering.

National customs legislation adaptation to EU requirements in the context of eastern partnership policy development

The research relevance is determined by the need to assess Georgia’s trade relations and customs activities in terms of their compliance with European requirements. The study aims to identify areas in the field of customs control that require further legislative regulation and harmonisation with EU legislation. The study employed the following research methods: analysis of statistical data on trade activity; comparison – to compare indicators of unrealised export potential between countries; graphical – to display the results; and generalisation – to summarise the information in line with EU requirements. The study determined the dynamics of Georgia’s trade and economic activities with the EU; assessed the use of export potential with different EU countries; and substantiated the effectiveness and efficiency of Georgia’s customs control reforms. The need to adapt the customs legislation to the common EU requirements is proved and the directions of specific measures for further improvement of customs activities are identified: application of transit (improvements to the guarantee management system are needed); control of sanctioned goods at the border (to speed up the EU’s response to specific requests); risk management system (to establish systematic internal and interagency information exchange); tax authorities (reorganisation and increase of profitability); customs protection of intellectual property rights. This will help bring Georgia’s economy closer to the EU economic area. The expediency of improving the quality of education and increasing public spending in this area has been substantiated, which will contribute to the professionalism of economic reforms. The results and conclusions are of practical importance for the Government in the development of customs policy and customs authorities in the implementation of customs procedures

The proposed Regulation to fight online child sexual abuse: an appraisal of privacy, data protection and criminal justice issues

ABSTRACT Protecting children online is a priority for the EU legislator. Since July 2021, an interim regulation allows service providers to derogate from confidentiality safeguards in the e-privacy Directive to fight child sexual abuse online. The European Commission aims to repeal this legislation with a proposal of May 2022. This Regulation will require providers to monitor users’ content communication for online child sexual abuse, among other things. Privacy experts worry that confidentiality standards (i.e. end-to-end encryption) will be weakened and that the Regulation will serve as a basis for indiscriminate interception of content communications. However, the implications of the proposal go beyond privacy and data protection and will impact criminal justice rights too. Therefore, this contribution presents a comprehensive analysis of the proposal from a privacy, data protection and criminal justice perspective. It examines the proportionality of the measure and its implications within the Area of Freedom, Security, and Justice (AFSJ). Specifically, it looks at purpose limitation issues in data exchanges and the admissibility of such evidence in criminal proceedings. The aim is to show that the EU, while aiming at increasing data circulation in the AFSJ, might not be ready for this challenge from an infrastructural and fundamental rights standpoint.

Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation.

<b><br>Introduction:</b> 'Off-label drug use' refers to the administration of drugs for unapproved indications or age groups, a different dosage or other form of administration. Considering the legal issues, there clearly exists a need to implement rules that would regulate the use of pharmaceuticals outside the scope of a marketing authorisation. The brevity and diversity of Polish laws in the field of health care leads to many interpretative doubts associated with particular legal acts.</br> <b><br>Aim:</b> We aimed to present clinical examples from everyday practice of off-label drug use from the medical and legal perspectives, and to support it with relevant legal acts.</br> <b><br>Material and method:</b> Off-label drug use in various otolaryngology subspecialties - otology (mesna), laryngology (bevacizumab, cidofovir and botulinum toxin) and head and neck surgery (botulinum toxin) - are presented and discussed in detail.</br> <b><br>Results:</b> Fourteen Polish legal acts regarding off-label drug use and 4 from EU legislation are commented on. The algorithm of cascade of decision-making processes in off-label drug use is shown.</br> <b><br>Conclusions:</b> Off-label use of medicinal products is not prohibited in Poland or the EU; nevertheless, it is undeniable that the unclear legal situation regarding the use of medicinal products for nonregistered indications creates difficulties. To minimise a doctor's liability risk, obtaining the informed consent from the patient for such treatment is advisable.</br&gt.

Determination of Perfluorinated Substances (PFAS) Using LC-ORBITRAP-MS in Certain foodstuffs of Animal Origin According to newly established EU legislation

Determination of Perfluorinated Substances (PFAS) Using LC-ORBITRAP-MS in Certain foodstuffs of Animal Origin According to newly established EU legislation

PROVING ANTITRUST DAMAGES IN CIVIL PROCEEDINGS – The Compatibility of Serbian Law with Directive 2014/104 –

Private competition law enforcement has been a recent phenomenon in the European Union. In the past, the EU law and member states’ national laws lacked elements that contributed to the preponderance of private enforcement in the United States, such as treble and punitive damages, the procedural right of a damaged party to request discovery of evidence, collective actions, etc. The interest in private enforcement of competition law has gradually increased after Regulation 1/2003 authorised national courts to implement Articles 101 and 102 TFEU, the EU courts established private enforcement principles, and Directive 2014/104 (Antitrust Damages Directive - ADD) laid down rules to facilitate proving competition law violations and damage resulting from them. The US model evidently inspired the EU legislator. At the same time, ADD attempted to balance the private interests of injured parties and the public interest for effective public enforcement. Specific ADD provisions instigated a public debate concerning their reach and alleged confrontation with general legal principles. Even though member states have taken comprehensive measures to implement ADD, national courts need to search for an equilibrium between private and public interests. Therefore, the full effect of Directive 2014/104 is yet to be seen. Private enforcement of competition law in Serbia is still in its initiation phase. The Serbian Competition Protection Act 2009 proclaimed the right of damaged persons to bring actions for damages, even though this right has already existed under the general rules of civil law. The Competition Protection Act failed to stipulate material conditions and procedural rules that would facilitate private enforcement. The Serbian legislator has not yet taken steps to transpose ADD into national law. This paper first analyses the development and principal features of the US and EU private enforcement models. After that it focuses on the ADD provisions expediting evidence collection and damage assessment. The second part of the paper analyses Serbian tort and civil procedure rules relevant to bringing actions for antitrust damages and case law on antitrust damages. The author concludes with proposals for Serbian legislators to harmonise national law with ADD.

EMCDDA framework and practical guidance for naming cathinones.

Cathinones are often sold as "legal" alternatives to controlled stimulants such as amphetamine, MDMA and cocaine. Cathinones are the second largest group of new psychoactive substances (NPS), with close to 170 monitored by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Although all cathinones are related to the parent compound cathinone, one of the psychoactive principles in khat, assigning consistent, informative and user-friendly common names to these substances is challenging. Over time different naming approaches have been applied, leading to cathinones being known by several names. This work provides a framework and practical examples for the consistent naming of cathinones which is easy to understand and can be applied by the forensic community, researchers, clinical practitioners, and policy makers. The scope of the issue and rationale for earlier naming approaches are also discussed. The new naming framework has been developed based on established naming approaches and centered around the common "cathinone," and "phenone" motifs/scaffolds. The proposed framework establishes clear rules to derive the EMCDDA framework names for cathinones. Each name is, in turn, composed by a principal name containing a parent letter, derived after the "cathinone" or the "phenone" scaffold. Additional substitutions are prepended to the principal name. The framework also provides for exceptions for several cathinones and structural analogs scheduled under UN and EU legislation.

Increasing non-cosmetic exposure and sensitization to isothiazolinones require action for prevention: Review.

Frequent use of methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) and MI in cosmetic products has been the main cause of widespread sensitization and allergic contact dermatitis to these preservatives (biocides). Their use in non-cosmetic products is also an important source of sensitization. Less is known about sensitization rates and use of benzisothiazolinone (BIT), octylisothiazolinone (OIT), and dichlorooctylisothiazolinone (DCOIT), which have never been permitted in cosmetic products in Europe. BIT and OIT have occasionally been routinely patch-tested. These preservatives are often used together in chemical products and articles. In this study, we review the occurrence of contact allergy to MI, BIT, OIT, and DCOIT over time, based on concomitant patch testing in large studies, and case reports. We review EU legislations, and we discuss the role of industry, regulators, and dermatology in prevention of sensitization and protection of health. The frequency of contact allergy to MI, BIT, and OIT has increased. The frequency of contact allergy to DCOIT is not known because it has seldom been patch-tested. Label information on isothiazolinones in chemical products and articles, irrespective of concentration, is required for assessment of relevance, information to patients, and avoidance of exposure and allergic contact dermatitis.

Analysis of regulatory implementation of regulation 536/2014 by European Union countries and Ukraine regarding the examination of clinical trials data and information

The article presents the results of a comparative analysis of regulatory requirements for expertise of clinical trials documentation, submitted for regulatory authority and ethic committees’ approval in EU member countries and Ukraine, outlining the main trends, considering the updated Regulation (EU) No 536/2014, which came into effect on January 31, 2023. Among the positive changes are simplification of safety reporting requirements, use of artificial intelligence in the process of clinical trials documentation examination for obtaining regulatory authority and ethic commission approval, introduction of a single portal for submitting materials for clinical trials, and functioning of database for the submission and review of initial Clinical Trial Application documents and obtaining authorization within the EU to facilitate the interaction between applicants and regulatory authority are highlighted. To harmonize Ukraine’s regulatory requirements with EU legislation, it is advisable to use a single portal for data exchange and document submission for applicants in regards to clinical trials, regulatory authority and local ethics committees. This will expedite the examination process of clinical trial documentation and simplify the monitoring of document review progress.

Cadmium and lead in fresh vegetables and vegetable products sold on the local market in the Republic of Serbia, 2018–2021

ABSTRACT Cadmium (Cd) and lead (Pb) concentrations were determined in samples of 31 species of vegetables (n = 719) and in vegetable products (n = 17), collected during the period January 2018 to September 2021. These originated from 33 countries, including Serbia. The samples were analysed by inductively coupled plasma – optical emission spectrometry (ICP-OES). Overall, Cd and Pb were found above the limit of detection in 123 (16.7%, n = 736) and 90 (12.2%; n = 736) samples, respectively. According to the former legislation, valid until the end of August 2021, the maximum levels (MLs) of Cd and Pb were exceeded in 1 and 2 samples of vegetables, respectively. Regarding the EU and Serbian legislation which is valid since September 2021 the MLs of Cd and Pb for vegetables were exceeded in 7 samples: Cd in 5 and Pb in 2 samples. In addition, 3 vegetable product samples exceeded the MLs for both cadmium and lead according to both former and current regulations.

Better safe than sorry? Digital campaigning governance in Germany

ABSTRACT How political speech is regulated has changed, with online spaces presenting new challenges. Private platforms now play a significant role in providing spaces for political speech with their own rules and algorithms. This paper examines the current state of legal regulation for political speech, both online and offline, and identifies gaps in governance. As we navigate the ever-evolving landscape of online political speech, it is essential to consider the changing and stricter rules that are being put in place. Private actors have played a crucial role in providing space for this speech. It is worth examining the similarities and differences between offline and online political speech and advertising regulation to ensure everyone's voices are heard and respected. Analyzing applicable public and private law, we investigate how different compliance pulls from national and EU law (existing and upcoming) influence the commitments made by the parties, using the most recent federal elections in Germany as an example. Thus, we assess the German legislative framework, which is also influenced by EU legislation. These investigations reflect new European rules, including the Digital Services Act. After analyzing how parties engage with national law and (self-regulatory) commitments, the paper provides suggestions for improving online speech governance.

Degressively proportional representation in the European Parliament: European Union law versus reality

ABSTRACT As the European Parliament is the first transnational representative body based on the Member States representation, the apportionment of seats among the European Union Member States may be a relevant issue. This article is conceived as an idiographic case study and presents an analysis of the composition of the European Parliament in the territorial representation perspective. According to the 2007 Lisbon Treaty, there should be degressively proportional representation in the European Parliament. Following that existing EU legislation implies an uneven representation of citizens in the European Parliament across the EU Member States, this study pursues the following two goals. Firstly, it seeks to quantify malapportionment (the degressive proportionality principle), i.e. distortion of the proportional representation of the Member States (malapportionment) and under-/over-representation of individual Member States, in European elections since 1979 when the direct elections of MEPs were introduced. Secondly, it aims to answer whether there has in fact been a degressively proportional representation in the European Parliament. This article concludes that malapportionment has stabilized at fourteen to fifteen per cent of the total seats since the 2004 European election, but there has been no degressively proportional representation in the European Parliament since 2004.

The harmonization of national legislation of the Republic of Moldova with the EU legislation and the acceleration of the accession process to the European Union

This article is a concise reflection of the EU integration process of the Republic of Moldova, that represents a key component of the country’s development strategy. Moldova interest regarding forthcoming accession to the European Union is not just a political and economic matter, it is also first a legal issue. Taking into consideration the new geopolitical context that appeared, on March 3, 2022, Moldova applied for EU membership. Shortly, on June 17 of the same year, the European Commission issued its opinion on the application for EU membership. And on June 23, 2022, the European Council granted candidate status to Moldova on the condition that it fulfills nine conditions in practice in one year. As a result, on October 5, 2023, the European Parliament voted the Resolution recommending the start of negotiations with the Republic of Moldova with a view of accession to the EU by the end of 2023.

The regulation of AI‐based migration technologies under the EU AI Act: (Still) operating in the shadows?

AbstractWhile Artificial Intelligence (AI) is becoming a key element in supporting the migration and border management policies of the European Union and its Member States, so far, AI‐based migration technologies have been tested and implemented with limited public scrutiny. In this context, the EU AI Act holds the promise of a regulation in line with the protection of fundamental rights and the rule of law. While Member States are bound by existing EU legislation when deploying AI, the Act represents the first attempt to regulate this technology in migration and border management. This paper examines the evolution of the Act throughout the negotiation process and its potential to hold actors involved in AI‐driven migration technology accountable, thereby promoting the rule of law. It argues that while the regulation offers promising and important elements, a closer examination brings to light important concerns about its ability to ensure accountability.

The More Favourable Provision Clause in EU Migration Law: Expanding Fundamental Rights through National Discretion?

Abstract Interaction between different levels of fundamental rights protection is a widely debated topic in EU scholarship, which has long dealt with situations in which national legislation lowered legal standards in the EU. Less explored, however, is the opposite case: when Member State regulations set standards higher than those enshrined at EU level. This can occur through application of the more favourable provision (MFP) clause – commonly enshrined in EU directives dealing with (but not limited to) immigration and asylum. Under it, Member States can apply more favourable standards insofar as they comply with EU legislation. Though seldom discussed in existing literature, the MFP clause is a critical issue of EU migration law and illustrative of challenges facing the EU constitutional order, for it highlights the relationship between fundamental rights protection in the multi-layered EU system and general principles of EU law. Against this backdrop, this paper will investigate the features of the MFP clause in EU migration law and analyse the CJEU’s adjudication in immigration and asylum cases, exploring its reasoning in testing application of MFP clause against EU law.

By-passing the National Level? Municipalities as Legal Actors in Multi-Level Governance in Norway and Sweden

This article aims at illuminating the role of Swedish and Norwegian municipalities as legal actors in multi-level governance. The research question is threefold: What is the role of Swedish and Norwegian municipalities as legal actors in relation to the European level? How do these roles affect local autonomy at the national level? What is the impact of the different affiliations at the European level, Sweden's full membership, and Norway only being a party to the EEA Agreement on these questions? Previous research has shown that municipalities have been able to magnify their influence, both externally and internally, through the intermediary of the European Union. The ability to magnify their influence will depend on the national constitutional framework and the formal affiliation to the European level, among other things. In this study, the role of the municipalities in Norway and Sweden is described by analysing the constitutional position of municipalities at the national level, the municipal influence on the drafting of EU legislation, the Nordic municipalities as actors before the ECJ and the EFTA Court and the municipal implementation of EU/EEA law. On a general level, the study found that the constitutional structures are mainly monolithic, although there are polycentric features. The ability of Norwegian and Swedish municipalities to by-pass national authorities is visible but cannot be described as strong. The role of the municipalities in acting at the European level is noteworthy, but the legal framework does not allow for a significant increase in local autonomy. The EEA affiliation of Norway implies that the municipalities have a weaker position at the European level.

When European Instances apply National Rules transposing Directives: the Direct Effect in an Atypical Situation

The process of European convergence involves Union institutions and bodies occasionally applying national rules that transpose directives. This updating of the role of the EU framework has raised certain problems of articulation, which, in particular, concern the possible direct effect of the provisions contained in the transposed directives. Despite significant shortcomings, adopting a functional and goal-oriented interpretation would extend the doctrine of the direct effect of directives to the institutions and bodies of the Union, in order to prevent asymmetries and perverse incentives. However, it would be desirable for the EU legislator to explicitly clarify how to approach the most contentious issues, strengthening legal certainty and reducing reliance on interpretations that may stem from disputes before the Court of Justice.

Modernisation of legislation in the field of economic and commercial activity in the context of European integration

The article deals with the issues of peculiarities of modernisation of legislation in the field of trade and economic activity in the context of European integration.It is noted that economic and trade activity is the industry which is subject to active modernisation, taking into account the requirements of the Association Agreement. The author concludes that the obligations to adapt Ukrainian legislation to EU legislation in trade have changed due to the fact that a number of EU acts have been amended or repealed, and therefore it is now important to implement the novelties of EU legislation in the period after ratification of the Association Agreement.
 The term «economic and commercial activity» used in the Commercial Code of Ukraine essentially means trading activities carried out by business entities. Expanding the scope of digitalisation of economic and commercial activities is another vector of European integration.
 The food supply chain is vulnerable to unfair trade practices due to a sharp imbalance between small and large agricultural market operators. In Ukraine, we see unfair practices when large retailers dictate the terms of market entry and payment for products. Therefore, the implementation of the provisions of Directive 2019/633 of the European Parliament and of the Council of 17 April 2019 on unfair trade practices between undertakings in the agriculture and food sectors is important for Ukraine.
 In general, EU legislation is quite dynamic, especially given the direction of EU policy towards the development of a green economy and digitalisation, and a number of provisions are being adopted to improve trade in these areas. For Ukraine, an important task is not only to adapt national legislation to the existing EU acts, but also to take into account the legal policy ideas that are actively discussed and developed in the EU, in particular, the provisions on harmonisation of business law.

Challenges and cooperation on the way of European integration in the sphere of customs affairs

The bylaws of national legislation adopted during martial law and their application in the context of improvement and harmonization with EU legislation and fulfillment of the terms of the Association Agreement between Ukraine and the European Union in the field of customs affairs are analyzed in the article. Attention is focused on strengthening of customs cooperation with the EU countries, as well as developing the administrative, personnel, information and technical potential of the Customs Service of Ukraine and the urgency of overcoming and simplifying of the customs procedures for the movement of goods across the customs border of Ukraine during martial law. Taking into account the cross-border nature of the activities of the customs authorities of the EU member states, attention is focused on the procedures of using of the international agreements during customs control and customs procedures. Certain problems of the law enforcement activities of customs bodies in interaction with other state bodies on three relevant areas of functioning, in particular customs rules, settlement of customs payments, customs services and formalities, are singled out.
 The peculiarities of law enforcement activity in the field of customs affairs are analyzed in detail, namely: its state-authority nature; implementation of law enforcement in a manner specifically provided for by legal norms on the basis of established procedures and in accordance with a clear procedural sequence. Certain areas of activity of state bodies for the restoration of Ukraine are considered, in particular, regarding the implementation of anti-corruption and institutional changes in the field of customs affairs. Considering the conditions of martial law, an attempt to delimit the powers of customs authorities and other state authorities in matters of customs affairs was made, and in the light of the activation of the processes of Ukraine’s accession to the EU, the possibilities of interaction with international partners in the field of ensuring the rights and freedoms of subjects of foreign economic activity were analyzed.
 The conclusion is drawn on need to involve the customs service in the development of the plan of measures for the recovery and development of Ukraine in order to simplify for business the conditions for moving (importing) technical means, equipment, and products necessary for the reconstruction and the export of Ukrainian products across the customs border. Bearing in mind the study of the EU experience and the determination of the possibilities of its using in Ukraine, the main directions for improving the interaction of customs authorities with public organizations and business associations in the conditions of war and the perspective of European integration are outlined.