EU Authorities Research Articles

World practice of providing scientific advice on the development and authorisation of innovative medicines

Current challenges to healthcare, i.e. the emergence of new diseases, lack of therapies for known diseases and life-threatening conditions, identification of patients who do not respond to standard treatment, on the one hand, and the evolution of scientific understanding of disease processes, medicines, therapies, causes of treatment failures, and implementation in clinical practice of innovations related to molecular biology and genetic engineering, on the other hand, create conditions and opportunities for the development of innovative medicinal products. A relatively new class of medicines is based on human cells and tissues (the term used in Russian legislation is biomedical cell products, BCP). However, the inability to accurately predict the efficacy and financial rewards of such medicines for pharmaceutical companies, as well as significant labour and financial costs associated with their development and clinical use, hinder their entry into the market. The aim of the study was to analyse the foreign regulatory setting for the development and launch of human cell- and tissue-based products, as well as approaches of foreign regulatory authorities to scientific advice, which can be drawn upon by the Russian expert authority when providing advice to BCP developers. The paper summarises the results of analysis of regulations establishing the procedure for providing scientific advice by EU, USA, and Russian regulatory authorities, and analyses the advice provided for the human cell- and tissue-based products which are now authorised in the EU and USA. The analysis of advice provided by foreign regulatory authorities shows that the largest number of consultations were given for medicinal products based on genetically modified cells for the treatment of cancer and genetic diseases. The questions were mainly related to the contents of specifications for finished pharmaceutical products, safety evaluation, curtailing of preclinical studies due to the lack of relevant animal/disease models, the number of subjects and efficacy endpoints in clinical studies, assessment of the appearance of replication-competent retroviruses.

Evaluation of a Health Informatics Postgraduate Program.

The 4th industrial revolution of informatics and data is an important factor of modern health care provision. The WHO, the EU and other governmental authorities have recognised the new needs. The health care professionals face this change in daily work. The higher education community has responded on time with a wide range of relevant programs. In order to achieve the best results for health care related educational programs an evaluation procedure is needed. In this work a brief part of the evaluation of a Health Informatics program is presented.

Modeling and Simulation as Tools to Increase the Protection of Critical Infrastructure and the Sustainability of the Provision of Essential Needs of Citizens

States and their cities are at the forefront of efforts to address many of today’s transnational security challenges. States cannot fulfill their basic functions, which include caring for the all-round development of their territory and the needs of its inhabitants, without the existence of critical infrastructure, which can be damaged, destroyed, or disrupted by malicious behavior. The legislation of EU authorities presents methods for improving the crisis management cycle within critical infrastructure protection. However, these methods are not elaborated. Modeling and simulation using software tools enable more accurate decision-making by security managers during the process of designing and evaluating the physical protection systems of critical infrastructure. This article presents a new software solution to the intrusion of unauthorized persons and its potential mathematical extension. The main innovative benefit of this newly created software tool is the possibility of creating more sophisticated attack scenarios using various 2D maps. Mathematical extension model response scenarios are constructed for various types of intruders, allowing more accurate training of defenders, which leads to more effective resource usage. This combination of software and mathematical solutions should allow physical protection system designers to test various intrusion scenarios of critical infrastructure elements.

Judicial and Extra-Judicial Challenges in the EU Multi- and Cross-Level Administrative Framework

AbstractThis Special Issue aims at interrogating the judicial and extra-judicial challenges that arise from the EU complex administrative framework, which can be characterized as both multi-level—arising from the vertical cooperation between EU and national authorities—and cross-level—arising from horizontal cooperation between national authorities themselves. It starts from the premise that there may be decisions affecting natural and legal persons which cannot be easily reviewed judicially, whereas in extra-judicial cooperation, the lack of common standards or practices across Member States may undermine the effectiveness of EU policies and objectives. This Special Issue focuses on various mechanisms of horizontal and vertical cooperation, such as regulatory patterns giving rise to transnational administrative acts and mutual recognition systems, case studies of composite procedures in the field of the genetically modified organisms regime and information sharing in asylum policy, as well as multi-level inspection activities for the enforcement of EU law. It further complements the analysis on the judicial challenges arising from those cooperative structures with an examination of extra-judicial avenues of control in the EU administrative framework, namely the “EU queries” process and the cooperation of ombud offices, as well as the audit of the EU budget. This Special Issue reflects on ways to overcome the current challenges of, and seeks to prompt further research on, the multi-layered EU system of administrative cooperation.

PROCESY ROZWOJOWE ROLNICTWA W KONTEKŚCIE WYZWAŃ GLOBALIZACJI I NOWYCH UJĘĆ KONCEPCJI ZRÓWNOWAŻONEGO ROZWOJU

The subject and aim of the paper is to present general trends of agricultural development, global conditions, and new concepts and forms of sustainable development. As part of the concept of sustainable development, which has been widely recognized as a development paradigm, in recent years we have seen the emergence of more than a dozen new proposals which modify or complement mainstream sustainable development. These concepts also apply to agriculture and rural areas. Based on an analysis of the literature, this paper presents selected concepts: the green economy, smart specializations, smart villages, the circular economy, responsible consumption and production, and the participatory economy. The role of international integration and EU authorities in disseminating these concepts as forms of innovation in the economic systems of the Member States of the European Union has been identified.

Are EU Policies Effective to Tackle the Covid-19 Crisis? The Case of Italy

ABSTRACT In response to the economic crisis unleashed by the Covid-19 pandemic, the EU authorities have launched extraordinary fiscal and monetary measures in support of member states. The impact of these measures is of great significance for Italy, the EU third-largest economy, which as a result of the pandemic has suffered a dramatic decline in GDP, and a further rise in the government debt to GDP ratio. Building on a stock-flow consistent, structural macro-econometric model, this paper shows that the currently planned EU measures are insufficient to boost the recovery of the Italian economy, and to ensure the sustainability of its government debt. The paper also assesses two potential alternative policies. A fiscal consolidation (i.e. austerity) policy would exacerbate the decline in GDP and further deteriorate the government debt to GDP ratio. By contrast, a money-financed fiscal stimulus policy could lead the Italian economy on a path of sustainable growth, with positive outcomes for employment and government finances.

Instruments for Managing the EU Labour Market in the Face of the COVID-19 Crisis

Purpose: The article presents in a multifaceted manner the instruments used in the EU member states to mitigate the effects of the COVID-19 pandemic in the labour market. Design/Methodology/Approach: Theoretical issues were examined on the basis of the analysis of available source literature on labour market economics and risk management. The research methods used in this paper include, critical analysis of the source literature, the method of comparative analysis and secondary data analysis. Findings: The article identifies actions taken by the EU member states to support the labour market and to develop a model of instruments intended for EU authorities and member states to reduce the risk of labour market disturbances during the COVID-19 pandemic. Practical Implications: The analysis and evaluation carried out in the article indicated that risk management on the EU labour market during the pandemic requires integrated protective measures. The results obtained may be used to formulate a long-term strategy for the EU labour market and programmes to counter the effects of the crisis. Originality/value: The issues as presented in the article concerning the instruments used to manage the EU labour market in the era of the COVID-19 pandemic have not been studied in Polish and foreign literature.

Piecemeal Transparency: An Appraisal of Regulation (EU) No. 2019/1381 on the Transparency and Sustainability of the EU Risk Assessment in the Food Chain

For some time, pressure was placed on the European Food Safety Authority concerning the manner in which it conducted risk assessments in relation to food safety. This pressure culminated in the introduction of Regulation (EU) No. 2019/1381 as the upshot to the European Citizens’ Initiative on glyphosate. Concerns were expressed in the initiative regarding the transparency of the scientific studies used to evaluate pesticides, and following a Fitness Check conducted by the European Commission. Effectively, the new Regulation seeks to impose an obligation on EFSA to publish industry studies at the beginning of the risk assessment process. However, the mandatory nature of this obligation raises a number of concerns as to whether the urge to increase the transparency of the work of the EU authorities is more important than keeping the research confidential, two converse ideals in the realm of European law and effective processes. The present article submits that this codified focus on the risk assessment process and its accessibility for European citizens is a new frontier for transparency within the EU risk assessment processes. Yet while the changes pioneered by this framework are laudable, the Regulation is not without its qualifications.

Year-round pesticide contamination of public sites near intensively managed agricultural areas in South Tyrol

BackgroundIn a previous study, we found that 45% of public playgrounds near intensively managed agricultural areas were contaminated with mainly endocrine active pesticide residues in spring. Here, we investigated potential contamination over the course of a year.MethodsResidue data were analyzed from 96 grass samples collected in spring, summer, autumn, and winter by the South Tyrolean Medical Service in 19 public playgrounds, four schoolyards, and one marketplace located within intensively managed agricultural landscapes. Samples were analyzed for 281 substances using gas-chromatography and mass-spectrometry.ResultsA total of 32 pesticide residues and one preservative agent were found. Almost all of the sites (96%) were contaminated with at least one residue during the year; in 79% of the sites, more than one residue was found. Among the detected residues, 76% are classified as endocrine active substances, with the highest concentrations of the insecticide chlorpyrifos-methyl (0.71 mg kg−1), the herbicide oxadiazon (0.64 mg kg−1), and the fungicides captan (0.46 mg kg−1) and fluazinam (0.23 mg kg−1). The number of residues, their concentrations, and the proportion of contaminated sites varied across seasons (p < 0.001). Twenty-five residues were found in 83% of the sites in spring (median concentration 0.240 mg kg−1), nine in 79% of the sites in summer (0.092 mg kg−1), three in 50% of the sites in autumn (0.076 mg kg−1), and four in 17% of the sites in winter (0.155 mg kg−1). Playgrounds already examined in 2017 in the previous study, were more often contaminated with multiple pesticide residues in 2018 (p = 0.045).ConclusionThis study confirms previous findings of widespread pesticide contamination of public sites within intensively managed agricultural areas. Moreover, pesticide residues were also found in periods with little or no pesticide application in the field (autumn and winter). It is worrisome that many of the detected residues are endocrine active substances and that some of them (thiacloprid, bupirimate, captan, folpet) are “suspected human carcinogens”, according to EU authorities. Thus, we call for more effective controls of pesticide applications to minimize pesticide drift into public places.

ПРАВОВЫЕ ОСНОВЫ БОРЬБЫ С ТЕРРОРИЗМОМ В ЕВРОПЕЙСКОМ СОЮЗЕ

In recent years, European states have been repeatedly subjected to deadly terrorist attacks. The threat faced by EU Member States is multifaceted: from the return of foreign terrorist fighters from conflict zones to the extremist activities of homegrown terrorists and «lone wolves». In order to prevent terrorist attacks and combat terrorism, EU authorities and national states develop counter-terrorism policies and legislation. Based on the long-term activities of the UN in this area and on its own experience, the European Union adopts a large number of political and regulatory legal documents. The EU’s anti-terrorism policy and legislation are becoming more effective and realistic year after year, and intergovernmental cooperation mechanisms are being developed in the form of international treaties or politically binding recommendations and guidelines. In recent years, a number of new legal and other standards have been developed, which, together with existing international and regional strategies, conventions, recommendations and agreements, form the basis for current and future work in the field of combating terrorism and preventing radicalization and extremism leading to terrorism. The article examines some key documents of the EU and the Council of Europe adopted after September 11, 2001, including the EU Counter-Terrorism Strategy of 2005, updated in 2016, as well as new directions and measures to combat terrorism in the last three years (2018-2020). Based on the legal databases of the Council of the EU, the European Commission, the European Parliament, and the Council of Europe, a quantitative sample and an approximate count of anti-terrorist and related regulatory legal and individual acts adopted in 2018-2020 were made. The proposals of scientists and experts, including those expressed at the forums of international organizations, on improving the EU Counter-Terrorism Strategy are summarized.

&lt;i&gt;Features of the EU authorities’ measures to restore the economy and maintain the competitiveness of the euro in the context of the COVID-19 pandemic&lt;/i&gt;

&lt;i&gt;Features of the EU authorities’ measures to restore the economy and maintain the competitiveness of the euro in the context of the COVID-19 pandemic&lt;/i&gt;

The European Union’s Security Conceptualisation vs. its Risk Prevention Capabilities

The European Union, as an area of unquestionable prosperity, on which the countries that make up it have been working since the 1950s, faces the constant challenge of combating threats to the security of its societies. In a changing world, these threats are constantly evolving. They were first summarised in the European Security Strategy and the list of threats was revised in Global Strategy published in 2016. The Union is therefore aware both of the processes of change in international relations and of the threats that this entails for the Union, its Member States and society. Does this awareness motivate Member States and EU authorities to consolidate their defence efforts? Are the measures to address the risks to the Union adequate to the degree of danger? Are the policies of the Union so developed as to maintain peace of mind in the face of threats? This article analyses the risks and attempts to answer these questions.

Illegal Migration in Tunisian Rap

This article explores illegal migration through Tunisian rap. It considers this music an aspect of resistance and protest against the socio-economic and political conditions obliging thousands of Tunisians to cross the Mediterranean in makeshift boats in search of better prospects and challenging the increasing security and legislative measures crippling mobility imposed by the EU and Tunisian authorities. This article contends that harga songs document the history of the working class in Tunisia and carve the identity of harraga as people who have been marginalised for generations. It concludes that EU-Tunisia security talks and dialogues remain ineffective as long as the root causes of illegal migration have not been addressed. Keywords: illegal migration, Tunisian rap, resistance, marginalization, security, immobility, identity

The Goals of EU Competition Law - A Comprehensive Empirical Investigation

Competition law and enforcement are experiencing something of an awaking in the last decade. Central to the renewed interest in the role of competition law was the question of what objective it was designed to achieve. It is impossible to decide if competition law is the appropriate tool to correct the various perceived faults and imperfections of markets if it is not first known what this tool was meant to accomplish. While this question has always existed in the background of competition law scholarship and enforcement, it started moving centre stage more recently with the rise of what is collectively becoming known as the neo-brandeisian antitrust wave, which sees an expanded role for antitrust law, free from the shackles of the welfare-maximalist and efficiency-obsessed Chicago School. A broader movement built around the awareness of increasing inequality and economic concentration has also contributed to popularizing the idea that competition law and policy may have a role to play, and that therefore we should re-open the debate of its goals and purposes. In this context, we set out to undertake an empirical investigation into the goals and purposes of competition law as manifested through Court of Justice of the European Union caselaw, European Commission decisions, opinions of Advocates General and official speeches and statements delivered by the Commissioners for Competition. In this first of a kind investigation, we analyse almost 4,000 sources covering articles 101 and 102 TFEU as well as concentrations, to distil seven broad goals of competition law—efficiency, welfare, economic freedom and protection of competitors, competition structure, fairness, single market integration, and competition process—as expressed through 74 keywords, and then analyse them to extract quantitative results and qualitative patterns and insights. We also make available the datasets we compiled for further use and enhancement by competition law scholars and authorities. The datasets and results paint a comprehensive picture of what the EU courts and authorities consider the goals and purposes of competition law to be. They show the evolution and distribution of all major goals and purposes of competition law throughout its history, they highlight similarities and differences among the Court, AGs, the Commission, and the Commissioners for Competition, and they highlight patterns in different types of cases (abuse of dominance, agreements, concentrations). In doing so, the study helps scholars and authorities ground competition law analysis on its proper goals, dispenses with the myth of single-themed competition law, demonstrates the some times contradictory and other times consistent choices of EU institutions, provides national competition authorities with a benchmark to compare their own practice with that of EU-level competition law to enhance harmonisation, and ultimately underscores how the goals and purposes of competition law shape its development and evolution.

Considerations on pollution from the use of biofuels

While, for thousands of years, natural pollution has reversible effects on environment, thanks to biological and biochemical cycles, the artificial pollution produced by industrial activities disturbs natural cycles and in most cases has irreversible consequences. Among the most polluting vehicles made by humans, we find the vehicles equipped with internal combustion engines. In the past decades, global automotive vehicles manufacturing has reached a high level thanks to his positive impact on people mobility. Therefore, reducing exhaust gas emissions from internal combustion engines represent a research topic for specialists around the world. The use of biofuels is a promising research direction. The EU authorities has issued different sets of standards for the harmful emissions that affect the quality of the environment. In this paper we present the results obtained in the laboratory using different biodiesel concentrations at different load and speed regimes.

Harmonization of Criminal Law in the Sphere of Cybercrime Control in EU Member States

Abstract. In this article are examined issues of cybercrimes in EU member states, legal regulation of this phenomena at the level of EU authorities and in member states. The main aim of this article is study of legal harmonization issues in EU member states on the basis of directive regulation of cybercrime control at the level of Council of Europe and European Parliament.

Nord Stream 2: A Political Economic Crime Novel and Its EU Legal Consequences

Hardly any other energy infrastructure project is as politically and legally controversial in the EU as Nord Stream 2, with the project company’s headquarters in Zug, to export gas from Russia through the Baltic Sea to Germany. This European infrastructure project is an excellent example of the intertwined economic, political and legal implications inherent in any such energy project in the EU single market. Just like an exemplary model case of a European law textbook, the following article aims to give an insight into the constantly developing new architecture of European energy law in the internal gas market, together with its European policy background, by means of concrete individual questions raised by this case. To this end, it proposes to take the concrete legal questions of this case and selectively illustrate the detailed and complex nesting of European law competences of the EU with the national competences of an EU Member State, here the Federal Republic of Germany, that regulates the EU internal gas market. This article focuses on the legal regime of exemptions from the legally required competitive conditions for the EU internal gas market, which is established by the relevant EU Gas Directive 2009/73EG in its Article 36 and Article 41a and its German implementation under Article 28a and 28b EnWG (Energiewirtschaftsgesetz, i.e. Energy Industry Act). This also includes a detailed presentation of the history of amendments to these standards. Finally, it should be made clear which legal, political and ultimately also economic risks await any investor in infrastructure projects with a construction period of several years on the EU internal market should they try to push through their large-scale project unchanged during the amendment of decisive relevant legal regulations by standard-setting EU authorities and against expanding political resistance in the EU and in EU Member States. These risks affect every investor who is involved in the EU internal market. Nord Stream 2, EU gas market, competition requirements, Russia, Gazprom, European energy security, Energy Charter Treaty, US sanctions, German Federal Network Agency, German Energy Industry Act (EnWG=Energiewirtschaftsgesetz)

Untangling the Inextricable: The Notion of 'Same Offence' in EU Competition Law

In the European Union, the ne bis in idem principle restricts the ability of EU and national enforcement authorities to prosecute or punish the same defendant for the same criminal offence more than once. That protection applies to competition fines due to its punitive and deterrent natures and their high degree of severity. In reviewing the ECJ jurisprudence, the article traces back the justification of the case law on the irrelevance of the legal interest protected as necessary requirement for the proper application of the ne bis in idem principle to specific situations where there was a duplication of penalty proceedings for formally distinct but materially overlapping offences, imputable the generalized lack of harmonization of penalty rules in the EU. The article argues that, in the area of EU competition law however, the unity of the legal interest is still a necessary requirement to apply the protection conferred by that principle. This is because, under the harmonized system of competition enforcement in the EU, unlike in other areas of EU law, the Commission and the national competition authorities share concurring competences on a clear differentiation based on the notion of affectation of EU trade, which makes the legal interest protected the critical element of the notion of same infringement. It follows that the Commission and the national authorities can deal with separate aspects of a same anti-competitive material conduct by pursuing separate offences corresponding to different legal interests protected. Moreover, competition is a horizontal discipline that has general application in all areas of the economy and intersects with sectoral regulations. This entails that concurrent proceedings to sanction materially different offences other than competition are possible without this infringing the non bis in idem protection. An illustration of this can be found in the area of the new economy where a competition infringement can be based on the abuse of data collected in violation of privacy rules. A same material practice based on inappropriate handling of data by an internet platform could well constitute at the same time an anti-competitive abuse and violate data protection rules, which should be pursed as separate offences. Disregarding the interest protected would lead to sacrificing one interest over another and lead the authorities into unacceptable choices in pursuing offences.

Getting the green light on green public procurement: Macro and meso determinants

Green public procurement (GPP) has been extensively adopted as a public administration tool for achieving sustainability outcomes. However, there is a marked lack of understanding regarding the determinants of GPP adoption beyond, that is, the characteristics of the contracting authority. Indeed, most studies have focused their attention on these micro determinants, with little being known about the macro and meso factors involved. In this paper, we contribute to the literature by analyzing macro and meso adoption factors. To do so, we explore GPP in the award criteria for twentyfive European countries as recorded in Tenders Electronic Daily database for the period 2006–2017. Our results show significant cross-country differences in GPP uptake and we identify factors beyond those of the contracting unit itself that condition GPP adoption. Specifically, more developed countries and a larger government size impact positively on GPP. GPP adoption has evolved favorably over time, and regional and local administrations show a clearer preference for GPP than is shown by national governments or EU authorities. We find that better governance is linked to GPP adoption and that larger contracts are more likely to include GPP. Our results confirm that join procurement between contracting authorities more probability to adopt GPP. Our results are useful for defining a more comprehensive decision-making framework for GPP.

Quality of life measurement in occupational skin diseases. Position paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes and Occupational Skin Disease.

The European Academy of Dermatology and Venereology (EADV) has started the 'Healthy Skin @ Work' campaign aimed to raise awareness among the public and EU authorities on the frequency and impact of occupational skin diseases (OSDs). The EADV Task Forces (TFs) on Quality of Life and Patient Oriented Outcomes (QoL/PO) and on OSD present their mutual position statement on QoL assessment in OSDs. The EADV TFs recommend the use of the DLQI as a dermatology-specific instrument and SF-36 as a generic instrument in health-related (HR) QoL studies on OSDs. The OSD-specific questionnaire, LIOD, is not recommended for general use in its present form because of its three months recall period. The EADV TFs discourage the use of non-validated and of non-validated modifications of previously validated HRQoL instruments. The EADV TFs wish to encourage research into: the HRQoL impact of OSDs other than occupational contact dermatitis and hand eczema; comparisons between the effects of different treatments and other interventions on HRQoL in OSDs; and into the HRQoL impairment of patients with OSDs from different countries, and with different provoking factors, to predict if the results of successful therapeutic and educational interventions may be generalized across countries and between occupations.