European Union Framework Research Articles

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.

BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.Materials and methodsThe study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis.Results and conclusionIn total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.

REDUCING CLIMATE IMPACTS ON WATER RESOURCES AS THE LEGAL AND ECONOMIC BASIS FOR ENVIRONMENTAL SECURITY IN THE EU CANDIDATE COUNTRIES: THE CASE OF UKRAINE

As climate change is one of the greatest challenges of our time, the legal and economic issues of global environmental security deserve high praise. In the area of industrial competitiveness, where the negative effects of global climate change include floods and droughts, forest fires, and rising sea levels, climate change is highly problematic. Climate impacts affect public and private agricultural infrastructure (including the coastal zone), resulting in lost productivity and increased costs for agriculture. The article applies climate change on a global scale in the form of greenhouse gas (GHG) emissions to determine how the mixtures and emissions of any one entity affect other areas (e.g., individual, community, company or country emissions). Exploring the theoretical and practical premises of climate change as a complex phenomenon, the novelty of this article is that it examines the current framework of the environmental-legal concept, not just the political implications of the legal framework. The research aim of the article lies in two dimensions: the European Union's current climate change policy framework (the climate and energy package, a set of climate change strategies and related policies targeting EU candidate countries); recent environmental operations in Ukraine as an EU candidate country under extraordinary conditions. This article examines recent changes in climate legislation and climate policy in EU member and candidate countries, as well as other highly developed countries, such as the United Kingdom, the United States, and China. Focusing on the impact of the EU Climate and Energy Package (2020 and 2030), this article examines the main implications of EU climate legislation regulating the EU Emissions Trading Scheme and promoting the role of renewable energy in global energy consumption and energy efficiency in general. As a result of this study, this analysis offers multifaceted conclusions based on the interaction of a number of current administrative acts on climate change and environmental policy on a global scale.

Protection of Reputation, Good Name and Personality Rights in Cross-Border Digital Media

Abstract Following the recent judgments of the Court of Justice in Mittelbayerischer Verlag and Gtflix tv, this paper analyses the European Union framework in relation to the enforcement of rights relating to personality, including those of legal persons, against harmful content posted online. As regards jurisdiction, special attention is given to the scope of the centre of interest of the victim as ground for jurisdiction. Furthermore, the fragmentation that results from attributing jurisdiction to the courts of the place(s) where the damage occurs under the so-called mosaic approach is discussed. Particular attention is devoted to the difficulties that arise in relation to the broad understanding by the Court of Justice of the place where the damage occurs as the connecting factor and its position regarding the mere accessibility of online content as the decisive element for determining jurisdiction. Additionally, the interplay between jurisdiction and choice of law and its implications on the territorial scope of orders and the cross-border recognition of judgments are considered.

Current approaches and challenges of sample preparation procedures for the safety assessment of paper and cardboard food contact materials: A comprehensive review.

In the European Union (EU), Regulation (EC) 1935/2004 provides a harmonized legal EU framework and sets out the general principles for safety and inertness for all Food Contact Materials (FCMs) and Food Contact Articles. From a food safety point of view, however, specific EU legislation for paper and cardboard FCMs is lacking, while at Member State level, national legislation differs among countries. More than 11,000 chemicals have been identified in all types of FCMs, most of them without any information on toxicity or migration potential from FCM to food. The present review shows a wide variability of protocols, approaches, and conditions used in scientific studies, which are difficult to compare. In this regard, procedures and conditions laid down in EU legislation for plastics and European Standards (EN protocols) may serve as a good basis for the future sample preparation procedures in the framework of paper and cardboard FCMs safety assessment. Challenges on sample preparation procedures are presented involving the interlinked steps of sample preparation, conditions used and their impact in chemical analysis and in vitro bioassay testing. Currently, there is no general consensus on the criteria for structuring, evaluating, and tuning sample preparation procedures for paper and cardboard FCMs. For this purpose, a set of modified criteria and a decision tree are proposed based on the literature. Along this, mass transfer processes occurring in paper and cardboard FCMs and parameters affecting chemical migration need to be accounted for prior to reaching general consensus on criteria for sample preparation procedures.

Legal and criminal prosecution of disinformation in Spain in the context of the European Union

Disinformation poses a very important and growing risk to our society, either alone or in association with other hybrid threats, which is being addressed at both the international and European Union (EU) as well as national level. Within the EU, a multidisciplinary and cooperative approach has been advocated between all the actors involved, in contrast to the strong regulatory perspective traditionally adopted in the history of European integration within the EU framework. For this reason, together with the inherent limitations imposed by the nature of the right to freedom of expression and information on any possible administrative censorship or criminal punishment, Spain has adopted only one recent regulation (Decree PCM/1030/2020) to establish the Spanish procedure to combat disinformation as required by European directive. Moreover, although fake news cannot be prosecuted directly in Spain outside the scope of crimes against the market and consumers, fake news can include very different types of criminal offence depending on the content and the intention with which it is disseminated. We illustrate these possibilities through some recent judicial decisions on this matter and declarations by the Office of the Attorney-General. It remains to be seen whether this soft approach to combating disinformation will be sufficient to combat this new plague on our contemporary society effectively.

INTEGRATING POLLUTION REGULATION REGIMES: A COMPARATIVE SURVEY OF THE FINNISH AND SOUTH AFRICAN LEGAL SYSTEMS

The South African environmental governance, particularly the pollution regulation regime, is fragmented. Fragmentation ultimately leads to an unsustainable governance effort which negatively impacts on the environment and development in general. In 2000, Finland comprehensively revised the legal structure on which its pollution regulation regime is based. This new regime provides for an integrated environmental authorisation for polluting activities, integrated authorisation procedures and institutions, which result in a more integrated and efficient governance regime. The integrated Finnish approach is based on an European Union framework directive that provides for Integrated Pollution Prevention and Control (IPPC). The Finnish reforms may suggest strategies to integrate the fragmented South African regime. This article commences by investigating the nature and extent of fragmentation in South Africa. It then proceeds to analyse the European framework directive on IPPC, and then to reflect in detail on the new Finnish approach. It concludes by providing some comparative suggestions to achieve integration in South Africa.

Proportionate response to the COVID-19 threat? Use of apps and other technologies for monitoring employees under the European Union's data protection framework.

This article explores the potential uses by employers of contact‐tracing apps and other monitoring technologies to mitigate the spread of COVID‐19, and the potential concerns that these raise in the context of the European Union's General Data Protection Regulation. Given the imbalance of power in the employment relationship, the authors call for national laws to strengthen employees' ability to refuse the use of such apps and technologies after the end of the COVID‐19 pandemic. When such tools are no longer needed to keep employees safe, additional regulations and guidance will be necessary to prevent future problems, such as function creep and other misuse by employers.

Review and Analysis of Models for a European Digital Building Logbook

The concept of a Digital Building Logbook (DBL) was first introduced with the European strategy ‘Renovation Wave’. It is considered as one of two fundamental parts of which the Building Renovation Passport is composed: the DBL and a Renovation Roadmap. As the implementation of the DBL is a European priority, this paper reviews the existing literature and analyses the most developed European Digital Building Logbook models. The analysis includes iBRoad, ALDREN, X-tendo, and the Study on the Development of a European Union Framework for Buildings’ Digital Logbook, from the perspective of seven key aspects: References used as a starting point for the model definition; Identification of the relevant stakeholders in the DBL; Identified potential user needs; Proposed structure of indicators; Data sources; Potential functionalities; and Operation and use. The results show that important advancement has been made, although there is still no consensus about crucial subjects, such as the indicators to be collected or how to collect and use them. This is probably due to the fact that the final functionalities (objective and scope) that the logbook should provide are not fully clear.

AYUDAS EUROPEAS A LA I+D+I. LOS PROGRAMAS HABITUALES FRENTE A LA EXCEPCIÓN DEL NEXT GENERATION

The new European Union's framework programme for research and innovation, Horizon Europe, will run for seven years from 2021 to 2027. This programme is an excellent opportunity for European SMEs and large companies to strengthen their industrial capacities and improve their competitiveness through the collaboration in international R&D projects. This article aims to provide an overview of this EU long-term financing instrument that started in the mid-80s, highlighting its relevance for the industrial sector as the main European R&D funding mechanism.

Including the Oft-Forgotten: The Necessity of Including Women and Indigenous Peoples in Nature-Based Solution Research

Nature-based Solutions (NbS) are a priority area for the European Commission. The European Union (EU) will fund projects on NbS under Horizon Europe, the EU's framework program for research and innovation (2021–2027). We argue that the Commission needs to fund more projects that actively include local communities in the development and implementation of NbS. Specifically, the Commission needs to fund projects that include two oft-forgotten stakeholder groups: women and indigenous peoples. The literature demonstrates that success of NbS is dependent on the inclusion of a variety of stakeholders and that indigenous peoples and women and girls are critically important stakeholders. As the inclusion of these stakeholders is vital to the success of NbS, funding projects that specifically include these stakeholders will help the EU to achieve two important policy goals: the goal to provide evidence for NbS and the goal to advance the development, uptake and upscale of NbS.

PFAS Molecules: A Major Concern for the Human Health and the Environment.

Per- and polyfluoroalkyl substances (PFAS) are a group of over 4700 heterogeneous compounds with amphipathic properties and exceptional stability to chemical and thermal degradation. The unique properties of PFAS compounds has been exploited for almost 60 years and has largely contributed to their wide applicability over a vast range of industrial, professional and non-professional uses. However, increasing evidence indicate that these compounds represent also a serious concern for both wildlife and human health as a result of their ubiquitous distribution, their extreme persistence and their bioaccumulative potential. In light of the adverse effects that have been already documented in biota and human populations or that might occur in absence of prompt interventions, the competent authorities in matter of health and environment protection, the industries as well as scientists are cooperating to identify the most appropriate regulatory measures, substitution plans and remediation technologies to mitigate PFAS impacts. In this review, starting from PFAS chemistry, uses and environmental fate, we summarize the current knowledge on PFAS occurrence in different environmental media and their effects on living organisms, with a particular emphasis on humans. Also, we describe present and provisional legislative measures in the European Union framework strategy to regulate PFAS manufacture, import and use as well as some of the most promising treatment technologies designed to remediate PFAS contamination in different environmental compartments.

Several remarks on the monetary policy of EU related to the position of National Bank of Slovakia and a vision for The European Banking Union

This article is divided into three parts – each concerning the monetary policy of EU. First part deals with relationships between monetary policy of EU and economic policy of EU. Second part is central to the research goal of this article. In this part the similarities and differences between the status of National bank of Slovakia and European Central Bank are compared according to their respective roles and functions. Last part of the article describes legal framework of European banking union as a corner stone of future development of monetary policy of EU.

Battery Size Optimization With Customer PV Installations and Domestic Load Profile

Photovoltaic (PV) is a highly feasible solution for modern renewable energy-powered residential buildings in terms of deployment and cost reduction of utility bills. The installation of solar PV systems along with optimal battery energy storage systems (BESS) size is the most popular energy cost minimization solution and will continue to increase rapidly in the coming years considering the European Union (EU) framework for nearly zero energy buildings (nZEBs). The current methods lack BESS size optimization and a comprehensive solution to charge/discharge BESS from PV and the grid. The main goal is to be self-sufficient and sustainable while having minimal dependence on the electrical grid. Therefore, this paper presents an efficient energy management model and optimal size of the BESS as two key factors to effectively minimize the total energy consumption cost of the nZEBs while having a minimum dependence on the grid. The energy management system is developed using linear programming and solved using simplex and interior-point methods. In addition, a heuristic algorithm is presented to determine the optimized charging and discharging schedule for nZEBs. A detailed techno-economic analysis of the proposed system is conducted for the whole year (covering all four seasons summer, winter, spring, and autumn) considering three common residential building cases and three different electricity pricing methods. We determined that seasonal electricity pricing is the favorable and economical option to schedule charging and discharging of BESS from the grid in several terms such as, minimum total hours of grid usage, the maximum number of charging hours of BESS from the solar PV system, maximum BESS discharging hours to sell energy, the minimum number of BESS charging hours from the grid, maximum number of discharging hours for energy usage within nZEBs, maximum revenue earned, and peak electrical load reduction for the grid.

Polish Higher-Education Institutions in International Cooperation: Evidence from the European Union Framework Programmes

Objective: Polish higher-education institutions (HEIs) compete for European funds with excellent European universities that have comprehensive support systems for applying for research grants. This paper’s aim is to analyse the patterns of participation of Polish higher-education institutions in the 7th and 8th EU framework programmes, and their relationship with the characteristics of universities and national and geographical effects. Research Design & Methods: This article uses the CORDIS database for analysing data concerning projects financed under FP7 and the Horizon 2020 Programme. Findings: The literature emphasises the weak starting position of Polish entities in competing for international grants. The low results of Polish institutions in EU FPs might be due to many factors, including system and structural, institutional, and mental barriers. Implications / Recommendations: There is the necessity for a detailed examination of the determinants of the success of research proposals and the development of a system that will support strategic decisions on applying for grants at Polish universities in order to increase the absorption of EU funds. Contribution / Value Added: New legislation in Poland has forced universities to change their expectations towards academic staff in order to achieve the highest possible categorisation of disciplines and universities. Polish scientists are under pressure to publish their research in reputable journals. Therefore, it might be possible to observe a direct emphasis on application for research grants and timely settlement of projects in case of obtaining grants.

Thinking With Transnational Institutional Ethnography: Moving Towards Spatially Conscious Methods for Studying Geographically Dispersed People and Institutions

Institutional ethnography (IE) is a valuable ontological approach for investigating the coordination of social relations, both locally and trans-locally. However, much of the work utilizing IE remains within the confines of a local or national empirical field. This means there are limited accounts of IE exploring geographically dispersed institutions that cross borders and span regions. This paper makes the case for critically thinking and building on Transnational Institutional Ethnography (TIE). In it, I argue that TIE requires adapting the methodological toolbox of IE to deal with expanded geographic space and diverse bodily locations. By drawing on empirical work exploring scholarly participation in the European Union Framework Programs for research, tensions are illustrated that surfaced while working with TIE. In this discussion, I examine the ways in which interpreting an empirical field as a transnational institution, constituted of geographically dispersed people and organizations, caused a re-examination of the methods in IE to acknowledge institutional experiences shaped by diverse material surroundings and differing geopolitical locations. The paper argues that working with spatially conscious methods in TIE contributes positively to both fieldwork and analysis.

How can interoperability stimulate the use of digital public services? An analysis of national interoperability frameworks and e-Government in the European Union

Abstract This article explores the role of interoperability in the development of digital public services in Europe, analyzing the effects of an European Union (EU)-level initiative (the European interoperability framework, EIF) and the development of e-Government services on how citizens interact online with public administrations. The EIF is a common EU framework providing guidance on public sector interoperability. EU countries are not mandated to follow the EIF, but they are encouraged to take up its guidance in their respective national interoperability frameworks (NIFs). Against this background, this article tests two hypotheses: (a) the introduction of NIFs facilitates the online interaction between citizens and public administrations and (b) better e-Government services encourage citizens to interact online with public administrations. Both hypotheses are confirmed by a panel data analysis covering 26 European countries over the period 2012–2019. The analysis relies on a dummy variable reflecting the adoption of NIFs, built by carefully examining official documents of the countries in the scope of the analysis. Based on the empirical results, this article puts forward two main policy recommendations. First, efforts to improve e-Government services across Europe should be intensified in order to support the overarching digital agenda of the EU and increase benefits for European citizens. Second, interoperability should become a central element when designing new digital public services. Therefore, the European Commission could foster a common approach to interoperability of digital public services across the EU by strengthening the governance of interoperability initiatives and encouraging the adoption of specific interoperability requirements.

Flood legislation and land policy framework of EU and non‐EU countries in Southern Europe

AbstractFloods are a widespread natural hazard affecting people and their assets in regions worldwide, including Southern Europe. Besides coastal floods, the Mediterranean region is highly prone to flash floods driven by short but intense precipitation events. With increasing flood risk due to climate change and socio‐economic conditions, governments are under pressure to reinforce flood protection measures, which could be a great challenge for the weak economies of non‐EU developing countries. This is of particular relevance to achieving international commitments such as the United Nations Sustainable Development Goals. Several policy frameworks have been developed to mitigate flooding risk, at European Union (EU) and global level. These frameworks call for a holistic risk reduction approach where governments, institutions, and households are all responsible for reducing risk. In practice, however, gray infrastructure remains the prevailing flood risk management measure in many countries. Incorporation into national legislation and implementation of the EU policy framework will increase constraints and pressures for non‐EU countries, particularly those strongly committed to becoming EU members in future. This article provides a comprehensive review of policies and measures implemented in four different southern European countries to mitigate flood hazard, and compares governance aspects between EU (Portugal and Slovenia) and non‐EU countries (B&H and Serbia). Understanding governance aspects and the status of flood‐related policy implementation is of critical importance in protecting people and enhancing resilience to climate change impacts. Programs of improvement measures and further integration of sustainable water management with other sectoral policies are required to reduce flood risks.This article is categorized under: Engineering Water > Planning Water Human Water > Water Governance Science of Water > Water Extremes

Competence Ratione Personae of Investment Tribunals: Claims Arising Out of Measures under the European Banking Union Framework

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Constructiońs health and safety Plan: The leading role of the main preventive management document on construction sites

The European Union's strategic framework seeks to better protect its millions of workers from work-related accidents and illnesses. One of the main challenges, included in the European Strategy 2014–2020, is to improve the application of existing health and safety regulations, one of the strategic objectives being to help small and medium-sized companies to better comply with safety regulations and health. This study focuses on the Construction Sector, considered one of the economic activities with the highest accident rate, hardship and danger. Its objective, based on the regulatory framework that regulates health and safety in the Sector, is to know the effectiveness of the main management tool that construction works have, the Health and Safety Plan. In this study, 3600 Health and Safety Plans were analyzed in the Autonomous Community of Castile-La Mancha, Spain. The results show that the Health and Safety Plans are documents that present great deficiencies and that do not comply with the regulatory requirements, putting at risk the management of prevention in the workplace and therefore the health and safety of its workers.

Peacebuilding conditionalities: An alternative to migration conditionalities for European Union development policy

SummaryMotivationThe European Union (EU) has securitized its development policy with migration conditionalities, resulting in the subordination of development objectives to the externalization of migration control. This has called into question the legitimacy and effectiveness of EU development policy while failing to provide a solution that prevents future refugee crises. How can these trends be reversed?PurposeThis article examines the feasibility and implications of peacebuilding conditionalities as an alternative to migration conditionalities with the aim of addressing the root causes of refugee crises, ensuring the effectiveness of EU development policy, and preserving its legitimacy.Methods and approachThe article outlines a theoretical framework to categorize development policy conditionalities and better understand their strengths and weaknesses. This is followed by an analysis of the EU’s financial, legal, and electoral framework in order to evaluate peacebuilding conditionalities as an alternative policy option.FindingsPeacebuilding conditionalities limit the ability of donor countries to influence migration behaviour while promoting capacity development by ensuring stability in migrants’ countries of origin. Replacing migration conditionalities with peacebuilding conditionalities is a feasible policy option in the current EU framework that can help prevent future refugee crises while encouraging synergy between Member States in development co‐operation—a promising policy area for European integration.Policy implicationsPeacebuilding conditionalities for development co‐operation would constitute a legitimate, effective, and integrating alternative to migration conditionalities at a time of crisis for the European project. With the prospect of a ceasefire in Libya, this would be especially suitable for a post‐conflict scenario.