The EU Approach towards Disaster Management - A Critical Appraisal in the Light of the Action Put in Place to Face the COVID-19 Pandemic

The purpose of this contribution is neither to provide a comprehensive analysis of all legal tools elaborated in Europe to face disaster scenarios nor to review their global effectiveness. Instead, it intends to carry out a legal assessment of the most relevant trends of EU disaster law in light of the EU reaction to the COVID-19 pandemic. With this in mind, the remainder of this contribution has been divided into four further sections. Section 2 provides a summary of the impact generated by the measures adopted at the EU level to face the pandemic on the allocation of competencies among the Union and its Members States. In the light of this, Section 3 describes the roles and responsibilities assumed by different EU institutions in dealing with the crisis, assessing their impact on the institutional framework (and balance) of the Union. Section 4 realises a general reflection on the main features and legal implications characterizing the instruments adopted by the Union in that context, with a particular emphasis on the recurrent use of soft-law acts. A summary of major outcomes is contained in Section 5

EU Citizenship and Money: A Liaison Dangereuse? International and EU Legal Issues Concerning the Selling of EU Citizenship

The pressure exerted by the economic and financial crisis has led EU actors to reshape the way in which some of the most relevant features of EU law are interpreted and applied. A significant example of such a "resilient approach" is given by the EU citizenship regime, which has revealed a Janus-faced attitude vis-\ue0-vis the crisis. On the one hand, the contents of EU citizenship\u2014and in particular the right to free movement\u2014have been considered by some EU countries as a threat to their state budget. On the other hand, some EU countries have used the EU citizenship regime as a tool to help them face the budget constraints brought on by the crisis. A clear example of the latter attitude is represented by the investor and citizenship schemes that have recently been adopted by Cyprus and Malta, where EU citizenship is reshaped as a "commodity" that can be sold\u2014subject to certain conditions\u2014by Member States. This article tries to shed light, from a legal point of view, on the practice of selling EU citizenship. After a short illustration of the schemes involved and the reactions they have provoked from EU institutions (notably, the European Parliament and European Commission), this contribution will consider possible limits to the selling of EU citizenship: first it will assess possible limits under international law, and then it will consider the specific obligations arising out of EU law. The article closes with a summary of the author's main findings

Europe(2020)

This contribution intends carrying out a legal reflection on the most relevant trends emerging from the response the European Union (EU) has elaborated in this respect of the COVID-19 pandemic. The piece has been divided into four parts. Part 1 provides a summary of the impact generated by the measures adopted at the EU level on the allocation of competences among the Union and its Member States, the latter representing a crucial element of every legal discourse on the Union. In the light of that analysis, Part 2 describes the roles and responsibilities assumed by different EU institutions in dealing with the crisis. In doing so, it assesses the impact of the EU’s response on the institutional framework (and balance) of the Union. Part 3 provides a general reflection on the main features characterising the instruments adopted by the Union in that context, with a particular emphasis on the recurrent use of soft-law acts. Finally, Part 4 zooms in on the major developments that occurred in 2020 regarding the Union Civil Protection Mechanism (ucpm), due to its major relevance in the EU disaster law discourse

Europe (2019)

The article describes the major developments occurred in Europe with regard to disaster law

The Odd Couple: a Legal Reflection on the Interaction Between Loyalty and Solidarity in the EU Legal System

This contribution seeks to explore the legal interaction between loyalty and solidarity at EU level, also when it comes to crisis situations. Section 1 identifies the major features of the principle of loyalty – also known today as principle of sincere cooperation – and briefly illustrates the role that the principle plays in the EU legal order. After having stressed the multifaceted nature of the concept of solidarity in the EU legal order, Section 2 discusses the possible interactions this concept may have with loyalty in securing the constitutional framework of the Union. Section 3 traces the ways in which loyalty and solidarity may interact in crisis scenarios. The major findings of the analysis are summarized in Section 5

Italy’s Contribution to a More Robust International Architecture for the CBRN Legal Landscape A Critical Appraisal

During the last decades, the landscape of Chemical, Biological, Radiological and Nuclear (“CBRN”) threats has significantly evolved. In the light of this, it does not come as a surprise that several initiatives have recently been put in place both at universal and regional level to deal with such threats, trying to introduce a more robust legal framework for CBRN events. The present article provides a global assessment on the role played by Italy in identifying and/or strengthening international obligations related to CBRN events. In the light of the piecemeal CBRN legal landscape, the article will not discuss each and every initiative put in place by Italy; rather, the analysis will be focused on the contribution given by Italy to multilateral initiatives which are likely to produce cross-cutting or horizontal impacts on the discipline

The digital services act: an analysis of its ethical, legal, and social implications

In December 2020, the European Commission issued the Digital Services Act (DSA), a legislative proposal for a single market of digital services, focusing on fundamental rights, data privacy, and the protection of stakeholders. The DSA seeks to promote European digital sovereignty, among other goals. This article reviews the literature and related documents on the DSA to map and evaluate its ethical, legal, and social implications. It examines four macro-areas of interest regarding the digital services offered by online platforms. The analysis concludes that, so far, the DSA has led to contrasting interpretations, ranging from stakeholders expecting it to be more challenging for gatekeepers, to others objecting that the proposed obligations are unjustified. The article contributes to this debate by arguing that a more robust framework for the benefit of all stakeholders should be defined

AI Risk Assessment: A Scenario-Based, Proportional Methodology for the AI Act

The EU Artificial Intelligence Act (AIA) defines four risk categories for AI systems: unacceptable, high, limited, and minimal. However, it lacks a clear methodology for the assessment of these risks in concrete situations. Risks are broadly categorized based on the application areas of AI systems and ambiguous risk factors. This paper suggests a methodology for assessing AI risk magnitudes, focusing on the construction of real-world risk scenarios. To this scope, we propose to integrate the AIA with a framework developed by the Intergovernmental Panel on Climate Change (IPCC) reports and related literature. This approach enables a nuanced analysis of AI risk by exploring the interplay between (a) risk determinants, (b) individual drivers of determinants, and (c) multiple risk types. We further refine the proposed methodology by applying a proportionality test to balance the competing values involved in AI risk assessment. Finally, we present three uses of this approach under the AIA: to implement the Regulation, to assess the significance of risks, and to develop internal risk management systems for AI deployers

Reliability of programmed death ligand 1 (PD-L1) tumor proportion score (TPS) on cytological smears in advanced non-small cell lung cancer: a prospective validation study

Introduction: Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) assessment is mandatory for the single agent pembrolizumab treatment of patients with advanced non-small cell lung cancer (NSCLC). PD-L1 testing has been validated and is currently certified only on formalin-fixed paraffin-embedded materials but not on cytological smears. Unfortunately, a significant proportion of patients, having only cytological material available, cannot be tested for PD-L1 and treated with pembrolizumab. In this study, we aimed to validate PD-L1 IHC on cytological smears prospectively by comparing clone SP263 staining in 150 paired histological samples and cytological smears of NSCLC patients. Methods: We prospectively enrolled 150 consecutive advanced NSCLC patients. The clone SP263 was selected as, in a previous study of our group, it showed higher accuracy compared with clones 28-8 and 22-C3, with good cyto-histological agreement using a cut-off of 50%. For cyto-histological concordance, we calculated the kappa coefficient using two different cut-offs according to the percentage of PD-L1 positive neoplastic cells (<1%, 1–49% and ⩾50%; <50%, ⩾50%). Results: The overall agreement between histological samples and cytological smears was moderate (kappa = 0.537). However, when the cyto-histological concordance was calculated using the cut-off of 50%, the agreement was good (kappa = 0.740). With the same cut-off, and assuming as gold-standard the results on formalin-fixed paraffin-embedded materials, PD-L1 evaluation on smears showed specificity and negative predictive values of 98.1% and 93.9%, respectively. Conclusion: Cytological smears can be used in routine clinical practice for PD-L1 assessment with a cut-off of 50%, expanding the potential pool of NSCLC patients as candidates for first-line single agent pembrolizumab therapy