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Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by national laws in line with the directive, EMA guidelines do not have legal force and alternative approaches may be taken, but these obviously require more justification. This new series of the BJCP, developed in collaboration with the EMA, aims to address this issue by providing an annotated version of some relevant EMA guidelines and regulatory documents by experts. Hopefully, this will help in promoting their diffusion and in opening a forum for discussion with our readers. [ABSTRACT FROM AUTHOR]

Recent jurisprudence of the European Court of Justice (ECJ) marks a striking shift towards a more restrictive interpretation of EU citizens’ rights. The Court's turnaround is not only highly relevant for practical debates about ‘Social Europe’ or ‘welfare migration’, but also enlightening from a more general, theoretical viewpoint. Several recent studies on the ECJ have argued that the Court is largely constrained by member state governments’ threats of legislative override and non-compliance. We show that an additional mechanism is necessary to explain the Court's turnaround on citizenship. While the ECJ extended EU citizens’ rights even against strong opposition by member state governments, its recent shift reflects changes in the broader political context, i.e., the politicization of free movement in the European Union (EU). The article theorises Court responsiveness to politicization and demonstrates empirically, how the Court's jurisprudence corresponds with changing public debates about EU citizenship. [ABSTRACT FROM AUTHOR]

The question of recycled papers in contact with foods is discussed in detail with respect to regulatory and technical aspects. The legal context is given, and major existing regulations are reviewed. The safety of recycled fibre use is examined with respect to chemical, microbiological and organoleptic contamination. Toxicological testing possibilities on finished paper products are discussed. The harmonization work in progress at the Council of Europe level is presented in detail, and the authors give their personal view on future evolution. [ABSTRACT FROM AUTHOR]

This policy paper summarizes four corridor studies on bilateral social security agreements (BSSAs) between four European Union (EU) member and two nonmember states, draws conclusions on their results, and offers recommendations. BSSAs between migrant-sending and migrant-receiving countries are seen as the most important instrument to establish portability of social security benefits for internationally mobile workers. Yet, only about 23 % of international migrants profit from BSSAs and their functioning has been little analyzed and even less assessed. The four corridors studied (Austria-Turkey, Germany-Turkey, Belgium-Morocco, and France-Morocco) were selected to allow for comparison of both similarities and differences in experiences. The evaluation of these corridors' BSSAs was undertaken against a methodological framework and three selected criteria: fairness for individuals, fiscal fairness for countries, and bureaucratic effectiveness for countries and migrant workers. The results suggest that the investigated BSSAs work and overall deliver reasonably well on individual fairness. The results on fiscal fairness are clouded by conceptual and empirical gaps. Bureaucratic effectiveness would profit from information and communication technology-based exchanges on both corridors once available. JEL Classification: D69, H55, I19, J62 [ABSTRACT FROM AUTHOR]

The European desire to ensure that bearers of EU rights are adequately compensated for any infringement of these rights, particularly in cases where the harm is widely diffused, and perhaps not even noticed by those affected by it, collides with another desire: to avoid the perceived excesses of an American-style system of class actions. The excesses of these American class actions are in European discourse presented as a sort of bogeyman, which is a source of irrational fear, often presented by parental or other authority figures. But when looked at critically, the bogeyman disappears. In this paper, I examine the European (and UK) proposals for collective action. I compare them to the American regime. The flaws and purported excesses of the American regime, I argue, are exaggerated. A close, objective examination of the American regime shows this. I conclude that it is not the mythical bogeyman of a US class action that is the barrier to effective collective redress; rather, the barriers to effective, wide-ranging group actions lie within European legal culture and traditions, particularly those mandating individual control over litigation. [ABSTRACT FROM AUTHOR]

In the European Union alone, there are currently approximately 5.5 million migrants with an irregular immigration status. Despite its promise of universality, international human rights law does not protect migrants, particularly those in irregular situations, to the same extent as it protects citizens. This paper examines state policies towards irregular migration and approaches to issues faced by irregular migrants, from No Borders to solidarity, arguing that to effectively address these pressing concerns, it is necessary to look beyond the law and the concept of human rights and to challenge the notion of the border. Hannah Arendt's nexus between rights and political membership expressed in the concept of the 'right to have rights' is considered in relation to today's undocumented migrants. Different manifestations of migrant activism are also analysed, demonstrating that undocumented migrants have a voice and have been using it to contest the state-dependent notions of citizenship and membership. [ABSTRACT FROM AUTHOR]

The purpose of this contribution is to discuss the extent of the Union's competence to adopt a comprehensive instrument of substantive contract law in light of the options set forth in the Commission's 2010 Green Paper on European contract law, with a view to exploring the limits of, and the relationship between, certain prominent Treaty provisions in the debate -- namely, Articles 114, 115, 81, 169 and 352 TFEU (ex Articles 95, 94, 65, 153 and 308 EC, respectively) -- and the roles played by the principles of subsidiarity and proportionality in guiding the exercise of Union competence inside, as well as outside, the EU decision-making process. Moreover, given the reference to certain American techniques in the Green Paper, this contribution seeks to facilitate discussion of the comparative dimensions of the constitutional assessment of contract law in the European Union and the United States. [ABSTRACT FROM AUTHOR]

In 2004 ten Eastern and Southern European countries will join the EU. Agriculture and agricultural policy is an important issue in this EU enlargement process, for several reasons. This paper assesses the implications of the enlargement process for agriculture and agricultural policies. [ABSTRACT FROM AUTHOR]

Since 1993, an environmental risk assessment (ERA) for a new drug application has been stipulated by EU Directive 93/39/EEC amending Directive 65/65/EEC. In early 2001, after several unpublished draft versions for an ERA guideline, a draft guideline/discussion paper for an ERA for non-GMO-containing drugs was published by the European Medicines Evaluation Agency (EMEA). The draft guideline describes a step-wise, tiered procedure for the ERA. The first tier consists of deriving a crude predicted environmental concentration (PEC) in the aquatic compartment for the active pharmaceutical ingredient (API) or its major metabolites, based on predicted amounts used and specific removal rates in sewage treatment or surface waters. If this crude PEC is <0.01 μg/l and no environmental concerns are apparent, no further assessment is deemed necessary. Else, in the second tier, a crude predicted no-effect level (PNEC) for the aquatic compartment is to be extrapolated by dividing the lowest 50%-effect concentration from acute ecotoxicity tests with algae, daphnia or fish (EC50, LC50) by an assessment factor (usually 1000). If the ratio PEC/PNEC is <1, no further assessment is deemed necessary. Lastly, in the third tier, further considerations on a case-by-case basis are needed. This may encompass refining the environmental fate information and thereby the PEC, considering further environmental compartments and their respective PECs (up to and including field studies), but also refining the PNEC. While the ERA addresses mainly the API, excipients of the formulated drug should be considered as well. In the case of medicinal products, the benefit for patients has relative precedence over environmental risks, meaning that even in the case of an unacceptable residual risk for new drugs after third-tier considerations, prohibition of a new API is not taken into consideration. Instead, possible mitigating or precautionary safety measures may consist of specific product labelling (i.e. package leaflets for the patients regarding returning and proper disposal of unused medicines), restricted use through in-hospital or in-surgery administration under supervision only, or the recommendation of environmental analytical monitoring up to ecological field studies. [Copyright &y& Elsevier]

The ISO 22000 standard is a relatively new approach to the EU markets. Nowadays popularity of that system is rising among food sector companies. It unifies the requirements concerning food production. Its subject of interest and structure are very similar to the ISO 9001 standard. This article discusses if the above standards are complementing each other or if they are simply interchangeable. [ABSTRACT FROM AUTHOR]

Although based on academic background and literature, my answer to the questions posed by the European Commission turns out to be rather political as from my point of view it is impossible to address those questions in a purely technical way. Although there are other, probably more relevant, obstacles to the internal market, I consider that there is enough evidence to assume that different legislation is an obstacle well worth looking at. I begin with the discussion of goals, strictly connected to the scope of application, and move to the debate on formal/informal harmonisation of contract law. As on one side there is not enough evaluation to sustain solidly that harmonisation or unification is better that diversity that meets local preferences, and on the other side liberty, subsidiarity and proportionality claim for parties' freedom to opt for their better solution, I support the view that Member States must be able to maintain their internal law but at the same time must wide the parties' scope of options with the approval of a Regulation on European contract law. In any case, a lot of assessment should still take place. [ABSTRACT FROM AUTHOR]

Assesses the European Union's (EU) Green Paper on its relations with the 71 Lome Convention countries after the millennium. Comparison of the proposals in the Green Paper and the Lome system; Views on the European Commission's thinking about EU-African, Caribbean and Pacific relations; Changes in the political environment; Importance of a gradualist or incremental approach in trying to create a relationship.

Over the past ten years, the language of crisis has become increasingly common in discourse about migration governance at the European Union (EU) level, and policy responses have been oriented by an emergency rationale that prioritizes short-term solutions over long-term planning. EU migration and asylum law incorporates several crisis response mechanisms, and the addition of a new set of instruments has recently been proposed. This paper offers a critical legal mapping of what counts as a "crisis" in EU migration and asylum law, and the mechanisms for responding to such crises. It exemplifies a complex system in which the tension between the imperative to address threats purportedly arising from unwanted migration is intricately intertwined with the necessity of granting Member States flexibility to respond to contingencies without compromising the integrity of the common EU asylum and migration system. [ABSTRACT FROM AUTHOR]

Evaluates the paper made by Polish author Michal Dobroczynski regarding Poland's plan to join the European Union (EU). Advantages of Poland being a member of the EU; Costs of the European integration to both the EU and Poland; Analysis of the historical causes and factors which have created an economic, political, social and cultural development gap between West and East Europe.

This paper examines institutional change in father‐specific leave ‐ a centre‐piece of the EU's work‐life balance directive (WLBD) ‐ from the perspective of gradual institutional change. The WLBD, a highly contentious directive, represents a litmus test for the possible impact of the European pillar of social rights (EPSR), on welfare state institutions, which are responsible for the organisation, financing and delivery of social rights in member states. The analysis comprises in‐depth case studies in Denmark, Germany, France and Poland, with different combinations of family and parental leave policies prior to the WLBD. The findings reveal that the EU's directive is leading to convergence in paternity leave, but to divergence in parental leave. Our study is important because it shows that even if EU directives in social policy in principle can lead to upwards social convergence across the EU, when they are relatively weak in terms of precise constraint, for instance, for the level of remuneration for leave, this leads to differentiated integration. This could undermine the very purpose of the EPSR, which seeks to improve social rights for all citizens across the EU. Similar dynamics are likely to be present in other areas at the welfare state‐labor market nexus, such as minimum wages or platform work, where the EU is also developing regulation under the auspices of the EPSR. [ABSTRACT FROM AUTHOR]

By providing financial resources, conditional to the implementation of the (social) recommendations in the Semester and the principles of the European Pillar of Social Rights, the Recovery and Resilience Facility (RRF) has opened new political and institutional opportunity windows for the multi‐level co‐production of social policies. The article first dives into how the RRF has been translated into national social policies choices, by assessing the alignment of reforms and investments with the Semester social recommendations and their capacity to address the social vulnerabilities identified in the Pillar's Social Scoreboard. Second, it sheds light on the interaction between the European Commission, in charge of assessing and monitoring the RRF, and the national governments, the key actors in setting‐up and implementing the plans. Comparing six case studies (Italy, Germany, Spain, Croatia, Belgium and Austria), the article shows that the RRF has only partially contributed to reinforcing member states' compliance with social Country Specific Recommendations and the role of the Social Pillar in the drafting of National Recovery and Resilience Plans has been very limited. This notwithstanding, the RRF has contributed to fasten‐forward the implementation of welfare reforms and initiatives which would have been remained on the paper, especially for whose countries with limited fiscal capacity. Furthermore, it provides empirical evidence of the collaborative approach between the Commission and the national government, substantiating the claim of the emergence of a new mode of coordinative Europeanization. [ABSTRACT FROM AUTHOR]

EU citizens migrating between EU member states are expected to be self-sufficient movers, with little access to social or integration support for the economically inactive. This generates challenges for both migrant EU citizens and local governments in places of destination. The latter are confronted with new social challenges resulting from migration that balances between mobility and settlement. How local governments respond to this crucially shapes EU citizenship and the evolving EU migration system. This paper looks at local responses to migrant EU citizens' integration needs and how we might understand these. The paper is exploratory and builds on in-depth research in Berlin, Hamburg, Gothenburg and Stockholm conducted in 2015–2016. It demonstrates that responses varied between short-term approaches addressing basic needs and long-term strategies focusing on integration. It argues that the integration strategy identified in Berlin is the result of a national context of bottom-up immigrant policy-making, certain historical experiences of immigration, and, crucially, the work of local policy entrepreneurs. [ABSTRACT FROM AUTHOR]

In recent years, forced marriage as a manifestation of violence against women has entered the public agenda in European Union countries. This is partly due to higher numbers of migrants from regions where it is a regular practice. This paper aims to show the different ways violence manifests itself in forced marriage, both symbolically and practically - in terms of experiences - based on a qualitative sample of women with a range of migration backgrounds residing in Catalonia. The intersectional gender approach of the analysis enables the interaction to be considered of various factors when it comes to understanding contexts of risk and violence, as well as exit strategies from forced marriage. [ABSTRACT FROM AUTHOR]

The recent so called Mediterranean refugee crisis has ignited concerns about the magnitude of the flows of asylum seekers to Europe. This paper examines the determinants of the destination choice of first time non-EU asylum applicants to the EU, between 2008–2020. It investigates the role played by policies related to employment rights, processing of asylum applications, attractiveness of the welfare system, economic factors and networks on the destination of asylum seekers within the EU. We find that the strongest pull factor for asylum seekers to a destination is social networks both in terms of previous asylum applicants as well as stock of previous migrants. Our findings also suggest that employment bans are not a strong deterrence for asylum seekers given their modest association to asylum flows. • This paper examines the pull factors for asylum seekers to EU destination countries. • We focus on non-EU first time asylum applicants between 2008-2020. • The results suggest that social networks are the strongest pull factor. • Policies in destinations are modestly associated to asylum flows. [ABSTRACT FROM AUTHOR]

The European Union has established a comprehensive legislative privacy framework aimed at protecting data pertaining to individuals. The EU is currently in the process of amending and supplementing its data protection legislation to prepare for the information society. In this article, Professor Lucas Bergkamp questions the desirability and necessity of the EU’s data protection regime in the information society. He examines the “other side” of data protection law and identifies its paradoxical and adverse effects. Based on a thorough analysis of how privacy law affects markets, he argues that data protection restricts consumer choice and freedom, and results in consumers receiving outdated, lower quality products and services at higher prices. The author proposes possible alternative approaches to data protection in Europe, and identifies the groundwork that needs to be conducted to devise a sensible, balanced privacy framework for the information society. [ABSTRACT FROM AUTHOR]

This paper critically examines the proposal to overcome the judicial definition of fundamental rights by using constitutional amendment procedures. Authors known as "political constitutionalists" have advocated weak‐form judicial review as an alternative to the constitutional practice currently prevailing in liberal democracies. The proposal under consideration here seeks to achieve this alternative by making constitutional amendment as easy as possible, i.e., through minimal constitutional rigidity. The discussion begins by questioning the idea of adopting institutional design as a suitable criterion for rating a judicial review system as "strong" or "weak." Then the alleged relevance of constitutional amendment in the specification of constitutional rights is called into question. Lastly, the paper reaches a double conclusion. On the one hand, minimal constitutional rigidity is not an alternative to prevailing constitutional practice, but a more collaborative version of the same practice; on the other hand, minimal constitutional rigidity only represents a genuine alternative design when it is part of a model ("strong popular sovereignty") aimed at overcoming the current constitutionalist paradigm. [ABSTRACT FROM AUTHOR]

In 2009 the European Commission published the art. 102 guidance regarding abusive exclusionary conduct by dominant undertakings. The guidance is based on the more economic approach to competition policy. This paper investigates the welfare implications of the more economic approach to loyalty rebates. First, the paper presents an economic framework linking weights attached to probabilities of false positives and negatives and the legal norm. After that, the paper discusses cases before the guidance paper (i.a. Hoffmann-La Roche), the guidance paper itself, and cases after the guidance paper (i.a. Intel). In the period after the guidance paper, we observe a non-linear increase in the weight attached to preventing false positives. The paper concludes that to further limit welfare losses due to false positives, the category of rebates that is assumed to be abusive should be defined in a restrictive way. Furthermore, in law enforcement priority should be given to cases that, considering all the circumstances, can be expected to be most harmful to consumers. [ABSTRACT FROM AUTHOR]

Traditionally, unfair pricing cases were considered a "taboo" in EU competition policy. During the recent years, however, the European Commission and a number of National Competition Authorities have investigated unfair pricing cases. Therefore, national and EU courts had the opportunity to rule on unfair pricing cases, by thus clarifying the legal test. The paper shows that United Brands is not the "only" legal test to assess unfair pricing cases; the CJEU has endorsed alternative "benchmarking" methods. Recent jurisprudence has also introduced some "safeguard tools" to minimize the risk of false negative errors, such as the requirement for the competition agency to verify its findings under "multiple" tests and the possibility for the dominant firm to put forward "objective justifications". The paper argues that the legal test of unfair pricing cases is becoming "clearer", by thus contributing to a further shift from the traditional non-enforcement paradigm. [ABSTRACT FROM AUTHOR]

In recent years, there have been numerous academic and policy debates on the delivery mechanisms of European Union (EU) funds in member states. Studies focused on issues arising, for instance, during the management and implementation of EU aid at the local level but devoted less attention to the economic and institutional impact of EU funds. To what extent do EU funds act as drivers of socio-economic development and institutional change? Theoretically, this paper contributes to debates about economic convergence and the institutional spillover effects generated by EU aid across national and local settings. Empirically, the paper evaluates the impact of EU aid in Bulgaria and Romania after a decade of EU membership. Firstly, the paper examines a mix of quantitative indicators and secondary sources on the socio-economic impact of EU funds in the two countries. Secondly, using original qualitative evidence, the paper assesses the spillover effects of EU aid on domestic institutions and stakeholders, policies and practices. Finally, the paper provides an analysis of the unintended domestic consequences triggered by EU funds. It contributes to growing debates on the impact of European aid and suggests potential avenues for policy development and for further academic research in this area. [ABSTRACT FROM AUTHOR]

The article reports on the adoption of a green paper on mental health in the European Union. The initiative was undertaken to eliminate divisions in the provision of mental health services in different member states. Proponents hoped to raise the profile of mental health services that is often a neglected area.

The aim of this paper is to assess whether the European Commission or the European Council shaped the European Union's response to the sovereign debt crisis through their respective agenda-setting powers. The paper uses process tracing complemented with interviews to demonstrate the influence of the European Commission and the European Council in this regard. Theoretically, the paper is anchored by a framework of agenda-setting dynamics which is used to assess the European Commission and European Council's influence in reforming the European Union's economic governance framework. A systematic analysis of the negotiations of these reforms between 2010 and 2013 indicate that the European Council wielded policy influence through its agenda-setting powers. Conversely, the European Commission exercised less influence in those negotiations, despite its position as the European Union's de facto agenda-setter. [ABSTRACT FROM AUTHOR]

The paper is focused on assessment of the transport services in small towns. Current legislation in the Slovak Republic, however, does not clearly determine which cities must provide the urban public transport (UPT). Analysis of the current state of the UPT evaluated 71 district towns of the SR and it was found out that 21 towns did not provide operation of the UPT. Another criterion for evaluation was the number of inhabitants of the city over 10,000 in Slovakia and selected regions of the Czech Republic and Poland. The paper presents results of a research conducted in the area of a transport operation, along with a proposal for the content of the methodology, based on a multi-criterial analysis to assess the need to introduce the UPT. The EU research results, regarding dependency of a GDP size and transport performances in UPT in selected EU states, Switzerland and Norway, are presented, as well. [ABSTRACT FROM AUTHOR]

This paper argues that the EU legislative process should be used for taking all decisions at European level that matter, banning the various backroads of European decision‐making (competence creep) that are currently legal but not legitimate. This is a silver bullet, resolving at once a range of seemingly disparate but intimately connected legitimacy problems across all areas of EU activity, that ultimately result from an incorrectly calibrated state of transnational constitutional democracy at EU level, where certain aspects are over‐constitutionalised while others remain fundamentally under‐constitutionalised. This is therefore the key transversal issue that the Conference on the Future of Europe and its ensuing changes should address. The paper makes various concrete proposals to this effect, including for a general legislative competence. [ABSTRACT FROM AUTHOR]

The aim of this article is to show the increased relevance of soft skills in a continuously changing environment. A research was carried out to examine and compare students' and employers' perceptions regarding the importance of soft skills in different European countries. Results show that 86% of respondents indicate an increased emphasis on soft skills over the last 5–10 years and that companies consider soft skills more important than students/graduates. Furthermore, major differences have also been identified in the ranking of the 20 soft skills listed in this paper, indicating different levels of priorities. This paper suggests that companies and Higher Education Institutions (HEIs) need to work together not only to increase students' awareness of the importance of soft skills but also to guide them in taking individual responsibility to acquire and develop these essential skills in order to continuously adapt to the changing labour market and improve their employability. [ABSTRACT FROM AUTHOR]

Over the last two decades, there has been a rapid expansion in the number of Taiwan programmes at universities in America and Europe; however, few of these Taiwan programmes have attempted to develop teaching courses. Where Taiwan courses have been introduced, they have tended to be in isolation and not well integrated into existing academic programmes. Among the universities with Taiwan programmes, only two have attempted to create comprehensive teaching programmes through which students can graduate with a degree in Taiwan studies: SOAS University of London and the University of Texas at Austin. The purpose of this paper is to compare the experiences of these two institutions in developing such niche teaching programmes. It begins with a discussion of how these two programmes first emerged and then goes on to review their distinct development trajectories and key features. The paper offers an analysis of how these two programmes were able not only to survive but also to expand their offerings and thrive in an academic environment that should be hostile to such niche programmes. It concludes with a review of the remaining challenges facing these teaching programmes. [ABSTRACT FROM AUTHOR]

Today the inclusion of non-citizens in the electorate is an increasingly common phenomenon. Yet, we know relatively little about under what conditions some states extend such voting rights to non-citizens earlier than others. In this paper, we investigate the timing of local enfranchisement policies for non-citizens in 28 democracies from 1980 to 2010 using event-history analysis. Adding to the conditions studied in earlier work, we examine the extent to which demographic composition, immigration policy regimes, and political partisanship relate to the timing of non-citizen suffrage. We find that higher shares of immigrant residents delay whereas EU membership and economic openness advance the timing of voting rights for non-citizens. At all demographic heterogeneity conditions, less permissive immigration regimes have been able to enfranchise non-citizens earlier. The findings suggest that, over time, having more left-wing parties in the government accelerates the timing of enfranchisement, while right-wing parties contribute to delays. The article brings forward new data and an original explanatory framework emphasising relevance of partisanship and immigration policy at different demographic contexts. Our analysis sheds light on the idiosyncratic state practices in the timing of enfranchisement reforms adding to the debates in migration and citizenship studies and the broader comparative politics field. [ABSTRACT FROM AUTHOR]

In the past decades we witnessed a rise of public participation in transport and land-use projects, and often those practices have been formalised in a solid juridical framework. In the Netherlands and other EU-countries, the cornerstones of this participatory planning framework are the Environmental Impact Study and the Environment Impact Assessment. However, historical appraisals of the impact of these instruments on participatory processes are lacking. Using the case study of the contested Dutch motorway project passing through the Amelisweerd forest (1970s), this paper aims to appraise the role of deliberative democracy concepts and practices. This paper is a plea for a novel academic agenda driven by the research questions: to what extent have participatory processes in transport, land-use and water management policies had an impact on deliberative democracy concepts and practices? Which role did citizens and users have in shaping the decision-making process? [ABSTRACT FROM AUTHOR]