EC Visa Facilitation and Readmission Agreements: Implementing a New EU Security Approach in the Neighbourhood

With the Eastern Enlargement successfully completed, the EU is searching for a proper balance between internal security and external stabilisation that is acceptable to all sides. This paper focuses on an EU foreign policy instrument that is a case in point for this struggle: EC visa facilitation and readmission agreements. By looking at the EU's strategy on visa facilitation and readmission, this paper aims to offer a first systematic analysis of the objectives, substance and political implications of these agreements as a means to implement a new EU security approach in the neighbourhood. In offering more relaxed travel conditions in exchange for the signing of an EC readmission agreement and reforming domestic justice and home affairs, the EU has found a new way to press for reforms in neighbouring countries while addressing a major source of discontent in these countries. The analysis concludes with the broader implications of these agreements and argues that even if the facilitated travel opportunities are beneficial for the citizens of the target countries, the positive achievements are undermined by the Schengen enlargement, which makes the new member states tie up their borders to those of their neighbours.EU, EC visa facilitation, readmission agreements, European Neighbourhood Policy, Stabilisation and Association Process, Justice and Home Affairs

What if? The implications of a Brexit-scenario on different EU policies. IES Policy Brief Issue 2016/4-10• April 2016

By bundling the manifold policy expertise of the researchers of the Institute for European Studies (IES), this paper forms part of a series of analyses investigating the potential implications of a ‘Brexit’ scenario for different EU policies. All papers ask the same three questions: 1) What is the state of the EU policy in focus

Introducing the IES Brexit-Project. IES Policy Brief Issue 2016/4• April 2016

By bundling the manifold policy expertise of the researchers of the Institute for European Studies (IES), this paper forms part of a series of analyses investigating the potential implications of a ‘Brexit’ scenario for different EU policies. All papers ask the same three questions: 1) What is the state of the EU policy in focus? 2) What is the UK’s role/interest in this policy field? 3) What are the potential implications of a ‘Brexit’ scenario at the policy-level? After Claire Dupont and Florian Trauner introduce the project, Richard Lewis sets the historical and cultural context and explains how the UK and the EU have come to such a low-point in their relations. Next, five policy fields are analysed: justice and home affairs; free movement policies; EU external representation; the (digital) single market; and environmental policy

10,000 border guards for Frontex: Why the EU risks conflated expectations. EPC Policy Brief, 21 September 2018

“Between now and 2027 we want to produce an additional 10,000 border guards. We are now going to bring that forward to 2020,” Jean-Claude Juncker, the President of the European Commission, told Austrian Chancellor Sebastian Kurz at the start of Austria’s sixth-months presidency of the Council of the European Union (EU) on 1 July 2018.1 In his State of the European Union (SOTEU) speech on 12 September, the Commission President confirmed this number and provided a blueprint for the future of Frontex.2 For the EU, the proposed increase in Frontex’s resources will likely become a key argument to counter criticism from populist parties and demonstrate its determination to manage migration effectively

The UK in Justice and Home Affairs: the engaged outsider. IES Policy Brief Issue 2016/6• April 2016

By bundling the manifold policy expertise of the researchers of the Institute for European Studies (IES), this paper forms part of a series of analyses investigating the potential implications of a ‘Brexit’ scenario for different EU policies. All papers ask the same three questions: 1) What is the state of the EU policy in focus? 2) What is the UK’s role/interest in this policy field? 3) What are the potential implications of a ‘Brexit’ scenario at the policy-level? After Claire Dupont and Florian Trauner introduce the project, Richard Lewis sets the historical and cultural context and explains how the UK and the EU have come to such a low-point in their relations. Next, five policy fields are analysed: justice and home affairs; free movement policies; EU external representation; the (digital) single market; and environmental policy

Bureaucratic migration politics in West Africa: opportunities and dependencies created by EU funding

This article delves into the role of bureaucrats and administrations in the development of national migration policies in West Africa. Based upon 87 interviews conducted in Accra, Dakar, and Brussels, it argues that the process of developing migration policies in Ghana and Senegal exhibits features of “bureaucratic politics.” West African bureaucracies have gained more national policy-making agency, due to the opportunities created by external funding from the European Union (EU) and the International Organization for Migration. EU funding fostered the policy expertise of local officials and provided certain administrative branches with resources to grow. In the process, bureaucracies in Ghana and Senegal have become more receptive to developing national migration policies and adapting to the EU external migration agenda. These findings add to an often-heard assumption in the literature about EU conditionality in its migration policy with non-EU countries — namely, that adaption to EU standards may be determined by not only the rewards given to foreign governments but also by the donors’ ability to establish a longer-term engagement with the bureaucracy. The research also demonstrates that EU migration cooperation reinforces the typical pattern of the postcolonial state, wherein the bureaucracy is funded by the state and external donors. The article addresses a gap in research on EU migration cooperation with the Global South and acknowledges the role of domestic bureaucracies in maintaining dependent postcolonial relationships with the EU in the realm of migration governance

Реке у опасности - изазови у очувању биодиверзитета у Дунаву

Реке представљају кључне екосистеме који пружају низ услуга екосистема које су од виталног значаја за благостање људи. Штавише, као кључни еколошки коридори, реке имају велики стратешки значај за глобалне еколошке функције и биодиверзитет. Река Дунав и њен слив, као и бројни други велики речни системи на свету, претрпели су озбиљне промене због многоструких дугорочних притисака које је изазвао човек и који озбиљно угрожавају еколошки интегритет система. Те претње такође нарушавају пружање различитих услуга екосистема које представљају основ за благостање људи у целокупном региону Дунава. С друге стране, ублажавање притисака које ствара човек представља кључно питање за управљање речним сливом, с циљем унапређења еколошког статуса и интегритета и гарантовања одрживог пружања услуга екосистема. У овом раду износимо становиште у смислу будућих аспеката управљања, нарочито узимајући у обзир комбиноване ефекте на очување биодиверзитета.Rivers are key ecosystems providing a multitude of ecosystem services that are vital for human well-being. Moreover, rivers have a high strategic importance for global ecological functions and biodiversity, as key ecological corridors. The Danube River and its basin – as many other large river systems in the world – have experienced severe changes and alterations due to multiple human-induced pressures over long times, highly threatening the system’s ecological integrity. These threats also impair the provision of a variety of ecosystem services that build the basis for human well-being in the entire Danube Region. In turn, the mitigation of human-induced pressures is a key issue for river basin management, aiming to improve the ecological status and integrity, and to guarantee the sustainable provision of ecosystem services. In this paper, we extend the view for future management aspects especially considering combined effects on biodiversity conservation.8. Конференција академија подунавске региј

norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis

Background & Aim: Primary sclerosing cholangitis (PSC) represents a devastating bile duct disease, currently lacking effective medical therapy. 24-norursodeoxycholic acid (norUDCA) is a side chain-shortened C-23 homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral norUDCA (500 mg/d, 1,000 mg/d or 1,500 mg/d) compared with placebo in patients with PSC. Methods: One hundred sixty-one PSC patients without concomitant UDCA therapy and with elevated serum alkaline phosphatase (ALP) levels were randomized for a 12-week treatment followed by a 4-week follow-up. The primary efficacy endpoint was the mean relative change in ALP levels between baseline and end of treatment visit. Results: norUDCA reduced ALP levels by -12.3%, -17.3%, and -26.0% in the 500, 1,000, and 1,500 mg/d groups (p = 0.029, tively, while a +1.2% increase was observed in the placebo group. Similar dose-dependent results were found for secondary end-points, such as ALT, AST, gamma-GT, or the rate of patients achieving ALP levels <1.5 x ULN. Serious adverse events occurred in seven patients in the 500 mg/d, five patients in the 1,000 mg/d, two patients in the 1500 mg/d group, and three in the placebo group. There was no difference in reported pruritus between treatment and placebo groups. Conclusions: norUDCA significantly reduced ALP values dose-dependently in all treatment arms. The safety profile of norUDCA was excellent and comparable to placebo. Consequently, these results justify a phase III trial of norUDCA in PSC patients. Lay summary: Effective medical therapy for primary sclerosing cholangitis (PSC) is urgently needed. In this phase II clinical study in PSC patients, a side chain-shortened derivative of ursodeoxycholic acid, norursodeoxycholic acid (norUDCA), significantly reduced serum alkaline phosphatase levels in a dose-dependent manner during a 12-week treatment. Importantly, norUDCA showed a favorable safety profile, which was similar to placebo. The use of norUDCA in PSC patients is promising and will be further evaluated in a phase III clinical study. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V.Peer reviewe

Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma

BACKGROUND & AIMS: We investigated the efficacy and safety of immune checkpoint inhibitor (ICI) rechallenge in patients with hepatocellular carcinoma (HCC) who received ICI-based therapies in a previous systemic line. METHODS: In this international, retrospective multicenter study, patients with HCC who received at least two lines of ICI-based therapies (ICI-1, ICI-2) at 14 institutions were eligible. The main outcomes included best overall response and treatment-related adverse events. RESULTS: Of 994 ICI-treated patients screened, a total of 58 patients (male, n = 41; 71%) with a mean age of 65.0±9.0 years were included. Median systemic treatment lines of ICI-1 and ICI-2 were 1 (range, 1-4) and 3 (range, 2-9), respectively. ICI-based therapies used at ICI-1 and ICI-2 included ICI alone (ICI-1, n = 26, 45%; ICI-2, n = 4, 7%), dual ICI regimens (n = 1, 2%; n = 12, 21%), or ICI combined with targeted therapies/anti-VEGF (n = 31, 53%; n = 42, 72%). Most patients discontinued ICI-1 due to progression (n = 52, 90%). Objective response rate was 22% at ICI-1 and 26% at ICI-2. Responses at ICI-2 were also seen in patients who had progressive disease as best overall response at ICI-1 (n = 11/21; 52%). Median time-to-progression at ICI-1 and ICI-2 was 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Treatment-related adverse events of grade 3-4 at ICI-1 and ICI-2 were observed in 9 (16%) and 10 (17%) patients, respectively. CONCLUSIONS: ICI rechallenge was safe and resulted in a treatment benefit in a meaningful proportion of patients with HCC. These data provide a rationale for investigating ICI-based regimens in patients who progressed on first-line immunotherapy in prospective trials. IMPACT AND IMPLICATIONS: Therapeutic sequencing after first-line immune checkpoint inhibitor (ICI)-based therapy for advanced hepatocellular carcinoma (HCC) remains a challenge as no available second-line treatment options have been studied in immunotherapy-pretreated patients. Particularly, the role of ICI rechallenge in patients with HCC is unclear, as data from prospective trials are lacking. We investigated the efficacy and safety of ICI-based regimens in patients with HCC pretreated with immunotherapy in a retrospective, international, multicenter study. Our data provide the rationale for prospective trials investigating the role of ICI-based regimens in patients who have progressed on first-line immunotherapy