Resilience at the European Level

Why should we need a European Federation of Addiction Societies?

EC State aid law represents an increasingly important part of EC competition law. The case law at national and European levels is growing rapidly, both in quantity and importance. Significant and increasingly frequent legislative and regulatory measures have been adopted at the European level in this field. There are various reasons for this developing EU focus on public intervention in the economy, however the fundamental and primary rationale is the completion of the internal market, and the pressure which that brings for liberalization and privatization. This volume analyses the concept of aid and examines fundamental questions concerning the scope of State aid law. It also offers a comparison with World Trade Organization (WTO) provisions on subsidies and looks at EEA and applicant states' State aid regimes. It then focuses upon selected areas of State aid law and policy. The final part of the book is devoted to an assessment of the system of remedies and enforcement both at the European Union and national level. The contributors to this volume come from a wide variety of backgrounds: they include academics, practitioners, the judiciary, and Government representatives at both national and EU level.

Mapping key actors in family support. A European perspective

The European Commissions Joint Research Centre gives leading researchers from across Europe and beyond access to its world class facilities and laboratories, enabling state-of-the-art experimental research, collaboration and capacity building with a European dimension. It does so through the program for Open access to JRC research infrastructures. The JRC hosts 56 high-value research infrastructures, most of which are unique at European and international level. Of these, 39 are suitable for opening access to external users in various fields of science: nuclear and radiological, chemistry, biosciences and life sciences, physical sciences and ICT. The main objectives of opening access to JRC research infrastructures are to: a) Establish a fair, clear and transparent procedure for giving access of external users to JRC physical research infrastructures; b) Maximize the use to the full potential of JRC physical research infrastructures in collaboration with researchers and industry. Access of users to JRC research infrastructures contributes to the dissemination of knowledge, improves related methods and skills, provides education and training and fosters collaboration at European level- Granting access within a structured framework maximizes the return on taxpayer funded investment that the JRC has made on its research infrastructures, making them available to external users in view of the limited resources now existing in Europe.

This article examines the potential for ‘Europeanising’ the policy process within Germany ‐ examining the constraints and facilitators that have played a defining role in ‘Europeanising’ asylum and immigration issues. It demonstrates that despite the magnitude of the asylum crisis within Germany, blockages evident within the domestic policy process initially prevented a domestic policy solution. In response the federal government instituted a concerted attempt to resolve the issue outside the domestic arena, exporting the issue to the European decisional level. The processes that governed policy making on the European level within this policy sector proved incapable, however, of adequately addressing the issue. Thus, although agreement on the need to harmonise asylum and immigration policies was forthcoming, consensus on the means to achieve and implement substantive policy harmonisation proved elusive. The ‘Europeanisation’ of asylum and immigration policies within Germany has therefore been inherently limited. In response the German government felt compelled to supplement measures agreed at the European level both with a renewed effort within the domestic arena to resolve the constitutional deadlock and through bilateral agreements with their eastern neighbours.

Since the 1990s at both European Union (EU) and country level political concepts and initiatives concerning rare diseases have emerged. At European level, there are currently three key policy documents establishing a political framework for action in the field of rare diseases and orphan medicinal products at European level: (1) The Orphan Medicinal Product Regulation (Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products) was proposed to set up the criteria for orphan designation in the EU and describes the incentives (e.g. 10‑year market exclusivity, protocol assistance, access to the Centralised Procedure for Marketing Authorisation) to encourage the research, development and marketing of medicines to treat, prevent or diagnose rare diseases. (2) The Commission Communication on Rare Diseases: Europe’s challenge 7, adopted on 11 November 2008, set out an overall Community strategy to support countries in diagnosing, treating and caring for the 36 million EU citizens with rare diseases. This Communication focuses on three main areas: 1) improving recognition and visibility of rare diseases, 2) supporting policies on rare diseases in MS for a coherent overall strategy, and 3) developing cooperation, coordination and regulation for rare diseases at EU level. (3) The Council Recommendation on an action in the field of rare diseases was adopted on 8 June 2009. The Recommendation engages the responsibility of Member States and concentrates on supporting and strengthening the adoption before the end of 2013 of national plans and strategies for responding to rare diseases, on improving recognition and visibility of rare diseases, on encouraging more research into rare diseases and forging links between centres of expertise and professionals in different countries through the creation of European reference networks in order to share knowledge and expertise and, where necessary, to identify where patients should go when such expertise cannot be made available to them. The role of patients’ organisations is also highlighted as particularly important. To aid the European Commission with the implementation of Community activities in the field of rare diseases, The European Union Committee of Experts on Rare Diseases (EUCERD) was formally established in 2009. At the same time, national strategies and policies in the field of rare disease (RD) are rapidly evolving. Up till now, several countries have taken action to adapt their health care system to meet the needs of the RD patient community or plan to do so. The first action point is to spot the expertise and organise healthcare pathways to reduce time to diagnosis and ensure appropriate care. A few European countries have already established centres of expertise for RD. The other ones have agreed to work on it according to the recommendations of the EUCERD. This will allow for health care users to access optimal care. Some experimental European reference networks of centres of expertise have been established. They are recognised as a desirable form of cooperation in the directive on cross‑border healthcare. Maximising scarce resources and coordinating efforts are also key elements for success in the field of research. Worldwide sharing of information, data and samples to boost research is currently hampered by the absence of an exhaustive rare disease classification, standard terms of reference and common ontologies, as well as harmonised regulatory requirements. The International Rare Disease Research Consortium (IRDiRC) was launched in April 2011 to foster international collaboration in rare diseases research. The European Commission and the US National Institutes of Health initiated the discussions, and other stakeholders, including other funding agencies, were also invited to join the consortium. In October 2011 there was a meeting to identify principal research topics and regulatory challenges in this international context, as well as to establish the governance of the consortium. IRDiRC will team up researchers and funding agencies in order to achieve two main objectives by the year 2020, namely to deliver 200 new therapies for rare diseases and diagnostic tools for most rare diseases.

This chapter examines the position of the third sector at the European level, where it has slowly been building a presence. Although great advances have been made, especially from the 1990s onwards, and the sector’s European networks are much stronger than before, it remains institutionally weak and has difficulties linking back to the national level and below. Vertical linkages between the European and national levels are often weak, which means that socially and politically they often constitute different worlds.

Analyzing the dynamics of the deadwood carbon pool in Spain through the European Level I Monitoring Programme

The chapter addresses the analysis of the general principles relevant for resolving the hypothetical cases in this book, as these general principles have been enumerated in the national reports as general principles at the European level. In the interlocking European legal order (or orders), general principles are applied at all levels, including that of the European Union, European human rights, and nation states. General principles at different levels contribute to the formation and application of principles at other levels. Domestic law at the nation state level contributes to the formation of principles at the levels of the European Union, European human rights, and international law. In the other direction, from the European and international law levels to the domestic, these supranational level principles influence the principles at the domestic level, and result in an influential interaction between the interlocking legal orders. The European legal orders and their domestic legal systems also interact with international law and law from other domestic jurisdictions.

Institutional ambiguity in implementing the European Union Marine Strategy Framework Directive

Lowland Farmland Birds III: Delivering Solutions in an Uncertain World. A report on the BOU’s Annual Conference held at the University of Leicester, 31 March–2 April 2009

1. Introduction Demonstrating the importance of parties operating at European level mainly through their functions of shaping the landscape of Europe by organizing elections and reflecting the landscape of pluralist Europe, the article opens scientific and normative concepts of political and political party operating at European distinguishing Europarties from foundation at European level. The author in parallel explains political-historical background of Europe and Estonia, views parties operating at European level comparatively to parties of a EU member state, Estonia, and representation in the European Parliament, gives an overview of Estonia's representation in Europarties, and tries to connect the analysis with attempts to coordinate European politics. The importance of the research underlying this article lies in contextualising the relevant normative developments with explanations of the nature of politics and representation in Europe on historical background, of transformation of Estonian politics on the European landscape from communist one-party system toward plurality, and of the inner trend toward greater cooperation in the framework of discursive plurality or even features of duopolism in competition that may sometimes refer to opposition as known from the Cold War era that may very generally be understood as the East-West opposition. (1) Political competition and opposition are different phenomena--while one can see continuity in party competition, one may see discontinuity in opposition. Continuity and discontinuity here could be understood similarly to their meanings in the history of human rights, where continuity marks the more permanent values, while discontinuity marks politicization of human rights. Being a lawyer with human rights research background, I could also explain as follows: discontinuity refers to the nature of human rights--the existence of mechanisms is required for their validation and implementation, politicians have used and use human rights for achieving aims, while continuity refers to emanation of human rights from something more continuous than pure processes, being connected with human nature and inner moral rules of societal-political co-existing. Concerning the research methods, I have tried to apply scientific and normative concepts and understandings of party toward parties at European level, in order to understand how the features that are characteristic to parties show with the parties at European level. This article aims at offering a structural analysis of transformation of parties in Europe rather than at content analysis of ideologies. The author has used several internet sources because not all of the manifestos and other documents of all the Europarties have been published on paper. The use of internet sources seems also justified in the rapidly developing information society, where it is difficult for traditional publications to adequately reflect all of the most recent developments. The article focuses on the registered parties at European level, whereas one should also be aware of the existence of other movements and groups as a source of direct legitimacy, the latter do not constitute an object of this research. The analysis of manifestos and other documents at European level allowed the following contextualizing findings: the European People's Party (EPP) determines itself as representing centre-right and the idea of federal Europe; the Party of European Socialists (PES) determines itself as a left-wing party, bringing together in the EU the socialist, social-democrat and labour parties; the Alliance of Liberals and Democrats in Europe (ALDE) supports liberal democrat values; the Alliance of European Conservatives and Reformists (AECR) determines itself as a conservative, non-federalist entity; the Party of the European Left (EL) claims to represent non-socialist left-wing; the European Democratic Party (EDP) determines itself as a transnational movement combining federalist and social aspiration; the European Alliance for Freedom (EAF) does not define itself on the left-right scale, allowing members with wide spectrum, but at the same time looking at the content of its activities, it opposes centralized, supranational control; the Alliance of European National Movements (AEMN) determines itself as a Christian confederalist party; the European Christian Political Movement (ECPM) determines itself as a Christian-democratic party, representing Christian socialists, embracing European Christian-democratic and Christian-social parties, NGOs and think tanks; the EU Democrats (EUD) does not take a position on left-right policy issues, although it considers itself a pan-European EU-critical alliance; etc. …

Purpose This study links the notion of responsible strategic communication to the field of lobbying at the European (EU) level. It provides empirical findings on the relevance of informal interaction and communication in EU public affairs (PA). Focusing on functional expectations and uses tied to informality from an actors’ perspective, this study not only includes lobbyists and their attempts to gain influence on political actors but also attempts of lobbyists to control journalistic output through informal relationships and exchange mechanisms. The results are discussed with a view to further inform the concept of “responsible lobbying.” Design/methodology/approach Building on a theoretical background from strategic communication, informal politics and interest group research, findings from a qualitative content analysis of 43 semi-structured interviews with actors from PA (n = 27) and journalism (n = 16) at the EU level are reported, focusing on one policy case. Findings The study shows motives for establishing and using informality for both actor types. Functional expectations relate to a range of tasks at the core of the respective actors’ day-to-day activities: monitoring political developments, pre-negotiating policy options in protected, confidential spaces with political decision-makers, receiving relevant sectoral background information and “technical coaching” on legislative dossiers directed to journalists. Originality/value Studies on lobbying have rarely been conducted from a strategic communications perspective, especially focusing the EU level. Albeit widely accepted, the understanding of lobbying and PA as an informal activity has not been scrutinized by academic research.

Encouraging good practice in the development of Sustainable Urban Mobility Plans

Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.