European Harmonization Research Articles

Transnationale Solidarität? Grenzüberschreitende Gesundheitsversorgung in der Europäischen Union

Einleitung: Im Mehrebenensystem der Europäischen Union (EU) liegt die Gestaltung der Gesundheitssysteme in der Kompetenz der Mitgliedstaaten. Über den Mechanismus der negativen Integration wächst jedoch der Einfluss des Integrationsprozesses auf die nationalen Gesundheitspolitiken. Die Mitgliedstaaten müssen bei der Regulierung ihrer Gesundheitssysteme die Bestimmungen des EG-Vertrags beachten. In den vergangenen Jahren haben, vermittelt über die Rechtsprechung des EuGH, v.a. die vier Grundfreiheiten und das europäische Wettbewerbsrecht gesundheitspolitische Wirkungen entfaltet. Fraglich ist, welche Auswirkungen die binnenmarktgetriebene Europäisierung von Gesundheitspolitik auf solidarische Steuerungsprinzipien im deutschen GKV-System haben.

Medication errors: problems and recommendations from a consensus meeting

Here we discuss 15 recommendations for reducing the risks of medication errors: 1. Provision of sufficient undergraduate learning opportunities to make medical students safe prescribers. 2. Provision of opportunities for students to practise skills that help to reduce errors. 3. Education of students about common types of medication errors and how to avoid them. 4. Education of prescribers in taking accurate drug histories. 5. Assessment in medical schools of prescribing knowledge and skills and demonstration that newly qualified doctors are safe prescribers. 6. European harmonization of prescribing and safety recommendations and regulatory measures, with regular feedback about rational drug use. 7. Comprehensive assessment of elderly patients for declining function. 8. Exploration of low-dose regimens for elderly patients and preparation of special formulations as required. 9. Training for all health-care professionals in drug use, adverse effects, and medication errors in elderly people. 10. More involvement of pharmacists in clinical practice. 11. Introduction of integrated prescription forms and national implementation in individual countries. 12. Development of better monitoring systems for detecting medication errors, based on classification and analysis of spontaneous reports of previous reactions, and for investigating the possible role of medication errors when patients die. 13. Use of IT systems, when available, to provide methods of avoiding medication errors; standardization, proper evaluation, and certification of clinical information systems. 14. Nonjudgmental communication with patients about their concerns and elicitation of symptoms that they perceive to be adverse drug reactions. 15. Avoidance of defensive reactions if patients mention symptoms resulting from medication errors.

Investor Protection in European Union: Post FSAP Directives and MiFID

A single European market will promote competition between service providers and improve the efficiency of financial systems and allocation of resources across Europe. To achieve the ambitious goal of the single European securities market, cooperation and harmonization among Member States, by a strong commitment to the integration of the market, is especially important. Nevertheless, the EC securities regulations did not fit well with the different national securities regimes and the fragmented market structures before the FSAP. This working paper aimed to assess European securities regulation from the perspective of investor protection. Beginning with the introduction of the FSAP, the four key directives of the FSAP will be discussed.Among the four directives, the Directive on MiFID should be considered as a milestone for investor protection since it pursues the progressive approach by the EC of systemic protection, when compared to the approaches adopted in the previous three directives that pursued fair distribution of investment information to investors. By increasing the role of the intermediaries in the European financial regulation, however, the MiFID gives the EC more centralized regulatory power on the fragmented European securities regulations. However, the EC should complement the directive with more comprehensive coverage over a broader range of investment instruments while supplementing ambiguous terms in the following implementing directives. The paper proceeds as follows: Section One briefly outlines the FSAP and these three early directives with respect to investor protection via information disclosure; and Section Two starts with a discussion of the MiFID regulatory framework and the significant progress made in European investor protection by its introduction. The MiFID, by imposing the duty of information disclosure and investor protection on the intermediaries, strengthens the nexus between the implemented regime and actual protection.

'Gold plating' of European Environmental Measures?

AbstractMinimum harmonization in European environmental law essentially means that the Member States have the power to lay down more stringent standards in this area of regulation than those laid down by European legislation. However, there were indications which seemed to suggest that Member States make very little use of their powers to lay down or maintain more stringent national standards. The general question to be dealt with in this paper is whether Member States actually use their power to lay down or maintain more stringent environmental standards after European harmonization. Based upon the papers and discussion at the meeting of the Avosetta Group of European Environmental Lawyers in Monção (Portugal), 6 and 7th February 2009, this paper aims to paint an impressionist picture of the contemporary practice of gold plating (or not) in the Member States.

Swedish Copyright Evergreens Mini-Maglite?

In April 2009 the Swedish Supreme Court recognized copyright protection for the Mini-Maglite® torch as “artware” without any requirement for a special expression level. The overall impression of the well known Mini-Maglite torch was held to be different from other similar torches.The Court held that it displayed a sufficient degree of independence and originality despite the fact that the functional design properties of the torch are neither new nor original. This article investigates the intersection between different IPR rules in Sweden and certain other European countries and the possible extent of the copyright legislation. It concludes that the Swedish position is untenable and that this demonstrates that there is a need for the European harmonization of substantive copyright legislation

OCCUPATIONAL LICENSING VERSUS COMPANY-LED TRAINING

ABSTRACT The paper provides an analysis of the major controversy which occurred between national aviation authorities during their work on the European harmonization of the aircraft technicians’ competence. The debate focused on the institutional method to assure the high skills level required for that profession: should Europe introduce a system of personnel licensing or a system of company-led training? Should competence assurance and monitoring be assigned to the aviation authority or should these responsibilities be delegated to approved companies? A series of 20 extensive interviews with aviation stakeholders in France, Germany and the United Kingdom showed: (i) the company training option highlights the fact that ‘organization’ is a traditional strategy for competence assurance in high-reliability contexts (like aircraft maintenance), the other main alternatives being occupational regulation and sorting by well-informed markets. (ii) The quality recognition required for the international outsourcing of safety-critical services favours the licensing system. In contrast to licensing, the design of the company training system fails to generate the transparency and trust necessary to reassure foreign customers. (iii) Both systems of competence assurance are densely intertwined with specific industrial relation patterns and vested interests. The distortion of these – national or local – equilibriums by European harmonization encounters strong opposition from the industry and/or unions.

A Major Step in the Harmonization of Procedural Law in Europe: The European Small Claims Procedure Accomplishments, New Features and Some Fundamental Questions of European Harmonization

textabstractEuropean civil procedural law has been in a constant state of flux since the coming into force of the Treaty of Amsterdam in 1999. The introduction of Article 65 EC Treaty was followed by numerous Community instruments in the field of civil procedure, mostly regulations that have direct binding force in the Member States. These have changed the face of litigation in the European Union.This paper focuses on the recent developments in European procedural law, and more in particular the establishment of the first two harmonized European procedures. The emphasis is on the European Small Claims Procedure, which as a full, adversarial procedure is more substantial than the primarily administrative European Order for Payment Procedure for uncontested claims. First on overview of harmonization of procedural law in Europe after the Treaty of Amsterdam is provided, then the European Small Claims Procedure is analyzed. The final section contains some thoughts on the harmonization of procedural law in Europe. First, the accomplishments and innovative features are discussed. Second, some difficulties and fundamental issues of the harmonization of procedural law in Europe are presented.

Finding copyright theory's future in its past: two books by Ronan Deazley

Copyright's history is one of continual expansion of the copyright-based industries and the laws on which they depend. Recently, they have grown exponentially in their economic and political importance and their impact on our daily lives. Copyright in the English-speaking world1 from the Statute of Anne in 17102 to today's statutes and treaties reflects this seemingly unending expansion of the rights of copyright holders. From a simple parliamentary grant of a right to exclusively print and reprint books for a maximum period of 28 years,3 copyright has grown almost beyond recognition. Copyright protection now encompasses not only books and printed material, but also music, drama, works of visual art (painting, sculpture, photography, etc.), audiovisual works (film, television, computer games), dance, databases, computer programs, architectural works, and recorded performances, to name only some of the works now included under the rubric of copyright and its neighbouring rights. The minimum duration of copyright protection under the Berne Convention4 is now the life of the author plus 50 years,5 and under the European Union's harmonization directive, the life of the author plus 70 years.6 The exclusive grant to the copyright holder has increased from merely printing and reprinting a book to include rights of adaptation, performance, and recording, and, in some cases a rental right and a right to control importation of legitimate copies. In addition to such original remedies as actions for damages and injunctive relief to stop further infringement, the copyright holder now can employ technological measures to encrypt their works and defeat copying with severe civil and criminal penalties levied against anyone who seeks to circumvent these restraints.7

Analysis of Discrepancies Between External Body Examination and Forensic Autopsy

At present in France, most of the medico-legal investigations are restricted to death scene investigation, which means there is only an external body examination without subsequent autopsy. The aim of our study was to show the limits of death scene investigation by establishing the rate of discrepancies between the results of external body examination and forensic autopsy.A retrospective study was carried out on 200 autopsy cases which were all preceded by death scene investigation and performed in 2002. For each case, age, sex, body weight, body state, place, and time of death were reported. The number of recent trauma lesions detectable at external body examination and at autopsy was studied. Conclusions about manner and cause of death between death scene investigation and autopsy were also studied. Discrepancy rate about interpretation of the lesions seen at external body examination and at autopsy was determined. Discrepancy between minor external trauma lesions and severe internal trauma lesions was also studied.The mean age of the studied population was 42.4 years. Sex ratio was 2.2. External body examination was limited by body state in 32% of the cases. The mean number of recent external trauma lesions recorded at autopsy was significantly higher than those recorded during death scene investigation. Manner and causes of death were undetermined after death scene investigation in 54.5% and 49% of the cases, respectively. When the cases were determined by death scene investigation, discrepancy rate, respectively, was 5% and 9% of all cases (n = 200) for manner and causes of death.Death scene investigation even carried out by a well-trained forensic physician is not reliable relative to cause and manner of death. Our study underlines the necessity in the future to perform more forensic autopsies in France, relying on the European harmonization of medico-legal autopsy rules.

Public GMO location register in Germany – Harmonization in Europe?

According to Article 31 (3b) of Directive 2001/18/EC, Member States shall establish public registers for recording the cultivation of GM plants grown under part C. The primary purpose is the monitoring of potential adverse environmental effects of such GMOs. The German GMO location register was established in February 2005 by the Federal Office for Consumer Protection and Food Safety (BVL). Actual data for the intention of GMO planting as well as the real cultivation area per year and postal code area are publicly available via internet. The German Gene Technology Act has the aim to broaden the location register towards an instrument of coexistence and transparency. After three years of experience we report on notification statistics, public interest, encountered difficulties and future plans of development. In addition we describe the situation in other EU Member States regarding the introduction and the access to public location registers. Requirements on the data base and data harmonization are discussed in the light of using location registers as a monitoring instrument throughout Europe.

The Shaky Ground Beneath the CEFR: Quantitative and Qualitative Dimensions of Language Proficiency1

Common European Framework: A manual. Language Testing, 22, 262-279. Fulcher, G. (2004). Deluded by artifices? The Common European Framework and harmonization. Language Assessment Quarterly, 1, 253-266. Little, D. (2007). The Common European Framework of Reference for Languages: Perspectives on the making of supranational language education policy. Modern Language Journal, 91, 645-655. McNamara, T. (2006, December). Proofs of identity: Some social and politicalfunctions of language tests. Paper presented at Lancaster University, England. Morrow, K. (Ed.). (2004). Insights from the Common Europe n Framework. Oxford: Oxford University Press. Takala, S. (Ed.). (2004). Reference supplement to the preliminary pilot version of the Manual for Relating Language Examinations to the CEFR. Strasbou g, Fra ce: Council of Eur pe. Wilkins, D. A. (1976). Notional syllabuses. Oxford: Oxford Univ rsity Press.

Accounting Regulation Changes in Lithuania: An Assessment

In the last decade undergoing accounting harmonization processes and their impact on corporate disclosure was continually discussed in the scientific literature. This paper extends this analysis by evaluating Lithuanian case. The aim of this study is to assess accounting regulation changes in Lithuania in the context of the European Union wide accounting harmonization processes. The paper addresses evaluates the background for accounting regulation changes in Lithuania, identifies de jure accounting regulation changes in Lithuania and compares them with the same of the European Union, and then assesses de facto implementation of accounting regulation by Lithuanian companies.

Green Accounting - A Helping Instrument in European Harmonisation of Environmental Standards

In today's global economy, organizations are increasingly called upon to demonstrate sound business management that includes concern for economic, social and environmental issues. The challenges created by global competition make it imperative for enterprises to continually rationalize and improve all resources and processes. Separation of responsibilities for the processes that underpin organizational outputs is unsustainable in today's competitive environment (Guido Guertler, 2001). On the base of literature review, we assert that recent achievements proved that ISO's management system standards have a global relevance of and a capacity to benefit from the very largest to the very smallest organizations in both public and private sectors. An Environmental Management System (EMS) provides a solid framework for meeting environmental challenges and realizing the above benefits. Most environmental legislation now originates at the European level, where the main legal instruments are EU directives and regulations. Traditionally, environmental regulation has covered the environmental media. From the early 1990s, a more integrated approach has been taken across all media with Integrated Pollution Control (IPC) and, more recently, the Integrated Pollution Prevention and Control (IPPC) European Directive (EC, 1996). We describe in our research the main types of environmental standards used across Europe and their impact on businesses performance. In conclusion we analyse the future key areas the environmental legislation is likely to be developed in.

Liberal family law in the making: Nordic and European harmonisation

This paper discusses the past and contemporary legal harmonisation exercises of family law in the Nordic countries and Europe. The critique is that the harmonised ‹European family law’ only entrenches the status quo and reiterates traditional family patterns, the male norm, heteronormativity, and a public/private divide represented in the neutral guise of a liberal rights discourse. Furthermore, the critics point out that the political economy of legal harmonisation is, to a large extent, ignored. In the Nordic countries, egalitarianism and broad political deliberation characterised much of the previous legal harmonisation, whereas rights discourse in its liberal sense is a novelty, more or less triggered by the European integration. This paper discusses the gendered implications of the emerging rights discourse in the Nordic countries and the linkages between family law, the labour market and social welfare. The paper argues that the harmonisation exercise cannot be regarded as one consisting only of legal norms and reasoning, but rather it should be discussed from the perspective of a political and epistemological challenge to the prevailing ‹truths’ about marriage, family and sexuality.

I08 Development of transfusion medicine in Europe A challenge for physicians, scientists and politicians

Modern transfusion medicine in Europe has successfully handled the major threats to a safe blood supply by “classical viral” transfusion-transmitted pathogens like HCV and HIV. However, this was only managed by utilizing major financial and expert resources. Today, European harmonisation of optimal use of blood components in clinical hemotherapy, uniform quality standards for blood donations, testing and component production as well as an increasing cost pressure in clinical care are tasks, which need our full attention. Modern cellular therapies and regenerative medicine are novel treatment options, which can only be handled by a close cooperation between clinicians and transfusion medicine specialists. Future challenges comprise proactive measures like pathogen inactivation for all blood components in order to diminish threats to blood safety by (re-)emerging pathogens, an adequate blood supply bearing in mind the ongoing ageing of most European populations and political decisions regarding a potential open “blood market” in Europe, which in our opinion should not be supported by the European Union.

Tax Harmonisation in Europe - The Determination of Corporate Taxable Income in the EU Member States

The aim of this paper is twofold. First, we want to examine whether and if so, to what extent, the concept of International Financial Reporting Standards (IFRS) meets the requirements of a Common Consolidated Corporate Tax Base (CCCTB) for the EU-wide activities of multinationals as proposed by the European Commission. Second, we estimate the consequences on the effective levels of company tax burdens in selected EU member states if IFRS are considered as a tool for defining the tax base. Our analysis reveals that IFRS could provide elements of a common and harmonised European tax base in certain areas. In particular, tax accounting still has to follow the realisation principle. Therefore, IFRS fair value-accounting cannot be adopted for tax purposes. A transition to tax accounting on the basis of IFRS has only minor effects on the effective tax burdens of companies.

Are UK genetic databases governed adequately? A comparative legal analysis

Given the burgeoning of genetic research and proliferation of human genetic databases, especially in the biomedical sphere, this paper explores whether the existing laws and regulatory structures for governing genetic databases in England and Wales are adequate. Through a critical survey of relevant rules, bodies and practices, it argues that the current UK framework is far from ideal in at least five major areas: (1) forms and styles of law used, especially the separate legislative regimes for physical biomaterial and data; (2) core definitions; (3) formal regulatory bodies, licensing and notification requirements; (4) ethics committees and other advisory panels; and (5) enforcement powers and sanctions. Such shortcomings could have major implications for stakeholders, hamper efforts to achieve European or international harmonisation of genetic database principles and practices, and undermine the UK’s standing as a world leader in genetics and biotechnology. Drawing on comparative analysis of governance strategies adopted in Estonia, Iceland and Sweden, the paper identifies alternative options and lessons from experiences abroad, suggesting possible avenues for reform that may warrant serious consideration in the UK.

On the Road to Anglo-Saxon Capitalism? German Corporate Governance Regulation between Market and Multilevel Governance

Financial internationalization and European regulatory harmonization put the German corporate governance regime under pressure to move towards a market-oriented, Anglo-Saxon model. While International Political Economy approaches expect Anglo-Saxon standards to spread across national borders, Comparative Political Economy predicts persistent diversity. In our paper, we trace the patterns and driving forces of change in two areas of corporate governance regulation, namely internal governance and accounting. In accounting, processes of multilevel coordination entailed a high degree of convergence towards Anglo-Saxon standards and institutions. A much greater stability of the domestic institutional framework can be seen in the case of internal governance. While political economy approaches offer important insights for analyzing these changes, both fail to account for the different patterns of convergence and divergence in the two cases. Therefore, we argue in favor of a policy analysis perspective to capture the sectorally distinct interplay of forces that shape the processes of regulatory change.

Biofuels and ecology

Biofuels and ecology

An Insider's Look into Policy Transfer in Transnational Expert Networks

Much of the recent academic literature on spatial planning in Europe focuses on either cross-national comparison of planning frameworks and planning practices or on transnational and transregional initiatives and their impact on planning in European countries. From those publications, it can be gleaned how similar themes are translated differentially in different national contexts. Although it is also a great source of European integration and harmonization, the phenomenon of the knowledge exchange within transnational expert networks of European planners at the level of cities has received less attention. In this paper, the knowledge exchange among planners in such a network is studied, highlighting the role of “transfer agents” (academic and/or policy experts operating in communities in different policy arenas) in the exchange process. It builds on the insights from existing literature on policy transfer and policy learning, and tries to add a new perspective on this body of literature from an insiders' perspective, i.e. participatory observation. The idea is that policy transfer can be fruitfully approached as a process of knowledge and information transfer between producers, senders, facilitators and recipients. Often this exchange is to a very large extent a process of absorbing appealing labels for policy solutions from the international or national policy levels, and then adopting an interpretation of it suitable to one's own context. The authors try to give meaning to this exchange process by using two mechanisms, i.e. social interaction and conceptual replication. By combining these two mechanisms the authors try to uncover which policy lessons are being transferred among seven European cities that joined the expert network on European sustainable urban development (Pegasus).