European Harmonization Research Articles

Public Health Policy and Law for Pandemic Influenza: A Case for European Harmonization?

This article provides a critical portrait of the current state of public health policies and laws governing pandemic influenza prevention and control in Europe. It examines the role of and relationship between national public health policy and national communicable disease legislation as tools for the prevention and control of pandemic influenza, the role of Europe in pandemic disease preparedness, and the concept of harmonization across European states, including an overview of supranational initiatives and powers created to enhance harmonization of national pandemic disease policy. Short case studies epitomize important concerns around harmonization in Europe. The article considers opportunities and impediments to further harmonization. Particular attention is paid to the essential role of law as a tool to underpin and implement preparedness policies and to protect individual rights against unjustified state intervention.

Continuing Medical Education and Professional Development in the European Union

Continuing medical education (CME) and its broader term continuing professional development (CPD) are indispensable as part of lifelong learning and may be regarded as equally or more important than undergraduate and postgraduate medical education. Pharmaceutical medicine occupies common ground between the clinical and healthcare professions, pharmaceutical industry and government, and thus, the same principles are applicable. However, the global status of CME/CPD education in pharmaceutical medicine is alarming. Surveys conducted among pharmaceutical medicine associations from 22 countries and pharmaceutical physicians in the US showed that a relatively low number of CME/CPD activities are developed across countries, a high percentage of pharmaceutical physicians lack formal postgraduate education in pharmaceutical medicine and, additionally, training needs in basic knowledge areas were detected. It is evident that further education efforts are necessary. The CME system has many variations across countries. The CME/CPD model, including credits or hours, is the currency by which regulatory bodies often assess competence all over the world. Accreditation systems have been developed primarily in the US and Europe in an attempt to self-regulate and advance practice standards, as well as to respond to environmental pressures for advancement of healthcare quality and insulation of any commercial influence on education. Initiatives for a European and/or global CME harmonization have been developed. However, the major problem is that the various CME systems are very different and fragmented. In spite of the tremendous amount of resources spent on maintaining and upgrading physicians’ knowledge and skills, the effectiveness of CME in producing changes in practice has been questioned. It has been argued that CME programmes, as currently practiced, do not adequately focus on improving clinical performance and patient health outcomes. The emphasis is put on measuring acquired knowledge based on training hours, instead of assessing competences and skills as a result of professional development. A new CME/CPD outcomes-based model for performance improvement through individualized and standardized education has been proposed, including physician’s self-assessment, self-reflection and practice-based learning. PharmaTrain is a public private partnership sponsored by the EU’s Innovative Medicines Initiative including 24 universities, 13 learned societies/associations and several partner training organizations. PharmaTrain aims to provide courses that are designed to meet the needs of pharmaceutical physicians and other professionals working in medicines development (basic diploma, masters and CME/CPD). The PharmaTrain CPD platform will include diploma and master extension and elective modules, both course based and standalone, aimed to facilitate lifelong learning. The successful development and use of the PharmaTrain CPD platform provides a valuable new opportunity to meet the current standards and expectations for CME/CPD posed by stakeholders and society at large.

European Harmonisation of Intellectual Property Law: Towards a Competitive Model and a Critique of the Proposed Unified Patent Court

This contribution compares the European harmonisation of intellectual property law (in particular of patent law) with harmonisation in European private law in general. This critical comparison allows lessons to be drawn on what to encourage and what to avoid in developing the two areas. Next to a comparative discussion of the need for harmonisation and of the used methods, ample attention is paid to the 2011 EU Proposal for unitary patent protection, aiming to create a unified European patent and the parallel effort to create a Unified Patent Court. In contrast with the approach of the European Union towards centralised patent protection, we offer an alternative account towards convergence of patent law. In this competitive model of patent law, the decision to apply for a national, European or unified patent is left to the parties. In addition, parties can not only address the future unified court, but are also allowed to address the national court of their choice. This should stimulate a competition among patent offices and courts to provide a patent protection that is uniform, of high quality, speedy and cheap. This has the potential to lead to ‘convergence through choice’ towards the patent regime that fares best in view of the needs of market actors.

Western driving regulations for unprovoked first seizures and epilepsy

PurposeTo review the legislation for non-commercial driving licenses in the Western world for unprovoked first seizures (UFS) and recurrence of established epilepsy, and to examine available evidence on the road traffic accident (RTA) risk in people with seizures. MethodsRegulations for non-commercial driving licenses were sought from appropriate national or state authorities and epilepsy societies. The literature was searched for consensus guidelines and data relevant to risk analysis, including an appropriate seizure-free period (SFP). ResultsThe SFP varied widely from 3 to 24 months and in most countries no distinction was made between UFS and recurrence of established epilepsy. In the European Union (EU), harmonisation is underway but implementation of the relevant directive has been slow. The excess risk of RTA in epilepsy is minimal, especially compared to other factors such as alcohol, and few accidents result from seizures at the wheel. Risk analysis supports the shortened SFPs that are being enacted in the EU. ConclusionRegulations across the world continue to vary widely, and the available data support rules which are less stringent than those currently in force in many parts of the Western world. The ongoing European harmonisation is encouraging but much work remains to be done in revising legislation elsewhere, and in strengthening the theoretical foundations underpinning driving regulations.

Testing the Global Applicability of Ground-Motion Prediction Equations for Active Shallow Crustal Regions

Abstract Large research initiatives such as the Global Earthquake Model (GEM) or the Seismic HAzard haRmonization in Europe (SHARE) projects concentrate a great collaborative effort on defining a global standard for seismic hazard estimations. In this context, there is an increasing need for identifying ground‐motion prediction equations (GMPEs) that can be applied at both global and regional scale. With increasing amounts of strong‐motion records that are now available worldwide, observational data can provide a valuable resource to tackle this question. Using the global dataset of Allen and Wald (2009), we evaluate the ability of 11 GMPEs to predict ground‐motion in different active shallow crustal regions worldwide. Adopting the approach of Scherbaum et al. (2009), we rank these GMPEs according to their likelihood of having generated the data. In particular, we estimate how strongly data support or reject the models with respect to the state of noninformativeness defined by a uniform weighting. Such rankings derived from this particular global dataset enable us to explore the potential of GMPEs to predict ground motions in their host region and also in other regions depending on the magnitude and distance considered. In the ranking process, we particularly focus on the influence of the distribution of the testing dataset compared with the GMPE’s native dataset. One of the results of this study is that some nonindigenous models present a high degree of consistency with the data from a target region. Two models in particular demonstrated a strong power of geographically wide applicability in different geographic regions with respect to the testing dataset: the models of Akkar and Bommer (2010) and Chiou et al. (2010).

“An ever closer union … ” – towards the “soft” convergence of European drug policies

PurposeA response to Chatwin's article (2010), which argues that European harmonisation of illicit drug policies remains far from realisation, this paper seeks to recommend developing a more specific conceptualisation of European integration in the area of illicit drugs and argues that harmonisation was not a realistic aim of the European Union (EU).Design/methodology/approachThis is a review paper which seeks to advocate the application of a more rigid analytical framework in drug policy analysis that takes into account the “soft” methods of governance used by the EU. The paper also uses secondary data sources to emphasise the argument.FindingsDomestic convergence has been observed across a number of policy areas.Research limitations/implicationsThe nature and level of convergence remains contested and more data are needed to clarify any trends. Future research would be necessary to demonstrate that convergence occurs as a result of EU action rather than other factors.Originality/valueThere remains little in the way of research on the processes of European integration and their specific impact on drug policy at the European and domestic level. This paper will be of value to scholars in the field of European integration who are seeking to expand their research into a new policy sector, as well as researchers in the drug field who are looking for a more formal analytical framework.

Biopatenting: “Angst” v. European Harmonization – The ECJ Decision on Stem Cell Patents

Case C-34/10 Brüstle v. Greenpeace1.Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:–any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;–it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.2.The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.3.Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

Toward a ground-motion logic tree for probabilistic seismic hazard assessment in Europe

The Seismic Hazard Harmonization in Europe (SHARE) project, which began in June 2009, aims at establishing new standards for probabilistic seismic hazard assessment in the Euro-Mediterranean region. In this context, a logic tree for ground-motion prediction in Europe has been constructed. Ground-motion prediction equations (GMPEs) and weights have been determined so that the logic tree captures epistemic uncertainty in ground-motion prediction for six different tectonic regimes in Europe. Here we present the strategy that we adopted to build such a logic tree. This strategy has the particularity of combining two complementary and independent approaches: expert judgment and data testing. A set of six experts was asked to weight pre-selected GMPEs while the ability of these GMPEs to predict available data was evaluated with the method of Scherbaum et al. (Bull Seismol Soc Am 99:3234–3247, 2009). Results of both approaches were taken into account to commonly select the smallest set of GMPEs to capture the uncertainty in ground-motion prediction in Europe. For stable continental regions, two models, both from eastern North America, have been selected for shields, and three GMPEs from active shallow crustal regions have been added for continental crust. For subduction zones, four models, all non-European, have been chosen. Finally, for active shallow crustal regions, we selected four models, each of them from a different host region but only two of them were kept for long periods. In most cases, a common agreement has been also reached for the weights. In case of divergence, a sensitivity analysis of the weights on the seismic hazard has been conducted, showing that once the GMPEs have been selected, the associated set of weights has a smaller influence on the hazard.

The Proposal for a Regulation on a Common European Sales Law: Deficits of the Most Recent Textual Layer of European Contract Law

On 11 October 2011, the European Commission published a Proposal for a Regulation on an optional Common European Sales Law (CESL). This text represents a milestone for the further development of European contract law. Our essay critically examines and evaluates the Commission’s proposal. It outlines the Commission’s draft as well as its background and deals with some of the most pressing doctrinal and policy issues raised by it. We show that the suggested range of application and the technical mode for opting into the CESL are flawed. Further, the CESL incorporates many elements and doctrines of the current acquis communautaire, such as unduly extensive information duties and withdrawal rights as well as a policing of standard contract terms, without reconsidering their proper purposes and uses. With respect to the rules on sales law, it is particularly the mandatory character of most of them that poses grave problems. We also demonstrate that the CESL’s optional character does not eliminate the quality concerns raised in this essay: The CESL might become a ‘success’ despite its shortcomings. Hence, notwithstanding its optional character, the proposed text should not be enacted. What is needed is a broad and thorough debate on the scope, forms and contents of contract law harmonization in Europe rather than the speedy legislative enactment of a flawed product.

Contract Theory: Is There a Path Through the Theoretical Jungle?

This piece, which examines ideas from both US and European contract law, considers whether there is any emerging consensus in contract theory. It suggests that what is styled a 'co-operative will theory' would provide a sound basis for developing the law, and that such a theory reflects the emerging consensus in European legal harmonization projects.

The Proposal for a Regulation on a Common European Sales Law: Shortcomings of the Most Recent Textual Layer of European Contract Law

On 11 October 2011, the European Commission published a Proposal for a Regulation on an optional Common European Sales Law (CESL). This text represents a milestone for the further development of European contract law. Our essay critically examines and evaluates the Commission’s proposal. It outlines the Commission’s draft as well as its background and deals with some of the most pressing doctrinal and policy issues raised by it. We show that the suggested range of application and the technical mode for opting into the CESL are flawed. Further, the CESL incorporates many elements and doctrines of the current acquis communautaire, such as unduly extensive information duties and withdrawal rights as well as a policing of standard contract terms, without reconsidering their proper purposes and uses. With respect to the rules on sales law, it is particularly the mandatory character of most of them that poses grave problems. We also demonstrate that the CESL’s optional character does not eliminate the quality concerns raised in this essay: The CESL might become a ‘success’ despite its shortcomings. Hence, notwithstanding its optional character, the proposed text should not be enacted. What is needed is a broad and thorough debate on the scope, forms and contents of contract law harmonization in Europe rather than the speedy legislative enactment of a flawed product.

How to build European private law: an economic analysis of the lawmaking and harmonization dimensions in European private law

In the process of building a European Private Law, the lawmaking and harmonization dimensions—the modes of harmonization and even more, the scope and reach of the harmonizing effect of the European rules- appear as crucial issues. We show how the harmonization strategy is as important a question as whether we should have European Private Law at all. We present an economic discussion of the different modes of harmonizing Private Law in the abstract, and how they are likely to differently affect outcomes. We also present in informal terms a simple economic model of how to build optimal harmonized rules and standards in a setting of pre-existing separate and diverse national ones, and we systematically explore how the different harmonization regimes (maximum harmonization, minimum harmonization, and pure co-existence of harmonized and national standards) affect the outcomes of the harmonization process.

The market for corporate control: do countries and technological regimes matter?

Using DATASTREAM and LexisNexis databases, we examine the experience from 1995 to 2005 for eight European countries and 21 sectors, and compute the frequency of merger transactions at sectoral level, controlling for the roles of country variables and focusing on distinct technological patterns of innovation. We found that, even in market‐based countries, where transfer of control is a frequent phenomenon, mergers are less frequent in those sectors where innovation follows cumulative processes and where takeovers represent a ‘breach of knowledge.’ This study provides empirical support to the fruitful line of research of varieties of capitalism (Hall and Soskice 2001) and shows that sectoral differences in M&A (mergers and acquisitions) may be seen in their complementarities with differences by country and their institutional frameworks. Results confirm that acquisitions may occur even in those economies where block‐holders are present, but where the good quality of institutions leaves no space for defence against takeovers. It also highlights the significant role played by takeover regulation, and suggests that the recent reforms in European harmonization should be implemented, so that the obstacles impeding takeovers can be removed. However, policy‐makers should also try to identify for which economies and sectoral fields of specialization, merger activities produce more beneficial effects and which turn out to be detrimental.

Paramedics in prehospital emergency medical systems across Europe

Emergency medical services (EMS) vary across Europe, with two predominant models: the Anglo-American model which uses mainly paramedics in a prehospital setting, where ‘the patient goes to the doctor’; and the Franco-German model which uses mainly physicians in a prehospital setting, where ‘the doctor goes to the patient’. No perfect model exists, and each country has an EMS model based upon the needs of the community and the available economic resources. This overview shows that the EMS in Europe are modern, efficient and structured in the same way. The dispatch centre, the means and the response times are similar; the biggest differences concern the personnel who staff ambulances and their training, although they all have to perform the same emergency procedures and manage similar types of patient. The role of emergency medical technicians (EMT) is vital in all prehospital EMS systems. However, the training of EMT with equal skills is very different, with great variations as a function of each country. European harmonization appears to be necessary, even if it seems difficult.

Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criterion for Alzheimer's disease.

The promise of Alzheimer's disease biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging measure in Alzheimer's disease and thus represents the most rational target for an initial effort at standardization. The authors of this position paper propose a path toward this goal. The steps include the following: (1) Establish and empower an oversight board to manage and assess the effort, (2) adopt the standardized definition of anatomic hippocampal boundaries on magnetic resonance imaging arising from the European Alzheimer's Disease Centers-Alzheimer's Disease Neuroimaging Initiative hippocampal harmonization effort as a reference standard, (3) establish a scientifically appropriate, publicly available reference standard data set based on manual delineation of the hippocampus in an appropriate sample of subjects (Alzheimer's Disease Neuroimaging Initiative), and (4) define minimum technical and prognostic performance metrics for validation of new measurement techniques using the reference standard data set as a benchmark. Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent was to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry was envisioned as a template that could be applied to other imaging biomarkers.

Regulating Audit in Europe: The Case of the Implementation of the EU Eighth Directive in Denmark 1984–2006

This paper analyses the consequences, in Denmark between 1984 and 2006, of the implementation of the European EU Eighth Directive on the qualification of statutory auditors. Although the Eighth Directive envisaged one group of statutory auditors in each Member State, there were two groups of auditors in Denmark, and the implementation of the Directive triggered a long conflict between the two groups about the education of the second-tier auditors. The analysis is based on the work of Abbott ((1988)) on professional jurisdictional disputes and shows how the local implementation of the Eighth Directive on auditor qualifications disturbed the balance of the ‘system of professions’ in Denmark and gave rise to an intra-professional conflict over the statutory audit jurisdiction. The jurisdictional dispute dragged on for two decades because of the complexity of the Danish regulatory system, where audit regulation takes place in overlapping committees between the profession, the state and the educational institutions. It was finally settled by educational differentiation of the two groups, and we discuss the implications of this settlement for the process of audit harmonisation in Europe.

Goodwill in the Current Greek Accounting Environment

The growing interest in the issue of intangible assets not only in the scientific community but also in some professional bodies internationally can be explained by several points of view. From the business perspective, enterprises are increasingly motivated by external and internal forces to measure and proactively manage their intangibles. With respect to the issue of intangibles, goodwill has been debated in many countries throughout the world. Despite the numerous efforts and the existence of international accounting standards there is not yet a common accepted accounting treatment for goodwill. This study attempts on the one hand to impress the accounting treatment of goodwill internationally, on the other hand analyses the major subjects in relation to the accounting treatment of goodwill in Greece, since 2005, year where the international accounting standards have been in use for the Greek listed companies. The results indicate that the accounting treatment for the goodwill in Greece, despite the effort for accounting harmonization in Europe from 2005, sustains many differences especially for the no listed companies. Keywords—Intangible Assets, Goodwill, International Accounting Standards, Greek Accounting System and Law

Country Effects and Sector Effects on the Harmonization of Accounting Policy Choice

In evaluating accounting harmonization in Europe, prior research has relied almost exclusively on index-based measures of the convergence of financial reporting practices. However, this approach offers little explanation of the impact of the harmonization process as the adoption of different accounting methods is attributable not only to the rules and regulations in force in the jurisdictions where sampled firms are domiciled but also to the specific characteristics of the firms that are selected for analysis. The study addresses this issue in order to determine the extent to which accounting harmonization took place in Europe prior to the recent switch to IFRS, by presuming that accounting will be harmonized not when there is uniformity but when 'all firms operating in similar circumstances adopt the same accounting treatment for similar transactions regardless of their domicile'. The paper sets out the results of a statistical analysis of financial reporting harmonization obtained by employing a logistic regression to predict the odds of using alternative accounting methods. The policies studied concern inventory, depreciation and goodwill. The empirical results suggest that, after allowing for international exposure and firm size, country effects continue to be far greater than sector effects, which is inconsistent with harmonized accounting.

The current limits of European harmonisation in consumer contract law

This paper is concerned with the Proposed Consumer Rights Directive. In particular it considers the choices to be made concerning minimum and maximal harmonisation. In doing so it draws upon previous experiences of harmonisation and in particular reflects on the approach of the European Court of Justice. The aim is to consider which areas of the Proposed Consumer Rights Directive require maximal harmonisation and which ones can be left to minimal harmonisation.

Growing trade of bioenergy in the EU: Public acceptability, policy harmonization, European standards and certification needs

Abstract Since 2000, the consumption of bioenergy in the European Union has grown, along with a concurrent growth in the trade of biomass for energy purposes (though traded volumes still remain small). Bioenergy production and trade will likely continue to increase into the future, driven by climate change concerns, emissions reduction targets, increasing concerns about domestic energy security and favourable policies. The harmonization of European standards and the development of certification systems are key issues to resolving potential negative effects of increased biomass trade. Certification systems not only address the issue of environmental sustainability from production to end-use, but also allow for product differentiation while adding value to sustainably produced products, which can ultimately enhance a competitive and sustainable bioenergy market. In addition to analyzing bioenergy trade growth in the European Union, a questionnaire survey of 92 bioenergy experts from eight member states within the European Union was conducted. Survey results show that bioenergy is highly accepted in the European Union but that there is a lack of European standards and policy harmonization, along with the absence of a competitive market or a certification system, all of which are necessary for sustainable production and trade of bioenergy. A large majority (63 percent) of the total respondents agreed that the certification of bioenergy is necessary to promote the sustainable use of biomass.