Esther Versluis

Even rules, uneven practices: Opening the ‘black box’ of EU law in action

While considerable attention is paid to the legal aspect of implementation of European directives, the practical ‘street-level’ implementation of EU law remains to a large extent a ‘black box’. This article sheds light on this black box with a study on the implementation of the Safety Data Sheets Directive in the Netherlands, Germany, the United Kingdom and Spain. This cross-national analysis reveals that different phases in the implementation process leave different traces. Although the member states correctly and completely transposed the directive, compliance by the regulated leaves something to be desired and enforcement by regulators is rare and varies considerably between and within the countries. This article looks into the factors that explain why even rules do not necessarily lead to even practices and argues for more attention for the phase of practical implementation.

Regulatory governance through agencies of the European Union? The role of the European agencies for maritime and aviation safety in the implementation of European transport legislation

In line with the trend of ‘agencification’ in Western countries, European Union (EU) agencies have been put forward as an instrument expected to improve the way rules are applied in the EU. So far, evidence confirming this expectation is lacking. By assessing the implementation of European transport legislation, this article provides an empirical insight into the role played by two EU agencies – the European Maritime Safety Agency (EMSA) and the European Aviation Safety Agency (EASA). The analysis shows that these EU-level agencies, although created as independent entities to enhance uniform implementation, remain highly dependent on the member states and the Commission. In terms of (legislative) enforcement their contribution has thus been limited. EU agencies such as EMSA and EASA currently seem to add more value by stimulating mutual learning processes among national regulatory authorities.

Analyzing the European Union policy process

Introduction PART I: THEORETICAL AND METHODOLOGY IN EU POLICY ANALYSIS Doing EU Policy Analysis Who do we Analyze? What do we Analyze? How do we Analyze? PART II: EU POLICY ANALYSIS IN PRACTICE Agenda-Setting S.Princen Policy-shaping Decision-making Implementation Evaluation Conclusions

Policy Making on Data Exclusivity in the European Union: From Industrial Interests to Legal Realities

After lengthening the duration of patents to twenty years in 1984, the pharmaceutical industry has turned to data exclusivity as a major vehicle for extending market protection, even after patents expire. Such protections give companies the power to tax consumers for innovation by charging above-market prices. This article draws upon unique information to describe how key actors lengthened data exclusivity for patented drugs to postpone generic competition in the European Union (EU) just before ten new members joined it. We explore the political route and the interests of different actors to understand the process by which industrial interests are translated into legal realities in the worlds largest harmonized market. Several factors influenced the outcome, including the role of the pharmaceutical unit of the Directorate General for Enterprise of the European Commission in promoting the interests of the innovative branch of the industry, the time pressure to find a viable compromise before EU enlargement, and the heterogeneous preferences of the other actors. The case illustrates the inherent tension between the desire of both health care administrators and patients for high-quality, low-cost medicines and the objective of the innovator pharmaceutical industry to find and approve new drugs that are price protected and sell them in a way that maximizes revenues.

Improving Compliance with European Union Law Via Agencies: The Case of the European Railway Agency

European Union agencies are increasingly used to stimulate domestic compliance with EU law, without concrete evidence for whether and how these bodies actually realize this. Through in‐depth analysis of the European Railway Agency, this article enhances our empirical understanding of the working and functioning of EU agencies, and advances our thinking about compliance in international settings. It leads us to the insight that – in order to be capable of stimulating domestic compliance – agencies should be flexible to resort to a mix of compliance strategies in order to be able to cope with the varying domestic compliance situations.

Issue salience in the European Policy Process: what impact on transposition?

Analyses of agenda setting and decision making have highlighted that issue salience plays an important role in those stages of the policy process. This article investigates the role of issue salience in the implementation stage, focusing on transposition. We examine the extent to which issue salience – the relative importance attached to an issue in relation to others – influences the timeliness of transposing European Union directives in national legislation. We analyse 143 European Union environmental directives adopted in the period 1996–2008 in ten member states. We operationalize issue salience as the salience of hazardous substances and materials, salience for political parties in government and salience for the general public. Our results show faster transposition when environmental issues are salient for the governing political parties, Green political parties are included in the government, and the general public ranks environmental issues as a top priority.

Clawing Back Lost Powers? Parliamentary Scrutiny of the Transposition of EU Social Policy Directives in the Netherlands

For quite some time parliaments were seen as the losers of European integration. As a reaction, several parliaments have sought to exert more control over the executive branch in EU decision-making. An alternative venue for ‘clawing back’ these lost powers is by influencing the domestic transposition of EU policies. Surprisingly, this opportunity for greater parliamentary involvement has not received much scholarly attention. Under what conditions do the parties in parliament engage in ex post scrutiny over transposition? To shed light on this question, this article provides a detailed study of scrutiny by the Dutch parliament over the transposition of two social policy directives, investigating four hypotheses regarding vote-seeking, policy-seeking and office-seeking incentives for parliamentary oversight. The analysis shows that the ex post scrutiny that takes place can mostly be summarised as low-profile scrutiny aimed at information-gathering and position-taking, especially by opposition parties.

Why Science Cannot Tame Politics: The New EU Comitology Rules and the Centralised Authorisation Procedure of GMOs

The centralised authorisation of GMOs in the European Union (EU) has received considerable academic attention in recent years, partly due to the fact thatMember States have not been able to agree on authorisation decisions in the comitology committee. As a consequence, these authorisations are given by the European Commission. These decisions are invariably in favour of authorisation despite the fact that Member States had been divided on this issue. Apart from the on-going discussions on a possible reform of the GMO authorisation (allowing for national restrictions or prohibitions), the new comitology rules brought about by the Lisbon Treaty are of equal importance as they might affect the authorisation of GMOs. In this article we discuss some of the changes to comitology and present empirical material on the first authorisation decisions after the entering into force of the new comitology rules. By drawing on delegation theory we will argue that, for the time being, the level of politicisation ofGMOauthorisation is unlikely to change.

Regulating the use of Bisphenol A in baby and children's products in the European Union: Current developments and scenarios for the regulatory future

Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ?Bisphenol A-free? (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and childrens toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EUs chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

Governing risks in international security

ABSTRACT Risks are omnipresent in contemporary international security. Despite a long tradition in security studies going at least back to Von Clausewitz, we consider that the topic of risk remains under-examined. This forum seeks to advance the research agenda on risk in security studies by showcasing work of scholars using advanced concepts of risk, based on insights from sociology, biology, psychology, and safety studies, to better understand the role of risk in international security. As a way of introduction, this short article sets out the main debates.