Recent European Legislation Research Articles

Mapping Service-Based Retailing to Improve Sustainability Practices in the Fashion Industry

The fashion industry is recognized among the most impactful industries in relation to environmental and social damage due to unsustainable models. While countless research studies focus on the supply chain and product innovation, the presented inquiry studies the fashion retail sector with the goal of systematizing existing sustainable practices based on service offerings. We present the results of an extensive case-study analysis conducted on 370 initiatives of different natures gathered among international companies and local actors in the European context that offer services oriented toward sustainability. As a result, we propose an ontology that encompasses three areas (services for environmental sustainability, culture of sustainability, and implementation of social sustainability) and comprehensively describes existing sustainability strategies for helping retailers preserve the environment, while promoting socially inclusive practices and disseminating the culture of sustainability. The innovation of retailing from a similar perspective aims at rendering businesses more resilient to survive market and social transformations, especially in consideration of the boost to sustainable and circular transformation advocated by recent European legislation.

Quantifying public and private investment in European biopharmaceutical research and development.

Robust biopharmaceutical research and development (R&D) ecosystems require investment from both the public and private sectors. In Europe, there is an interest in growing biopharmaceutical R&D given its contribution to public health and the economy, which requires an understanding of current public and private investment. In addition, recent European draft legislation has focused on the public sector's contributions to biopharmaceutical R&D to inform pharmaceutical prices. However, there is little empirical evidence on the specifics of public and private funding for medicine R&D in Europe. This paper performs aggregative data collection to quantify 2019 investment in biopharmaceutical R&D by the public and private sectors in 6 countries: Belgium, France, Germany, Norway, Poland, and the United Kingdom. We find that, across these countries, the private sector accounts for just under two-thirds of investment. We contrast results to those obtained using high-level R&D indicators from the Organization for Economic Co-operation and Development (OECD) and contextualize differences. We then provide 2013-2019 estimates for Belgium, France, Germany, and the United Kingdom (countries with data to support such analysis), and show that total spending grew over those years, although proportions attributable to each sector remained stable. These findings should provide further evidence for debates on policies to effectively grow the biopharmaceutical R&D sector.

Effect of Mineral or OFMSW Digestate Fertilization on Ryegrass and Nitrogen Leaching

The current guidelines of waste management are aimed at the recovery and recycling of biowaste while respecting the protection of human health and the environment. The recent European legislation on fertilizers provides for the use of digestates derived from the organic fraction of municipal solid waste (OFMSW). The objectives of this study were to verify the fertilizing effect of three types of OFMSW digestates on the ryegrass culture comparing mineral fertilization and to evaluate the nitrogen lost to leaching in soil diversely fertilized following simulated rainfall. The ryegrass was grown in pots. The soil was fertilized with mineral fertilizer or OFMSW digestates. For each treatment, five mowing procedures were performed on the crop, and the ryegrass biomass production and nitrogen concentration were determined from the ryegrass samples. During the experiment, six rains were simulated, and the leached nitrogen was analyzed. The results showed that: (i) the fertilizing effect of OFMSW digestates on nitrogen nutrition of ryegrass was similar to ammonium sulphate fertilization, confirming the agronomic validity of these by-products to reduce the use of synthetic fertilizers; (ii) soil fertilization with OFMSW digestates had a positive effect limiting nitrogen loss due to leaching compared to mineral fertilization, highlighting the soil-improving properties of these by-products, in particular of the composted digestate.

Bioelectrochemical treatment of municipal solid waste landfill mature leachate and dairy wastewater as co-substrates

Despite solid wastes’ landfill disposal limitation due to recent European legislation, landfill leachate disposal remains a significant problem and will be for many years in the future, since its production may persist for years after a site’s closure. Among process technologies proposed for its treatment, microbial fuel cells (MFCs) can be effective, achieving both contaminant removal and simultaneous energy recovery. Start-up and operation of two dual-chamber MFCs with different electrodes’ structure, fed with mature municipal solid waste landfill leachate, are reported in this study. Influent (a mix of dairy wastewater and mature landfill leachate at varying proportions) was fed to the anodic chambers of the units, under different conditions. The maximum COD removal efficiency achieved was 84.9% at low leachate/dairy mix, and 66.3% with 7.6% coulombic efficiency (CE) at a leachate/dairy ratio of 20%. Operational issues and effects of cells’ architecture and electrode materials on systems’ performance are analyzed and discussed.

V. Griechenland. “Actio ad exhibendum” for the protection of the right to proof according to Greek law and the focus of the recent European legislation (Directive 2014/104/EU, Regulation (EU) 679/2016)

V. Griechenland. “Actio ad exhibendum” for the protection of the right to proof according to Greek law and the focus of the recent European legislation (Directive 2014/104/EU, Regulation (EU) 679/2016)

Feuille de route et droits de la défense : les enquêtes défensives à l’étranger

The Italian criminal law system, unlike the systems in many other European countries, allows the defense to carry out defensive investigations on behalf of his/her client. In this contribution, the shortcomings of the recent European legislation on the matter are analyzed, as well as the issue of the validity in Italian criminal proceedings of defensive investigations conducted by the defense council abroad. The admissibility in the criminal case of defensive investigations conducted abroad by an Italian defense lawyer was, in fact, already rejected ten years ago by the Italian Court of Cassation. The Court stated that the official state instruments of international mutual legal assistance in criminal matters must be used if investigations are carried out abroad. The authors argue in this contribution that this position cannot be upheld in a unified Europe and deserves fundamental reconsideration. They also advocate a European solution of defensive investigations abroad – a possible topic for a new EU roadmap on defensive rights

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines.

The power of financial transparency: An event study of country-by-country reporting standards

We show that recent European legislation requiring oil, gas and mining companies to disclose their tax payments on a country-by-country basis was associated with significant decreases in firm value. This suggests that tax evasion creates considerable rents for firms in extractive industries and that disclosure rules have the potential to reduce these rents.

Prospective analysis of the flows of certain rare earths in Europe at the 2020 horizon

This paper proposes a forecast of certain rare earth flows in Europe at the 2020 horizon, based on an analysis of trends influencing various actors of the rare earth industry along the value chain. While 2020 is indicated as the forecast horizon, the analysis should be considered as more representative of the next decade. The rare earths considered here are used in applications that are important for a low-carbon energy transition and/or have a significant recycling potential: NdFeB magnets (Pr, Nd, Dy), NiMH batteries (Pr, Nd) and fluorescent lamp phosphors (Eu, Tb, Y). An analysis of major trends affecting the rare earth industry in Europe along the value chain (including extraction, separation, fabrication, manufacture, use and recycling), helps to build a scenario for a material flow analysis of these rare earths in Europe. The scenario assumes in particular that during the next decade, there exists a rare earth mine in production in Europe (with Norra Kärr in Sweden as a most likely candidate) and also that recycling is in line with targets proposed in recent European legislation. Results are presented in the form of Sankey diagrams which help visualize the various flows for the three applications. For example, calculations forecast flows from extraction to separation of Pr, Nd and Dy for magnet applications in Europe, on the order of 310tons, 980tons and 80tons rare earth metal resp., while recycled flows are 35tons, 110tons and 30tons resp. Calculations illustrate how the relative contribution of recycling to supply strongly depends on the situation with respect to demand. Considering the balance between supply and demand, it is not anticipated any significant shortage of rare earth supply in Europe at the 2020 horizon, barring any new geopolitical crisis involving China. For some heavy rare earths, supply will in fact largely outweigh demand, as for example Europium due to the phasing out of fluorescent lights by LEDs.

Cold Reading The Blue Book: A. L. Kennedy's Critique of Mind Reading

This article looks at the use A. L. Kennedy's most recent novel, The Blue Book (2011), makes of practices associated with mind reading in both narrative fiction and the performances of stage mediums. Kennedy's novel takes mediums' techniques of cold and warm reading and embeds them into its own narrative technique. These techniques are analyzed here in terms of current narratological debates about second-person narration and mind reading in unnatural narrative, but also in the context of recent European legislation that has reclassified the legal status of mediumship performances.

Impact of FAME Content on the Regeneration Frequency of Diesel Particulate Filters (DPFs)

Modern diesel vehicles utilize two technologies that have been motivated by recent European legislation: diesel fuel blends containing Fatty Acid Methyl Esters (FAME) and Diesel Particulate Filters (DPF). Oxygenates, like FAME, are known to reduce PM formation in the combustion chamber and reduce the amount of soot that must be filtered from the engine exhaust by the DPF. This effect is also expected to lengthen the time between DPF regenerations and reduce the fuel consumption penalty that is associated with soot loading and regeneration. This study investigated the effect of FAME content, up to 50% v/v (B50), in diesel fuel on the DPF regeneration frequency by repeatably running a Euro 5 multi-cylinder bench engine over the NEDC until a specified soot loading limit had been reached. The results verify the expected reduction of engine-out PM emissions with increasing FAME content and the reduction in fuel consumption penalty associated with reducing the frequency of DPF regenerations.

Hedging its Bets: The UK and the Politics of European Financial Services Regulation

Some argue that European financial services regulation is witnessing a shift from a ‘market-making’ to a ‘market-shaping’ paradigm after the global financial crisis. This so-called ‘new’ political economy explanation stresses the role of ideas to understand this change. We consider this claim by providing an in-depth examination of recent European hedge fund legislation from the perspective of two key ‘market-making’ coalition members: the UK government and the hedge fund industry. We accept that the legislation represents a set-back for the ‘market-makers’ but question whether it represents a victory for the ‘market-shapers’. Moreover, we cast doubt on the causal role of ideas, calling for a domestic politics approach.

Development and implementation of a simplified residential energy asset rating model

Recent European legislation (Energy Efficiency Directive) has allocated some responsibility for residential end use energy efficiency to energy supply companies. In order to overcome data and modelling limitations associated with statistical and engineering modelling approaches to energy efficiency and renewable energy retrofit measures, energy suppliers and policy-makers often use simplified methods with limited data requirements to assess dwellings. One approach employed is an asset rating method (ARM); a standardised approach to residential energy demand estimation which is outlined in ISO EN 13790 (Energy Performance of Buildings Directive). Although it is a simplified method which industry is well-equipped to deliver, it is time-consuming to apply ARMs to the large domestic customer bases of energy suppliers. A small per-dwelling time saving will result in significant overall efficiencies for these users. This study examines the effect that reducing input data requirements of the ARM has on the accuracy of the methodology and comments on the trade-off between model simplification and accuracy. We find that it is possible to maintain a high degree of accuracy (∼95%) with 20 fewer variables than the baseline model. This is equivalent to almost 40% fewer variables than in the full model and represents a significant saving in effort

European integration through standardization: How judicial review is breaking down the club house of private standardization bodies

Standardization is slowly but slowly but surely marching forward into the public domain. The revision of the European standardization package is stimulating this development because the use of private standards in public policy is supposed to spur technological innovation and reduce barriers to trade. This may explain why the Commission wants to speed up the standardization process. In the meanwhile, however, a number of important legal issues remain unaddressed in recent European policy and legislation on standardization, such as: how far "delegation" of public rulemaking to private standardization bodies may go and if and when this could come into conflict with the alleged voluntary and self-regulatory nature of these standards; whether copyrights that rest on standards limit the access to pieces of legislation that refer to standards in an unlawful way, and who is responsible for the content of the standards: the state or the market? Our hypothesis is that the "club mentality" of standards makers has, until recently, worked as an effective shield against market dynamics and judicial review. However, under the influence of recent case law from the ECJ and national highest courts, the "club house" of the standards bodies is starting to show cracks.

Towards an ecosystem approach for understanding public values concerning marine biodiversity loss

Recent European legislation requires the adoption of an ecosystem-based approach for managing marine systems in which societal values and good science contribute to attainment of 'good environmental status' for Europe's seas by 2020. At present, there is a lack of studies that consider public values for marine biodiversity changes taking into account the cultural diversity within Europe. We used a contingent valuation survey to explore respondents' marginal willing- ness to pay (WTP) and motivations to prevent 3 levels of species loss (10, 25 and 50%) as compared to current levels for fish and all marine species. The survey was undertaken in 2 sites: the Azores islands (NE Atlantic) and the Gulf of Gdansk (Baltic Sea). Results, based on 747 interviews, showed that motivations underlying WTP for marine species conservation encompassed primarily bequest values and direct use values. Respondents from different locations differed in their atti- tudes and values towards marine biodiversity conservation. Scope tests revealed significant differ- ences in WTP for different levels of species loss; however the magnitudes of the scope sensitivity were constrained by a lack of awareness about the consequences of biodiversity changes and the welfare tradeoffs involved. This result highlights the need for the scientific community to better communicate knowledge about the link between biodiversity changes and human wellbeing and to embrace a fuller dialogue between policymakers and the public. A successful ecosystem based approach must accommodate the diversity of preferences and hence may need to be adapted to reflect regional diversity within Europe.

O Sistema Português de Farmacovigilância

In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 years, the NPS has been adapting to the EU requirements in the area of pharmacovigilance, and is currently a mature and well implemented system, with the objectives of the evaluation of the safety profile of marketed drugs and triggering of actions to reduce the risk of these drugs. From the second half of 2012, new adaptation will be run with the implementation of recent European legislation on Pharmacovigilance, published in December 2010. Among other changes, there is the possibility for consumers to report their suspicious of ADR directly to the NPS (exclusive, so far, to health professionals). This work aims to be a reflection about the evolution of the National Pharmacovigilance System and its growing importance in the protection of public health.

Deskilling, agrodiversity, and the seed trade: a view from contemporary British allotments

Over the last half-century, quality control standards have had the perverse effect of restricting the circulation of non-commercially bred vegetable cultivars in Britain. Recent European and British legislation attempts to compensate for this loss of agrodiversity by relaxing genetic purity standards and the cost of seed marketing for designated “Amateur” and “Conservation” varieties. Drawing on fieldwork conducted at a British allotment site, this article cautions against bringing genetically heterogeneous cultivars into the commercial sphere. Such a move may intensify the horticultural “deskilling” of British allotment gardeners, who have come to rely on commercial seed catalogs as sources of germplasm and knowledge. Horticultural deskilling also entails the delegation of seed selection activities to professional breeders and the potential loss of agrodiversity. The activities of dedicated seed savers who save and circulate the seed of genetically heterogeneous “heritage” varieties, in a manner similar to the management of landraces in the global South, may provide a better model for attempts to safeguard vegetable diversity in the global North.

Local Community Participation in Italian National Parks Management: Theory versus Practice

The need for participation of local communities in the management of protected areas (PAs) is widely acknowledged, and its implementation is viewed as an indicator of sustainable practice. Such participation is increasingly mentioned in the recent European Union (EU) policy and legislation, yet little statutory guidance and few minimum requirements are available. Italy, as an EU Member State, has committed itself to incorporate participation in PA management. However, to date, there has been no assessment of how participation has materialized in practice. This paper presents the results of an investigation of participatory practices focusing specifically on local community involvement in Italian National Park management. The investigation is based on a review of the state-of-the-art theory on participation in PA management, specifically addressing the following questions: what levels of participation are preferable, what methods should be utilized in order to enable effective PA management and who should participate? The results show a discrepancy between best practice theory and practice for the case of Italy. More importantly, the results indicate the need for the development of practical guidance and a common participation framework for PA management in Europe.

Credit Rating Agencies

This paper critically reviews the debate on CRAs and, in the light thereof, analyses the European regulatory approach to CRAs, thereby combining insights from economics and law. We first provide some basic background on the function of CRAs. Thereafter, we focus on the two main tasks for which CRAs have come under criticism, namely the issuing of sovereign ratings and the rating of structured instruments. Finally, we zoom in on the question of whether and how CRAs should be regulated given their function, focusing on recent European legislation that aims to standardize the conduct of CRAs.

Nitrite in feed – Legal background, status of analytical methods and technological knowledge

Feed materials in general and especially those from sugar industries are affected by recent European legislation setting maximum limits for nitrite contents in feed materials, which have not previously been subject to legal limits. Legal limits for undesirable substances require analytical methods to verify compliance. After reviewing analytical studies and historical data on nitrite contents in feed materials it became obvious, that molasses currently being produced in Europe would only comply with this limit in a few cases and that difficulties would arise from the lack of existing validated analytical methods for this purpose. This impedes also the monitoring of the status quo for studies about possible technological measures as demanded by European authorities. This publication describes in detail the legal background and nutritional consequences of limiting the nitrite content in feed. The analytical challenge of identifying and developing appropriate and reliable methods for detecting nitrite contents in the complex matrices of feed at that low level and that are suitable to be carried out in factory laboratories is outlined. Following a review of the knowledge on this subject, it was found that there are currently no studies, which deal with the import, formation, distribution and degradation of nitrite along the sugar manufacturing process. The task for the future is primarily to find and validate appropriate analytical methods which are essential for investigating the technological processes in the sugar industry in order to find measures to control the nitrite level in feed.