European Market Research Articles

First experience in endoscopic lung volume reduction with the FreeFlow Coil #4: A case series with three patients

Lung volume reduction therapy is an established treatment for patients with severe emphysema of the lung. In Germany, the treatment with nitinol coils is the only method for endoscopic lung volume reduction in patients with positive collateral ventilation approved by the Gemeinsamer Bundesausschuss. Therefore this procedure can be performed as standard-of-care and has assured reimbursement. After the production of the initial coils was stopped for years, when the only manufacturer had been bought by a large corporation, by the end of 2022 there was a new nitinol-coil, the so called Coil #4, becme available in the European market. The new Coil #4 has a different shape, different application catheter and the implantation procedure differs from that of the original product. We report our experience in endoscopic lung volume reduction with the new Coil #4 in three patients with emphysema. The procedure was performed without complications. All three of them showed improvement in lung function parameters meeting minimal clinically important differences. In two of three patients, we also saw clinically relevant improvement in the 6MWT distance und improvements in SGRQ und CAT-Score. In our opinion, this case series is just a prospect of the possibilities that come with the Coil #4. With due caution, we will continue to offer the Coil #4 as a treatment for selected patients under constant evaluation of the outcome until more data is available.

Assessing the Impact of Derivatives on the 2008 Financial Crisis and the Effectiveness of Subsequent Regulatory Reforms

The 2008 financial crisis was a global financial catastrophe that reflected the misuse of financial derivatives in financial markets, such as credit default swaps, asset-backed securities and collateralized debt obligations, exposing significant weaknesses in the global financial system. These financial instruments were designed to hedge against debt risk, but their lack of transparency and massive misuse ultimately led to the accumulation of systemic risk that accelerated the financial crisis. Since then, regulatory authorities around the world have realized the necessity for stronger regulatory frameworks, and a series of significant reforms have been implemented, such as the Dodd-Frank Wall Street Reform and Consumer Protection Act in the United States, the European Market Infrastructure Regulation in the European Union, and the Basel III international regulatory framework, with the objectives of increasing transparency in financial markets and improving the risk management measures of financial institutions. This paper will explore the role of derivatives in the 2008 financial crisis and examine the effectiveness of these regulatory measures introduced after the crisis in enhancing stability of financial system.

ESG Impact on Stock Valuation- An Empirical analysis of European Markets

ESG Impact on Stock Valuation- An Empirical analysis of European Markets

Synthetic opioids have disrupted conventional wisdom for treating opioid overdose

More than 90 % of opioid overdose deaths in North America are now caused by synthetic opioids, and while they are not as prevalent in the European illicit drug market, there are indications that they may become so in the near future. Multiple publications have argued that neither higher doses of naloxone nor more potent opioid receptor antagonists are needed to reverse a synthetic opioid overdose. However, the unique physicochemical properties of synthetic opioids result in a very rapid onset of respiratory depression compared to opium-based molecules, reducing the margin of opportunity to reverse an overdose. While intravenous administration rapidly delivers the high naloxone concentrations needed to reverse a synthetic opioid overdose, this option is often unavailable to first responders. A translational mechanistic model of opioid overdose developed by the FDA’s Division of Applied Regulatory Science provides an unbiased approach to evaluate the effectiveness of overdose reversal strategies. Reports using this model demonstrated the naloxone tools (2mg intramuscular and 4mg intranasal) used by many first responders can result in an unacceptable loss of life following a synthetic opioid (fentanyl, carfentanil) overdose. Moreover, sequential (2.5minutes between doses) administration of up to four doses of intranasal naloxone was no more effective at reducing the incidence of cardiac arrest (a surrogate endpoint for lethality) than a single dose, suggesting that attempts at titration may not provide the rapid absorption required to reverse a synthetic opioid overdose. This model was also used to compare the effectiveness of intranasal naloxone to intranasal nalmefene, a recently FDA-approved opioid receptor antagonist with a more rapid absorption and a higher affinity at mu-opioid receptors compared to intranasal naloxone. Intranasal nalmefene resulted in large and clinically meaningful reductions in the incidence of cardiac arrest compared to intranasal naloxone. Furthermore, simultaneous administration of four doses of intranasal naloxone was needed to reduce the incidence of cardiac arrest to levels approaching those produced by a single dose of intranasal nalmefene. These data are consistent with evidence that synthetics have indeed disrupted conventional wisdom in the treatment of opioid overdose.

The challenges of Internationalisation of Chinese companies in Europe: A systematic review

This paper systematically reviews the challenges and strategic responses of the internationalization of Chinese companies into European markets. This research work has identified a number of key obstacles that Chinese firms meet in Europe concerning entry strategies and operational modes, resulting from regulatory barriers, cultural differences, and competitive pressures, which have adverse impacts on market entry and operations by Chinese firms in Europe. The review shows that the complex, fragmented European regulatory environment and its stringent requirements, especially under the General Data Protection Regulation, have remained a big challenge in terms of compliance. Cultural differences entail large adjustments in product offerings and market strategies to suit various European consumer preferences and business practices. Furthermore, the high competitive environment within the European markets has meant that these Chinese companies must continuously innovate and differentiate in order to generate and sustain competitive advantage. Indeed, strategic responses identified include investment in local regulatory expertise, cultural localization, and brand building and innovation. This paper provides an overview of the relevant challenges and strategies for Chinese firms in Europe, and it also points out that much more research is needed on the changing dynamics of internationalization in this context. Keywords: Internationalization, Regulatory Barriers, Cultural Differences, Competitive Pressures, Chinese Firms, European Markets.

Dietary management and access to treatment for patients with glucose deficiency syndrome type 1: an overview review with focus on the European regulatory framework.

Glut-1 deficiency Syndrome (GLUT-1 DS) is a rare disease caused by a mutation in the SLC2A1 gene that codes for the glucose transporter protein GLUT-1 DS. Currently, there is no indicated drug therapy for this condition and ketogenic diet (KD) is the most effective remedy to treat it. The objective of this study was to review the published literature that evaluated the effectiveness of KD in the dietary management of GLUT-1 DS syndrome, describing the state-of-the-art the treatment pathway for patients with GLUT-1 DS syndrome in light of the current European regulatory framework within the National Health Services. The literature search was carried out on September 10, 2023, and all studies conducted in humans diagnosed with GLUT-1 deficiency syndrome and treated with KD were included. A total of 156 scientific papers have been extracted. Applying the exclusion criteria, 38 articles have been considered eligible. In 29 out of 38 studies, the main outcome for determining the efficacy of KD was the measurement of the number of epileptic seizures, demonstrating that patients treated with KD experienced improvements with a clear reduction in the number of epileptic attacks. Currently, in the European Union, only one country provides full reimbursement by the national health system for KD. Although they are crucial for the treatment of GLUT-1 DS, according with current food regulations, KD are not evaluated on the basis of an unambiguous efficacy result, but only on the basis of safety. As a result, it is desirable to carry out clinical studies in the coming years based on the determination of efficacy in target populations, also in view of the marketing of these products on the European market.

Energy shocks in the Euro area: Disentangling the pass-through from oil and gas prices to inflation

We develop a Bayesian Structural VAR model to study the relationship between different energy shocks and inflation dynamics in Europe. Specifically, we model the endogenous transmission from shocks identified by the global market of crude oil and the European natural gas market to two target macroeconomic variables, i.e. inflation expectations and realized headline inflation rate. Our results demonstrate that, since the post-pandemic recovery, inflation in the Euro area is mostly driven by energy price shocks and aggregate supply factors. In particular, the high peaks of the Eurozone inflation are mostly associated with natural gas supply shocks.

The role of food trade in the European Single Market in the years 2000-2022

The role of food trade in the European Single Market in the years 2000-2022

Impacts of large-scale deployment of vertical bifacial photovoltaics on European electricity market dynamics

Self-sufficiency, climate change and increasing geopolitical risks have driven energy policies to make renewable energy sources dominant in the power production portfolios. The initial boom in the mid-2000s of global photovoltaic installations demonstrated the feasibility of the ambitious renewable energy targets. However, this rapid scale-up has introduced challenges, including price volatility and system integration issues. This communication calls the attention to these emerging challenges and offers quantitative insights on how rapid adoption of a more diversified photovoltaics deployment strategies can mitigate price volatilities, reduce fossil fuel dependence and steer Europe towards a forward-thinking sustainable energy pathway. The analysis reveals that as innovative bifacial photovoltaic systems are incorporated on a large-scale disruptive scenario, four main patterns emerge: economic value of solar production increases, base-load electricity price decreases, sun-rich countries expand their solar contributions, whereas nations with ample grid interconnections enhance their energy imports from neighbouring countries. It also underscores the importance of maintaining photovoltaics an attractive option for energy investors and traders in the future. Establishing this groundwork is critical since a successful integration of large-scale solar systems contributing to decrease price volatilities in Europe and US will carry significant repercussions for global energy policy formulation.

Solving Investors’ Problems with Access to Evidence in Damages Litigation: Suggestions for a Future Issuer Liability Regime

AbstractPrivate enforcement’s role in the European secondary securities market is narrow. Issuer companies’ civil liability for violations of the inside information disclosure obligation is no exception. While trying to avoid the shadow of the US class action institution, European scholarship has long explored ways to increase the role of private enforcement in the securities market. Harmonising issuer liability is one of the suggestions to create a more prominent role for private enforcement. Even though harmonising issuer liability would be a welcome option for legal certainty and investor protection, it seems unlikely to happen in the near future. As an initial step towards potential harmonisation, this article analyses credit rating agencies’ (CRAs) liability and liability for competition law violations from the viewpoint of information asymmetry in litigation. It evaluates whether the legislative solutions in the CRA III Regulation and the Competition Damages Directive regarding plaintiffs’ access to evidence could be used as models for a potential issuer liability regime. The article finds that the choices made in the Competition Damages Directive could serve as viable models for issuer liability. The provisions in that Directive solve the information asymmetry between the plaintiff and the defendant by granting the plaintiff access to evidence in litigation through a court order.

Realized Volatility Spillover Connectedness among the Leading European Currencies after the End of the Sovereign-Debt Crisis: A QVAR Approach

This paper examines the time-varying spillover effects and connectedness between the euro and other EU and non-EU currencies after the end of the sovereign-debt crisis. We employ the Quantile Vector Autoregression connectedness approach using intraday data for seven currencies (the euro, the British pound, the Swiss franc, the Polish zloty, the Hungarian forint, the Czech koruna, and the Norwegian krone) spanning from 1 January 2016 to 30 November 2022. The results indicate that, almost in all quantiles, the currencies of Eastern European Group countries (i.e., Czech Republic, Hungary, and Poland) are net contributors of information spillovers to other currencies, while currencies of non-EU countries (Switzerland, UK, and Norway) are net takers. Further, we find that the euro is the highest transmitter of net information spillovers to all other currencies until 2021. Interestingly, after 2021, the euro changes to net information spillover taker from all other currencies; highlighting that external shocks (e.g., COVID-19, the energy crisis) have significant risk spillover effects on the European currency market. Policymakers and market participants could benefit from knowing which currency drives developments to avoid unexpected consequences.

Environmental Dynamics in The Sumatran Coffee Landscapes: Opportunities and Challenges Through Spatial Perspectives

The coffee industry in Indonesia, particularly in the Sumatran landscape, emerges as a vital contributor to the nation's economy, impacting regional growth. Nevertheless, this landscape faces ecological threats from rapid deforestation, resulting in a substantial loss of primary forest cover. This historical deforestation along with climate crisis presents challenges for coffee plantations. The study employs geospatial analysis to comprehensively outline challenges and opportunities for smallholder coffee farmers in Sumatra, particularly in the Arabica (Central Aceh) and Robusta (Tanggamus) landscapes. The study shows non-shade coffee plantations covered approximately 23,453 ha in Central Aceh and 43,991 ha in Tanggamus. Additionally, mixed agroforestry areas were prevalent, comprising about 132,569 ha in Tanggamus and 19,450 ha in Central Aceh. Tanggamus and Central Aceh have become favorable areas for Robusta coffee and Arabica coffee, respectively. One significant opportunity identified for coffee development in Central Aceh is that 86% of existing coffee farms already adhere to EUDR. Furthermore, 94% of existing coffee farms in Tanggamus meet EUDR standards, opening doors for more farmers to access the European market.

A Survey on Potentially Beneficial and Hazardous Bioactive Compounds in Cocoa Powder Samples Sourced from the European Market.

Cocoa (Theobroma cacao, L.) represents an important market that gained relevance and became an esteemed commodity thanks to cocoa powder, chocolate, and other related products. This work analyzed 59 cocoa powder samples from the European market. Three distinct subgroups were identified: organic or conventional, alkalized or not alkalized, and raw or roasted processing. The impact of the technological process on their pH, color, and compositional traits, as well as their content of biogenic amines and salsolinol, was evaluated. The phenolic fraction was also investigated through both common and emerging methods. The results depict that the influence of the agronomical practices (organic/conventional) did not significantly (p < 0.05) affect the composition of the cocoa powders; similarly, the roasting process was not a determinant of the compounds traced. On the other hand, the alkalinization process greatly impacted color and pH, no matter the cocoa's provenience or obtention or other processes, also resulting in reducing the phenolic fraction of the treated samples. Principal component analysis confirmed that the alkali process acts on pH, color, and phenolic composition but not on the content of other bioactive molecules (biogenic amines and salsolinol). All the samples were safe, while the alkalized powders saw a great reduction in beneficial biocompounds. A novel strategy could be to emphasize on the label whether cocoa powder is non-alkalized to meet the demand for more beneficial products.

Quantification of 700 mycotoxins and other secondary metabolites of fungi and plants in grain products

This work reports on the validation of a liquid chromatography–tandem mass spectrometric method for the simultaneous quantification of more than 700 mycotoxins and other secondary fungal metabolites and plant toxins in pasta, biscuits, crackers and musli. The “dilute and shoot” approach was found to be fully applicable to these complex matrices, as only 7–14% of the analytes exhibited significant matrix effects while recoveries of the extraction were outside the target range of 70–120% for only 26 compounds. Data on repeatability (based on 7 brands per matrix) and on intermediate precision was compliant to the related < 20% criterion for 95–98% and 99% of all analytes, respectively. The limits of quantification were much lower than the related regulatory limits set for mycotoxins in cereal products. Application of the method to 157 samples from the European market revealed the presence of enniatins and deoxynivalenol in the majority of the samples. No regulatory limits were exceeded except the sum of ergot alkaloids being higher in a few samples than the 50–150 µg/kg to be implemented as of July 2024.

EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain.

Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms.

Commercial loop-mediated isothermal amplification (LAMP) assay for rapid diagnosis of Pneumocystis pneumonia: An alternative to immunofluorescence assays

A commercial loop-mediated isothermal amplification (LAMP) assay is available for the detection of Pneumocytis jirovecii (Eazyplex®, Amplex diagnostics, Germany). Few centers currently use this LAMP assay in France. Recently, the commercialization of reagents used to perform the P. jirovecii immunofluorescence assay (IFA) was stopped. This study aimed to assess the position of the commercial LAMP P. jirovecii assay in the diagnostic strategy for Pneumocystis pneumonia.Over 24 months (August 1, 2021, to September 1, 2023), all bronchoalveolar lavage fluid (BALF) samples with a request for P. jirovecii detection were analyzed with the commercial Eazyplex® LAMP assay, using a Genie 2® device (Amplex, diagnostics), in parallel with the techniques used for direct examination. Specific P. jirovecii quantitative real-time PCR (qPCR) was subsequently performed.In total, 346 BALF samples were analyzed by Diff-Quik coloration, IFA, and the commercial Eazyplex® LAMP assay for initial screening.Twenty-six cases of PCP were retained based on radiological, biological and clinical criteria.Among the 26 cases of PCP, 11 BALF samples were positive using the initial screening techniques: four with the three techniques, six by IFA and Eazyplex®, and one only by IFA. The eleven BALF samples were positive with the specific P. jirovecii qPCR assay, with a mean quantification cycle (Cq) of 27 [19–32].The commercial Eazyplex® LAMP assay is able to provide a result in 25 min and its sensitivity is similar to that of BALF direct examination techniques, such as IFA, which is a technique no longer available on the European market. The sensitivity of the commercial Eazyplex® LAMP assay is however clearly inferior to that of the specific P. jirovecii qPCR assay and, therefore, cannot replace the specific qPCR, but may have a place in the diagnostic strategy.

Biopreparations for the decomposition of crop residues.

Recently, there has been growing interest in biopreparations that intensify the decomposition of crop residues. These preparations can promote nutrient cycling and soil fertility, ultimately supporting healthy plant growth and increasing agricultural productivity. However, the development and commercialization of biopreparations poses unique challenges. Producers of biopreparations struggle to develop highly effective preparations, which then face regulatory hurdles and must win market acceptance. This literature review provides up-to-date data on microbial preparations available commercially on the European market, along with information on current relevant regulations. Challenges for the development and commercialization of new biopreparations are also discussed. The development and commercialization of biopreparations require a comprehensive approach that addresses the complex interplay of microbial and environmental factors. The need for more specific regulations on biopreparations for decomposing crop residues, clearer instructions on their use, and further research on the overall impact of biopreparations on the soil metabolome and optimal conditions for their application were indicated. Moreover, manufacturers should prioritize the development of high-quality products that meet the needs of farmers and address concerns about environmental impact and public acceptance.

Leadership shift in the global soybean market: Dynamic connectedness approach (TVP-VAR)

The price transmission in international soybean market has been extensively examined. However, recent econometric advancements have enabled the application of dynamic connectedness methodology as outlined by Antonakakis and Gabauer (2017) [1], which is based on a Time-varying Parameter Vector Autoregressive (TVP-VAR) model. This approach captures the time-varying connectedness of time series, considering potential risk shock emitters and receivers. The connectedness index (Diebold and Yilmaz, Jan. 2012) [2] was developed using Generalized Forecast Error Variance Decomposition (GFEVD) and the Generalized Impulse Response Function (GIRF) (Koop et al., Sep. 1996; Pesaran and Shin, Jan. 1998) [3,4]. This study aims to understand the dynamic connectedness and price leadership. The research examined markets including the US Soybean futures market (Chicago Board of Trade), Rotterdam Port spot market representing the European soybean market, Paranaguá port representing Brazil, Argentina represented by Rosario Futures and Spot, and the Chinese domestic spot market and the Dalian futures on behalf of China. The research spanned approximately ten years, from September 2009 to May 2019. The findings suggest that the soybean market has reached a high level of maturity, able to withstand exogenous shocks for at least the past seven years. The net pairwise directional connectedness revealed dynamic and bidirectional causality. The dynamic connectedness index showed a highly connected and developed market in the West (Chicago Futures, Rotterdam, Paranaguá, and Rosario Futures and Spot). However, the connectedness between Western and Eastern markets was relatively low, indicating some level of market isolation. Furthermore, the pairwise connectedness index between Eastern market (China spot and Dalian Futures) was also considerable low. Lastly, Paranaguá and Rosario overtook Rotterdam as price-leading markets and were identified as the primary net transmitters of shocks, indirectly implying causality. Chicago, Rosario, and Paranaguá formed a triumvirate leading international prices, while Rotterdam adopted a secondary leading position, deviating from its historical role as the price leader.

Transitioning to a renewable hydrogen system: Optimal infrastructure for self-sufficient hydrogen supply in Austria by 2030

In this study, we employ an optimization model to optimally design a self-sufficient, independent of any imports and exports, hydrogen infrastructure for Austria by 2030. Our approach integrates key hydrogen technologies within a detailed spatial investment and operation model – coupled with a European scale electricity market model. We focus on optimizing diverse infrastructure components including trailers, pipelines, electrolyzers, and storages to meet Austria's projected hydrogen demand. To accurately estimate this demand in hourly resolution, we combine existing hydrogen strategies and projections to account for developments in various industrial sectors, consider demand driven by the transport sector, and integrate hydrogen demand arising from its use in gas-powered plants. Accounting for the inherent uncertainty linked to such projections, we run the analysis for two complementary scenarios. Our approach addresses the challenges of integrating large quantities of renewable hydrogen into a future energy system by recognizing the critical role of domestic production in the early market stages. The main contribution of this work is to address the gap in optimizing hydrogen infrastructure for effective integration of domestic renewable hydrogen production in Austria by 2030, considering sector coupling potentials, optimal electrolyzer placement, and the design of local hydrogen networks.

ANALYSIS OF MODERN TRENDS IN LABOUR MARKET TRANSFORMATION IN UKRAINE

The article examines the main aspects of transforming the labor market in Ukraine in the context of the destructive impact of the war and the associated economic instability. The primary factors affecting the labor market, such as migration processes, changes in the structure of employment, digitization of the economy, and the introduction of the latest technologies, are considered. The consequences of military operations on the transformation of the labor market are analyzed. Current trends in the demand for new professions, demographic changes, and the impact of state regulatory policy on employment support are explored. The prospects for developing the labor market in the context of Ukraine's European integration and the potential for increasing the competitiveness of Ukrainian workers in the European labor market are determined. The necessity of enhancing the adaptability of the workforce to modern challenges and optimizing state employment programs to ensure sustainable economic development of the country in the future has been demonstrated.