System In Germany Research Articles

Unlocking the value of innovative medicines: Insights from the advanced therapy medicinal products (ATMP) innovation systems in Germany and Sweden

ObjectivesGenerally low uptake in the advanced therapy medicinal products (ATMP) market and difficult patient access has been observed across Europe. The objective is to analyze the key challenges of the ATMP innovation ecosystem around R&D, entrepreneurial activities, framework conditions and legitimacy and to highlight how national level activities can impact on patient access to ATMPs in Sweden and Germany. MethodsAn exploratory case studies approach was applied for analyzing ATMP development and uptake in Sweden and Germany between 2010 and 2021. A mixed methods and multi-level approach was used to collect data, including desktop research and 17 expert interviews. ResultsGermany is performing well and apart from better patients' engagement has lower barriers for ATMP development and diffusion compared to Sweden. The main hindrances in Sweden include a lack of collaboration between stakeholders in translational research, conservative HTA assessment and lack of innovative payment models. Both countries could benefit from better streamlined regulation on different aspects around clinical trials (i.e. ranging from legislation on genetically modified organisms for gene therapy medicinal products and master file approach for raw materials). ConclusionsDespite a number of hindrances around ATMP development and uptake, the evidence in terms of technological development on the one side and unmet patient needs on the other side, shows that ATMPs will play an important role in the future of modern healthcare systems. It is clear that further national level collaboration between academic, clinical and industrial players is necessary to overcome the existing hindrances and boost further development of ATMPs in Europe.

Disentangle the price dispersion of residential solar photovoltaic systems: Evidence from Germany

Although Germany has the largest capacity of installed residential photovoltaic (PV) systems in Europe, comprehensive evidence on transparent pricing information remains missing. This study disentangles why PV quote prices are subject to significant dispersion and analyzes which factors influence particularly low- and high-priced systems in Germany. We create a comprehensive cross-sectional dataset of 19 561 PV system quotes from 2011 to 2022 and use regression analyses to investigate the effects of system characteristics, installation scope, and location-related parameters on quoted prices. Our results reveal highly volatile annual price dispersion consistent over 11 years and large price differences despite similar system characteristics. Applying hedonic regression techniques, we reveal spatially fine-resolved price heterogeneity with up to 20% difference in the German PV market. System characteristics such as battery usage, installation scope, and system capacity have the most significant effect sizes and are instead control variables. More insightful, the installer density shows price-lowering effects, whereas more PV installations per region, higher solar radiation, and higher labor wages cause price-increasing effects. Quantile regression results reveal that installer density promotes the price reduction of high-priced systems more. Scaffolding, AC installation, and elevation are significant price-increasing factors but with small effect sizes. Finally, DC optimizers affect the levels of high-priced systems more than low-priced ones.

Opportunities for and barriers to anticipatory governance of two lake social–ecological systems in Germany and Canada

Abstract Climate change effects are already being felt around the globe, and governance systems need to adapt to this new reality to foster greater resilience in social–ecological systems (SES). Anticipatory governance is a concept proposed for such a purpose. However, its definition remains rather vague in the literature, as is its practical use for decision makers. In this paper, we contribute to filling these two shortcomings. First, we conducted a systematic literature review of the concept and derived the following main criteria: foresight, networked engagement, integration and feedback. Second, we use the identified criteria to analyse two social–ecological systems around lakes in Lower Saxony, Germany and in Quebec, Canada. In both cases, data were generated using a participatory approach (interviews and workshops) with local stakeholders. We examined these data, identifying opportunities and barriers to anticipatory governance. Our findings support, with empirical data for the first time, the claim in the literature that ensemble‐ization—the fact that all anticipatory governance criteria must be put forward jointly and not in isolation—is a facilitator for the emergence of anticipation. Furthermore, by highlighting opportunities and barriers to anticipatory governance within two temperate lake SES cases, we illustrate how to understand a given system's limitations with respect to anticipatory governance, as well as how to engage with the concept through concrete, already existing opportunities. The proposed course of actions could help design more anticipatory governance systems to support decision‐making processes that could enhance SES resilience. Read the free Plain Language Summary for this article on the Journal blog.

Monitoring the SARS-CoV-2 Pandemic: Prevalence of Antibodies in a Large, Repetitive Cross-Sectional Study of Blood Donors in Germany-Results from the SeBluCo Study 2020-2022.

SARS-CoV-2 serosurveillance is important to adapt infection control measures and estimate the degree of underreporting. Blood donor samples can be used as a proxy for the healthy adult population. In a repeated cross-sectional study from April 2020 to April 2021, September 2021, and April/May 2022, 13 blood establishments collected 134,510 anonymised specimens from blood donors in 28 study regions across Germany. These were tested for antibodies against the SARS-CoV-2 spike protein and nucleocapsid, including neutralising capacity. Seroprevalence was adjusted for test performance and sampling and weighted for demographic differences between the sample and the general population. Seroprevalence estimates were compared to notified COVID-19 cases. The overall adjusted SARS-CoV-2 seroprevalence remained below 2% until December 2020 and increased to 18.1% in April 2021, 89.4% in September 2021, and to 100% in April/May 2022. Neutralising capacity was found in 74% of all positive specimens until April 2021 and in 98% in April/May 2022. Our serosurveillance allowed for repeated estimations of underreporting from the early stage of the pandemic onwards. Underreporting ranged between factors 5.1 and 1.1 in the first two waves of the pandemic and remained well below 2 afterwards, indicating an adequate test strategy and notification system in Germany.

Orchard meadows: consumer perception and communication of a traditional agroforestry system in Germany

Europe has a large variety of historic cultural agroforestry systems which provide numerous ecosystem services. Traditional agroforestry landscapes are characterized by a high level of biodiversity, but they lack an economic basis due to considerable time and financial effort required for cultivation, maintenance, and harvesting. Orchard meadows (OM) are a typical example for agroforestry systems. They combine large fruit trees with undercropping or livestock raising. This study investigates consumer knowledge and preferences for OM products and the possibilities of improved communication to increase consumer demand. Focus groups were conducted with German consumers. The results demonstrate that consumers have a very positive perception of OM juice in terms of taste, local production, health, and environmental benefits. In order to increase the demand for OM juice, communication with consumers needs to be improved by highlighting these positive attributes.

Financing health promotion, prevention and innovation despite the rising healthcare costs: How can the new German government square the circle?

The German health system is under pressure due to increasing costs of healthcare provision and rising demand for health services. With the new coalition government, Germany has increased efforts to build a modern, innovative infrastructure for prevention and high-quality health services. The coalition agreement has a strong climate, innovation, and sustainability focus, reflecting at the same time the ambition of the new government to implement a preventive, inter-connected, and modern healthcare system in Germany. However, the agreement lacks detailed information on the achievement of the plans, especially concerning the question of how those measures should be funded in light of increasing expenditures for healthcare. Thus, the objectives of this study are to interpret the new government’s plans and answer the question of how Germany in the new legislative period can ensure and fund population-based prevention programmes, health-promoting measures and innovative solutions despite the rising healthcare costs. By analysing the relevant content of the coalition agreement and drawing on an expert workshop, this paper suggests the establishment of a prevention fund and flexible remuneration model for digitalised and innovative forms of care in the new legislative period. Our findings may help identify feasible approaches to sustainable financing of health promotion, prevention and innovation in the German healthcare system.

Visualizing Benefits of Case Management Software Using Utility Effect Chains

Labor shortages lead to crucial investment decisions, such as selecting software supporting work processes. The healthcare sector stands out because of additional restructuring due to demographic changes. This is particularly true for the care sector; hence, customized case management software (CMSW) solutions for healthcare professionals are being developed. In an increasingly profit-oriented healthcare system, sustainability, cost-effectiveness and quantification of benefits of investments play a major role. We analyzed research dealing with the benefits of case and care management software and, additionally, interviewed case managers who use recently developed CMSW within a case study. We used utility effect chains to visualize and quantify the gathered benefits of an information system (IS) investment along with the healthcare system in Germany. The findings show that benefits from care management software need to be seen more holistically. Utility effect chains can serve as a helpful instrument for the visualization of indirect benefits in healthcare. The most significant benefits of CMSW were found to be various cost savings for each of the participating stakeholders, a reduction in redundant entries of patient data and the prevention of cost-intensive revolving door cases. Additionally, the insight into patient records reduces time-consuming communication among health experts and family caregivers.

Performance of the flood warning system in Germany in July 2021 – insights from affected residents

Abstract. In July 2021 intense rainfall caused devastating floods in western Europe and 184 fatalities in the German federal states of North Rhine-Westphalia (NW) and Rhineland-Palatinate (RP), calling into question their flood forecasting, warning and response system (FFWRS). Data from an online survey (n=1315) reveal that 35 % of the respondents from NW and 29 % from RP did not receive any warning. Of those who were warned, 85 % did not expect very severe flooding and 46 % reported a lack of situational knowledge on protective behaviour. Regression analysis reveals that this knowledge is influenced not only by gender and flood experience but also by the content and the source of the warning message. The results are complemented by analyses of media reports and official warnings that show shortcomings in providing adequate recommendations to people at risk. Still, the share of people who did not report any emergency response is low and comparable to other flood events. However, the perceived effectiveness of the protective behaviour was low and mainly compromised by high water levels and the perceived level of surprise about the flood magnitude. Good situational knowledge and a higher number of previously experienced floods were linked to performing more effective loss-reducing action. Dissemination of warnings, clearer communication of the expected flood magnitude and recommendations on adequate responses to a severe flood, particularly with regard to flash and pluvial floods, are seen as major entry points for improving the FFWRS in Germany.

Unfair Commercial Practices and Individual Consumer Claims for Damages – The Transposition of Art. 11a UCP Directive in Germany and Austria

Abstract Article 11a(1) UCP Directive obliges the Member States to provide individual rights for consumers harmed by unfair commercial practices. This new provision is intended to ensure that consumers have access to proportionate and effective remedies, including compensation for damage suffered and, where relevant, a price reduction or the termination of the contract. Although the laws against unfair competition in Germany and Austria have similar basic structures, the transposition of Art. 11a(1) UCP Directive shows some significant differences in the way national law provides individual protection for consumers. The legal systems in Germany and Austria are confronted with challenges both in the correct transposition of Art. 11a(1) UCP Directive and the incorporation of individual consumer claims for damages into the structures of domestic law. This article intends both to give a first overview and also to attempt to answer some of the open questions.

Diagnosis and Therapy of Female Urinary Incontinence. Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/091, January 2022): Part 1 with Recommendations on Diagnostics and Conservative and Medical Treatment.

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, etiology, classification, symptoms, diagnostics, and treatment of female patients with urinary incontinence. Specific solutions for the diagnostic workup and appropriate conservative and medical therapies for uncomplicated and complication urinary incontinence are discussed.

Diagnosis and Therapy of Female Urinary Incontinence. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry No. 015/091, January 2022): Part 2 with Recommendations on Interventional/Surgical Therapy of Overactive Bladder, Surgical Treatment of Stress Urinary Incontinence and Diagnosis and Therapy of Iatrogenic Urogenital Fistula.

Aim This completely revised interdisciplinary S2k-guideline on the diagnosis, therapy, and follow-up care of female patients with urinary incontinence (AWMF registry number: 015-091) was published in December 2021. This guideline combines and summarizes earlier guidelines such as "Female stress urinary incontinence," "Female urge incontinence" and "Use of Ultrasonography in Urogynecological Diagnostics" for the first time. The guideline was coordinated by the German Society for Gynecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe, DGGG) and the Working Group for Urogynecology and Plastic Pelvic Floor Reconstruction (Arbeitsgemeinschaft für Urogynäkologie und plastische Beckenbodenrekonstruktion e. V., AGUB). Methods This S2k-guideline was developed using a structured consensus process involving representative members from different medical specialties and was commissioned by the Guidelines Commission of the DGGG, OEGGG and SGGG. The guideline is based on the current version of the guideline "Urinary Incontinence in Adults" published by the European Association of Urology (EAU). Country-specific items associated with the respective healthcare systems in Germany, Austria and Switzerland were also incorporated. Recommendations The short version of this guideline consists of recommendations and statements on the surgical treatment of female patients with stress urinary incontinence and urge incontinence. Specific solutions for the diagnostic workup and treatment of uncomplicated and complicated urinary incontinence are discussed. The diagnostics and surgical treatment of iatrogenic urogenital fistula are presented.

Spatial distribution of Mesozoic deposits and their temperature ranges within the Weser-Wiehengebirge Syncline of the inverted Lower Saxony Basin, Minden area, Germany

Abstract. The provision of climate-neutral, sustainable, and independent heat sources is an essential part of the ongoing transformation of heating systems in Germany. The city of Minden, located at the junction of the river Weser and the Middleland Canal, with its strong industrial sector, faces a massive transition of how heat and energy will be provided for industrial processes as well as heating in the commercial and residential sectors. In our study, we evaluate the structural requirements for the exploitation and utilization of deep geothermal energy from regional Mesozoic rocks, which are known to source thermal springs in the greater Minden area, and geothermal projects in other parts of the North German Basin. The compilation of geological data, seismic data, and rock properties from wells is used to construct a regional structural model as well as temperature distributions based on depth uncertainties of the respective stratigraphic units. Our investigations indicate several stratigraphic units ranging from the Middle Jurassic, Keuper, and Muschelkalk to the Middle Bunter at depths greater than 4100 m below mean sea level with suitable temperatures greater than 150 ∘C. Seismic data reveal the presence of faults, which may act as a conduit for thermal waters in the northern part of Minden. Our study also provides a basis for further geothermal exploration and exploitation south of Minden, where an operating geothermal system has already been established in the city of Osnabrück and further north, where the potential reservoirs are located at greater depths as shown by hydrocarbon exploration data. First estimations of the geothermal power output for two selected reservoir horizons yield up to 11.3 and 14.3 MW (10 % probability to yield these or higher values), respectively. We conclude that the subsurface of the inverted part of the Lower Saxony Basin principally fulfills the requirements (formation temperatures) for deep geothermal production not only for residential and commercial use but also for industrial processes. However, future detailed reservoir analyses and thermo-hydraulic investigations on a regional scale require additional exploration work like newly acquired seismic surveys and deep exploration wells.

Cost and cost-effectiveness of four different SARS-CoV-2 active surveillance strategies: evidence from a randomised control trial in Germany

IntroductionThe COVID-19 pandemic has entered its third year and continues to affect most countries worldwide. Active surveillance, i.e. testing individuals irrespective of symptoms, presents a promising strategy to accurately measure the prevalence of SARS-CoV-2. We aimed to identify the most cost-effective active surveillance strategy for COVID-19 among the four strategies tested in a randomised control trial between 18th November 2020 and 23rd December 2020 in Germany. The four strategies included: (A1) direct testing of individuals; (A2) direct testing of households; (B1) testing conditioned on upstream COVID-19 symptom pre-screening of individuals; and (B2) testing conditioned on upstream COVID-19 symptom pre-screening of households.MethodsWe adopted a health system perspective and followed an activity-based approach to costing. Resource consumption data were collected prospectively from a digital individual database, daily time records, key informant interviews and direct observations. Our cost-effectiveness analysis compared each strategy with the status quo and calculated the average cost-effective ratios (ACERs) for one primary outcome (sample tested) and three secondary outcomes (responder recruited, case detected and asymptomatic case detected).ResultsOur results showed that A2, with cost per sample tested at 52,89 EURO, had the lowest ACER for the primary outcome, closely followed by A1 (63,33 EURO). This estimate was much higher for both B1 (243,84 EURO) and B2 (181,06 EURO).ConclusionA2 (direct testing at household level) proved to be the most cost-effective of the four evaluated strategies and should be considered as an option to strengthen the routine surveillance system in Germany and similar settings.

Monitoring Blood Supply in Germany: A Regulatory Perspective

Background and Objectives: A sufficient supply of safe, high-quality blood components for transfusion is essential to the healthcare system in Germany. The requirements for the current reporting system are laid down in the German Transfusion Act. The present work elaborates on the advantages and limitations of the current reporting system and investigates the feasibility of a pilot project that collects specific data on blood supply based on weekly reports. Materials and Methods: Selected data on blood collection and supply from 2009 to 2021 derived from the §21 German Transfusion Act database were examined. In addition, a pilot study over a period of 12 months was conducted on a voluntary basis. The number of red blood cell (RBC) concentrates was documented and stock availability was calculated weekly. Results: From 2009 to 2021, the annual number of RBC concentrates decreased from 4.68 to 3.43 million, the per capita distribution decreased from 58 to 41 RBC concentrates per 1,000 inhabitants. These figures did not change significantly during the COVID-19 pandemic. The data of the 1-year pilot project represented 77% of the released RBC concentrates in Germany. Percentage share of O RhD positive RBC concentrates fluctuated between 35% and 22% and for O RhD negative concentrates between 17% and 5%. The availability of O RhD positive RBC concentrate stocks varied between 2.1 and 7.6 days. Conclusion: The data presented shows a decrease in annual RBC concentrate sales over an 11-year period and no further change over the past 2 years. A weekly monitoring of blood components detects acute problems in RBC provision and supply. Close monitoring seems helpful but should be combined with a nationwide supply strategy.

Kommunalfinanzen in Zeiten steigender Zinsen

Abstract Rising interest rates will impact municipal budgets in Germany by increasing the cost of loans and making it more difficult to finance necessary investments in infrastructure and transformation. While most municipalities should have sufficient leeway to deal with higher interest rates, highly indebted municipalities may be strongly affected by rising interest rates. In these municipalities, interest costs are increasing strongly, budgetary margins are narrower anyway, and these municipalities are more dependent on loans to finance their investments. Rising interest rates thus once again reveal the unresolved and fundamental challenges for the municipal financial system in Germany.

Are insolvency proceedings opened too late? The case of Germany, Croatia and Slovakia

Purpose: The aim was to analyze insolvency proceedings in Germany, Croatia and Slovakia and answer the research question whether insolvency proceedings are opened too late in the observed countries and how this issue can be explained. Methodology: Comparative analysis of insolvency systems in Germany, Croatia, and Slovakia was con-ducted. Furthermore, the financial profile (liquidity) of firms in pre-insolvency and insolvency proceedings in Germany, Slovakia and Croatia was analyzed and respective results were compared with data on government effectiveness and the rule of law in the observed countries. The one-way ANOVA was performed to test the differences in liquidity among companies that initiated pre-insolvency and insolvency proceedings.Results: The results indicate that German companies respond to signs of crises earlier in comparison to Croatian and Slovakian companies and these differences cannot be explained only by criminal law measures which are not equally effective across jurisdictions, but they depend to a large extent on government effectiveness and the rule of law in a country.Conclusion: The results show that despite the similarities in the civil law frameworks, insolvency proceedings in Croatia and Slovakia are still initiated on average much later than in Germany. Moreover, according to the results, criminal law sanctions against the late initiation of insolvency proceedings can have preventive effects. However, while they can increase the number of timely insolvency proceedings, their effective-ness is still limited by the efficiency of the judicial system measured by the strength of institutions and their consistent application.

Fact of forest serviceʼs certification system for forestry enterprise and chainsaw certification system in Germany

Fact of forest serviceʼs certification system for forestry enterprise and chainsaw certification system in Germany

Calculating fire danger of cured grasslands in temperate climates – the elements of the Grassland Fire Index (GLFI)

Background Increasing extreme weather events due to climate change require updated environmental monitoring and prediction systems in Germany. Aim The Grassland Fire Index (GLFI), developed by the German Meteorological Service ~15 years ago for temperate climates, was revised to improve fire-danger predictions during the fire season. Our paper gives insight into the new model version. Methods The former fire-behaviour core, i.e. Fosberg’s Fire Weather Index (FWI), is replaced by the standardised fire-reaction intensity, a different fuel-moisture of extinction term, and a replica of the fire-spread rate of the Canadian FFBP-System. A standardised ease-of-ignition index is added as a measure of ignition success. The fire module is supplied with diurnal dead-grass fuel-moisture calculations based on the water-budget and energy-balance concept. Key results The GLFI output is compared with diurnal fuel-moisture measurements and results of Wotton’s Grass-Fuel-Moisture model, Fosberg’s FWI, and Cheney’s rate of spread equation. The GLFI computes periods with a high fuel moisture more realistically, whereas it exceeds Cheney’s rate-of-fire spread systematically at lower wind speeds, which leads to higher danger ratings during calm-air conditions (as requested by users). Conclusions and Implications The GLFI estimates dead-fuel moisture and fire danger on open, horizontal topography according to the current scientific level. Model extensions are necessary to run the model on complex topography under varying greenness and occasional frost conditions.

Techno-economic analysis of battery storage systems and hydrogen-based storage systems as an alternative to grid expansion in the medium voltage grid in Germany

<abstract> <p>The decentralization of the energy system in Germany is leading to enormous investments in grid expansion, as the current regulation creates an obligation to expand the power grid to eliminate bottlenecks. Meanwhile, opportunities to leverage grid-friendly control of storage systems are neglected to alleviate the need for investment. For this reason, it is necessary to investigate intelligent alternatives to grid expansion, such as storage systems, to efficiently integrate distributed technologies into the power system and reduce the need for grid expansion. In this work, two representative configurations of a medium voltage grid in Germany are developed for the years 2022 and 2050, and different storage systems are compared economically with the grid expansion in a model-based simulation. Hydrogen storage and battery storage were chosen as storage systems. The results show that grid expansion is the least expensive option if only the grid expansion costs are included in the analysis. However, if additional uses for the storage systems are considered, the battery storage systems are more economical. While in the scenario for 2050 the grid expansion causes costs of approx. 56,000 EUR per year, revenues of at least 58,000 EUR per year can be achieved via the revenue opportunities of the battery storage, representing a 3.5% margin. Heat extraction, arbitrage trading, and avoidance of grid expansion in superimposed grid levels were integrated as additional revenue streams/sources. A robust data basis and cost degressions were assumed for the simulations to generate meaningful results. Overall, hydrogen storage systems are economically inferior to battery storage systems and grid expansion for this use case. The results demonstrate the complexity of analyzing the trade-offs in terms of storage as an alternative to grid expansion as well as the opportunities presented using battery storage instead.</p> </abstract>

СИСТЕМА БАЗОВОГО СОЦИАЛЬНОГО ОБЕСПЕЧЕНИЯ В ФРГ (2005–2023 ГГ.)

Ensuring the basic social needs of the population, especially the most vulnerable groups of society, is an important area of social policy. The paper is dealing with the study of basic social security in Germany in 2005–2023, identifying the structure and special system for providing social benefits to the population. The chronological scope of the research is defined by significant changes in the structure and legislative regulation of basic assistance. Since 2005, the Twelfth Book of the Social Code has come into force, regulating the allocation of the first element of basic social security – social assistance. It consists of livelihood assistance, basic security for old age and disability, health aids, care assistance, assistance in overcoming certain social difficulties and assistance in other life situations. In 2023, the second element of the system, unemployment benefits-2, was replaced by a citizen benefit. In the course of the research, the author came to the conclusion that the features of the basic social security system in Germany at the present stage of development are its continuous process of reform and adaptation to the challenges of modern times, annual indexation of payments in accordance with socio-economic development, modernization in accordance with demographic factor and expansion of categories of applicants for social benefits.