The Evolution of Fintech: A Regulatory Approach Perspective

The financial sector industry is fast changing with the rapid emergence of Fintech in Europe. This paper explores the evolution and current state of the Fintech sector in the European Union, focusing on its key dimensions and the challenges it faces. Using comprehensive indexes such as the Aggregate Fintech Activity Index and data from Statista and Eurostat, the study provides a multi-dimensional analysis of Fintech activity in the European Union. It examines trends and key drivers shaping Fintech`s development based on four dimensions: the number of Fintech companies, market capitalization, number of users and average transaction value per user. Findings underline regional disparities, with northern European countries leading in Fintech adoption due to advanced digital infrastructure, widespread use of online banking and digital payments, financial literacy and regulatory support. The study highlights Fintech`s dual role in advancing financial inclusion and disrupting traditional banking systems, emphasizing the need for strategic regulatory and market approaches to ensure sustainable sector growth.

Improving Organ Transplantation in the United States—A Regulatory Perspective

EU Regulation 1107/2009 aims at ensuring that pesticides do not pose unacceptable risks to humans, animals, or the environment. As non‐target organisms can be adversely affected by pesticide use, their protection is pivotal. Therefore, EU Regulation 1107/2009 requires that the risks to non‐target organisms are determined when assessing a pesticide application for the authorisation of a plant protection product. Off‐target drift is a major exposure route for non‐target organisms living in the field‐adjacent habitats. Spray drift deposition values currently used in the EU regulatory environmental exposure assessment rely on data from outdated experiments conducted in Germany, which may not fully represent various meteorological and crop conditions across Europe. Modelling can be an alternative to experiment‐based spray drift curves. However, for EU regulatory purposes, a ready‐to‐use model that predicts spray drift depositions for upward and sideways sprayed crops is currently not available. Recently, the statistical model SPEXUS has been developed for predicting spray drift deposition from upward and sideways spraying in Dutch apple orchards. The model is based on a wide range of experimental drift deposits that reflect conditions in the Netherlands but can be adapted for other fruit crops and other climate zones by using appropriate relationships based on crop development stage and local weather conditions. The broader validity of the model was tested by comparing the results of SPEXUS with data obtained from EU datasets. In addition, the currently used German Ganzelmeier‐Rautmann deposition curves were compared to the same EU datasets. The results showed that the Ganzelmeier‐Rautmann curves both underestimated and overestimated the spray drift deposits. However, overestimation — considered a conservative approach from a regulatory perspective — was the most frequently observed outcome. As a result, it seems most practical, for now, to continue using the Ganzelmeier‐Rautmann spray drift curves for upward and sideways sprayed crops. However, advanced models like SPEXUS offer advantages by accounting for variable weather conditions, application techniques and crop types and structures. The recommendation is to extend SPEXUS to other crops and cultivation techniques across Europe. This would require a wide range of spray drift data from different European climate zones, cropping systems and a variety of spray drift techniques. To obtain these data to refine, expand and validate the model it is advised to engage with agricultural research institutes and universities across the EU that are involved in spray drift research.

As this article goes to press in late 2016, the precision medicine community has amassed over 20 years of companion product development experience in the field of oncology. This article reflects on what we have achieved and learned along the way, how the companion paradigm is playing out in immunooncology and why we are likely to achieve much more in the next 10 years than we have in the previous two decades. Also considered here are some of the disruptive operational and business model changes we will see in the coming years as these new opportunities are realized.

Financial transparency and fraud detection have become critical concerns for regulators, financial institutions, and stakeholders in the modern digital economy. The rise of complex financial instruments, cross-border transactions, and sophisticated fraud schemes necessitates the development of advanced regulatory technology (RegTech) frameworks capable of ensuring accurate reporting, real-time monitoring, and compliance enforcement. This paper presents a conceptual and systematic approach for designing a RegTech framework aimed at improving financial transparency and enhancing fraud reporting accuracy. It synthesises developments in artificial intelligence, blockchain, machine learning, data analytics, and digital reporting, highlighting their roles in strengthening regulatory oversight. The framework emphasises the integration of risk-based analytics, automated compliance monitoring, and continuous feedback mechanisms to improve decision-making and reduce operational inefficiencies. A critical literature review is conducted to explore recent advances in fraud detection, transaction monitoring, audit automation, and regulatory compliance. The study identifies current gaps in regulatory approaches and proposes an integrated framework that combines technological, procedural, and regulatory perspectives. This paper contributes to the growing body of knowledge on RegTech and provides practical guidance for regulators, financial institutions, and technology developers seeking to implement robust, accurate, and transparent financial monitoring systems.

The good availability of medicines and medicine shortages have become global issues during recent years. Medicine shortages are often affected by universal determinants, but the availability of medicines is also depending on national characteristics. This commentary aims to discuss the issue of the availability of medicines and medicine shortages in outpatient care in Finland, taking in consideration both national characteristics and global determinants that effect on the availability of medicines in other countries but Finland also. In this commentary, a regulatory approach is applied.

This comment is a response to Al‐Hamdani et al. (forthcoming) in this issue. The authors of that paper advocate plain packaging and warning label regulation for cannabis drawing on research from Canadian tobacco labelling and based on the public health dangers of cannabis. While we acknowledge the harmful effects of cannabis for some vulnerable consumers, this paper highlights the benefits of cannabis legalization and proposes regulatory oversight more akin to alcohol with a goal of responsible usage, information, and access; rather than one drawn from tobacco labeling, a product with few discernable benefits and myriad documented harms. Highlighted advantages include increased tax revenues, enforcement cost savings, therapeutic benefits, positive environmental impacts, and social benefits such as a reduction in racial disparities related to marijuana prosecutions. We discuss how a regulatory approach that mirrors alcohol control can better foster consumer protection, fair competition, and public interest in this emerging industry.

Chapter 2 - Food and Toxicologic Pathology

The scope of direct transactions globally with almost zero transaction cost and keeping transactions anonymous without facing any centralized control has caused a huge demand for cryptocurrency worldwide whereas its excess volatility, no underlying backings, no centralized control, and anonymity behind transactions have contributed significant risk for the entire financial system. Unlike cryptocurrency, Central Bank Digital Currency, being a virtual currency backed by the central bank or the monetary authority of a country serves all the functions of money, such as a store of value, a unit of account, and a medium of exchange, facilitates the attainment of macroeconomic goals and financial stability. To ensure the safeguarding of the interest of the people, business enterprises, and the financial system of a country from a broader perspective, adequate regulatory measures regarding cryptocurrency are a must. There should be proper harmonization and coordination among the countries regarding the regulatory approach as the markets of cryptocurrency are integrated globally.

This chapter describes the regulatory perspective of the leaking underground storage tank problem and to develop the best regulatory position, especially for petroleum hydrocarbon contamination. It identifies some basic regulatory concerns, reviews contaminant fate from a regulatory perspective, describes some regulatory approaches, and presents an approach that considers the present state of the science as applied to the local operational level. The most immediate concern at a leaking tank site is public safety. Exposure pathways may include direct contact, inhalation of hydrocarbon vapors, and ingestion of contaminated water and food. Changes of land use from service stations to residential and other commercial developments has led to concerns long-term low level human exposure to benzene vapors. Much of the local agency effort has been directed toward determining acceptable cleanup levels for soil or, in some cases, determining the proper point of application of groundwater cleanup standards.

Should the EU Reshape its Competition Legal System to Regulate Algorithmic Cartels?

This paper discusses of the feasibility of ecodesign requirements on computer servers and presents a case study. Computer servers have been analysed in an ecodesign preparatory study. For the most representative products, the least life cycle cost (LLCC) has been identified: it minimizes the total cost of ownership for the consumer and fosters manufacturers to improve their products with existing technologies as well and providing the optimum level from a regulatory perspective. On the basis of the LLCC assessment and related product efficiency level, ecodesign requirements can be proposed, bearing in mind the principle of technology neutrality and pushing the market towards increased efficiency levels. The preparatory study confirmed that computer servers are products responsible for a significant share of electricity consumption in the EU. Ecodesign requirements could result in environmentally effective and sustainable policy options, also from an industry competitiveness perspective. The requirements may cover hardware aspects, in particular efficiency of the power supply units, operating temperature and product's efficiency, both in idle and active state. For the latter, the presence of standardized and accurate testing methods is crucial. Moreover, possible resource efficiency requirements may be proposed, in particular to promote reparability, reusability and recyclability. In order to help identifying the best regulatory approach, several policy options are outlined.

National and international governments are in the process of establishing testing programs and strategies to assess the safety of currently used chemicals with regard to their potential to interact with the endocrine system of man and wildlife, resulting in potential impacts on reproduction, growth, and/or development. Specifically, the USA, Japan, EU, and OECD have established testing approaches and regulatory frameworks with aim to assess the risks associated with chemicals that have endocrine disrupting properties (EDCs). While there has been a large amount of efforts over the past two decades in context with the assessment of chemical safety, no comparable attempts to harmonize and mutually accept testing strategies and decision-making criteria for environmental monitoring and assessment exist to date for EDCs. In fact, many of the current environmental programs such as the European Water Framework Directive (WFD) or the US Clean Water Act do not explicitly test for EDCs, and considering the unique requirements and endpoints required to assess the endocrine potential of a sample, these programs are unlikely to appropriately address exposure to these chemicals. This is of great concern since EDCs are ubiquitous in the environment, especially in aquatic ecosystems. One of most important sources for EDCs in the environment is the effluent from sewage treatment plants. Many EDCs such as the natural and synthetic estrogens 17β-estradiol and 17α-ethinylestradiol, respectively, are not completely removed with conventional wastewater treatment systems. In recognition of these concerns, in Europe, there is increasing pressure to further develop advanced wastewater treatment methods, such as ozonation and activated carbon treatment for a broad application in municipal wastewater treatment. Another issue is the continuing lack of understanding of the environmental relevance of the phenomenon of ED. A great number of studies have been conducted to describe potential ED in wild and laboratory animals. Most of these studies relied on biomarkers of estrogenicity such as vitellogenin induction in males and mild histological alterations (e.g. occurrence of testicular oocytes), and to date - with few exceptions - no convincing evidence of population relevant impacts of exposure to EDC in the wild exist. In conclusion, while there has been a great deal of research and efforts in context with the hazard assessment and regulation of EDCs, there is still a large number of remaining uncertainties and issues. These range from animal rights concerns due to significant increases in the use of animals to fulfill testing requirements, associated needs for alternative testing concepts such as in vitro, in silico, and modeling approaches, lack of understanding of the relevance of the exposure of man and wildlife to EDCs, and the need for inclusion of EDCs in current environmental programs such as the WFD. In this article we attempted to summarize the current state-of-the-art of regulatory and scientific approaches in context with EDCs, and to identify issues and future needs to address current shortcomings in the field.

An Examination of the Regulatory and Reimbursement Processes for Biobetters and Comparison With Biosimilars.

The development of fintech has brought significant changes and utilized technology to improve efficiency, such as in investment services, online loans, and digital payments, all of which provide convenience for the public. In addition, there are still many legal and social issues that cannot be ignored, such as frequent violations of collection ethics, both directly by fintech platforms and through third parties (debt collectors). Legally, these violations give consumers the right to sue. This situation indicates a discrepancy between the applicable laws and their implementation in society. This study formulates two main issues: (1) how are the laws related to ethical debt collection in online lending services in Indonesia regulated, and (2) what factors cause unethical debt collection practices to continue despite the existence of regulations. The method used was normative juridical with a regulatory and conceptual approach, including provisions in the Consumer Protection Law, OJK regulations, and ethical guidelines for debt collection. The results of the study show that even though rules are in place and enforced, there are still legal loopholes in social and regulatory factors that contribute to violations. From a regulatory perspective, there is an emphasis on administrative sanctions, so that violations that actually constitute criminal offenses cannot be punished with administrative sanctions alone. From a social perspective, there is a lack of public awareness regarding their rights.