Regulatory Tools Research Articles

Current issues of the implementation of the institutional and economic mechanism in the development process of environmentally oriented entrepreneurship in the agricultural sphere

In view of the global environmental trends, in the process of functioning of the domestic ecologically oriented entrepreneurship, the analysis and improvement of the relevant regulatory and legal tools, which allows to make strategically important decisions at different levels of management, becomes particularly relevant. The development and implementation of national and regional programs for the development of the agro-industrial complex and rural areas should be aimed at preserving the environment, meeting the needs of consumers for high-quality and safe products that meet international quality standards. Environmental assessment of investment projects, formation of investment-attractive types of land use, implementation of formalized environmental management systems are fundamentally important on the way to solving this issue. Such a systematic approach is the key to the development of greening of agrarian entrepreneurship and integration into the global economy. The purpose of this article is: improvement of the institutional and economic mechanism of ecologically oriented entrepreneurship in the agrarian sphere of the region in the conditions of European integration by developing directions for the harmonization of normative and legal legislation in this sphere. In order to ensure the set goal, the following tasks were solved within the scope of this study: the specifics of legal support for the development of ecologically oriented entrepreneurship in the conditions of the realities of the domestic economy and European integration processes were clarified; on the example of the Carpathian region of Ukraine, the conceptual directions of the formation and effective development of ecologically oriented entrepreneurship in the context of economic European integration are analyzed; directions for the harmonization of regulatory legislation in this area have been developed and substantiated.

Flexible regulation for dynamic products? The case of applying principles-based regulation to medical products using artificial intelligence

ABSTRACT Emerging technologies including artificial intelligence (AI) enable novel products to have dynamic and even self-modifying designs, challenging approval-based products regulation. This article uses a proposed framework by the US Food and Drug Administration (FDA) to explore how flexible regulatory tools, specifically principles-based regulation, could be used to manage ‘dynamic’ products. It examines the appropriateness of principles-based approaches for managing the complexity and fragmentation found in the setting of dynamic products in terms of regulatory capacity and accountability, balancing flexibility and predictability, and the role of third parties. The article concludes that successfully deploying principles-based regulation for dynamic products will require taking serious lessons from the global financial crisis on managing complexity and fragmentation while placing equity at the centre of the framework.

Role of the regulator in enabling a just culture: a qualitative study in mental health and hospital care

ObjectivesA just culture is considered a promising way to improve patient safety and working conditions in the healthcare sector, and as such is also of relevance to healthcare regulators who...

High-Resolution Fuel Consumption Model for Better Characterizations of High-Speed Scenarios

A detailed and accurate fuel model fuel consumption model that reflects real-world fuel consumption is required as input for devising and executing a model policy for prospective regulatory tools. The fuel consumption model based on the vehicle-specific power (VSP) has rapidly become the primary development direction since the release of the Motor Vehicle Emissions Simulator (MOVES) model. However, fuel consumption cannot be accurately characterized under high-speed scenarios. This work develops two fuel consumption models for the light-duty (gasoline) vehicles that can better characterize fuel consumption for light-duty vehicles under high-speed scenarios. For model 1, the VSP of −5kW/ton is a crucial turning point. When VSP∈ [−30, −5] kW/ton, the fuel rate is only determined by speed. When VSP∈(−5, 30], the fuel rate will gradually increase with VSP, and the growth characteristics will vary with speed. Model 2 develops the new interpretations for VSP and forms the one-to-one correspondence between the fuel rate and the new VSP. The two models can separately improve the accuracy by 12.2% and 13.8% compared with the conventional model. The fuel factor differences become significant when speed is higher than 65 km/h, which are separately 30.66% and 28.13% higher than the conventional VSP model when the speed is 100 km/h. Further, the fuel factors of the two models for freeways are, respectively, 6.33% and 7.56% higher than the conventional VSP model, and the distinction for arterial, collector, and local street roads is not notable.

The Borders of the Law: Legal Fictions, Elusive Borders, Migrants’ Rights

Bordering processes take place through different means and are carried out by different actors. Laws and regulatory activities have a prominent place among border-drawing instruments: Their capacity to mobilise actors, allocate funds, and determine procedures and remedies make them a formidable and multifaceted bordering tool. It is therefore not surprising to notice that EU institutions have heavily relied on regulatory tools when the need to resort to new bordering processes emerged in the aftermath of the so-called migration crisis. This article delves into a particular (re-)bordering process emerging from the legislative proposals attached to the Commission’s 2020 New Pact on Migration and Asylum: the attempt to uncouple the duty to fully respect and protect fundamental rights from the reality of migrants’ presence on national territory. This objective is pursued by the proposed legislative package through non-entry fictions, capable of untangling the legal notion of “border” from its physical reality for the purpose of immigration law (only). The analysis of the relevant provisions provides the reader with a number of insights into the transformation of EU borders. First, borders (as defined by the law) are subject to a peculiar legal regime. Secondly, the legal notion of borders is increasingly independent of its physical/geographical correspondence. Thirdly, legal border lines are not linked to any place on the ground, but rather follow irregular migrants as they move, confining them to areas of less law, no matter their location.

Appraisal of Selected Themes on the Impact of International Standards on Labour and Social Security Law in South Africa

For many years, South African courts have relied on International Labour Organisation conventions to interpret and give meaning to the fundamental social security and labour law rights enshrined in the Constitution, 1996. Social security and labour law has been one of the ILO's major initiatives of promoting decent work agenda since its inception in 1919. Decent work refers to the availability of employment in conditions of freedom, justice, security and human dignity. This is a multidimensional concept introduced by the ILO in 1999. It has four key components, namely, employment conditions, social security, workplace rights and social dialogue. To this end, the preamble to the ILO Constitution sets out several objectives in this regard, including the protection of workers from illness, accidents, the protection of children, women, and the support of the elderly. The ILO pursues these noble values and goals by developing international labour and social security standards, which member states must ratify and incorporate into their national law. The purpose of these ILO standards is to provide a standard framework or regulatory tool to guide member states in establishing, improving and maintaining social security and labour law systems domestically, regionally and internationally. Against this background, this article examines selected themes on the impact of international standards on labour and social security rights enshrined in the Constitution. It looks at some of the relevant international instruments which have influenced the promotion and protection of these rights. Furthermore, it shows how the courts have infused these standards into their judgments in South Africa.

Appraisal of selected themes on the impact of international standards on labour and social security law in South Africa

For many years, South African courts have relied on International Labour Organisation (hereafter ‘the ILO’) conventions to interpret and give meaning to the fundamental social security and labour law rights enshrined in the Constitution, 1996. Social security and labour law has been one of the ILO's major initiatives of promoting decent work agenda since its inception in 1919. Decent work refers to the availability of employment in conditions of freedom, justice, security and human dignity. This is a multidimensional concept introduced by the ILO in 1999. It has four key components: employment conditions, social security, workplace rights and social dialogue. To this end, the preamble to the ILO Constitution sets out a number of objectives in this regard, including the protection of workers from illness, accidents, the protection of children, women, and the support of the elderly. The ILO pursues these noble values ​​by developing international labour and social security standards, which member states must ratify and incorporate into their national law. The purpose of these ILO standards is to provide a standard framework or regulatory tool to guide member states in establishing, improving and maintaining social security and labour law systems domestically, regionally and internationally.
 
 Against this background, this article examines selected themes on the impact of international standards on labour and social security rights enshrined in the Constitution. It looks at some of the relevant international instruments which have influenced the promotion and protection of these rights. Furthermore, it discusses the application of these standards in domestic courts, and shows how the courts have infused these standards into their judgments.

CLIPreg: constructing translational regulatory networks from CLIP-, Ribo- and RNA-seq.

The creation and analysis of gene regulatory networks have been the focus of bioinformatics research and underpins much of what is known about gene regulation. However, as a result of a bias in the availability of data types that are collected, the vast majority of gene regulatory network resources and tools have focused on either transcriptional regulation or protein-protein interactions. This has left other areas of regulation, for instance, translational regulation, vastly underrepresented despite them having been shown to play a critical role in both health and disease. In order to address this, we have developed CLIPreg, a package that integrates RNA, Ribo and CLIP- sequencing data in order to construct translational regulatory networks coordinated by RNA-binding proteins and micro-RNAs. This is the first tool of its type to be created, allowing for detailed investigation into a previously unseen layer of regulation. CLIPreg is available at https://github.com/SGDDNB/CLIPreg. Supplementary data are available at Bioinformatics online.

FEATURES OF THE CONCEPT STATE REGULATION OF NATIONAL DEVELOPMENT MINING INDUSTRY

The organization and maintenance of sustainable socio-economic progress of the country are closely connected not only with the rational use of the country’s natural resources, but also with the implementation of effective state policy on the protection and reproduction of natural biogeocenoses. The construction and implementation of such a policy must meet both the tactical and long-term prospects of economic and social development of the state. The strategic importance of the mining industry for society requires regulation to ensure sustainable development and should be regulated at the state level, but to be specific to regional specifics while taking into account national interests. The article identifies the basic theoretical provisions on the need, extent and methods of regulating the economy, environmental and economic, sustainable and innovation and technological development. The task of state regulation of economic development of the mining industry is substantiated. It is proposed to consider as a set of state measures in the coal, oil and gas, metallurgy, electricity and utilities, aimed at efficient use of natural resource potential based on mining, as well as their exploration, development, primary processing, use and marketing , as a result of which there are progressive changes of production and service and structural nature in the economy of the country and its regions. The purpose of state regulation is the efficient use of natural resource potential based on the extraction of minerals from the subsoil, as well as their exploration, development, primary processing, use and marketing. A set of measures of state regulation of economic development of the mining industry in the areas of planning, regulation, regulation, supervision and control is described. Particular attention is paid to regulatory tools, namely permits with appropriate administrative support, tax, investment. In determining the specifics of regulating the development of the industry, attention is focused on its relationship with the policy documents of the national and regional levels.

CRISPR/dCas9-RpoD-Mediated Simultaneous Transcriptional Activation and Repression in Shewanella oneidensis MR-1.

Extracellular electron transfer (EET) of electroactive microorganisms (EAMs) is the dominating factor for versatile applications of bio-electrochemical systems. Shewanella oneidensis MR-1 is one of the model EAMs for the study of EET, which is associated with a variety of cellular activities. However, due to the lack of a transcriptional activation tool, regulation of multiple genes is labor-intensive and time-consuming, which hampers the advancement of improving the EET efficiency in S. oneidensis. In this study, we developed an easily operated and multifunctional regulatory tool, that is, a simultaneous clustered regularly interspaced short palindromic repeats (CRISPR)-mediated transcriptional activation (CRISPRa) and interference (CRISPRi) system, for application in S. oneidensis. First, a large number of activators were screened, and RpoD (σ70) was determined as the optimal activator. Second, the effective activation range was identified to be 190-216 base upstream of the transcriptional start site. Third, up- and downregulation was achieved in concert by two orthogonal single guide RNAs targeting different positions. The activation of the cell division gene (minCDE) and repression of the cytotoxic gene (SO_3166) were concurrently implemented, increasing the power density by 2.5-fold and enhancing the degradation rate of azo dyes by 2.9-fold. The simultaneous CRISPRa and CRISPRi system enables simultaneous multiplex genetic regulation, offering the potential to further advance studies of the EET mechanism and application in S. oneidensis.

Ethical Decision Making in Iot Data Driven Research: A Case Study of a Large-Scale Pilot.

IoT technologies generate intelligence and connectivity and develop knowledge to be used in the decision-making process. However, research that uses big data through global interconnected infrastructures, such as the ‘Internet of Things’ (IoT) for Active and Healthy Ageing (AHA), is fraught with several ethical concerns. A large-scale application of IoT operating in diverse piloting contexts and case studies needs to be orchestrated by a robust framework to guide ethical and sustainable decision making in respect to data management of AHA and IoT based solutions. The main objective of the current article is to present the successful completion of a collaborative multiscale research work, which addressed the complicated exercise of ethical decision making in IoT smart ecosystems for older adults. Our results reveal that among the strong enablers of the proposed ethical decision support model were the participatory and deliberative procedures complemented by a set of regulatory and non-regulatory tools to operationalize core ethical values such as transparency, trust, and fairness in real care settings for older adults and their caregivers.

Marine protected areas in the context of climate change: key challenges for coastal social-ecological systems.

Climate and ecological emergencies play out acutely in coastal systems with devastating impacts on biodiversity, and the livelihoods of communities and their cultural values. Marine Protected Areas (MPAs) are one of the key management and regulatory tools against biodiversity loss, playing a role in strengthening bio-cultural diversity and sustainability of coastal social-ecological systems. What is unclear though is the effectiveness of static protections under climate change as species move. Next to ecological uncertainty, regulatory uncertainty may play a role in weakening marine conservation. We asked whether MPAs are ecologically effective now and can sustain or improve to be so in the future while facing key climate and regulatory uncertainties. MPAs can support the protection of cultural values and have an impact on activities of sea-users and the sustainability of social-ecological systems. As such, questions surrounding their legitimacy under a changing climate and increased uncertainty are pertinent. We argue that MPA governance must be cognisant of the interdependency between natural and human systems and their joint reaction to climate change impacts based on an integrated, co-developed, and interdisciplinary approach. Focusing on the UK as a case study, we highlight some of the challenges to achieve effective, adaptive and legitimate governance of MPAs. This article is part of the theme issue 'Nurturing resilient marine ecosystems'.

Sanitation policy in India – designed to fail?

After three decades of disappointing experience with sanitation promotion, the Indian government launched the Swachh Bharat Mission (SBM) in 2014, with great fanfare and optimism. Yet SBM failed to live up to the expectations. This article argues that the dull outcomes are the result of design flaws in the program. The study finds that the goals of SBM are poorly chosen, with private sanitation services being prioritized over those which create public value in Indian context. Furthermore, SBM emphasizes financial and information tools while overlooking the regulatory and organizational tools and their synergies, which makes it nothing more than a poorly designed conditional cash transfer scheme. The design approach employed in the article not only opens the black box of sanitation policy tools but also generates valuable recommendations to guide sanitation policy in developing countries.

RSAT 2022: regulatory sequence analysis tools.

RSAT (Regulatory Sequence Analysis Tools) enables the detection and the analysis of cis-regulatory elements in genomic sequences. This software suite performs (i) de novo motif discovery (including from genome-wide datasets like ChIP-seq/ATAC-seq) (ii) genomic sequences scanning with known motifs, (iii) motif analysis (quality assessment, comparisons and clustering), (iv) analysis of regulatory variations and (v) comparative genomics. RSAT comprises 50 tools. Six public Web servers (including a teaching server) are offered to meet the needs of different biological communities. RSAT philosophy and originality are: (i) a multi-modal access depending on the user needs, through web forms, command-line for local installation and programmatic web services, (ii) a support for virtually any genome (animals, bacteria, plants, totalizing over 10 000 genomes directly accessible). Since the 2018 NAR Web Software Issue, we have developed a large REST API, extended the support for additional genomes and external motif collections, enhanced some tools and Web forms, and developed a novel tool that builds or refine gene regulatory networks using motif scanning (network-interactions). The RSAT website provides extensive documentation, tutorials and published protocols. RSAT code is under open-source license and now hosted in GitHub. RSAT is available at http://www.rsat.eu/.

Legal Model Construction Approach of Big Data Transaction Management in the Digital Information Perspective

This paper constructs and applies the legal model of transaction management in the digital information perspective based on the approach of big data. To solve the problem, it is necessary to integrate various legal tools, construct an idealized legal model of big data transaction management, conduct interprofessional and interdisciplinary research on the big data transaction management problems that are difficult to be regulated by the existing legal norms, and selectively design and arrange the corresponding system, to provide the digital regulatory tools for the operation of the digital economy and promote the scientific and standardized development of the digital economy. Based on the decentralized blockchain platform, sealed bidding is used to achieve information isolation among nonconspiratorial data buyers, and through the big data auction algorithm, the purpose of the conspirators cannot be achieved and anticomplicity is realized. The model is based on smart contracts and combined with auction theory to achieve anticollision in the process of big data auctions. Based on the model, we construct an anticomplicity big data auction mechanism and dissect the big data auction algorithm. The correctness of the model and algorithm is demonstrated through simulation. After the data is hosted, the data will be completely owned by the big data trading center. In the data transaction process, the big data transaction center provides data resource information to data buyers, so that data buyers can select the required data. Second is the construction of a multilevel regulatory system in the administrative supervision of the construction of the central national security leading institutions led by the interregional collaborative regulatory system and in the industry self-regulatory supervision of the implementation of the data trading platform data trading supervision obligations. The balance between the development of the data trading industry and data trading security is comprehensively maintained from multiple perspectives of legislation and law enforcement.

Efficiency incentives in the nursing home sector: Lessons from implementing the new Quality Framework in the Netherlands

In many markets there is some form of regulation; and when new policy measures are introduced into a particular sector, the question of how to structure an adequate regulatory process arises. This paper contributes to the literature by describing the approach taken in the nursing home sector in the Netherlands, explaining all the steps needed for implementation and how regulatory challenges were addressed. These challenges involved making methodological choices and the integration of elements (incentives, quality, cost-efficiency, data validation, organizational commitment) into a consistent and credible regulatory framework. Drawing lessons for other sectors and countries, we particularly emphasize the usefulness of Data Envelopment Analysis as a flexible and adaptable regulatory tool for both learning and incentive provision. However, the scope and specification of the model must be consistent with costaccounting practices and quality definitions in order for DEA to be implemented effectively.

Transnational Network and Information Flow in African Refugees and Undocumented Migrants’ International Migration Process

This paper analyses the role of information flow under transnational (social) networks to understand African refugees and undocumented migrants’ migration to Austria. Existing research pointed to the international refugee crisis with industrialised countries targeted border governance that has prompted the emergence of the transnational (social) network, which builds (kinship-based) connectivity and interchangeable acquaintances between migrants in host and country of origin to influence and facilitate migrants’ pre and post mobility process. However, the network often faces weak ties with exploitation and subjugation to human trafficking. Based on twenty qualitative problem-centred face-face interviews, data are collected and analysed with content analysis technique to fill in the gap. The findings indicate that pre-mobility guidance, directive, and legislative decoder regulatory tools influence transnational networks with a lack of well-managed network that may impair pre and post-mobility processes to shape African refugees and undocumented migrant international migratory pathways in an information flow setting. This study demonstrated actor-based network-driven advocacy governance. The outcome points to the strategic mobilization of collective information to resource vulnerable people and refugees or undocumented migrants to meet their needs. This is relevant to collective action in contemporary neoliberal society targeting freedom and movements that may not only constrain ethnic minority group mobility, but the universal human rights principles, public policy learning process, informal institution collaborative actions, and democratic values in times of crisis-related super-diversity societies.

TRANSFORMATION OF ECONOMIC POLICY PRIORITIES UNDER COVID-19

The aim of this paper is to analyze the main challenges of the new paradigm of economics in the context of Covid 19, the economic role of the state and the scale of state intervention in the economy. Economics teaches us that there is a time for budget expansion and a time for budget constraints. There are times when the government has to intervene in the value chain and there are times when it has to leave the markets alone. Sometimes the tax has to be high and sometimes low. Trade in some areas should be more independent and regulated elsewhere. Globalization is one of the primary variables impacting the state's economic condition in the modern world. The most important function of the state in the context of globalization is not only to protect the national economy from external influences (so-called "external shocks"), which is virtually impossible today, but also to effectively participate in international economic ties and increase the country's global competitiveness. In this aspect, the contemporary state plays a critical role. In turn, Georgia must construct a "Georgian model" of economy that will serve as the "core" of an economic model that would attract investment (in the real economy), generate employment, expand exports, and deliver true prosperity to all Georgians. Today is the day when, at the state's initiative, the country's economic priorities are defined and the country's distinctive economic potential is fulfilled. The modern economic crisis, which was triggered by the Covid-pandemic, has demonstrated that a route out of the current predicament is conceivable when the anti-crisis strategy is based on increased government participation in the economy. To accomplish so, the government and the public sector must play a larger role in crisis management. Despite these examples, the economic regulation of the state has always had strategic and tactical significance. For any country, there are and will always be state problems that are either not addressed through the supply-demand mechanism or are associated with negative side effects. Based on the existence of such cases, a set of free market economic measures is being developed through state programming of the economy and the use of regulatory tools. In view of the above, it is necessary to reconsider and reform the role and rights of the state in modern economic relations. The need to establish the state as a factor of progressive development in the economy should be emphasized during the reform. In addition, it should include legislative activities such as – compliance with labor safety conditions, regulation of the minimum wage, resolution of social conflicts, etc.

From Single-Player Games to Metaverse: A Futuristic Analysis of Challenging Legal Issues in the Video Game Industry in China

Abstract The video game industry in China is developing rapidly, and as the technologies behind games evolve many legal problems have arisen. This paper provides a detailed account of the legal problems related to legal determination of virtual objects, game modding, cloning, cracking, webcasting and machinima. It points out that the current trend in both court judgments and scholarship is to focus merely on addressing specific problems through the lens of application of the current laws lacks a holistic and futuristic perspective that needs to be considered in conjunction with the future trends in the development of the games industry. This paper suggests that we must watch game developments carefully and assess the potential impact of related legislative moves and legal decisions. The paper concludes that the disruptive power of new technologies will be better regulated by a network of regulatory tools rather than law alone.

Structure of AcrVIA2 and its binding mechanism to CRISPR-Cas13a

Phages and non-phage derived bacteria have evolved many anti-CRISPR proteins (Acrs) to escape the adaptive immune system of prokaryotes. Thus Acrs can be applied as a regulatory tool for gene edition by CRISPR system. Recently, a non-phage derived AcrVIA2 has been identified as an inhibitor that blocks the editing activity of Cas13a in vitro by binding to Cas13a. Here, we solved the crystal structure of AcrVIA2 at a resolution of 2.59 Å and confirmed that AcrVIA2 can bind to Helical-I domain in LshCas13a. Structural analysis show that the V-shaped acidic groove formed by β3-β3 hairpin of AcrVIA2 dimer is the key region that mediates the interaction between AcrVIA2 and Helical-I domain. In addition, we also reveal that Asp37 of AcrVIA2 plays an essential role in the functioning of the V-shaped acidic groove, and the functional dimer conformation of AcrVIA2 is stabilized by hydrogen bonds formed between Tyr41 of one monomer with Glu35 and Asp37 of the other monomer. These data expand the current understanding of the diverse interaction mechanisms between Acrs and Cas proteins, and also provide new ideas for the development of CRISPR-Cas13a regulatory tool.