Parliamentary Control of Public Finances: European Experience and Ukrainian Realities under Conditions of War and COVID-19 Pandemic

The war and the COVID-19 pandemic posed a great challenge to Ukraine from the point of view of public finances. The purpose of the study is to systematize the European experience and analyze the Ukrainian practice of implementing parliamentary control of public finances in the conditions of war and the COVID-19 pandemic. The methodological basis of the study is a systematic approach to the study of the process of parliamentary control of public finances in the conditions of war and the COVID-19 pandemic. To achieve the goal, the research used scientific methods such as: the dialectical method, the method of comparative analysis, the methods of synthesis and systematization, ion, generalization, and the graphic method. The mechanism of parliamentary control in the field of public finances in Ukraine is analyzed, which allows the legislative branch of power to guarantee that public funds are used responsibly and efficiently. The functions of the Accounting Chamber of Ukraine, which is an independent body that monitors and controls public finances in Ukraine, are analyzed. The problems with ensuring parliamentary control of public finances are outlined, and measures to improve the efficiency of these processes are presented. The experience of the member states of the European Union in the implementation of parliamentary control of public finances has been analyzed, which will contribute to the analysis of the possibilities of implementing successful experience in Ukrainian practice.

The Impact of Digitalization on the Sustainable Development of Ukraine: COVID-19 and War Challenges for Higher Education

Higher Education plays an important role in ensuring the Sustainable Development of the countries. The purpose of the article is to systematize scientific approaches to the study of the impact of digitalization on ensuring the Sustainable Development of Ukraine and its regions in the conditions of modern COVID-19 and military challenges. The methodological basis of this study is a systematic approach, as well as general and special scientific research methods, namely: systematic analysis and generalization, grouping, induction and deduction, -logical, scientific ion and modeling, graphic methods. The authors verified that Higher Education has a tangible positive impact on the dynamics of Sustainable Development of Ukraine and its regions. First of all, this influence is carried out through the educational and research activities of universities. The article emphasizes that it was digitalization that allowed universities to maintain their competitive positions in the educational services market in the conditions of COVID-19 and war challenges.

Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective.

AREAS COVERED: An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical device guidelines has been basically stable, then rapidly rose. EXPERT OPINION: The rise of the COVID-19 pandemic and digital health technologies explains 50% of the upward momentum in guidelines since the mid-2010s. Concomitantly, medical device and medicinal guidelines became moderately correlated. This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of 'innovation saltus' - i.e. discrete periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science; namely, examination of guidelines (as proxy measures of regulations) and their influence on innovation.

Firms? sustainability, financial performance, and regulatory dynamics: Evidence from European firms

This study examines the association between firms' ESG reputational risk and financial per-formance under the EU regulatory policy changes and the COVID-19 period. Analyzing a panel of 1,816 European listed firms during the period 2007-2021, we document evidence that firms with lower ESG reputational risk have reduced information asymmetry, are less financial constrained and perform better. To establish causality, we design a quasi-natural experiment focusing on the 2014/95/EU directive of non-financial disclosing and the COVID-19 exogenous shock. Our findings are robust to several estimation techniques that address endogeneity, self-selection, and model sensitivity. Crown Copyright (c) 2022 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Firms’ sustainability, financial performance, and regulatory dynamics: Evidence from European firms

This study examines the association between firms’ ESG reputational risk and financial performance under the EU regulatory policy changes and the COVID-19 period. Analyzing a panel of 1,816 European listed firms during the period 2007-2021, we document evidence that firms with lower ESG reputational risk have reduced information asymmetry, are less financial constrained and perform better. To establish causality, we design a quasi-natural experiment focusing on the 2014/95/EU directive of non-financial disclosing and the COVID-19 exogenous shock. Our findings are robust to several estimation techniques that address endogeneity, self-selection, and model sensitivity.

Do Economic Recovery Packages Open a Window of Opportunity for Corruption and Mismanagement? The Case of Italy in the Aftermath of the Covid-19 Pandemic

This paper explores the effects of the pandemic on corruption and mismanagement in Italy, a country where the Covid-19 crisis is supposed to have significantly increased the risk of corruption. It proposes a novel operationalization of safeguards for accountability that are attached to the disbursement of recovery funds. Emergency law decrees and their implementing acts have been coded to assess whether the discretion in the allocation of recovery funds has been constrained by transparency requirements and enforcement provisions. Findings reveal that safeguards for accountability have been strengthened over time but that they have followed various patterns across recovery measures targeting businesses and people. [ FROM AUTHOR] Copyright of Public Organization Review is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Does Information-and-Communication-Technology Market Openness Promote Digital Service Exports?

ICT has become an important support for the booming trade in services in the digital era. However, the extent to which trade activities can benefit from ICT will depend on the regulatory constraints and the market-openness level of the ICT market. This study empirically examines the impact of ICT market openness on digital service exports on the basis of bilateral trade data at the industry level from 2007 to 2019 from 50 countries. The results show that: (1) ICT market openness seeks the combination of effective regulation and moderate openness, which is mainly reflected in three policy areas: improving information interconnection and sharing, reducing access restrictions and promoting fair competition;(2) The ICT market openness in both exporting and importing countries can significantly boost digital service exports, but in different ways. Exporting countries expand digital service exports mainly by promoting fair competition, while importing countries have the most obvious positive impact on exports through the reduction of access restrictions;(3) The greater the gap between the ICT development levels, and the lower the bilateral risk levels between the two trading countries, the greater the marginal effect that ICT market openness will have on the promotion of digital service exports. Thus, improving market openness indicates an important direction for ICT regulatory reform, but the impact on digital service exports will vary by specific policy area and by trading-partner country.

Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.

The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2) small numbers of children affected by a particular disease, (3) difficulties with study design, (4) lack of definitive outcome measures and assessment tools, (5) the need for additional safeguards for children as a vulnerable population, and (6) logistical hurdles to completing trials, especially with the need for longer term follow-up to establish safety and efficacy. There has also been an increasing awareness of the need to engage patients and their families in drug development processes and to address inequities in access to pediatric clinical trials. The year 2020 ushered in yet another challenge-the COVID-19 pandemic. The pediatric drug development ecosystem continues to evolve to meet these challenges. This article will focus on several key factors including recent regulatory approaches and public health policies to facilitate pediatric rare disease drug development, emerging trends in product development (biologics, molecularly targeted therapies), innovations in trial design/endpoints and data collection, and current efforts to increase patient engagement and promote equity. Finally, lessons learned from COVID-19 about building adaptable pediatric rare disease drug development processes will be discussed.

Scientific and Regulatory Policy Committee Brief Communication: 2019 Survey on Use of Digital Histopathology Systems in Nonclinical Toxicology Studies.

Histopathologic evaluation and peer review using digital whole-slide images (WSIs) is a relatively new medium for assessing nonclinical toxicology studies in Good Laboratory Practice (GLP) environments. To better understand the present and future use of digital pathology in nonclinical toxicology studies, the Society of Toxicologic Pathology (STP) formed a working group to survey STP members with the goal of creating recommendations for implementation. The survey was administered in December 2019, immediately before the COVID-19 pandemic, and the results suggested that the use of digital histopathology for routine GLP histopathology assessment was not widespread. Subsequently, in follow-up correspondence during the pandemic, many responding institutions either began investigating or adopting digital WSI systems to reduce employee exposure to COVID-19. Therefore, the working group presents the survey results as a pre-pandemic baseline data set. Recommendations for use of WSI systems in GLP environments will be the subject of a separate publication.

Research on Health Disparities Related to the COVID-19 Pandemic: A Bibliometric Analysis.

With the outbreak of the 2019 coronavirus (COVID-19) pandemic, the issue of increasing health disparities has received a great deal of attention from scholars and organizations. This study analyzes 2282 papers on COVID-19-related health disparities that have been retrieved from the WOS database, with 58,413 references. Using bibliometric analysis and knowledge mapping visualizations, the paper focuses on the academic structure and research trends by examining the research distribution of countries, journals and authors, keywords, highly cited articles, and reference co-citation. The results show that the United States has contributed the most, and the International Journal of Environmental Research and Public Health has published the largest number of papers on this topic. As for the core authors, Michael Marmot is the most productive. Issues such as racial health, mental health, and digital health disparities have been the trending topics of the COVID-19-related health disparities. The research directions include the features, factors, and interventions of health disparities under the influence of COVID-19. As such, this study provides literature support and suggestions to investigate COVID-19-related health disparities. The findings of the paper also remind public health regulators to consider factors of health disparities when developing long-term public health regulatory policies related to the pandemic.

REGULATORY POLICY TRANSFORMATION IN CONDITIONS OF NON-STATIONARY ECONOMY IN EASTERN EUROPEAN COUNTRIES: PRACTICAL APPROACH

European economic processes have always been the center of public interest. 2010-2019 were characterized by economic development and result achievements in the conditions of information flows exchange and digital changes. However, the pandemic effects of Covid-19 have negatively influenced economic activity, causing significant uncertainty in subsequent economic processes, which were reflected in GDP trends and determined the non-stationary economic conditions. And although the first half of 2021 marks GDP growth, the economic recovery, projected in the traditional scenario, is not enough to reach the precrisis level of production again. The purpose of the study is to identify the effects on European countries economic development and to develop proposals for directions and instruments of regulatory policy transformation, which would take into account the current non-stationary economic conditions. Achieving the goal led to the usage of scientific and practical methods of cognition, including the method of deduction and induction, system analysis, synthesis, generalization, mathematical methods and models. The study characterizes the nature of non-stationary economic development and identifies the need for regulatory influence to ensure further economic growth. The analysis proposes to use GDP as an indicator of economic processes dynamics with the specification of system of direct and indirect influence factors using a multifactor dynamic model. The assessment of depth and nature of their impact allowed to divide them by the stationary and non-stationary criterion. On the basis of received values the directions of regulatory policy transformation in the conditions of non-stationary economic processes have been offered.

New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 : In Responding to a Global Health Crisis, Industry is Discovering New, Efficient Ways of Meeting Objectives.

The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented learning opportunities and revealed how the pharmaceutical industry can improve upon traditional processes. To stay competitive while remaining compliant with agency regulations and guidance, companies need to implement new process/tools that allow for more flexible work models, consider expanding the use of decentralized/hybrid trials, and capitalize on the use of real-world evidence (RWE) and cloud-based data systems. In addition, regulatory agencies should retain the agility exhibited during current reviews of potential new therapies, applying this momentum to other areas of unmet medical need. Further, agencies should consider a globally acceptable application platform. This article, by the Pharmaceuticals' Head of Regulatory Affairs at Bayer AG, examines how impacts of the COVID-19 crisis will continue beyond the pandemic period to the benefit of patients, drug developers, regulators, clinicians, and caregivers.