Regulatory Setting Research Articles

Planning the Energy Transition: A Comparative Examination of Large-Scale Solar Energy Siting on Agricultural Land in Australia

The siting of large-scale solar energy projects on agricultural land has raised questions of how land use risks can be balanced. This balancing exercise creates a regulatory paradox. Solar energy is vital to energy system decarbonisation to mitigate climate change effects and create energy security. Yet, agricultural land may be negatively impacted where solar energy is not sited and regulated effectively to ensure arable land remains productive. The policy goals of facilitating solar energy development and arable land protection fall to planning regulatory regimes in Australia which, to date, have had varying approaches to assessing solar energy development on arable land. This article explores how the twin policy goals of increasing solar energy and arable land preservation can be achieved via planning regimes with effective siting and co-location legal tools. Such planning tools can encourage the development of renewable energy to reach net-zero emissions goals while ensuring appropriate regulatory settings providing co-benefits to agricultural activities. The article provides a comparative analysis of the planning regimes in three Australian states, Queensland, New South Wales (NSW), and Victoria, and their varied approaches to assessing solar energy development on agricultural land. This comparative evaluation is viewed against the backdrop of increasing climate change risks and the need to urgently transition to renewable energy successfully proffered by effective planning regulation.

PMI’s IQOS and cigarette ads in Israeli media: a content analysis across regulatory periods and target population subgroups

BackgroundIQOS, manufactured by Philip Morris International (PMI), is the highest selling heated tobacco product globally. IQOS went through several regulatory changes in Israel: from no oversight to minimal tobacco legislation,...

Some considerations on target estimands for health technology assessment.

Some considerations on target estimands for health technology assessment.

How environmental regulation can drive innovation: Lessons learned from a systematic review

AbstractRegulation is often seen as a barrier to innovation. However, if done properly, it can actually serve as a driver of innovation. To understand how environmental regulation can be designed to stimulate innovation, we scrutinise the scientific literature related to regulation, innovation and the environment. Fifty one carefully selected studies are examined with regard to their scope, results and geographical affiliation, and their findings were distilled into ten lessons on how to design environmental regulation to stimulate innovation. Subsequently, we discuss the validity and implications of the lessons. We find that the lessons are overarching concepts of principal nature that are applicable for most regulatory settings. We also find that recent EU regulations on plastics, nanomaterials and waste support many of the lessons learned, while some are completely neglected. The lessons offer important guidance and can be seen as a checklist of what regulators must consider when designing new regulation.

Fifty shades of CEO duality: CEO personal risk preference, duality and corporate risk-taking

PurposeThis study investigates whether and how chief executive officers (CEOs) with personal risk-taking preference (expressed in owning a pilot license) will act differently when they are vested with additional power serving as board chairs.Design/methodology/approachRegressions analyses are performed using a sample of Standard and Poor’s (S&P) 1,500 firms with available data during 1996–2009. CEO's risk-taking outcomes are measured using firms' total risk, idiosyncratic risk and research and development expenditures (R&D) investment.FindingsFirms led by pilot CEOs have greater firm risks, yet CEO duality attenuates the relationship. Further channel tests show that CEO duality suppresses CEO's risk-taking tendencies through managers' reputation concerns.Research limitations/implicationsThe findings highlight the importance of incorporating human factors into consideration of appropriate governance structures for a firm. Future studies can expand the existing data and further explore the relationship between human factors and governance structures on other firm strategies.Practical implicationsRegulators may focus mainly on regulatory setting based on the “best practice” of governance yet overlook human influence in corporate dynamics. For shareholders, hiring managers with distinct styles will change corporate outcomes but different governance mechanisms could be devised to adapt to CEOs with various personalities.Originality/valuePrior studies show that both CEO personal preferences and firms' governance structure affect corporate policies, and this paper complements prior studies by exploring how the two may interact to shape corporate policy and its outcomes. This paper also adds to the literature showing that CEO duality could serve a disciplinary role.

The scope of food fraud revisited

Food fraud is an emerging field of study in academic literature. The aim of this paper is to evaluate whether current understanding of food fraud in literature is in congruence with incidents of food fraud in the Netherlands. The discussion that follows is based on an analysis of 53 empirical cases on food fraud investigations conducted at the Netherlands Food and Consumer Product Safety Authority (NVWA), the nationwide enforcement body tasked with investigating food fraud. The findings elucidate the differences between food fraud and other (food) crime and highlight the discrepancies with academic definitions to date, most notably with respect to incidents of ‘food laundering’ and by emphasizing the existence of intentional facilitators. We thus suggest adjusting the scope of what type of behavior can be considered as food fraud by conceptualizing three forms of food fraud: food laundering, fraudulent food enhancement, and facilitative food fraud. Food laundering encompasses the use of illegal material as food, whereas fraudulent food enhancement describes a situation where legal food is value-enhanced through deceitful cost-cutting measures. Facilitative food fraud captures the role of facilitative actors that operate illegally and intentionally for economic advantage. Based on these concepts, we suggest a modified definition as follows: food fraud is committed by any actor who is intentionally involved in illegal acts for economic advantage, thus causing or facilitating illegal food to be laundered into the supply chain or for food to be fraudulently value-enhanced. Future research should focus on testing these concepts and this definition with empirical studies from different regions and regulatory settings, and introduce additional data sources outside of enforcement, such as employee or victim surveys.

What Causes Non-Performance Financing? Insights From Islamic Commercial Banks in Indonesia and Malaysia

This study aims to assess the determinants of Non-Performing Financing (NPF), particularly in the Islamic Commercial Banks (ICBs) setting. It seeks to test the effect of financing to deposit ratio (FDR), capital adequacy ratio (CAR), and return ratio (RR) on NPF at the ICBs in Indonesia and Malaysia, being the largest Islamic financial hubs in SoutheastAsian region. The whole population were 13 ICBs in Indonesia and 16 ICBs in Malaysia for the observation period from 2014 to 2018, resulting in 142 observations. The period was selected to avoid the effect of COVID-19 pandemic towards the variables tested in this study. This study uses multiple linear analyses of panel data to analyze the data collected. It was found that FDR, CAR, and RR, respectively, have an impact on the level of NPF. At the country-specific level, for ICBs in Indonesia, FDR was found to have a positive effect on the NPF level, while CAR and RR have a negative effect on NPF. Meanwhile for ICBs in Malaysia, all independent variables, namely FDR, CAR, and RR have a positive effect on the NPF level. The slightly variation in the findings may be attributed to the different regulatory settings in the two countries which may need further evidence. The findings of this study imply that NPF determinants may have different influence in two neighboring countries despite they seem to share many similar regional characteristics. The findings also suggest that to maintain low level of NPF the ICB may need to focus on the attributes of FDR, CAR and RR.

Costly sanctions and the treatment of frequent violators in regulatory settings

Regulators typically treat frequent violators more harshly. When does such harsh treatment maximize overall compliance? We consider the role of two factors: responsiveness to penalties and costs of sanctions. A novel insight is that maintaining a credible threat of sanction against infrequent violators is relatively cheap because that threat seldom needs to be backed up. In a Clean Water Act application, the marginal sanction deters ten times as many violations when directed at infrequent violators. On net, this difference is due to a sanction cost effect, not because infrequent violators are marginally more responsive to the threat of punishment.

ON THE BASIS OF PERCEPTION: A MODERATED MEDIATION ANALYSIS OF DOING BUSINESS AND CORRUPTION

One of the landmark projects from the World Bank was the initiative called the Ease of Doing Business (EODB), which captures business regulatory settings in countries worldwide. The EODB scores have long indicated a country’s attractiveness in doing business with private sectors and have attracted many scholars, policymakers, and practitioners to explore. Many researchers have indicated that doing business scores were associated with economic growth, international relations, business development, and many other areas. This study contributes to the debate on how business regulations are associated with the perception of corruption index (CPI) using moderated mediation analysis. The results find that GDP per capita mediates the relationship between EODB and CPI and that country’s income category moderates the mediation. The relationships are explored for a period of ten years, from 2010 to 2019 worldwide (n= 146). The country’s income category moderated the mediating impact of GDP per capita by softening the influence of EODB on CPI ( .3013, BootSE = .0507, LLCI =0.2246, ULCI= 0.4226). The author suggests corroborating factor analysis and exploring the variables using more advanced path analysis for future research

Critical Remarks on Reference-Scaled Average Bioequivalence

More than a decade ago the option to assess highly variable drugs / drug products by reference-scaled average bioequivalence was introduced in regulatory practice. Recommended approaches differ between jurisdictions and may lead to different conclusions even for the same data set. According to our knowledge, implemented methods have not been directly compared for their operating characteristics (Type I Error and power). We performed Monte Carlo simulations to assess the consumer risk and the clinically relevant difference for the recommended regulatory settings. In all methods for reference-scaled average bioequivalence the Type I Error can be inflated with a consequently compromised consumer risk. Furthermore, the clinically relevant difference could vary between studies performed with the same reference product. Only average bioequivalence with fixed - widened - limits would both maintain the consumer risk and offer an unambiguously defined clinically not relevant difference. As long as such an approach is not implemented in regulatory practice, we recommend adjusting the level of the test a.

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products.

Regulatory frameworks on tobacco and other nicotine-containing products (TNCP) continue to evolve as novel products emerge, including electronic nicotine delivery systems (e.g., electronic cigarettes or vaping products), heated tobacco products, or certain smokeless products (e.g., nicotine pouches). This article focuses on selected regulations for TNCPs that do not make health claims, and on the opportunities to use new approach methodologies (NAMs) to meet regulatory requirements for toxicological information. The manuscript presents a brief overview of regulations and examples of feedback from regulatory agencies whilst highlighting NAMs that have been successfully applied, or could be used, in a regulatory setting, either as stand-alone methods or as part of a weight-of-evidence approach to address selected endpoints. The authors highlight the need for agencies and stakeholders to collaborate and communicate on the development and application of NAMs to address specific regulatory toxicological endpoints. Collaboration across sectors and geographies will facilitate harmonized use of robust testing approaches to evaluate TNCPs without animal testing.

A Methodology Combining IDEF0 and Weighted Risk Factor Analysis for the Strategic Planning of Mine Reclamation

The reclamation of lignite surface mines is a long-term commitment of high complexity. These reclamation projects consist of land use repurposing, reinstatement of landforms and landscape, remediation of polluted soils and water bodies, restoration of ecosystems, and other related activities, which are usually developed when mines enter the ultimate phase of their operational life. Nowadays, reclamation is supported by regulatory settings and legislative provisions, which motivate the affected communities to move towards a circular economy and sustainable development. This paper investigates the geoenvironmental and socioeconomic problems of reclamation and draws research questions on how the strategic planning of a reclamation project can be performed and how the relevant project risks can be investigated and managed. In turn, a prototype methodology based on experts’ judgment is suggested with a case study combining: (a) the IDEF0 (Integrated DEFinition Function) modelling technique, as a low cost and easy-to-develop tool enabling strategic planning of reclamation projects, and (b) the Weighted Risk Factor analysis (WRF) as a suitable method for effective risk analysis and response planning in post-mining frameworks. Finally, a discussion on the methodology and proposals for further research are provided.

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A tale of six climates: Reflections and learnings after the development of six industry-specific safety climate scales

Introduction: Researchers are finding merits in utilizing industry-specific safety climate scales that capture the nuances of context, and tend to show stronger associations with safety behavior and outcomes like incidents. Yet, to date, guidance around the practicalities of developing and validating such industry-specific scales is lacking in the safety science literature. Method: In this paper we outline our experiences developing six industry-specific safety climate scales and highlight strengths and limitations of our approach. We also briefly review the industry-specific safety climate literature and offer highlights for consideration when developing such scales. Our method to develop industry-specific safety climate scales followed an established best practice structure: literature review of existing published industry scales, collation and review of existing scale items, consultation interviews with industry experts, item drafting, exploratory and confirmatory statistical analyses, and finally, a real-world ecological validity test. Results: Our research highlighted the diversity of safety climate dimensions (both the conceptual and content domains of each dimension) when it is considered at an industry level. Also, the literature reviews revealed a dearth of industry-specific safety climate scales in the areas we engaged with, so our project filled a glaring gap in research and practice. Best practice safety climate scale development methods are provided to stimulate further research. Conclusions: We conclude with reflections on the nature of safety climate within and across industries, and offer suggestions for future lines of research across other contexts (e.g., national culture, geography, and regulatory settings). We suggest that industry-specific safety climate scales have a specific use case, such as identifying specific areas to improve and evaluating the impact of safety interventions. Practical Applications: This article provides applications for both applied researchers (to improve capabilities in safety climate scale development) and practitioners who wish to measure organisational safety climate and design effective interventions. Engaging with regulators to build safety climate scales is powerful because their personnel have rich experiences to share across multiple workplaces. Organisational researchers can engage with survey panels to build robust scales. Finally, industry-specific nuances can lead to richer insights into an organisation’s safety climate.

The impact of research and development expenditure on firm performance and firm value: evidence from a South Asian emerging economy

PurposeThe main purpose of the study is to analyze the impact of research and development (R&D) expenditure on firm performance and firm value in an emerging economy.Design/methodology/approachIn this study, firm performance is examined by firm financial performance (return on asset (ROA) and return on equity (ROE)) and market performance (Tobin's Q (TBQ)). This study conducted a multivariate analysis on the sampled data using pooled ordinary least square (OLS) regression method. In addition, both the level and lagged models have been used to test hypothesis in order to get the results.FindingsAll the empirical results from different models found significant and positive association of R&D expenditure with firm performance and firm value. The study also validates that all results are robust and free from outliers and multicollinearity issues.Research limitations/implicationsMost of the studies regarding the R&D expenditure and its impact were conducted on developed countries addressing only firm performance. Whereby, this study examined the impact of R&D expenditure on both firm's financial performance and market performance as well as firm value in the context of an emerging economy.Practical implicationsThe outcomes of the study will enable the entrepreneurs, managers, investors and policymakers with more confidence to invest in R&D expenditure that will also ensure the organizational sustainability in the long run.Originality/valueMost of the prior studies regarding the R&D expenditure and its impact were conducted on developed countries addressing only firm performance. Herein, both firm's financial performance and market performance along with firm value have been analyzed in the context of an emerging economy. This paper is unique empirical research study due to different institutional and regulatory setting as well as corporate characteristics. This study strongly advocates the organizational learning theory, agency theory and resource-based view theory of firms' allocation of funds for future growth and innovation.

Governing food safety through meso‐institutions: A cross‐country analysis of the dairy sector

AbstractThis article builds on new institutional economics to characterize the functions played by meso‐institutions in bridging the gap between the macro‐institutional layer at which general rules are established and the micro‐institutional layer within which transactions are organized. The argument is substantiated through a comparative analysis of the regulatory settings designed to secure the safety of raw milk in Brazil, Canada, and Italy. We show that similar rules may lead to very different operational impact, depending on the arrangements through which these rules are implemented. The analysis also points out some consequences for the organization of supply chains and public policies.

Ad hoc network

There is no one set definition for the phrase “ad hoc networks”. The term refers to the ability for members of a network to establish a network connection between devices. Yet, ad hoc networks pertain to both the technical domain of network infrastructures, the social, political and economic modes of self-organisation they enable, and the regulatory and policy settings that enable them.

Dividend payment and financial restatement: US evidence

PurposeThe purpose of this paper is to investigate the impact of financial restatement on corporate dividend payment. Firms that announce financial restatements rupture their corporate reputation and adversely affect investors’ confidence. Consequently, firms must attempt to regain lost reputation and market confidence.Design/methodology/approachThis study uses the US regulatory setting to examine the association between corporate dividend policy and financial restatement over the 2001–2017 financial years.FindingsThe findings evidence a robust positive association between financial restatement and dividend payouts, indicating that firms pay higher dividends following the year of financial restatement. Several sensitivity tests were conducted to confirm the robustness of the findings.Originality/valuePrior research indicates that corporate dividend payouts enhance a firm’s reputation by reducing information asymmetry and providing a positive signal to investors regarding future financial performance. This study provides valuable evidence that dividend payout can be used as a channel for image restoration by firms with lost reputations because of financial restatement.

Practical considerations in utilizing cluster randomized controlled trials conducted in biopharmaceutical industry.

Cluster randomized controlled trials (cluster RCTs), also known as parallel-arm group-randomized trials, are trials in which the randomized units are groups of participants, as opposed to individual participants. These trials have largely been implemented to address broad public health issues, but with the growing interest in use of real-world data in the regulatory setting, this design may be increasingly considered for industry trials. The key difference between cluster RCTs and traditional RCTs is the intraclass correlation coefficient (ICC) that needs to be considered in cluster RCTs. In this article, we discuss some key practical considerations that are related to ICC in the design, conduct, analysis, and report stages of a cluster RCT. These key considerations related to ICC can lead to improvement in how we translate research findings from cluster RCTs into practices in the biopharmaceutical industry.

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Editorial Policy