Regulatory Reform Research Articles

Regulatory Reform: Results and Challenges

Abstract Over the last century, the United States has witnessed three approaches to achieving better regulatory outcomes: the removal of “economic” regulations in certain sectors; regulatory impact analysis (RIA) of new “social” regulations; and retrospective analysis of existing regulations. This article reviews the rationale for each approach, the results to date, and the remaining challenges. It finds that both institutional and technical factors influence the success of reform efforts.

Shadow Economy and Environmental Sustainability in Global Developing Countries: Do Governance Indicators Play a Role?

Environmental sustainability has been a challenging issue all over the globe, with air pollution posing a significant threat. One main factor contributing to air pollution is the growth of the shadow economies. This study investigates the effect of the shadow economy on air pollution and explores how these effects depend on the levels of governance indicators. We utilize key air pollution indicators: carbon dioxide (CO2) and nitrous oxide (N2O) emissions. Furthermore, we examine the role of key governance indicators: corruption control, the rule of law, and regulatory quality. The study utilizes an annual panel dataset of 107 selected developing countries worldwide, spanning from 2002 to 2020, and employs the System GMM technique, which effectively tackles the omitted variable bias, potential endogeneity, and simultaneity issues in the model. The estimation results indicate that a sizeable shadow economy significantly increases the levels of CO2 and N2O emissions. Moreover, the results reveal that robust governance frameworks, evidenced by enhanced corruption control, a stronger rule of law, and superior regularity quality, mitigate the adverse effects of the shadow economy on CO2 and N2O emissions. This highlights a significant substitutability between the shadow economy and governance indicators, indicating that improvements in governance formworks will not only reduce the size of the shadow economy but also weaken its harmful impact on air pollution. Policy initiatives should thus focus on strengthening governance mechanisms, particularly enhancing control of corruption and the rule of law to effectively reduce the environmental impact of the shadow economies in developing countries. Additionally, governments should prioritize reforms in regulations and legal frameworks to limit the expansion of the shadow economy, thereby decreasing their contribution to air pollution.

Crypto-Enabled Espionage: The Growing Threat to National Security

This paper examines the growing threat of crypto-enabled espionage and its impact on national security. The research addresses the central questions on how cryptocurrencies facilitate espionage, and what the implications for national security are. Using a qualitative approach, the study draws on existing literature, case studies, and intelligence reports to explore how cryptocurrencies are increasingly being leveraged by state and non-state actors for covert operations. The findings reveal that the key features of cryptocurrencies—such as anonymity, decentralization, and the lack of regulation make them highly attractive to espionage actors. Specific cases, including the use of cryptocurrencies by North Korean and Russian state sponsored espionage networks, demonstrate how these actors bypass financial surveillance systems. The study concludes that while cryptocurrencies offer significant advantages for espionage, they pose severe challenges for national security agencies, especially in terms of monitoring and preventing illicit activities. To address these threats, stronger international cooperation, regulatory reforms, and advancements in blockchain surveillance technology are necessary. The paper recommends further research into counterintelligence strategies that incorporate blockchain technology and artificial intelligence for monitoring crypto-enabled espionage.

DISP-13. TELEHEALTH UTILIZATION IN NEURO-ONCOLOGY: EXPERIENCE AFTER THE COVID-19 PANDEMIC

Abstract BACKGROUND Central nervous system (CNS) tumors are frequently characterized by physical disabilities, and treatment is often associated with side effects, as well as financial toxicity and loss of income owing to disease-related neurological deficits. Treatment at centers with specialized neuro-oncology care is associated with an overall survival benefit. However, access to such centers can be limited for many patients. Telehealth services represent an option for improving access to specialized care. During the COVID-19 pandemic public health emergency (PHE), regulatory and reimbursement changes provided patients improved access to neuro-oncology by telehealth. METHODS We retrospectively analyzed our institutional utilization of telehealth visits in the neuro-oncology vs solid tumor oncology practice after the COVID-19 pandemic. RESULTS Between July 2020 and April 2021, telehealth represented 24.1% of all neuro-oncology visits compared to 13.3% for all solid tumor groups. Between May 2021 and April 2023, telehealth visits remained frequent in neuro-oncology compared to solid tumor groups (34.6% vs 15.2%). Utilization rates declined across the practice in the year following expiration of the COVID-19 PHE in May 2023, though remained high for neuro-oncology at 34.1% vs 15.2% for solid tumor groups. Overall, telehealth visit utilization for neuro-oncology has remained more than double that of the oncology practice as a whole. CONCLUSIONS The striking difference between telehealth visit utilization in neuro-oncology compared with general medical oncology indicates that patients with CNS tumors, and those that provide care for these patients, have come to depend on this mode of care delivery. Even after expiration of the COVID-19 PHE, telehealth use remains high in neuro-oncology at our institution. Prospective evaluation to determine the safety of and clinical outcomes associated with telehealth visits for individuals with CNS tumors are critically needed. Such data may promote regulatory and reimbursement reform enabling broader adoption, service sustainability, and improved access to specialized care.

Barriers to opioid use in the Arab world.

The Arab world consists of 22 countries, representing 5.5% of the world's population. Morphine consumption accounts for less than 1% of the world's consumption. This is the first study to identify barriers to opioid use in the Arab world. This study aimed to investigate the barriers to opioid use in pain management in the Arab world. Online survey was developed to investigate barriers to governance, prescribing, distributing, dispensing and administering, as well as educational barriers in the Arab world. The questionnaire was sent via email and a mobile app to one expert physician in pain management and one licensed pharmacist from each Arab country. With the exception of Tunisia, Djibouti and Comoros, 34(77%) participants from 19 Arab countries answered the survey. Most countries lack local opioid production, necessitate special licenses for physicians, and restrict opioid prescribing to medical specialists. Special prescription forms are mandated, and pharmacists lack the authority to correct prescription errors or accept refill or verbal orders on opioids. Storage requirements for empty ampoules and prescriptions are enforced. Nurses are not allowed to carry opioids during home visits, and only first degree relatives can collect opioids for patients. Furthermore, the integration of palliative care and pain management curricula into pharmacies and medical schools is lacking. There is a wide range of regulatory and other barriers to opioid use in the Arab world. There is a substantial need for regulatory review and reform, as well as for educational initiatives, in most Arab countries.

Real Estate Inflation and Housing Finance in India : Mapping the Correlation between Raising Property Prices & Increasing Home Loans among Indian Cities

Focusing specifically on India — a country that has recently faced recessions partially due to housing bubbles, like many other nations around the world — this research explores in depth how development of real estate linked financing sector have fuelled mortgage led asset price inflation across different cities (both metros & Tier II/III) over decades. Drawing upon a variety of market statistics, policy and economic indicators, the research identifies strong relationships between housing loan availability — by way of loosening mortgage regulations — and property price growth. The study shows that metropolitan cities have witnessed growth in housing loans at a CAGR of 10-12% over last decade (2010–2020) resulting into similar annual price appreciation for real estate standing between 010-15%. Tier II and III cities alternatively, exhibited slower but more stable growth trends in property prices of 6-8% driven by government push & infrastructure developments. The research emphasizes how this relationship has been altered by a number of variables, including as urbanization, demographic changes, government housing programs, and regulatory reforms like RERA and GST. The results imply that although housing financing has played a significant part in promoting the expansion of the real estate market, the influence varies greatly depending on local market dynamics, infrastructural development, and the state of the local economy.

Legal Protection of Notaries in Document Validation through Technology-Based Systems: A Comparative Legal Review of Indonesia, the United States, the Netherlands, and Australia

This paper examines the legal framework and challenges notaries face in adopting technology-based systems for document validation in Indonesia, with a comparative analysis involving the United States, the Netherlands, and Australia. Indonesia's legal framework, particularly Law No. 2 of 2014 on the Office of Notary, has yet to fully accommodate electronic signatures and remote notarization. The requirement for in-person meetings for authenticating notarial acts creates a regulatory barrier to implementing cyber notary services. Furthermore, Indonesian notaries face limited access to essential data systems, such as Dukcapil (Civil Registration Directorate) and BPN (National Land Agency), complicating the verification of personal identity and property documents. In contrast, the United States has adopted e-notary systems, using blockchain technology to ensure data integrity and mitigate fraud risks. The Netherlands provides an integrated platform, allowing notaries to validate documents remotely by accessing national databases in real time. Meanwhile, Australia has implemented a Digital Identity Program to facilitate efficient online authentication of documents. These innovations demonstrate how interoperability, regulatory flexibility, and digital literacy can enhance notary services and legal certainty. This paper proposes regulatory reforms in Indonesia, including revising existing laws to support remote notarization and electronic signatures. Second, developing integrated data platforms for real-time access. Third, providing training programs for notaries to adopt new technologies and ensure data security. By aligning Indonesia’s legal framework with international best practices, cyber notary services can enhance efficiency, security, and legal protection for both notaries and the public, meeting the demands of the digital era.Comparison

Improving access to domestic innovative medicines: characteristics and trends of approved drugs in China 2010-2024.

China has initiated drug regulatory reforms since 2015. Here, we analyze the characteristics and trends of domestic innovative drugs approved for marketing in China from January 2010 to May 2024 to explore the effectiveness of drug regulatory reform. Overall, 219 drugs were approved, with growth in chemicals and therapeutic biologics post-reform. Single-arm trials as an important option for clinical trial design of antineoplastic agents increased. The time for each link from investigational new drug (IND) to new drug application (NDA) has been shortened post-reform. Moreover, the time for access to medical insurance for approved drugs has been shortened and price reductions have been increased. China's drug regulatory reforms have made progress in improving the accessibility of domestic innovative drugs.

Research and development investment of Chinese chemical pharmaceutical companies under the national pooled procurement: a retrospective panel data analysis, 2013–2022

ObjectiveTo generate evidence about changes in the research and development (R&D) investment of Chinese chemical pharmaceutical companies before and after the implementation of the national pooled procurement, to respond to...

Empowering Thai community pharmacists in combating antimicrobial resistance: Qualitative insight and sentiment analysis

BackgroundAntimicrobial resistance (AMR) is increasing globally and poses a significant public health challenge. Community pharmacists, especially in primary care settings, play a pivotal role in mitigating the irrational use of antibiotics, a key driver of AMR. ObjectivesThis study aims to explore qualitative insights from community pharmacists regarding antibiotic supply and usage, analyze sentiments related to AMR, and highlight the crucial role of community pharmacists in AMR stewardship at the primary care/community level. MethodsThis study engaged community pharmacists in Thailand through semi-structured interviews to obtain in-depth insights into the antibiotic supply and perceptions of AMR. Additionally, sentiment analysis, which evaluates the emotional tone of the pharmacists' responses, was conducted to enrich the findings. ResultsInterviews with 23 community pharmacists highlighted the practices, challenges, and strategies related to antibiotic supply and use. Key findings include the identification of barriers such as patient demand and lack of awareness about antimicrobial resistance (AMR), alongside strategies for improvement such as public education and professional development. Sentiment analysis reveals a cautiously optimistic perspective toward enhancing rational antibiotic use, underscoring the importance of comprehensive approaches that combine education, ethics, and regulatory measures to address the complexities of antibiotic management at community pharmacies. ConclusionThis study underscores the necessity of public awareness, pharmacist–patient relationships, and regulatory reforms for the rational use of antibiotics in community pharmacies. These findings emphasize that pharmacist education and adherence to professional ethics are essential for mitigating antimicrobial resistance and promoting rational antibiotic use.

World Health Organization Guidance on Health Practitioner Regulation: An Overview

ABSTRACT: The World Health Organization has released its first comprehensive Guidance document on health practitioner regulation, addressing a critical gap in global health policy. This Commentary provides an overview of the Guidance, which aims to support countries in strengthening their regulatory systems for health practitioners. The Guidance, developed through a rigorous process involving a literature review and expert consultation, covers a broad range of health practitioners and focuses on optimizing their utilization to meet population health needs. Key highlights include the description of the global regulatory landscape, identification of regulatory challenges in all societies, and policy considerations to realize dynamic, effective, and agile regulation. The COVID-19 pandemic is cited as an important example of a catalyst for regulatory reforms that enhanced workforce availability and access. This paper, co-authored by members of the World Health Organization Technical Expert Group, emphasizes the importance of aligning regulatory systems with broader health workforce and system priorities, adopting a risk-based approach, and addressing implementation gaps. It encourages policymakers, regulators, and researchers to use the Guidance to assess and update their regulatory systems and to generate more robust evidence on the impact of health practitioner regulation on health outcomes.

Using benevolent leadership to improve safety behaviour in the construction industry: a moderated mediation model of safety knowledge and safety training and education

Objectives. Despite extensive regulatory reform, safety research and safety programmes over the past several decades, the construction sector remains notoriously dangerous in different regions across the world. Despite the fact that effective leadership is crucial for improving workplace safety behaviour (SB), there have been insufficient studies on how benevolent leadership (BL) affects such behaviour. Methods. Using a cross-sectional design, this research examines the influence of BL on employees’ SB. The mediating role of safety knowledge and the moderating role of safety training and education were also observed. Data obtained from 413 employees of construction firms in Turkey were used to verify the links. Results. BL has positive influences on employees’ SB and safety knowledge. Safety knowledge has a positive influence on SB and partially mediates the BL–SB link. At a low level of safety training and education, the BL–safety knowledge link is weaker for firms whose employees receive low safety training and education. At high levels of safety training and education, both the direct and indirect links between BL and SB are stronger for firms with high levels of safety training and education. Conclusion. The findings significantly extend safety literature through the lens of implicit followership theory.

Decentralized Clean Energy for Rural India: The Role of Small Modular Reactors

India's rapid development and expanding population have intensified the need for sustainable energy solutions. This is particularly significant in addressing the growing disparity in energy access between urban and rural communities. As the country shifts from traditional fossil-fuel-based power generation to cleaner technologies, nuclear energy is poised to play an increasingly vital role. Small Modular Reactors (SMRs) represent a promising option to meet these energy demands in a decentralized and environmentally friendly manner, especially in rural regions. In this perspective article, we explore the technological, economic, social, and environmental advantages of deploying SMRs in rural India. SMRs offer the potential for faster and cheaper build, as well as stable and reliable power, which is essential for driving economic growth in underdeveloped areas. However, several challenges need to be addressed, including regulatory and legislative hurdles that could impede the integration of SMRs into the existing energy mix. This article also suggests solutions such as leveraging India’s existing reactor technology expertise, utilizing the mature supply chain framework, co-locating SMRs with renewable energy sources, and advocating for necessary regulatory and legislative reforms. These would help SMRs serve as a crucial bridge in facilitating a smoother transition from fossil fuel plants to clean energy technologies, particularly in underserved rural communities.

Regulatory reforms will boost African vaccine production and access

Regulatory reforms will boost African vaccine production and access

Evaluation of value adding components from postharvest biomass of Thai medicinal cannabis var. Hang Kra Rog Phu Phan

Thailand has undertaken regulatory reforms to facilitate the cultivation and commercialisation of Cannabis sativa L. for medicinal purposes. The prominent cannabis strain in Thailand is Hang Kra Rog Phu Phan (HRPP), distinguished for its high tetrahydrocannabinol (THC) content. The recent adoption of a biocircular approach within the industry reflects a commitment to minimising losses and enhancing value-added processes. However, there is limited information on biomass generation from the postharvest management of this cannabis strain and the development of value-added products. This study aims to address this gap by conducting a survey of local cannabis farms and evaluating the quantity of cannabis biomass by-product materials resulting from the production process. According to the survey, stems were the most abundant materials followed by leaves and roots. These by-products were subsequently gathered and examined for its chemical components. The results of proximate analysis highlighted that the dried leaves had a high protein content up to 19.27 %, the highest in three types of biomasses. The composition of fat, fibre, ash, and carbohydrates varies depending on the type of biomass. By using sequential extraction, it was found that the extraction yield of pectin in the leaf materials was as high as 13.82 %, and in the stem part, it was at 13.02 %. Meanwhile, cellulose was found in the highest proportion from the roots, at 83.77 %. Confirmation of the composition of polysaccharides using microarray profiling revealed that these biomasses contain various types of polysaccharides (pectin, cellulose, hemicellulose). Analysis of bioactive compounds revealed that the total phenolic and total flavonoid content were the highest in the leaf biomass, consisting of 11.57 and 14.91 mg/g DM, respectively. The leaves also had the highest antioxidant activity. Quantitative analysis of the metabolites in the leaves found contents of rosmarinic acid 2.55 mg/g DM, catechin 2.33 mg/g DM, vanillin 2.32 mg/g DM and in the cannabinoid group, the highest quantity of cannabinol (CBN) 2.63 mg/g DM was found. The findings from this study could serve as a guideline for utilising biomass generated from the production process of cannabis that could be used for pharmaceutical, food, and feed purposes.

The Fifth Industrial Revolution and the Gig Economy: Assessing Technological Advancements Gaps, Regulatory Gaps and Skills Development Needs in Delhi NCR, India

The gig economy in India has grown significantly over the past decade, with millions of workers engaging in platform-based employment. Simultaneously, the world is transitioning to the Fifth Industrial Revolution, characterized by the integration of advanced technologies such as artificial intelligence, robotics, and automation with human-centered values. This study explores the impact of the Fifth Industrial Revolution on gig workers, focusing on working conditions, job security, access to skills development, and the adequacy of current regulatory frameworks with special reference to Delhi &NCR region. A mixed-methods approach was employed, combining quantitative data from surveys of gig workers and qualitative insights from in-depth interviews with platform executives and policymakers. The study found that while technological advancements have improved working conditions in some areas, job security remains a significant concern for gig workers. Additionally, access to skills development is strongly correlated with workers' ability to adapt to new technologies, but many face barriers to acquiring necessary training. The study also reveals a widespread perception that current regulations, including the Social Security Code, 2020, are inadequate in addressing gig workers' needs. These findings highlight the urgent need for comprehensive regulatory reforms and greater investment in skills development to ensure that gig workers can fully benefit from the opportunities of the Fifth Industrial Revolution while being protected from its risks.

Brazilian natural gas market dynamics: A data panel analysis of the Brazilian market compared with Argentina, Colombia, Mexico, and India using Porter's five forces framework

This study offers a comparative analysis of natural gas markets in Brazil, Mexico, Colombia, Argentina, and India, spanning from 2000 to 2020. Leveraging panel data and historical time series analysis, coupled with Porter's Five Forces framework, it examines industry dynamics across upstream, downstream, midstream, and upstream dimensions. Insights into competitive landscapes are derived, considering regulatory frameworks, resource availability, infrastructure development, and demand patterns. Despite Brazil's efforts to enhance domestic production, infrastructure, and regulatory reforms, challenges persist, hindering sectoral growth. Comparative studies underscore the need for policy improvements to align with investment commitments. This study contributes novel insights into the competitive positioning of natural gas markets, offering actionable recommendations for stakeholders. Identifying potential bottlenecks informs strict decision-making in the global energy landscape.

The Effects of Governance-Related Regulatory Reform: Ownership Structure and Earnings Management in Vietnamese Listed Firms

The purpose of this study is to examine how the influence of the internal corporate governance mechanism, namely ownership structure, on firms’ earnings management (EM) practices and insider choices between accrual-based and real EM changed after regulatory reform in Vietnam. The author considers the role of three ownership types, managerial, state and foreign, and assess how the relation between ownership structure and EM was affected by the Code of Corporate Governance reform. The study relies on a comprehensive sample of 4,408 firm-year observations of 596 firms listed on either the HOSE or HNX between 2008 and 2016. The study finds a significant effect of the reform on the relation between ownership structure and EM. Thus, the reform mitigated agency problems of managers and foreign investors in Vietnamese listed firms. The study contributes to the literature as it provides a more complete picture of the effects of managerial, state and foreign ownership on EM where the protection of minority investors is generally weak and legal enforcement is low in a developing economy.

Migration and Economic Development: The Role of Migrant Flows in Shaping Turkey’s Emerging Economy and Uncovering Hidden Conflicts and Challenges

This research examines the economic impact of migration on Turkey's emerging economy, with a particular focus on the contributions of migrant remittances, labor market dynamics, and the socio-political challenges associated with large-scale migrant flows. By employing econometric models and field research, the study explores the relationship between remittance inflows and key economic indicators such as GDP growth, employment rates, and poverty reduction. Additionally, the research uncovers hidden conflicts and social tensions that arise from migration, including labor market inequalities and integration challenges faced by both migrants and Turkish workers. The project evaluates government policies, such as the EU-Turkey refugee agreement, and their effects on economic development and social stability. Field research in migrant-receiving communities reveals the complexities of labor competition and the social dynamics created by migrant dependency in sectors such as agriculture and construction. Findings highlight the need for inclusive migration policies that balance the economic benefits of remittances with the social integration challenges faced by migrant populations. This study also advocates for stronger labor protections and regulatory reforms to mitigate tensions and reduce exploitation in low-wage sectors. The research contributes to the broader understanding of migration’s role in shaping Turkey’s economy and provides insights for policymakers seeking to address both the economic and social dimensions of migration.

Corporate Governance in Nigeria: Evolution, Regulatory Frameworks and Challenges

Aims: Undoubtedly, good corporate governance is critical for economic growth and development. In Nigeria, corporate governance has undergone a considerable revolution, driven by regulatory reforms, global standards as well as the need to strengthen corporate institutions. This review explored the evolution of corporate governance practices in Nigeria and the operating environment of the Nigerian Stock Exchange highlighting the milestones, regulatory frameworks and key challenges inhibiting the corporate sector. The review emphasized the roles of the regulatory agencies including the Securities and Exchange Commission (SEC), Financial Reporting Council of Nigeria (FRCN), Central Bank of Nigeria (CBN), National Insurance Commission (NAICOM), Pension Commission (PENCOM) as well as the Nigerian Communications Commission (NCC) in enforcing governance codes and principles. Study Design: It is a theoretical review that explores developments in the corporate governance landscape in Nigeria. Place and Duration of Study: The place of study is Nigeria and the duration is 1960 to 2024. Methodology: The study examined policy documents exploring different codes and mechanisms of corporate governance from inception to date. Results: While notable progress has been made through the introduction of corporate governance codes, mechanisms and regulatory oversight, challenges such as corruption, insider abuse and enforcement of governance policies remain prevalent. Conclusion: The review underscored the need for continuous improvement in corporate governance given its role in promoting transparency, accountability, increasing stakeholder awareness as well as stronger enforcement to ensure good governance practices and sustainable economic growth.