Regulatory Reform Research Articles

Balancing medical innovation and affordability in the new healthcare ecosystem in China: Review of pharmaceutical pricing and reimbursement policies

AbstractThe China Basic Medical Insurance Program was created in 1999 with three objectives: equal accessibility, affordability, and quality. Today, it has become the biggest medical insurance program in the world, covering 95% of China's population. Since 2015, China's healthcare ecosystem has been reshaped by increasing innovation, which has in turn been driven by regulatory reform, enhancement of research and development capability, and capital market development. There has also been improved regulatory efficiency to reduce lags in launching drugs. In 2022, nearly 20% of novel active substances launched globally were from China. China has also risen to become the second biggest contributor to innovation in terms of pipelines. Using a “fast‐follow” strategy, many locally developed innovative drugs can compete with products from multinational companies in their quality and pricing. However, China's pharmaceutical and biotechnology industry will continue to face challenges in pricing and reimbursement, as well as a shortened product lifecycle with rapid price erosion. The government has already accelerated the timeline for updating the drug reimbursement list and is willing to create a high‐quality medical insurance program. However, some obstacles are hard to overcome, including reimbursement for advanced therapies, limited funding and an increasing burden of disease due to an aging population. This article reviews the trajectory of medical innovation in China, including the challenges. Looking forward, balancing affordability and innovation will be critical for China to continue the trajectory of growth. The article also offers some suggestions for future policy reform, including optimizing reimbursement efficiency with a focus on high‐quality solutions, enhancing the value assessment framework, payer repositioning from “value buyer” to “strategic buyer”, and developing alternative market access pathways for innovative drugs.

Mitochondrial Donation: The UK Experience

Mutations in mitochondrial DNA (mtDNA) are inherited exclusively from our mothers and can cause a broad range of debilitating and fatal diseases. Reproductive technologies designed to uncouple the inheritance of the mitochondrial genome from the nuclear DNA genome may enable affected women to have a genetically related child with a greatly reduced risk of mtDNA disease. Such technologies involve transplantation of the nuclear DNA from the egg of an affected woman to an enucleated egg from an unaffected donor. Nuclear genome transplantation can be performed either before or after fertilisation. The latter involves transfer of pronuclei, which separately contain the maternal and paternal genomes. In parallel with legal and regulatory reform to permit therapeutic application of so called “mitochondrial donation” techniques in the UK, we have conducted preclinical studies to test the safety and efficacy of pronuclear transplantation (PNT). In 2017 Human Fertilisation and Embryology Authority (HFEA) approved the cautious use of PNT in the UK and granted the first licence for its therapeutic application in 2018. I will discuss the scientific, legal, and regulatory hurdles in the path from proof of concept to translation of mitochondrial donation to clinical treatment.

Control Beyond Ownership: Open‐Book Accounting in Unbalanced Supply Chain Networks*

AbstractOpen‐book accounting is a practice to disclose the full cost structure of suppliers to customers to achieve cost efficiency in supply chains. However, the dominant market power of customers could interfere with this goal in practice. Using unique data on the suppliers of large Korean business groups, we find that open‐book accounting is associated with profit rate regulation by customers. Suppliers' price growth is capped despite the increase in supplied goods. Profit rates of suppliers significantly co‐move in times of low average profitability. Using an exogenous regulatory reform that outlawed coercive open‐book accounting, we find the tendencies significantly reversed post‐reform.

Institutional Formation in Tumultuous Times: Reforming English Social Housing Regulation Post-Grenfell

English social housing regulation theoretically exists to promote the social purpose of the sector, yet the success of regulation against this objective has been questioned amidst concerns with the quality of service provided by landlords. Following the Grenfell Tower fire, the government initiated a reform process to reverse a policy of regulatory passivity on consumer standards. This paper conceives of regulatory reform as a case of institutional formation; a dynamic process that shapes conduct via rules, practices and narratives. It fills an empirical gap on how regulatory practice has responded to an ambiguous institutional environment where the governmental narrative was committed to improving standards, but formal legislation lagged. Quantitative text analysis demonstrates that the Regulator of Social Housing (RSH) has re-emphasised consumer standards post-Grenfell. But the process of institutional formation has been punctuated by social, political and economic crises, and the power of the regulator to enforce improved standards has been limited by legislative delays.

질서행정과 규제개혁

From an administrative law perspective, policing does not only refer to the police in the formal sense, but to administrative actions that are practiced for maintaining order in various areas. However, as order administration is carried out in many administrative areas, regulations will expand accordingly for the purpose of risk prevention. As a result, there will be an increase in the infringement of fundamental rights of individuals. Even if regulations have traditionally been aimed at preventing risks, the purpose of regulations today is not simply about control. It also serves to guide the direction for development of society and functions as a driving force. In order to prevent risks, it is necessary to find ways to promote social and public utility by allowing t is study suggests the following directions for regulatory reform in order administration.
 First, checking the viability of regulations based on the unnecessity of regulations should be prioritized rather than strengthening regulations to expand the purpose of regulation. Second, unclear and unpredictable regulations should be clarified with regulatory reform. Third, regulations should comply with the principle of proportionality. In regulatory reform, the principle of proportionality should be applied to determine whether a regulation should be deregulated or strengthened. Fourth, the criteria, procedures, and methods to be considered in the regulatory reform process should be fully discussed in advance. The relevant procedures and methods should be designed to prevent arbitrary and subjective judgment on individual regulations in exceptional circumstances. Fifth, judicial control should be strengthened when active administrative actions for risk prevention and control are expanded. Sixth, the social costs of regulation should be fully examined.

NFTs and the Legal Landscape -A New Frontier in Intellectual Property, Digital Ownership, Financial Crime, Collective Organisations and Consumer Protectio

In the ever-evolving digital landscape, Non-Fungible Tokens (NFTs) have emerged as a disruptive force, challenging the traditional paradigms of digital asset ownership and control. As Fortnow and Terry aptly highlight, NFTs seek to redefine the relationship between creatives, users, and digital artwork, a relationship historically dominated by powerful online intermediaries operating under the access model [1].The prevailing access model, underpinned by a blend of technological, legal, and market dynamics, has largely curtailed the ability of creators and individual internet users to exert meaningful control over digital assets. Instead, these assets are predominantly governed by centralized intermediaries, offering seemingly unlimited access. While this model boasts advantages, such as a robust rights management system ensuring IP security and user convenience [4], it is not without its criticisms. The most glaring concern for creators is the 'value gap' -the disparity between the value generated by intermediaries and the compensation received by content creators [3]. This concern was so profound that it catalysed significant reforms in the EU's digital platform regulations in the form of the DSM Directive and, most recently, the DSA Act [2].Centralized intermediaries, with their overarching influence, have not only skewed the value distribution but have also left users vulnerable. The tentative nature of access rights means users can be deprived of their digital assets without warning, rendering them powerless against potential misuse by these intermediaries [5].This special issue of the journal underscores the profound impact of NFTs on Intellectual Property law. We are privileged to feature contributions that delve deep into this relationship from diverse legal perspectives. Dr. Ioanna Lapatoura offers a compelling analysis of the intricate relationship between NFTs and trademark law, using the MetaBirkins case as a focal point. Daniel Becker and Aylton Gonçalves, on the other hand, explore the implications of NFTs within the Brazilian legal framework. However, the legal ramifications of NFTs extend beyond IP law. In that context, Matteo Alessandro challenges traditional notions of property in light of NFTs, while Marica Ciantar examines the transformative potential of NFTs and Decentralized Autonomous Organizations (DAOs) in reshaping collective organizational governance. Prof. Dr.Yulia S. Kharitonova exploredlegal issues of decentralized services in the context of utility NFTs. J.-G. A. Hanneman researched DAOs and AI-based Smart Contracts. The darker aspects of NFT transactions are also addressed, with Ass Prof. Dr. Dimitrios Kafteranis, Dr. Huseyin Unozkan and Prof. Dr. Umut Turksen elucidating their alignment with financial crime regulations. Moreover, the discourse on NFTs in private law is expanded upon by Dr. Elena Tzoulia, who highlights their intersection with the secondary digital consumer protection acquis in the EU.This issue serves as a testament to the multifaceted legal challenges and opportunities presented by NFTs. Through the insightful contributions of our esteemed authors, we hope to foster a deeper understanding and stimulate further discourse on this pivotal topic.

Quality and quantity of data used by Health Canada in approving new drugs

BackgroundThis study examined multiple aspects about the approval of new drugs: the characteristics of the drugs, the quality and quantity of information that Health Canada discloses about the demographics of patients enrolled in clinical trials, the characteristics of the trial, and the type of review that it uses. It examines whether there have been changes in these measures between 1 September 2012 and 31 March 2022.MethodsA list of all new drugs approved, type of review used, and drug characteristics was generated from Health Canada annual reports. Therapeutic categories were identified from the World Health Organization Collaborating Center for Drugs Statistics Methodology. The Summary Basis of Decision documents of Health Canada were used to identify patient demographics in clinical trials and clinical trial characteristics.ResultsHealth Canada approved 326 new drugs for 407 indications. The percent of orphan drugs approved increased from 35.6 to 51.3%. The number of indications per drug decreased (p = 0.0817) as did the number of pivotal trials per drug (p = 0.0091). The percent of Phase 3 trials dropped from 76.3% in 2012–2015 to 64.8% in 2019–2022 (p = 0.005). There was also a statistically significant decrease in the percent of trials that were randomized, controlled, and blinded. The clinical trial characteristics of orphan drugs and the type of review used were both significantly different compared with non-orphan drugs. The percent of trials which had information about the number of patients enrolled, the percent of trials that provided the age of the patients, and the sex breakdown all significantly increased.ConclusionThe results show that there has been a change in regulatory standards that may be due to them becoming less rigorous, because of an adaptation to the number of orphan drugs being submitted or a combination of both reasons. At the same time, there has been some improvement in the transparency of data. Health Canada has recently embarked on a series of reforms in drug regulation and clinical trial management. These changes need to be closely evaluated to be sure that they enhance the efficacy and safety of new drugs.

Volatility Analysis of Indian Banking Sector using Bollinger Bands

This research paper aims to analyze the bank volatility in India by examining various factors that contribute to fluctuations in the Indian banking sector. The study investigates the impact of regulatory reforms, macroeconomic indicators, financial stability, and global factors on bank volatility. The research utilizes a comprehensive dataset covering a period of one year i.e (01-04-2022 to 31-03-2023) to provide an in-depth understanding of the dynamics of bank volatility in India. We have used Bollinger bands to understand the volatility of three premier banks in India namely, HDFC Bank, ICICI Bank and STATE BANK OF INDIA in Indian stock market. The findings of this study will contribute to the existing literature on banking in emerging markets, understand the factor of volatility in present times and will also provide valuable insights for policymakers and stakeholders in the Indian banking sector.

Reform and Simplification of Legislative Regulations in Indonesia

Objective: The objective of this research is to analyze the reform and simplification of existing laws and regulations in Indonesia. This involves assessing the current legislative system's hindrances, focusing on the synchronization of legislative planning at both central and regional levels with development planning and policies. The aim is to understand how reform can optimize the performance of state administrators, create a sense of security at work, avoid excessive levies on society, increase budget efficiency, and attract investment, particularly foreign investment.
 
 Method: This research adopts a normative legal approach to examine the existing legislative system in Indonesia. The method involves a comprehensive analysis of legal and regulatory frameworks, emphasizing the need for reform and simplification. The research delves into the complexities of the legislative process, tracing the transformation from individual interests to public issues, with a focus on societal interests and humanitarian principles. Mapping the needs and planned legislative programs is a crucial aspect of the method to maintain the effectiveness and relevance of each regulation.
 
 Result: The research findings indicate that the reform and simplification of legal regulations in Indonesia play a vital role in optimizing the performance of state administrators, ensuring a secure work environment, preventing excessive levies on society, enhancing budget efficiency, and attracting investment, especially foreign investment. The results highlight the importance of aligning legislative planning with development goals and policies to address the current deviations from the intended material content in legislative regulations.
 
 Conclusion: In conclusion, the research underscores the significance of reforming and simplifying existing laws and regulations in Indonesia. The legislative system's shortcomings, including the lack of synchronization with development planning and deviations from intended content, pose challenges that need to be addressed. The establishment of legal certainty, realization of justice, and provision of social benefits are identified as the primary objectives of any legal regulation. Therefore, it is crucial to map the needs and plan legislative programs effectively to maintain the relevance and effectiveness of the regulatory framework.

Infrastructure Investment and Job Creation under the U.S. 2021 Economic Stimulus Plan

The U.S. 2021 Economic Stimulus Plan prioritized strategic infrastructure investments to revive the economy, create jobs, and foster sustainable growth. This analysis explored their impact, revealing direct job creation across industries and regions, alongside ancillary employment through the supply chain. These investments addressed disparities, notably boosting employment in distressed regions. Moreover, they hold potential for long-term economic impact, modernizing infrastructure, fostering innovation, and promoting sustainability, notably in renewable energy and eco-friendly projects. The study recommends continued investment in sustainable infrastructure, regulatory reforms, and innovation initiatives for lasting economic and societal benefits. In conclusion, the infrastructure investments within the stimulus plan laid a resilient foundation for economic recovery, job creation, and sustainable development, showcasing broader implications beyond immediate employment gains.

The Independent Medicines and Medical Devices Safety Review: Regulatory Reform and Remedies

For years, groups of patients and their families in the United Kingdom raised their concerns about three medical interventions. The first was a possible link between hormone pregnancy tests and fetal malformations and deaths; the second was the physical and neurodevelopmental impacts of in utero valproate exposure; and the third was life-changing adverse events caused by pelvic mesh implants for pelvic organ prolapse repair and stress urinary incontinence management. In response to their tireless campaigning, the Independent Medicines and Medical Devices Safety (IMMDS) Review was commissioned by the Secretary of State for Health and Social Care in 2018. The review, chaired by Baroness Cumberlege, found a catalogue of institutional, systems and structural failures within both the medical establishment and healthcare system more broadly. Drawing on the IMMDS Review findings on pelvic mesh, in this article, I consider the dire consequences when medical devices go wrong. Drawing on firsthand experience as lead researcher for the IMMDS Review, I examine some of the background, outline some key findings and reflect on the strategic changes recommended to medical device regulation and the redress prompted by the pelvic mesh scandal. In so doing, I contextualise and consider the relevant regulatory frameworks, the fundamental systems failures and the other issues identified. Three years on, this article also provides an opportunity to assess the extent to which the IMMDS Review recommendations have been successfully operationalised, as well as to take stock of the improvements that still need to be made.

Vertical Regulatory Reform and Air Pollution: Evidence from China’s City-County Merger

Vertical Regulatory Reform and Air Pollution: Evidence from China’s City-County Merger

Impact of environmental supervision reform on green innovation in mineral enterprises

This study aims to investigate the impact of environmental regulatory reform on the green innovation performance of mineral enterprises and the transformation of mineral cities. It analyzes the progress in the green innovation performance and urban transformation of mineral enterprises. Besides, the study categorizes environmental supervision system reform, green innovation performance of mineral enterprises, and urban transformation into distinct dimensions and establishes research hypotheses. Testing is performed through a questionnaire and subsequent data analysis. The results demonstrate the effectiveness of the questionnaire. Furthermore, the overall assessment received an average score of 3.8, signifying that most participants held relatively positive views regarding environmental regulatory system reform. The standard deviation of the scores was 0.97, indicating some diversity and variations in individual overall assessments. Hence, this study contributes to the green innovation performance of mineral enterprises and the transformation of mineral cities under environmental regulatory system reform.

Reform and Breakthrough in Business Regulations for Empowering MSMEs in Indonesia and the Netherlands

There are too many overlapping MSMEs determination policies which result in hampering MSMEs empowerment. The dynamics of global change require a fast and responsive response because, without policy reformulation, economic growth will stagnate or even slow down. This article delves into the necessity of regulatory reform to enhance the ease of doing business for MSMEs, using the Omnibus Law method. Conducted as normative legal research, this study uses normative legal research and analyzes secondary data to examine the existing challenges. The findings reveal various obstacles faced by MSMEs, including complexities in obtaining business licenses, cumbersome tax payment systems, limited access to business capital, and the absence of a formal business entity. To address these regulatory issues, alternative solutions are proposed through the Omnibus Law method, emphasizing the simplification of regulations, fostering public participation, and harmonizing both vertical and horizontal regulations. Moreover, drawing lessons from the Netherlands, where the government established the Dutch Advisory Board on Regulatory Burdens (ATR) to reduce administrative burdens on SMEs, Indonesia can prioritize similar measures to simplify regulations and lower costs. By emulating the ATR's independent and collaborative approach, Indonesia has the potential to establish its own advisory body, fostering a supportive business environment for SMEs and promoting economic growth.

An empirical study on micro, small, and medium enterprises access to finance in Kosovo: A survey based analysis

This study investigates the access to finance among Micro, Small, and Medium Entities (MSME) in Kosovo, providing an understanding of the financial landscape of this important sector. Utilizing a quantitative research design, the study administered a structured questionnaire to a representative sample of 250 MSME in Kosovo, encompassing a variety of industries and sizes. The questionnaire measured the types of financing used, perceived barriers to accessing finance, and the impacts of financial constraints on the business.Data analysis included descriptive statistics, inferential statistics, and regression analysis. Findings suggest a reliance on internal funds among most MSMEs, with high-interest rates and stringent collateral requirements identified as major barriers to accessing external finance. Moreover, firm size and years of operation appeared to positively influence access to finance. The study concludes with recommendations for regulatory reforms, financial sector development, and capacity building to ease these barriers and enhance MSME growth and competitiveness.Further research is encouraged to probe the effectiveness of different interventions and delve deeper into the experiences of MSMEs in navigating their financial constraints.

Confronting standards-making in food safety: Standards recalibration and regulatory reforms in China’s dairy industry

In 2012, the Beijing First Intermediate Court’s ruling reignited public controversy over a 2010 revision of China’s national raw milk standard. A consumer rights activist filed an open information application, requesting that China’s Ministry of Health disclose meeting minutes related to the revision. His request hinged on public perception that China’s dairy corporations helped lower quality and safety thresholds for domestic raw milk supplies, while the country still reeled from the 2008 melamine scandal. The case re-emerged as Chinese policymakers, seeking to strengthen and respond to domestic and international food safety concerns, crafted and revised standards and restructured government agencies to address shortcomings in the 2009 Food Safety Law. As the case unfolded, China was flexing its international power in standards-setting despite criticism of its domestic standards regime. Grounded in fieldwork conducted during this period, I trace the intersection and dissonance between standards, regulations, and best practices crafted by government institutions and private sector actors alongside their recalibration in practice. I use the 2010 revision debate to explore the efforts of scientific experts and government officials to convey the standard to different actors, not as acts of translation but rather as acts of transformation, as regulations and regulatory practices move across disparate sites and media.

Corporate governance reforms, societal trust, and corporate financial policies

While formal institutions are considered important in affecting corporate behaviors, little attention has been paid to the role of informal institutions in such relation. We employ the (formal) corporate governance reforms and the (informal) individual countries' trust levels to examine how the informal institution moderates the impacts of the formal institution on corporate financial policies. Using a sample of 88,929 firm-year observations across 35 countries, we document a positive effect of corporate governance reforms on corporate financing and investment. More importantly, we find that the positive effect of the formal regulatory reforms is more pronounced with lower levels of informal country-level trust. Further analysis shows that corporate governance reforms lead to both lower under- and over-investment, and the effect is also stronger in low-trust countries. Our study sheds light on the interactive relation between corporate governance and trust and indicates that countries can offset the negative lack-of-trust effect on economic outcomes through formal regulatory reforms.

The Ways to Prevent Intentional Tax Evasion

Tax evasion poses a substantial challenge to governments worldwide, undermining public revenue and eroding trust in the tax system. This article explores a multifaceted approach to preventing intentional tax evasion. Drawing from a review of academic research, case studies, and policy initiatives, it delves into strategies encompassing behavioral economics, legal and regulatory reforms, technology and data analytics, international cooperation, and transparency measures. The article emphasizes the importance of fostering a culture of compliance, deterring evasion through legal means, leveraging technology for detection. It also underscores the significance of addressing corporate tax evasion, whistleblowing, and transparency.

Does an effective audit committee influence firm performance? –The moderation role of knowledge intensity

Purpose This study aims to examine the relationship between audit committee (AC) effectiveness and firm performance (FP) with the moderation of knowledge intensity while observing the varying effect of each AC characteristic’s influence on its effectiveness. Design/methodology/approach This study examines 133 companies covering five years from 2016 to 2020 using the partial least squares-structural equation model and weighing AC effectiveness-related characteristics through multiple regression between AC characteristics and the AC effectiveness construct. Findings The results indicate that the knowledge intensity of the firms negatively influences the relationship between their AC effectiveness and FP, implying that the ACs are not sophisticated enough to monitor the knowledge component of the firm’s assets. Among AC characteristics, six attributes have a significant positive impact, two have a negative impact and three have no significant influence on AC effectiveness while influencing FP. Research limitations/implications Apart from guiding the regulators, managers and other stakeholders to choose an appropriate mix of AC characteristics for enhancing FP, the study contributes to the existing literature by providing evidence that ACs are ineffective in monitoring the knowledge assets of the company compared to physical assets. Originality/value This study is pioneering in investigating the moderation role of knowledge intensity on the relationship between AC effectiveness and FP. While providing a comprehensive and holistic view of AC effectiveness by considering 11 AC characteristics’ individual as well as aggregate effects on FP, it removes the obsolescence of earlier research in the Indian context owing to the latest regulatory reforms.

Balancing Civil and Political Rights: Constitutional Court Powers in Indonesia and Austria

This study focuses on analyzing the role and challenges faced by the Constitutional Court in upholding political and civil rights in Indonesia and Austria. This research explores various conceptual and comparative aspects of law through normative research methods and delves deeper into how these institutions operate in practice. Analysis shows that the Constitutional Courts in both countries serve as the primary guardians of justice and human rights. However, it must also operate in a complex environment, dealing with social, political, and international challenges. The study found that changes in laws and regulations have significant potential to strengthen the authority and effectiveness of the Constitutional Court. This is reflected in the constitutional evolution in both countries, where legal and regulatory reforms have played an important role in shaping and defining the authority of the Constitutional Court. This study confirms the importance of increasing the capacity and legal knowledge of members of the Constitutional Court, as well as the need for greater understanding and appreciation from the public of this institution's vital role and function. This research contributes to understanding how constitutional institutions can adapt and evolve to meet challenges in enforcing political and civil rights.