Regulatory Initiatives Research Articles

Medicines Regulatory Science Expertise in Africa: Workforce Capacity Development and Harmonisation Activities Towards the Establishment of the African Medicines Agency.

The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs' regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.

Informational Obsession, Opinion Control and Freedom of Expression in Financial Regulation – Some Critical Perspectives

The theoretical underpinnings of financial regulation have led to an obsessive quest for transparency. This has not only led to a gradual increase in disclosure requirements, but has also generated some other unintended consequences, such as structural conflicts of interests, which affect the modes of information (and opinion) production of influential actors. Credit rating agencies, for example, have also in their own right raised new regulatory concerns. Within this wider context, this article explores whether regulatory initiatives to stringently discipline credit rating agencies’ activities (particularly with a view to issuing sovereign ratings), or other initiatives which reflect an increasing willingness to control speech in financial markets (for instance those targeting activist shareholder strategies), are in line with relevant principles guaranteeing the freedom of expression which have seemingly remained a blind spot of financial regulators. Financial regulation, transparency, disclosure, information, opinion, freedom of expression, financial disintermediation, credit rating agencies, shareholder activism, financial evaluation

対面ビジネスとしての不動産流通業のあり方

Face-to-face business practices for real estate transaction were originally shaped according to legal regulation. Now existing business practices are gradually starting to change owing to ongoing regulatory reform initiative which aims to relax regulation on S&P process such as the explanation of important matters.

Solutions and Strategies to Reduce Damaging Impact of Single-Use Plastic Bag in Toledo City

The goal of this study is to gain a better understanding of residents' personal concerns about improper plastic disposal and to give voice to their thoughts about the Toledo City Government's prospective ideas and approaches for minimizing the city's plastic pollution. Residents of Magdugo, Toledo City, Cebu, Philippines, have been subjected to increasing levels of plastic pollution. The vast number of discarded plastic items that eventually end up in canals, drainage systems, and city streets, generating flooding that poses a severe challenge in agriculture, health, and sanitation. According to the findings, the city's inefficient waste management system has resulted in a massive accumulation of durable plastics. Toledo City, on the other hand, has improved waste management, restored cleanliness, and minimized the environmental effect of plastics through regulatory initiatives. The majority of citizens in Toledo City have enthusiastically embraced the city's ordinance prohibiting the use of plastic bags. Plastic bag littering has been shown to decrease throughout the city, resulting in a cleaner and healthier environment. The city's achievement might serve as a model for other places that have yet to abolish plastic bags. As a result of a cleaner and healthier environment, people have become more productive, and tourists have returned to the city, contributing to the city's economic growth. Policy management in the reduction of plastic pollution.

From P4 medicine to P5 medicine: transitional times for a more human-centric approach to AI-based tools for hospitals of tomorrow.

Within the debate on shaping future clinical services, where different robotics and artificial intelligence (AI) based technologies are integrated to perform tasks, the authors take the chance to provide an interdisciplinary analysis required to validate a tool aiming at supporting the melanoma cancer diagnosis. In particular, they focus on the ethical-legal and technical requirements needed to address the Assessment List on Trustworthy AI (ALTAI), highlighting some pros and cons of the adopted self-assessment checklist. The dialogue stimulates additionally remarks on the EU regulatory initiatives on AI in the healthcare systems.

Selection of Smart Grids Projects of Common Interest—Past Experiences and Future Perspectives

This paper discusses the authors’ experience gained with the selection of Projects of Common Interest (PCIs) in the thematic area of smart grids deployment, in the context of the TEN-E Regulation. It presents the framework for assessing candidate electricity smart grids for inclusion in the European Union list of PCIs, in view of the TEN-E Regulation and the existing literature on assessment methodologies for energy infrastructure projects. It also provides an overview of smart grid projects included in the PCI lists, with the aim to shed light on the types of projects and their contribution to accelerating the development of European cross-border energy infrastructure projects to respond to EU energy and climate targets. The paper concludes with discussion of recent regulatory initiatives and their potential implications on the presented methodology.

Exploring the alternative solutions and strategies of toledo city government for the damaging impact of single-use plastic bag in the environment

The object of research: The aim of this research is to gain a better understanding of residents' personal concerns about improper plastic disposal and to give voice to their thoughts about the Toledo City Government's prospective ideas and approaches for minimizing the city's plastic pollution.
 Investigated problem: Residents of Magdugo, Toledo City have been subjected to increasing levels of plastic pollution. The vast number of discarded plastic items that eventually end up in canals, drainage systems, and city streets, generating flooding that poses a severe challenge in agriculture, health, and sanitation.
 The main scientific results: According to the findings, the city's inefficient waste management system has resulted in a massive accumulation of durable plastics. Toledo City, on the other hand, has improved waste management, restored cleanliness, and minimized the environmental effect of plastics through regulatory initiatives.
 The area of practical use of the research results: The majority of citizens in Toledo City have enthusiastically embraced the city's ordinance prohibiting the use of plastic bags. Plastic bag littering has been shown to decrease throughout the city, resulting in a cleaner and healthier environment. The city's achievement might serve as a model for other places that have yet to abolish plastic bags.
 Innovative technological product: As a result of a cleaner and healthier environment, people have become more productive, and tourists have returned to the city, contributing to the city's economic growth.
 Scope of the innovative technological product: Policy management in the reduction of plastic pollution

Public Value and Citizen-Driven Digital Innovation: A Cryptocurrency Study

ABSTRACT Public value theory was conceived in a time before the far-reaching consequences of the digital era were fully realized, without sufficient explicit consideration of the dynamic and disruptive shifts that might occur on the technological frontier, especially when driven by civil society. As such, the disruptive and citizen-driven nature of many digital technologies, such as cryptocurrencies and the blockchain, has yet to be incorporated into the public value discourse. This article examines the relevance of the public manager to disruptive digital innovations, arguing that value creation is a function of addressing the digital aspirations of citizens, and making technological disruption into a conduit for public value co-creation that is driven by citizens. This is accomplished through mechanisms such as regulatory and policy initiatives that ensure public managers strike a balance between innovation and accountability. It theorizes this using Moore’s strategic triangle to foresee a role for proactive engagement by public managers in citizen-driven public value creation that balances innovative impulses and stronger accountability.

Exploring The Alternative Solutions and Strategies of Toledo City Government for The Damaging Impact of Single-Use Plastic Bag in the Environment

The object of research: The goal of this study is to gain a better understanding of residents' personal concerns about improper plastic disposal and to give voice to their thoughts about the Toledo City Government's prospective ideas and approaches for minimizing the city's plastic pollution.Investigated problem: Residents of Magdugo, Toledo City have been subjected to increasing levels of plastic pollution. The vast number of discarded plastic items that eventually end up in canals, drainage systems, and city streets, generating flooding that poses a severe challenge in agriculture, health, and sanitation. The main scientific results: According to the findings, the city's inefficient waste management system has resulted in a massive accumulation of durable plastics. Toledo City, on the other hand, has improved waste management, restored cleanliness, and minimized the environmental effect of plastics through regulatory initiatives. The area of practical use of the research results: The majority of citizens in Toledo City have enthusiastically embraced the city's ordinance prohibiting the use of plastic bags. Plastic bag littering has been shown to decrease throughout the city, resulting in a cleaner and healthier environment. The city's achievement might serve as a model for other places that have yet to abolish plastic bags. Innovative technological product: As a result of a cleaner and healthier environment, people have become more productive, and tourists have returned to the city, contributing to the city's economic growth. Scope of the innovative technological product: Policy management in the reduction of plastic pollution

Clinical Potential of Patient-Reported Outcome Measures in Occupational Therapy.

This column advocates the clinical potential of patient-reported outcome measures (PROMs) to advance value for occupational therapy patients and the profession. It positions PROMs in the context of value-based health care, provides an overview of emerging applications of PROMs for individual patient care, and introduces clinical advantages of the Patient-Reported Outcomes Measurement Information System. Occupational therapy practitioners should leverage the opportunities afforded by regulatory initiatives that include PROMs to meaningfully and equitably amplify the patient's voice in clinical contexts. What This Article Adds: This column highlights why occupational therapy practitioners should consider using patient-reported outcome measures in their everyday clinical practice.

Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?

Global regulatory agencies have transformed their approach to approvals in their processes for formal review of the safety and efficacy of new drugs. Opportunities for innovation have expanded because of the coronavirus disease 2019 (COVID‐19) pandemic. Several regulatory‐led initiatives have progressed rapidly during the past year, including patient‐focused drug development, model‐informed drug development, real‐world evidence, and complex innovative trial designs. Collectively, these initiatives have accelerated the rate of approvals. Despite demands to focus on urgent needs imposed by the COVID‐19 pandemic, the number of new drug approvals over the past year, particularly for rare diseases, has outpaced expectations. Advancing therapeutics for nervous system disorders requires adaptive strategies that align with rapid developments in the field. Three relentlessly progressive diseases, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, and Parkinson’s disease are in urgent need of new treatments. Herein, we propose new regulatory initiatives, including innovative trial designs and patient‐focused drug development that accelerate clinical trial conduct while meeting critical regulatory requirements for therapeutic approval.

Ensuring contestability and fairness in digital markets through regulation: a comparative analysis of the EU, UK and US approaches

ABSTRACT In a society where individuals increasingly spend time on the internet, large online platforms have become, for many, unavoidable actors. As it is increasingly argued that competition policy alone cannot address all the systemic problems that they create in digital markets where quick reactions are indispensable, there seems to be a consensus across the globe that legislative action must be taken against a specific sub-set of these large online platforms in order to foster contestability and fairness. This contribution aims to analyse how the EU, UK and US legislators intend to do so through regulation. First, the scope of the digital platforms that would be subject to these regulatory initiatives, and the potential discrepancies in this regard, will be clarified. Then, the general approach and options taken in each of these jurisdictions to address this dependence issue will be outlined. Finally, the main discrepancies between these different approaches will be summarized.

Platform work in Europe: Lessons learned, legal developments and challenges ahead

Several years since first emerging in Europe, platform work continues to represent a ‘social dilemma’ for workers, social partners, policymakers and society as a whole. As a result of intense litigation, analysis and reporting, much is known about the contractual and working conditions in this growing labour market segment. While the European Union (EU) institutions are considering adopting a new Directive based on Art. 153 TFEU, there are a number of significant top-down and bottom-up national cases worth discussing. Workers across Europe have been reclassified by many courts; some governments have taken regulatory initiatives to address the risk of precariousness and have implemented new comprehensive legal instruments to safeguard a level playing field for both workers and platforms. This article discusses how existing and new domestic and EU labour law provisions can improve the labour conditions of platform workers. Its overarching goal is to address possible policy gaps and the implications for EU social law by exploring the lessons that can be drawn from recent policies and legal developments. Section two briefly touches upon the policymaking initiatives in France, Spain and Italy. Moreover, it presents and reviews the main outcomes of litigation at the domestic level, focusing on the pervasive role played by algorithmic management. After introducing the Pillar of Social Rights (EPSR), section three critically analyses two key achievements at the EU level: the Directive on transparent and predictable working conditions and the Recommendation on access to social protection for workers and the self-employed. Section four explores the elasticity of the triad of Directives that regulate atypical forms of employment (part-time, fixed-term and temporary agency work). It is argued that the narrow construction of the Directives’ scope of application could represent an obstacle. However, an adaptive and purposive approach by the Court of Justice of the European Union (CJEU) could result in the classification of platform workers as falling within the scope of the social acquis in certain fields. Finally, section five concludes by providing concrete policy proposals focussed on cross-border issues, algorithmic transparency, the introduction of a presumption of employment status and collective bargaining.

Leveraging the Entrepreneurial Method as a Tool for the Circular Economy: The Case of Wood Waste

New global and domestic policy and regulatory initiatives promoting a circular economy have renewed interest in the beneficial repurposing of commercial waste streams. Likewise, consumer trends and customers’ increased understanding of what they purchase, where it comes from, and what happens to it post-consumption have forced firms to consider reducing and reusing their production waste streams. The forest products industry is an exemplar of becoming more adept at reorganising and exploiting repurposed waste streams for beneficial reuse. This paper explores three case studies from the Australian forestry sector that illustrate how wood waste is being profitably repurposed as an input into other products. We use the lens of the entrepreneurial method to explore how firms recognise, strategically access, and exploit the sustainable opportunities that can range from sustainably sourced inputs to environmental-, social-, and governance-driven consumption and investments. Effectual logic allows the reconceptualisation of forestry waste streams into inputs for use in creating new commercial products and provides a theoretical framework. While the repurposing of wood waste is profitable for the forestry firm, we found that social and economic gains reach far beyond the region in which these activities occur. Innovations often stimulate other innovations, resulting in a virtuous cycle within regional Australia’s emerging circular economy.

Macolin and beyond: legal and regulatory initiatives against match manipulation

Macolin and beyond: legal and regulatory initiatives against match manipulation

Revisiting Total Particle Number Measurements for Vehicle Exhaust Regulations

Road transport significantly contributes to air pollution in cities. Emission regulations have led to significantly reduced emissions in modern vehicles. Particle emissions are controlled by a particulate matter (PM) mass and a solid particle number (SPN) limit. There are concerns that the SPN limit does not effectively control all relevant particulate species and there are instances of semi-volatile particle emissions that are order of magnitudes higher than the SPN emission levels. This overview discusses whether a new metric (total particles, i.e., solids and volatiles) should be introduced for the effective regulation of vehicle emissions. Initially, it summarizes recent findings on the contribution of road transport to particle number concentration levels in cities. Then, both solid and total particle emission levels from modern vehicles are presented and the adverse health effects of solid and volatile particles are briefly discussed. Finally, the open issues regarding an appropriate methodology (sampling and instrumentation) in order to achieve representative and reproducible results are summarized. The main finding of this overview is that, even though total particle sampling and quantification is feasible, details for its realization in a regulatory context are lacking. It is important to define the methodology details (sampling and dilution, measurement instrumentation, relevant sizes, etc.) and conduct inter-laboratory exercises to determine the reproducibility of a proposed method. It is also necessary to monitor the vehicle emissions according to the new method to understand current and possible future levels. With better understanding of the instances of formation of nucleation mode particles it will be possible to identify its culprits (e.g., fuel, lubricant, combustion, or aftertreatment operation). Then the appropriate solutions can be enforced and the right decisions can be taken on the need for new regulatory initiatives, for example the addition of total particles in the tailpipe, decrease of specific organic precursors, better control of inorganic precursors (e.g., NH3, SOx), or revision of fuel and lubricant specifications.

6G NR-U Based Wireless Infrastructure UAV: Standardization, Opportunities, Challenges and Future Scopes

Providing ubiquitous connectivity for people and equipment with a wide range of service conditions is regarded as the major design goal of 6G networks. Moreover, the future 6G networks need to be extremely flexible to enable reliable and low-latency access for the dynamic number of mobile user equipment. The current base stations (BSs) and remote relay antennas are mostly, on the other hand, installed at fixed geographic locations based on long-term traffic patterns with little re-deployment flexibility. For most 6G applications, where dynamic data traffic occurs in both spatial and temporal domains, such rigid radio access networks (RANs) are unable to maintain ubiquitous connectivity. On the other hand, the rapid advancement of unmanned aerial vehicle (UAV) technology is creating a unique opportunity for the cellular operator to realize flying wireless infrastructure called wireless infrastructure UAV (WI UAV). WI UAV supports wireless connectivity and can stir itself to improve spectral efficiency, coverage, and quality of service of the end-users. This paper introduces 6G new radio in the unlicensed band (NR-U)-based WI UAV that can be used as a base station, relay, or data collector/disseminator. UAV are categorized based on their characteristics, applications, and operations. Further, this paper discusses various regulatory and standardization initiatives for integrating UAVs into the cellular network. Non-standalone NR-U network architecture is designed and explained for WI UAV. Several opportunities and design challenges of NR-U for the WI UAV are discussed and future scopes of WI UAVs are presented.

Interest Articulation and Lobbying in Unregulated Legal Contexts: The Case of Albania

The main argument of this paper is that the legal regulation of lobbying is an important factor for disciplining/curbing the undue (illicit) influence of different interests’ groups on the political-making process, especially in countries with post-communist and nonconsolidated democracies as Albania. In three decades of political and economic transition from a one-party communist system to a democratic one and towards a market economy, the democratization of Albania has faced various problems, which have often led to a loss of public confidence in the political class and apathy of citizens towards the political system. In many cases, this has come as a result of the perception or even the disclosure by the media and the public of corruption scandals, political clientelism, or undue influences in the decision-making processes in Albania. Surely, it can be said that political scandals of trading or exercising illicit influences on public officials can affect, as numerous cases have shown, every democratic political system in the world. However, they are more likely to occur in new democracies (post-communist) countries that face weak state structures and a legal environment that is not yet well consolidated and where a culture of informality exists alongside written rules and laws. For this purpose, that of disciplining and controlling the influences that specific interests exert on the decision-making process of governments, legislatures, or other regulatory agencies, a good part of European countries have considered undertaking legal regulatory initiatives for lobbying activity in their environments.

Improvements in Patient Safety Structures and Culture following Implementation of a National Public Program: An Observational Study in Three Brazilian Hospitals

Objective: The aim of this study was to observe and describe the changes in the structures for patient safety (PS) and PS culture (PSC) at the level of health facilities, following the implementation of the National Patient Safety Program (NPSP). Methods: An observational, longitudinal, and descriptive study including follow-up of changes in structure and activities for PS and assessments of PSC before and 15 months after the NPSP enforcement. Three Brazilian hospitals with different management logistics participated in the study (federal public, state public, and private). PSC was measured using the AHRQ’s instrument, adapted and validated for the Brazilian context (Hospital Survey on Patient Safety Culture [HSOPSC]). Changes in structure and activities to improve PS were mapped against the NPSP objectives. Changes in PSC were assessed by the hospital and discussed considering a change theory based on the literature. Results: Structural changes occurred in all hospitals but at a different pace and extension. A PS unit, adoption of some PS protocols, and training on PS occurred in the three hospitals. PSC significantly improved in all facilities. Public hospitals had the worst baseline PSC but showed greater improvements. The state hospital presented few structural changes and soon had the lowest ratings of PSC. Conclusions: This study demonstrates that external regulatory initiatives can trigger, even if unevenly, actions promoting PS and relevant internal structural changes, which in turn seem to increase awareness and improvement in PSC.

Health, safety and environmental (HSE) regulation and outcomes in the offshore oil and gas industry: Performance review of trends in the United Kingdom Continental Shelf

This paper contributes to understanding health, safety and environmental (HSE) regulation and performance in the offshore oil and gas industry. The United Kingdom Continental Shelf (UKCS) is used to explain how both safety investments by oil companies and regulatory initiatives can collectively contribute to enhancing standards, thereby reducing total accident and incident costs. We apply theoretical and analytical dimensions: firstly, by characterising an economic approach for evaluating HSE investments, and secondly, undertaking comparative statistical analysis of UKCS safety performance. Our findings indicate that the cost-benefit approach has been beneficial for evaluating HSE investment decisions to meet stricter regulatory compliance standards. Regarding the comparative analysis, we find that there has been a considerable improvement in safety in the UKCS over the past two decades, indicated by declining hydrocarbon releases (safety indicator) and declining injury rates (health indicator). Nonetheless, while produced water discharges (environment indicator) have also declined, the data also shows that the frequency of oil spill incidents have increased by 62% compared to 2002 baseline levels. This is partly explained by several recent unplanned shutdowns, especially between 2013 and 2016, and consequent reductions in production efficiency due to ageing infrastructure. Overall, the findings suggest that fair, effective, and participatory regulatory regimes can ensure a collective drive by all stakeholders towards improving industry safety performance and promote a better safety environment.