Regulatory Initiatives Research Articles

What About Justice and Power Imbalances? A Relational Approach to Ethical Risk Assessments for AI

Despite the surge in research on the ethical risks of Artificial Intelligence (AI) there is still a clear need for methodologies and practical strategies to assess ethical risks of AI applications. As risk assessment becomes a cornerstone of regulatory initiatives (e.g. EU AI Act) the question remains to what extent these methods are capable of addressing more complex normative issues related to voluntariness, justice and power imbalances in the deployment of AI. The current article examines three common categories of ethical risk assessment: (1) bilateral assessments, such as impact assessment for AI, (2) multilateral assessments, where the perspective of a group of stakeholders is included in the assessment and (3) foresight assessments, where future impacts and risks are assessed. Subsequently, it will make a case for relational risk assessment methods as a supplementary approach to the ethical analysis of AI. It takes as a starting point the three-party model as developed by Hermansson & Hansson (Risk Management 9(3):129–144, 2007) to identify salient ethical issues as they arise in the relationship between three critical parties or roles present in all risk related decisions: the decision-maker, the risk-exposed and the beneficiary. This model is then adjusted to better fit with AI contexts and applied to AI in credit risk scoring to evaluate its merits. Overall, the article seeks to contribute to the development of a more fine-grained understanding of the ethical risks of AI, emphasising the importance of addressing and interrogating relational dimensions such as power imbalances as ethical risks of AI applications.

The Paradox of Corporate Sustainability Due Diligence: Impact on the Financial Sector

In this article, the author examines the obligations imposed on companies, particularly financial undertakings, by two key regulatory initiatives: the Responsible and Sustainable International Business Conduct Act (RSIBCA) and the Corporate Sustainability Due Diligence Directive (CSDDD). Both frameworks aim to introduce hard law requirements for sustainability due diligence, covering human rights and environmental impacts. While the RSIBCA is still subject to political approval in the Netherlands, the CSDDD has been adopted and imposes binding obligations across the European Union after adoption by the Member States. The article highlights the key differences and similarities between these initiatives and their specific impact on regulated financial undertakings. Through fictional case scenarios, the article explores how financial undertakings must navigate the complexities of due diligence, climate transition plans and general duty of care under these rules.

Experiences of abortion care in Australia: a qualitative study examining multiple dimensions of access

BackgroundThe United Nations’ Sustainable Development Goals identify universal access to sexual and reproductive health services as a global priority. Yet barriers to abortion access remain, including legal restrictions, cost, stigma, and limited services and information. The aim was to identify barriers to and facilitators of abortion care access experienced in Australia.MethodsThis qualitative phenomenological study examined abortion access in Australia, where abortion is decriminalised, from March 2020 to December 2022. We used social media and flyers in clinics to recruit adults who had sought abortion care, then interviewed them in-depth. We mapped participant experiences to five dimensions of access identified by Levesque et al.’s patient-centred access to healthcare framework: approachability, acceptability, availability and accommodation, affordability, and appropriateness.ResultsThe 24 participants lived across Australia and sought abortion during the COVID-19 pandemic. Approachability: Before seeking abortion, most did not know where to access information about the service and where to obtain it. Acceptability: Many were uncomfortable disclosing their abortion to family or friends; they reported that healthcare providers demonstrated varying levels of support. Availability and accommodation: Regional participants travelled far and faced long wait-times, exacerbated by pandemic restrictions. Affordability: Participants described financial stress paying for the service, travel, and related expenses. Appropriateness: Most participants expected judgemental care. Experiences varied widely: many participants experienced unempathetic, rushed, or judgemental interactions with healthcare staff, and many also reported at least one non-judgmental and supportive interaction on the same pathway to care.DiscussionAbortion seekers experienced varying obstacles when seeking care. The findings illustrate the need for population- and system-level initiatives such as: providing accurate information about and normalising abortion; implementing system-level strategies to reduce wait times, travel, and costs, especially for rural populations; and developing regulatory and quality improvement initiatives to increase the workforce and its readiness to provide high-quality, non-judgemental abortion care. Challenges seeking care during pandemic restrictions illustrate the importance of social support during care and choice between abortion modalities and service types. Consumer voices can help understand the diverse pathways to abortion care and inform solutions to overcome the multidimensional barriers to access.

Governing Silicon Valley and Shenzhen: Assessing a New Era of Artificial Intelligence Governance in the United States and China

This article examines recent developments in artificial intelligence (AI) governance in the United States (US) and China, exploring their implications for each country’s development trajectory. Drawing on a framework informed by the philosophy of technology, the article delves into not only the differences between the two countries’ approaches but also the reasons behind these differences. The US, after years of industry self-regulation, is slowly moving towards concrete legislation, while China is centralizing its development and regulatory initiatives. Despite China’s expressed desire for values-pluralistic international governance, existing tensions between the two, coupled with the US’s burgeoning coalition centered around AI with “democratic values,” might pose challenges to collaboration and international governance. Nonetheless, the article contends that both systems can be accommodated within a values-pluralistic human rights framework, potentially paving the way for meaningful international governance efforts.

Concentrations and predictors of select nutrients in Canadian human milk samples from the Maternal-Infant Research on Environmental Chemicals pregnancy cohort

BackgroundHuman milk (HM) composition data are widely used in clinical, regulatory, and public health initiatives. The existing HM profiles in United States and Canadian nutrient databanks are outdated and now considered inappropriate to estimate current nutrient intakes. Recent reviews have underscored the limited North American data available to generate a new profile. ObjectivesTo describe concentrations and sources of variability of nutrients in HM from a large cohort collected in Canada. MethodsThe Maternal-Infant Research on Environmental Chemicals (MIREC) study recruited participants in the first trimester of pregnancy from 10 Canadian cities between 2008 and 2011. HM samples (n = 559–835, depending on nutrient) were collected 3–10 wk postpartum and analyzed for minerals (calcium, magnesium, phosphorus, potassium, sodium, manganese, molybdenum, zinc, copper, iodine, selenium), vitamin D [vitamin D3, 25-hydroxyvitamin D3], folate vitamers (folic acid, 5-methyltetrahydrofolate, total folates), and fatty acids (panel). We examined associations between participant characteristics and log-transformed nutrient concentrations using linear regression. ResultsConcentrations of HM components in MIREC samples were within the range observed in literature except for manganese, which was >100-fold lower than the value in the existing Canadian nutrient databank profile [2.43 (standard deviation 2.84) compared with 260 ng/g]. In multivariable models, concentrations of folate vitamers, vitamin D, and fatty acids demonstrated greater variability with maternal and sample characteristics than minerals. Factors such as relevant supplement use, body mass index, and for vitamin D, skin color and season, had a larger impact on nutrient concentrations than characteristics typically standardized in HM research, such as maternal or infant health, and method of collection. ConclusionsHM mineral concentrations from this study meet the methodological inclusion criteria for updating nutrient databank values and dietary reference intakes. Consideration of factors such as diet, skin color, and BMI will be important for selecting studies for developing representative reference values based on HM.

A digital service standardization model for Nigeria: The role of NITDA in regulatory compliance

The digital transformation in Nigeria has accelerated the need for effective standards and regulations to ensure quality and interoperability of digital services. The National Information Technology Development Agency (NITDA) plays a crucial role in this context by overseeing regulatory compliance and fostering a conducive environment for digital innovation. This review presents a comprehensive model for digital service standardization tailored to Nigeria's unique socio-economic and technological landscape. The proposed model emphasizes the importance of regulatory frameworks established by NITDA in promoting consistency, reliability, and security across various digital platforms and services. The model outlines key components necessary for effective standardization, including policy formulation, compliance monitoring, and stakeholder engagement. It integrates best practices from international standards while adapting them to local needs and challenges. Central to the model is the role of NITDA in developing and enforcing standards that align with global benchmarks, thereby ensuring that Nigerian digital services are competitive and secure. A significant aspect of the model is its focus on regulatory compliance, which is vital for maintaining the integrity of digital services and protecting user data. The review discusses how NITDA's regulatory initiatives address common issues such as data privacy, cybersecurity, and service quality. By examining case studies and industry feedback, the review highlights the impact of NITDA's efforts on improving the overall digital service ecosystem in Nigeria. The model also addresses the need for continuous evaluation and adaptation of standards in response to technological advancements and emerging threats. It proposes mechanisms for regular updates and revisions to standards, ensuring that they remain relevant and effective. Additionally, the review explores the role of collaborative partnerships between NITDA, industry stakeholders, and academic institutions in advancing digital service standardization. The proposed digital service standardization model provides a structured approach to enhancing regulatory compliance and fostering a robust digital environment in Nigeria. It underscores the pivotal role of NITDA in driving these efforts and offers a framework for ongoing improvement and adaptation to the dynamic digital landscape.

A Demonstration of the Risk-Informed NEI 18-04 Design Evaluation Model for the Modular High-Temperature Gas Reactor

Several advanced reactor designs are now under active development in the United States and elsewhere, promising sustainable solutions to the growing world energy needs. The designs currently being considered are quite diverse and different from the more established light water reactor technology that has dominated the operating commercial nuclear landscape. While advanced reactor concepts were first explored in the dawn of the nuclear age, they are now being reconsidered under the light of modern needs, and specifically, for their flexible operating conditions and inherent safety characteristics. In response, the U.S. Nuclear Regulatory Commission staff is moving forward with development of 10 CFR Part 53 rulemaking, which is a more risk-informed, technology-agnostic framework for licensing and regulating such new designs. The nuclear industry response to this regulatory initiative resulted in the technical report by the Nuclear Energy Institute, NEI 18-04 Revision 1, which provides an implementation roadmap of the risk-informed approach when defining the safety case for a new plant design. The implementation of this safety case may be a nontrivial exercise for an actual reactor design. This paper provides a demonstration of performing such an analysis for a representative advanced reactor. Public information from the General Atomics high-temperature gas reactor design was considered in this demonstration. The analysis workflow was facilitated with the FPoliSolutions’ proprietary Risk-Informed System Engineering (RISE) digital platform, a product that was presented in previous publications. RISE is one application of FPoli’s enterprise digital platform, which was created to facilitate orchestration of complex workflows leveraging recent technologies developed at national laboratories, such as Idaho National Laboratory’s RAVEN and EMRALD frameworks. The analysis described in the paper includes the selection and classifications of events, the integration of probabilistic risk analysis artifacts, and event modeling simulations for consequence evaluations. The results are then used for system, structures, and components safety classification and a synthesis of the safety case for the design in line with the frequency-consequence targets presented in NEI 18-04. The purpose of the analysis, as framed in RISE, is to readily produce outputs and views that can aid users and regulators in making risk-informed decisions to demonstrate their plant safety case.

A Systematic Scoping Review of the Collaborative Governance of Environmental and Cultural Flows

This study systematically reviews English-language papers about the collaborative governance of environmental and cultural flows. With mixed-methods analyses, we illustrate that the determination of environmental flow needs is common, with authors in 42 countries across 112 watersheds describing their management. In contrast, cultural flows (characterized by attention to both ecological and non-ecological needs, decision-making authority of Indigenous Nations, and Indigenous rights) were reported only in papers by authors in commonwealth, colonial countries: Australia, Canada, and New Zealand. Evaluated against the Organisation for Economic Co-operation and Development’s (OECD) Water Governance Principles, we found that the literature reported efforts that considered appropriate local and regional scales, information and data, regulatory frameworks, and capacity building of communities and authorities engaged in environmental and cultural flow initiatives. However, there was limited consideration of the roles of communities in policymaking, which was more common in jurisdictions with decentralized governance. In jurisdictions with democratic community-based initiatives, environmental and cultural flows have not been approached in merely technical processes to communicate hydro-social-ecological information to decision-makers. Instead, the initiatives have created the context for evaluating new developments at the watershed level in light of communities’ social and ecological water goals, collaborating during unique drought and flooding conditions, working to rebalance power in decision-making through water justice, creating ecological and Indigenous reserved water rights, granting legal personhood for rivers, and protecting water for the environment and dependent people in water markets. Going forward, we identify a need for greater attention to community roles in environmental and cultural flows protection in water governance including policy creation and evaluation, regulatory initiatives, strategic planning, and impact assessments.

Comprehensive review of smart city cybersecurity strategies

With cities rapidly advancing technologically, the rise of smart cities brings innovative solutions to urban challenges. However, this integration of technologies within urban infrastructures introduces new cybersecurity risks. This review explores the cybersecurity issues that smart cities face and discusses strategies to address these threats. Smart cities rely on interconnected networks of devices and systems to enhance efficiency, sustainability, and citizen services. Yet, this connectivity also creates a complex environment that is vulnerable to cyberattacks. A key concern is the wide array of IoT devices deployed across smart city infrastructures, which often lack robust security mechanisms, making them susceptible to exploitation by cybercriminals. The interconnected nature of these systems heightens the potential impact of cyberattacks, posing significant risks to critical infrastructure, public safety, and privacy. Threat actors can exploit vulnerabilities in interconnected systems, disrupting essential services, manipulating data, or even causing physical harm. Since smart cities heavily depend on data-driven decision-making, ensuring data integrity and confidentiality is a top priority. To mitigate these risks, various cybersecurity strategies have been proposed and implemented. These include technical solutions, regulatory frameworks, and collaboration among stakeholders. Technical measures like encryption, authentication mechanisms, intrusion detection systems, and secure software development practices are essential. Additionally, strong access controls and network segmentation can limit the scope of potential attacks. Regulatory initiatives also play a crucial role in improving cybersecurity standards and ensuring compliance among stakeholders. Establishing clear guidelines for data protection, privacy rights, and incident response protocols is vital for safeguarding citizens' interests. Collaborative efforts between government agencies, the private sector, academia, and cybersecurity experts are crucial in sharing information and collectively defending against emerging threats. Securing smart cities requires a comprehensive approach that integrates technical measures, regulatory frameworks, and collaborative efforts to create a resilient and secure urban environment for all citizens. Keywords: Cybersecurity, Smart City, AI, Technology, Security.

Legitimacy considerations in regulation for local mobile communication network business in Finland and the UK

The article explores the legitimacy of local 5G and upcoming 6G mobile communication networks in Europe. The paper paves the way for a new perspective for understanding the legitimacy of local 5G/6G mobile communication networks by applying the business model-based ecosystem perspective and legitimacy as a theoretical foundation. As regulations are expanding to consider the novel deployment model of local 5G and 6G mobile communication networks, the legitimacy of such networks is under-explored. Analyzing the regulatory approaches taken by two national regulatory authorities (NRA) in Europe, Finland and the UK, we identify seven legitimacy-related themes including innovation orientation, awareness and knowledge of how to build and design local networks, European harmonized spectrum management, competition, cybersecurity and risk assessment and equipment availability. Our study lays the groundwork for exploring how the application of the business model-based ecosystem perspective can be utilized to advance regulatory initiatives for local mobile communication network businesses. It also identifies which legitimacy-related aspects are involved in setting regulatory priorities.

Navigating regulatory sandbox initiatives for innovation diffusion in fintech lending: A systematic review

Navigating regulatory sandbox initiatives for innovation diffusion in fintech lending: A systematic review

Exploring seafarers' knowledge, understanding, and proficiency in SEEMP: A strategic training framework for enhancing seafarers' competence in energy-efficient ship operations

With 2.89 % of global carbon emissions caused by human activity, the maritime industry faces an imminent challenge in curbing its carbon footprint despite regulatory initiatives. As the shipping sector expands, the industry faces a projected increase in carbon emissions. Recognizing the key role of seafarers in emission reduction, this article introduces a comprehensive training framework designed to enhance awareness, knowledge, understanding, and skills for implementing energy-efficient ship operations. This study utilizes structural equation modeling to assess the effectiveness of seafarers' training on energy-efficient operation of ships (EEOS) by surveying 144 seafarers across 42 shipping companies worldwide and using structured questionnaires. This study found significant positive correlations between implementing the Ship Energy Efficiency Management Plan (SEEMP) and the training programs initiated by the International Maritime Organization (IMO) and shipping companies. The results of this study indicate that traditional institutional and specialized training programs on EEOS are relatively ineffective for seafarers in implementing SEEMP onboard ships. Furthermore, the study argues that computer and simulator-based training facilitates knowledge, understanding, and proficiency of SEEMP among seafarers more effectively than the onboard training provided by the ship's master and the chief engineer. The proposed training framework emphasizes the importance of initial training using the IMO E-Learning course and IMO “Train the Trainer” programs, followed by shipping companies' in-house training by classification societies, company project teams, and simulator-based training by service providers. The study proposes a strategic training framework that encompasses in-house training conducted by shipping companies in collaboration with partners, simulator-based training provided by specialized training providers, and ongoing onboard training facilitated by the vessel's master and chief engineer, with integration of computer-based training (CBT). This strategic approach intends to improve seafarers' competence in energy-efficient ship operations to meet predetermined carbon intensity targets, which aligns with the broader goal of leading the maritime industry toward a future of net-zero emissions.

The Fundamental Rights Impact Assessment (FRIA) in the AI Act: Roots, legal obligations and key elements for a model template

What is the context which gave rise to the obligation to carry out a Fundamental Rights Impact Assessment (FRIA) in the AI Act? How has assessment of the impact on fundamental rights been framed by the EU legislator in the AI Act? What methodological criteria should be followed in developing the FRIA? These are the three main research questions that this article aims to address, through both legal analysis of the relevant provisions of the AI Act and discussion of various possible models for assessment of the impact of AI on fundamental rights.The overall objective of this article is to fill existing gaps in the theoretical and methodological elaboration of the FRIA, as outlined in the AI Act. In order to facilitate the future work of EU and national bodies and AI operators in placing this key tool for human-centric and trustworthy AI at the heart of the EU approach to AI design and development, this article outlines the main building blocks of a model template for the FRIA. While this proposal is consistent with the rationale and scope of the AI Act, it is also applicable beyond the cases listed in Article 27 and can serve as a blueprint for other national and international regulatory initiatives to ensure that AI is fully consistent with human rights.

Assessing Cross-Border Telemedicine Data Exchange in the European Union: A Call to Action.

Background: Telemedicine offers potential benefits for health care delivery. However, evidence of cross-border telemedicine data exchange within the European Union (EU) remains limited. The objective of this communication provides a brief outline of the regulatory framework, initiatives, and challenges associated with cross-border telemedicine data exchange in the EU, setting the stage for a comprehensive evidence assessment. Methods: We explore the current regulatory landscape (European Health Data Space), existing initiatives (the European Electronic Health Record Exchange Format), and interoperability challenges (e.g., legal, technical, semantic) facing EU cross-border telemedicine data exchange. Results: There is a need for thorough evidence assessment of cross-border telemedicine and related data movements. Conclusion: Understanding the current landscape of cross-border telemedicine is crucial. This article highlights the need for evidence assessment through a formal review to inform future research and policy initiatives in this domain.

The Importance of Economic Assessments to Support Changes in Livestock Farming Practices: A Focus on Antimicrobial Use

SummaryThe intensification of livestock farming reshaped the epidemiological, economic and environmental landscape of production systems. With the resulting increase in disease pressure, farmers turned to readily available and cost‐efficient tools to help manage animal health and even increase productivity – antimicrobials. Growing concerns around antimicrobial resistance (AMR) have prompted regulatory and private initiatives to curtail antimicrobial use (AMU) in livestock. The latter indicates that farmers/livestock industry are taking some ownership of the problem and playing a key role in the solution. In fact, recent research has found that farmers are willing to adjust farming practices if this does not affect financial viability of their businesses. However, our scoping literature review found that information is lacking or insufficient for farmers to make these decisions. It is also vital to understand the extent to which farm‐level decisions are producing negative externalities, and what needs to be changed to ensure societal optimum. While advocating for a sustainable reduction in AMU in livestock production, it is important to provide adequate information on the alternatives to their application in managing animal health and welfare. Evidence on the economic, productive and/or epidemiological benefits of such alternatives, when compared to the current situation, are crucial if farmers are to change their production practices with regards to AMU.

Business and human rights as Swedish foreign policy: The soft implementation of international regulatory norms

AbstractThis article aims to explain why national governments choose soft policies in the domestication of international norms even when those norms may explicitly call for harder measures. The article achieves this aim by exploring domestic adoption of National Action Plans (NAPs) for implementing the United Nations Guiding Principles on Business and Human Rights (UNGPs). The UNGPs are an international soft law instrument that calls for a mix of voluntary and mandatory policies to promote human rights due diligence, and NAPs are soft domestic policy instruments that lack the bindingness of mandatory due diligence legislation now found in several states. Most governments with NAPs have adopted them specifically as foreign policies, treating them not as regulatory initiatives but as tools for enhancing national reputations. Using a range of primary and secondary sources, the article constructs a case study of Sweden to explain why governments might opt for softer implementation of the UNGPs in the form of NAPs. It draws several conclusions: (1) governments may emulate the approach to domesticating international regulatory norms that is promoted by international organisations; (2) support from domestic actors motivates norm implementation, and the policy style selected is likely to reflect power constellations in the state and, under consensus‐based governance systems, the lowest common denominator of actor preferences; and (3) path dependency following institutional venue selection influences the type of policy developed and adopted. These findings shed new light on the reasons why international policy norms are implemented in ‘softer’ ways than perhaps intended by their architects.

Field Study on the Assessment of Antimalarial Drug Quality Using Minilab Kitin India

Background: A lack of proper anti-malarial medication use can lead to drug resistance, failed therapy, and even death. It is unclear how widespread the use of fake anti-malarial medications is in India. Better malaria treatment and the execution of regulatory initiatives to improve anti-malarial drug quality necessitate regional research into the quality of available anti-malarial pharmaceuticals. This study aimed to look into the quality of anti-malarial drugs in regions of India where malaria is common. Conclusions about the prevalence of substandard anti-malarial medications in Indian communities can be drawn from the findings. Methods: Samples of anti-malarial pills were bought from stores in five different Indian areas. One hundred and fifty anti-malarial drug samples were gathered. Using a GPHF minilab lab kit, the quality of the following samples was determined: chloroquine (n=50), artemether lumefantrine (n=50), artesunate sulphadoxine-pyrimethamine (n=14), and primaquine (n=31). Results: This research confirmed that 98% of the tablets disintegrated properly in a minilab disintegration test. As a result, when compared to both the full set of standards and 80% of the samples, 99% of the samples passed the preliminary qualitative TLC test. Only 4% of samples (those with insufficient amounts of the active medicinal component) failed the quantitative HPLC test. Conclusion: Anti-malarial medicine counterfeiting has been found to be quite uncommon in India compared to other countries. However, further research is needed, such as post-marketing surveillance, to ensure that effective anti-malarials are distributed to the public.

Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013-2022.

The effectiveness of the regulatory initiatives, strategies, and incentives put forth in the first two authorizations of the Generic Drug User Fees Act (GDUFA) were evaluated using factors including the number of Abbreviated New Drug Application (ANDA) withdrawals and first-cycle approvals. GDUFA was originally authorized in 2012 for FY 2013-2017 (GDUFA I) and reauthorized for FY 2018-2022 (GDUFA II). ANDA approvals were analyzed from the Drugs @ FDA database covering 2013-2022. From the applications, the approval time, dosage form and route of administration (ROA), product indication, market status of the product, first generic status, company and company size filing the ANDA were noted. Despite the COVID pandemic, there was more than a 40% increase in ANDA approvals during GDUFA II relative to GDUFA I. Oral and parenteral drugs were the two leading categories of approved generics during both iterations of GDUFA. There was more than a 120% increase in withdrawn applications during GDUFA II, which reflects the partial refund that is now offered to incentivize companies to withdraw inadequate applications prior to review. This also appears to have contributed to an increase in the number of first-cycle approvals, which increased by 100% between GDUFA I and II. Due to the COVID-19 public health emergency, there was a decrease in activity within the generic drug program and market. Therefore, it is important to consider this impact when observing actual trends from this study.

Shaping the future: Proposed bills to regulate new and emerging tobacco and nicotine products in Latin America and the Caribbean amidst public health concerns and industry interests.

To examine legislative efforts to regulate new and emerging tobacco and nicotine products (NETNPs) in Latin America and the Caribbean (LAC) between 2017 and 2022. Analysis of on-line national legislation databases to track NETNP bills using standard snowball search methods. Bills were identified in 15 out of the 33 LAC countries, accounting for a total of 91 bills targeting NETNPs (Table 1). Mexico had the highest number (n=38) of bills, followed by Brazil (n=16), Argentina (n=10), Colombia (n=8) and Chile (n=5). The remaining countries introduced two or fewer NETNP bills. Among the identified 91 bills, the majority (n=60) addressed both electronic cigarettes and HTPs, almost one third of bills (n=29) applied only to electronic cigarettes, and only two focused solely on HTPs. Six of the 15 countries with identified bills, enacted one NETNP law including Barbados, Bolivia, Costa Rica, Guyana, Mexico, and Panama. Since 2019, there has been a steady increase in the amount of NETNP bills introduced in LAC. In 2017 and 2018, 10 NETNP bills were introduced each year followed by 23 NETNP bills introduced in each 2019 and 2020, 19 in 2021, and 16 by August 2022. The substantial increase in the number of NETNP bills introduced since 2019 indicates the growing importance of regulating NETNPs in LAC. As NETNPs continue to evolve and grow it is important to continue monitoring and evaluating tobacco and nicotine regulatory initiatives while also staying ahead of the evolving market of NETNPs. Previous studies have analyzed the regulatory environment of new and emerging tobacco and nicotine products (NETNPs) but it is less known about legislative and regulatory efforts and attempts. This is the first known study to analyze legislative bills to regulate NETNPs in Latin America and the Caribbean (LAC). The substantial increase in the number of NETNP bills introduced in LAC since 2019 indicates the growing importance of regulating NETNPs in LAC. As NETNPs continue to evolve and grow it is important to continue monitoring and evaluating tobacco and nicotine regulatory initiatives while also staying ahead of the evolving market of NETNPs.

Transformacja sektora energetycznego Unii Europejskiej

S Such geoeconomic and geopolitical factors as Russian armed aggression against Ukraine caused the energy crisis in the European Union (EU), exposing the EU’s vulnerabilities due to its overdependence on Russian fossil fuel imports. As a consequence of gas supply disruptions, substantial rises in energy prices and heightened safety concerns, the EU's energy policies have been thoroughly reassessed. Therefore, the article aims to examine the profound ramifications of Russia's military aggression against Ukraine on European energy markets and elucidate the strategies articulated in European Commission initiatives intended to reduce reliance on Russian fossil fuels. Within this framework, the REPowerEU plan is especially beneficial for the rapid diversification and increased integration of renewable energy sources. These initiatives have the potential to result in a structural transformation of the EU's energy landscape, necessitating coordinated regulatory initiatives, infrastructure advancements, and cooperative energy diplomacy. Current research reveals the potential for economic expansion, strengthened industrial primacy and progress towards achieving climate neutrality by 2050 through the environmentally sustainable metamorphosis of Europe's energy framework. The results of this scientific research can also be used for the further implementation of the strategy of achieving sustainable development of the EU member states in the context of the development of clean energy, which will allow meeting the needs of the population of these countries in the near future without endangering future generations.