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With the diffusion of prosumerism, where households act both as producers and consumers of energy, policy makers must strike a balance between encouraging microgeneration and regulating this new prosumer segment on the energy market. However, effective policy implementation depends on prosumers’ behavioural reactions. This paper provides evidence on the interplay between digital real-time information and regulation of self-consumption for rooftop photovoltaics (PV) in Croatia. Croatian households that produce more annual electricity than they consume are automatically re-classified as renewable traders, which means additional administrative duties and less favorable tax treatment. This creates perverse incentives to reduce PV generation or increase energy consumption by year-end. We document the behavioural reactions to this policy design, indicating that energy production and consumption are highly elastic regarding regulatory incentives, but only if these incentives are made transparent and accessible with timely information. We collected two survey waves (n = 54 and n = 80) and smart meter data (n = 39), which illustrate the behavioural reaction before and after year-end. According to the survey wave before year-end, almost half of the participants considered curtailing their PV output. According to the smart meter data, a sizable share did indeed take action by shutting down PV production or by powering additional devices to reduce the surplus near year-end. In a second survey wave in the new year, prosumers provide ex-post insights on the specific measures taken to reduce surplus. We discuss research insights regarding the transparency and control offered by metering feedback, and how this can influence household behaviour within regulatory frameworks. [ABSTRACT FROM AUTHOR]

This article conducts a bibliometric analysis to investigate regulatory barriers faced by entrepreneurs and start-ups in the renewable energy sector. The research highlights how inconsistent and outdated regulations in many regions challenge the growth and scalability of renewable energy ventures. Key barriers include complex permitting processes, restrictive grid connection policies, and inadequate support mechanisms such as subsidies and tax incentives. The study underscores that although global investment in renewable energy technologies has grown, many emerging and developing economies lag behind due to high capital costs and regulatory hurdles. The methodology involves data collection from the Scopus database using specified keywords such as "entrepreneurship," "start-ups," "renewable energy," and "regulatory barriers." One hundred seven documents published between 2002 and 2024 were analysed through bibliometric techniques using tools like Biblioshiny and Excel. The study cleans and processes data by removing irrelevant terms and consolidating synonyms to improve the accuracy of the bibliometric analysis. Key research indicators, such as the h-index, g-index, m-index, and citation rates, are employed to evaluate the impact of publications and authors. The analysis also focuses on co-citation networks, clustering keywords, and tracking the evolution of themes over time. Results reveal that regulatory barriers to renewable energy entrepreneurship are widely studied but fragmented. Five main keyword clusters were identified: renewable energy technologies, policy and regulatory frameworks, business models, economic development, and environmental sustainability. A notable trend is the convergence of interdisciplinary research, combining economic, policy, and technological perspectives on overcoming barriers. The analysis highlights a significant publication growth in recent years, peaking in 2022 with 15 publications, which reflects an increasing academic interest in this area. The most cited papers often discuss solutions to regulatory challenges, such as streamlining administrative processes, improving grid access, and implementing supportive financial mechanisms. Case studies from leading renewable energy markets, like Germany and California, showcase successful strategies that have fostered innovation and allowed start-ups to thrive. However, the study emphasises that many emerging markets continue to struggle with outdated regulatory frameworks that hinder the commercialisation of new technologies, particularly in energy storage. The study concludes that future research should focus on detailed longitudinal studies and interdisciplinary approaches that combine legal, economic, and technological analyses. Policymakers are urged to adopt flexible, adaptive regulations to support innovation in renewable energy, ensuring that start-ups can leverage technological advancements and contribute to the global energy transition.

This study explores the multifaceted growth challenges faced by Knowledge-Based Firms (KBFs) within Iran’s Information and Communication Technology (ICT) sector. The research identifies critical barriers across several domains, including financial constraints, market development limitations, and political, regulatory, and legal complexities. Through a comprehensive analysis, the study reveals that financial challenges are intensified by limited access to high-quality equipment and skilled personnel. Additionally, both domestic and international market development face significant hurdles. Regulatory and legal issues, such as inadequate intellectual property protections and cumbersome administrative processes, further exacerbate these challenges. The study underscores the need for strategic policy reforms, improved governmental coordination, and targeted support mechanisms to address the evolving needs of these firms. The findings highlight the importance of optimizing tax policies, facilitating international market entry, revising regulatory frameworks, and enhancing support for knowledge-based law enforcement to foster sustainable growth and innovation in Iran’s ICT sector. Abstrak dalam Bahasa Indonesia. Penelitian ini mengeksplorasi tantangan pertumbuhan yang kompleks yang dihadapi oleh Perusahaan Berbasis Pengetahuan (KBFs) dalam sektor Teknologi Informasi dan Komunikasi (ICT) di Iran. Penelitian ini mengidentifikasi hambatan kritis di berbagai bidang, termasuk keterbatasan keuangan, keterbatasan pengembangan pasar, serta kompleksitas politik, regulasi, dan hukum. Melalui analisis yang komprehensif, penelitian ini mengungkapkan bahwa tantangan keuangan diperparah oleh terbatasnya akses terhadap peralatan berkualitas tinggi dan tenaga kerja terampil. Selain itu, pengembangan pasar domestik dan internasional menghadapi hambatan yang signifikan. Masalah regulasi dan hukum, seperti perlindungan hak kekayaan intelektual yang tidak memadai dan proses administratif yang rumit, semakin memperburuk tantangan ini. Penelitian ini menekankan perlunya reformasi kebijakan strategis, peningkatan koordinasi pemerintah, dan mekanisme dukungan yang tepat untuk mengatasi kebutuhan yang berkembang dari perusahaan-perusahaan ini. Temuan ini menyoroti pentingnya mengoptimalkan kebijakan pajak, memfasilitasi masuknya pasar internasional, merevisi kerangka regulasi, dan meningkatkan dukungan untuk penegakan hukum berbasis pengetahuan guna mendorong pertumbuhan yang berkelanjutan dan inovasi dalam sektor ICT di Iran

Purpose – The objective of this research is to investigate the barriers impacting the integration of Industry 5.0 (I5.0) in supply chain sustainability. By understanding these challenges, this study aims to provide valuable insights that can guide organizations in successfully implementing the transformative potential of I5.0. The ultimate aim is to improve operational efficiency and advocate for sustainable practices within supply chains. Design/methodology/approach – Research has used industry expert interviews, a comprehensive literature review and the decision-making trial and evaluation laboratory approach for analysis. Industry expert interviews serve to capture first-hand insights from professionals well versed in the field, providing practical perspectives on the barriers to I5.0 adoption. Findings – This study identifies technological challenges, organizational barriers, regulatory impediments and economic constraints as pivotal factors inhibiting the widespread adoption of I5.0 in supply chain sustainability. Research limitations/implications – This research serves as a foundation for future investigations into overcoming barriers to I5.0 adoption, guiding scholars and practitioners in refining strategies for successful implementation. Practical implications – The findings offer practical insights for organizations aiming to adopt I5.0, informing decision-makers on key challenges and facilitating the development of targeted strategies to overcome them. Social implications – The social implications lie in fostering sustainable business practices through the adoption of I5.0, contributing to environmental responsibility and societal well-being. Originality/value – This research contributes original insights from practitioners, policymakers and researchers in navigating the complex landscape of I5.0 adoption, ensuring meaningful contributions to both academia and industry.

This article conducts a bibliometric analysis to investigate regulatory barriers faced by entrepreneurs and start-ups in the renewable energy sector. The research highlights how inconsistent and outdated regulations in many regions challenge the growth and scalability of renewable energy ventures. Key barriers include complex permitting processes, restrictive grid connection policies, and inadequate support mechanisms such as subsidies and tax incentives. The study underscores that although global investment in renewable energy technologies has grown, many emerging and developing economies lag behind due to high capital costs and regulatory hurdles. The methodology involves data collection from the Scopus database using specified keywords such as "entrepreneurship," "start-ups," "renewable energy," and "regulatory barriers." One hundred seven documents published between 2002 and 2024 were analysed through bibliometric techniques using tools like Biblioshiny and Excel. The study cleans and processes data by removing irrelevant terms and consolidating synonyms to improve the accuracy of the bibliometric analysis. Key research indicators, such as the h-index, g-index, m-index, and citation rates, are employed to evaluate the impact of publications and authors. The analysis also focuses on co-citation networks, clustering keywords, and tracking the evolution of themes over time. Results reveal that regulatory barriers to renewable energy entrepreneurship are widely studied but fragmented. Five main keyword clusters were identified: renewable energy technologies, policy and regulatory frameworks, business models, economic development, and environmental sustainability. A notable trend is the convergence of interdisciplinary research, combining economic, policy, and technological perspectives on overcoming barriers. The analysis highlights a significant publication growth in recent years, peaking in 2022 with 15 publications, which reflects an increasing academic interest in this area. The most cited papers often discuss solutions to regulatory challenges, such as streamlining administrative processes, improving grid access, and implementing supportive financial mechanisms. Case studies from leading renewable energy markets, like Germany and California, showcase successful strategies that have fostered innovation and allowed start-ups to thrive. However, the study emphasises that many emerging markets continue to struggle with outdated regulatory frameworks that hinder the commercialisation of new technologies, particularly in energy storage. The study concludes that future research should focus on detailed longitudinal studies and interdisciplinary approaches that combine legal, economic, and technological analyses. Policymakers are urged to adopt flexible, adaptive regulations to support innovation in renewable energy, ensuring that start-ups can leverage technological advancements and contribute to the global energy transition. [ABSTRACT FROM AUTHOR]

The concept of sustainable entrepreneurship is becoming an increasingly pivotal area of focus in the global effort to address a range of pressing challenges, including climate change, resource scarcity, and social inequality. Entrepreneurs who integrate economic, environmental, and social goals into their business models can serve as pivotal agents in achieving both profitability and societal well-being. Nevertheless, despite the growing interest in sustainable business models, entrepreneurs encounter considerable obstacles that impede the scalability and success of their ventures. This study focuses on the identification and analysis of the principal obstacles across five key dimensions: economic, regulatory, social, technological, and environmental. The aim of this research is to examine the difficulties encountered by those engaged in sustainable entrepreneurship and to suggest strategies for surmounting these challenges. Methodologically, the study employs a multi-dimensional approach, with each challenge examined through qualitative analysis. The economic challenges, including the high initial costs and difficulties in accessing funding, are identified as some of the most significant barriers. The presence of regulatory challenges, such as inconsistent environmental policies and the absence of governmental incentives, serves to further complicate the business landscape. Furthermore, social challenges, such as consumer reluctance to pay higher prices for sustainable products and resistance to adopting new, eco-friendly habits, also play a crucial role in hindering the success of sustainable ventures. Furthermore, the absence of access to sophisticated green technologies and the requisite expertise to deploy them constitutes a substantial technological impediment for entrepreneurs. The results of the study indicate the existence of several potential avenues for addressing these challenges. For example, the increasing consumer demand for environmentally friendly products and services, in conjunction with technological advancements, presents a substantial opportunity for sustainable entrepreneurship. The practical value of the research lies in its strategic recommendations, which encourage collaboration between policymakers, businesses, and investors. Such collaborative endeavours can facilitate the creation of an enabling environment for sustainable entrepreneurship, thereby reducing economic and regulatory burdens while simultaneously promoting technological advancements. In conclusion, the study emphasises the necessity of a coordinated approach in order to overcome the barriers faced by sustainable entrepreneurs. By capitalising on emerging opportunities and cultivating a supportive ecosystem, entrepreneurs can simultaneously achieve financial success and a positive impact on society and the environment.

The regulation of legal practice has been based predominantly on geographical boundaries. To varying degrees, foreign lawyers are prohibited from engaging in the practice of law in host jurisdictions without local admission, and in some cases with the added complexity of nationality or residency requirements. This is notwithstanding that increasing international trade and other transnational activities, enabled by advancements in technology that facilitate efficient transportation and communication, are creating a growing demand for legal services across borders. While much has been written about how technology is changing the nature of legal practice, the approach taken by this article is to assess whether technology is playing this change-role in a solely deterministic manner. In examining this question, this article applies soft technological determinism to argue that, while technology is an important factor, it does not have a mono-causal effect in shaping changes to cross-border legal practice. Rather, these changes are being influenced by an interplay of technological progress and non-technological factors such as similarities in legal systems, harmonisation of laws and trade affiliations.

The regulation of legal practice has been based predominantly on geographical boundaries. To varying degrees, foreign lawyers are prohibited from engaging in the practice of law in host jurisdictions without local admission, and in some cases with the added complexity of nationality or residency requirements. This is notwithstanding that increasing international trade and other transnational activities, enabled by advancements in technology that facilitate efficient transportation and communication, are creating a growing demand for legal services across borders. While much has been written about how technology is changing the nature of legal practice, the approach taken by this article is to assess whether technology is playing this change-role in a solely deterministic manner. In examining this question, this article applies soft technological determinism to argue that, while technology is an important factor, it does not have a mono-causal effect in shaping changes to cross-border legal practice. Rather, these changes are being influenced by an interplay of technological progress and non-technological factors such as similarities in legal systems, harmonisation of laws and trade affiliations. [ABSTRACT FROM AUTHOR]

Successful integration of Circular Economy (CE) within economic systems can significantly contribute to sustainable development by promoting economic growth through closed-loop systems. Nonetheless, despite CE principles aligning closely with the United Nations’ Sustainable Development Goals (SDGs), their integration into public policy faces limitations. This study adopts a qualitative research approach, drawing insights from academic literature and European legislation, so as to shed light on the challenges and barriers obstructing the effective implementation of CE principles within the framework of the EU. Focusing on regulatory obstacles, this research analyzes the intersection of Sustainability Economics (SE) with CE, identifies major CE principles and observes the challenges involved in incorporating them into public policy. It then reviews European Union (EU) milestones in adopting CE, under both the Juncker Commission and the von der Leyen Commission, and assesses the obstacles in integrating CE within EU public policy. The study found that major challenges highlighted in the literature include insufficient awareness, limited infrastructure for recycling and reusing materials, and ensuring collaboration between governments, industries, and consumers. Continuing to implement comprehensive policy frameworks is essential for promoting CE practices in the EU.

Energy communities (ECs) are an important tool towards a fair energy transition. Hence, the European Union (EU) has positioned ECs at the centre of its energy strategy and the foreseen transformation of its energy system. This paper aims to give an overview of key aspects and challenges for the implementation of the EC concept. Firstly, the regulatory framework is examined with a focus on the new definitions for ECs introduced by the EU, Renewable Energy Communities (RECs) and Citizen Energy Communities (CECs). Secondly, examples of established ECs and their main objectives are mentioned. Additionally, based on the identified challenges and requirements of establishing ECs, the key technologies that are implemented or have the potential to be deployed in an EC are examined, as well as innovative cross-cutting services that are optimally suited to be integrated in an EC. Moreover, the data management challenges linked to some of these technologies are considered. Finally, an overview of actual or potential financing schemes to support the EC development is given. Overall, the analysis highlighted the regulatory, technical and financial aspects and challenges that ECs are facing and the need to address them so that the EC concept is effective and successful. The main challenges identified for each of these aspects are the regulatory compliance with the legal framework, the data management dimension when innovative technological concepts are adopted and the financing of new projects. [ABSTRACT FROM AUTHOR]

Introduction. The article considers the conditions for providing a guarantee of safe innovative development of the tourism industry of Ukraine. The study was aimed at finding ways to ensure safe innovative development of the tourism industry in Ukraine. Method. A comprehensive approach to assessing the safe state of innovative development of the tourism industry in the economic system of the country was substantiated. Results and interpretation. The system of indicators for assessing the level of the social component of safe innovative development of the tourism industry in the territorial tourist destination was presented. The trend of changing the number of tourism entities in the TTD and Ukraine as a whole in terms of the functionality of a secure system of innovative development is analyzed. Optimization methods of risk management of safe innovative development of tourist enterprises in the territorial tourist destination are offered. The general index of a safe condition of innovative development of territorial tourist destinations is offered and defined.

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

India's power system has been evolving rapidly through multiple structural and operational reforms. The evolution is driven by multiple factors, including deregulation of the power system and ambitious government programs to increase Renewable Energy (RE) in the power generation portfolio and provide energy access in rural India. The use of RE and Electric vehicles (EVs) introduces its own set of challenges to the network operator. With the promotion given to RE and EVs in India, the Demand Response (DR) can become a key part of the puzzle that can help the Indian power sector for its smooth working. The importance of DR is because of its potential to alleviate network congestion, improve reliability, and be cost-effective while maintaining demand-supply balance. This paper presents the potential that DR has in the Indian power sector as well as the challenge preventing proper utilization of DR in India. [ABSTRACT FROM AUTHOR]

The hydrocarbon-rich Gulf states are located in the heart of the global sunbelt which endows them with some of the highest solar resources in the world. Peak load hours in these countries also align well with daily and seasonal solar radiation levels. Nevertheless, actual deployment of renewable power, including solar, is among the lowest in the world. This article analyzes why solar power has seen some success in a few states, while in others there has been little momentum. To address the question, the authors undertake a qualitative, case-based inquiry into solar power development through data collected from interviews with solar power developers based in the Gulf. Our findings are two-fold. First, the quality of a regulatory regime (planning and enforcement) plays a significant role in explaining variations in solar deployment across the Gulf. Second, the most impactful pathways through which regulatory regimes affect solar power deployment include governance, competition among differently-sized developers, procurement, labor, and evenness within the same national jurisdiction. In so doing, the article offers policy-relevant implications for scaling up solar power sector in the Gulf and contributes to the wider literature on business-state relations in the region. • Interviews reveal pathways through which variations in regulatory regimes impact solar power deployment. • Utility-scale and distributed power developers share common but also possess distinct perspectives on solar power regulations. • Local content requirements should evolve and align with local capacities to support growth in solar power. [ABSTRACT FROM AUTHOR]

Energy communities (ECs) are an important tool towards a fair energy transition. Hence, the European Union (EU) has positioned ECs at the centre of its energy strategy and the foreseen transformation of its energy system. This paper aims to give an overview of key aspects and challenges for the implementation of the EC concept. Firstly, the regulatory framework is examined with a focus on the new definitions for ECs introduced by the EU, Renewable Energy Communities (RECs) and Citizen Energy Communities (CECs). Secondly, examples of established ECs and their main objectives are mentioned. Additionally, based on the identified challenges and requirements of establishing ECs, the key technologies that are implemented or have the potential to be deployed in an EC are examined, as well as innovative cross-cutting services that are optimally suited to be integrated in an EC. Moreover, the data management challenges linked to some of these technologies are considered. Finally, an overview of actual or potential financing schemes to support the EC development is given. Overall, the analysis highlighted the regulatory, technical and financial aspects and challenges that ECs are facing and the need to address them so that the EC concept is effective and successful. The main challenges identified for each of these aspects are the regulatory compliance with the legal framework, the data management dimension when innovative technological concepts are adopted and the financing of new projects.

Introduction. The article considers the conditions for providing a guarantee of safe innovative development of the tourism industry of Ukraine. The study was aimed at finding ways to ensure safe innovative development of the tourism industry in Ukraine. Method. A comprehensive approach to assessing the safe state of innovative development of the tourism industry in the economic system of the country was substantiated. Results and interpretation. The system of indicators for assessing the level of the social component of safe innovative development of the tourism industry in the territorial tourist destination was presented. The trend of changing the number of tourism entities in the TTD and Ukraine as a whole in terms of the functionality of a secure system of innovative development is analyzed. Optimization methods of risk management of safe innovative development of tourist enterprises in the territorial tourist destination are offered. The general index of a safe condition of innovative development of territorial tourist destinations is offered and defined. [ABSTRACT FROM AUTHOR]

As a result of previous multilateral negotiations tariff rates are generally low and cannot explain the reasons for recent proliferation of preferential trade agreements (PTAs). The aim of the paper is to look for other motivations of EU PTAs and to assess their importance for the EU. The main research methods are statistical, review and assessment of WTO documents and critical analysis of literature.

Export controls are domestic trade restrictions placed on technologies that have been determined to be important to the national security concerns of a country. In recent years, the policy purpose for maintaining export control regulations have shifted, and how these new export control regulations would interact with new emerging technologies is something that should be analyzed and considered. The passage of the United States (US) Export Control Reform Act (ECRA) of 2018 and the proposed regulatory changes for the European Union's (EU) Council Regulation (EC) No. 428/2009 have shifted the focus of dual-use export controls so that the national security goals of these controls have broadened to include economic security and human rights concerns. This paper argues that the infusion of geoeconomics into US national security considerations and the proposed expansion to include human rights considerations into EU export control regulations are made mutually exclusive of each other and were not made to expand the reach of export controls in a unifying way. Rather, the purpose and structural change to export control regulations serves to create more regulatory barriers on the trade of emerging technology industries that would not only impact the US and the EU, but also their international trading partners. [ABSTRACT FROM AUTHOR]

• 95% of respondents manufacturers have a strategy to pursue innovation. • Innovation targeted at low- and middle- income countries. • Partnerships with biotechs and universities key in driving innovation. • Access to partnerships, in-licensing/ joint ventures seen as barrier to novel vaccines. Development of novel vaccines and improving existing vaccines is critical to addressing areas of unmet or under-addressed health needs globally and to improving existing vaccination coverage and equity. However, vaccine innovation is costly and highly complex. To understand how vaccine manufacturers from developing countries approach innovation, a survey was conducted among company members of the Developing Countries Vaccine Manufacturers Network, in collaboration with the Clinton Health Access Initiative. The survey confirmed that vaccine manufacturers from developing countries are committed to vaccine innovation: 95% of respondents have interest in pursuing vaccine innovation, with strategies targeted towards supplying to low- and middle-income countries. Key barriers to innovation were also surveyed, with respondents highlighting challenges regarding access to in-licensing or joint venture partnerships, financing, and regulatory barriers. Opportunities for innovation are also discussed. [ABSTRACT FROM AUTHOR]

The European Commission (EC) recommends that policy within the EU should consider how to make the regulation of new genomic techniques 'more resilient, future-proof and uniformly applied' than is presently the case. In this article, we explore what this might mean for the EU and what solutions might exist. [ABSTRACT FROM AUTHOR]

This study focuses on identification, categorization and comparison of regulatory barriers to internationalization for the small and medium‐sized enterprises (SMEs) from an emerging market context. Primary data were collected to develop and validate a structural model to assess the salient regulatory barriers of internationalization with a particular attention to the SMEs in Bangladesh. Structured questionnaire has been used to collect data from 212 SMEs operating in Bangladesh. The results indicate that both administrative and economic regulatory barriers are significant for the internationalization of SMEs whereby administrative regulatory barriers are slightly more substantial. This study provides further discussion from both theoretical and methodological aspects. By developing and validating structural model, this study contributes to the literature on small business and regulation with particular attention to the emerging markets. [ABSTRACT FROM AUTHOR]

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This paper presents a SWOT analysis of the impact of recent EU regulatory changes on the business case for energy storage (ES) using the UK as a case study. ES technologies (such as batteries) are key enablers for increasing the share of renewable energy generation and hence decarbonising the electricity system. As such, recent regulatory changes seek to improve the business case for ES technologies on national networks. These changes include removing double network charging for ES, defining and classifying ES in relevant legislations, and clarifying ES ownership along with facilitating its grid access. However, most of the current regulations treat storage in a similar way to bulk generators without paying attention to the different sizes and types of ES. As a result, storage with higher capacity receives significantly higher payment in the capacity market and can be exempt from paying renewable energy promotion taxes. Despite the recent regulatory changes, ES is defined as a generation device, which is a barrier to a wide range of revenue streams from demand side services. Also, regulators avoid disrupting the current energy market structure by creating an independent asset class for ES. Instead, they are encouraging changes that co-exist with the current market and regulatory structure. Therefore, although some of the reviewed market and regulatory changes for ES in this paper are positive, it can be concluded that these changes are not likely to allow a level playing field for ES that encourage its increase on energy networks.

TTIP aims at conducting a trade policy which reduces regulatory barriers. This would enable certain goods and services to move freely or more easily from the EU to the US and the other way around, resulting in gains from cost savings and efficiencies. However, this can potentially have implications in the way risk regulation is implemented in the EU, and it has therefore raised an important debate on both sides of the Atlantic. Indeed, the United States and the European Union do not seem to share the same values in terms of risk assessment and risk management. The EU can be described as more risk averse and has developed stricter standards to address consumer health and safety or environmental issues. This paper examines whether an EU-US trade partnership is capable of reducing regulatory barriers while safeguarding the approach towards risk regulation developed in the EU for the last two decades. To address this topic, the paper focuses on the cosmetics sector which is of great importance in Europe since it employs large numbers of people and contributes heavily to the economy. Besides, the large regulation of the market and the high rates of trade between the EU and the US in the sector will most probably enhance the applicability of TTIP. Therefore, it is interesting to study how the negotiations on the trade agreement might impact the regulation of cosmetic products in Europe. As an international standard hegemon in the cosmetics sector, the EU has incentivised voluntary rules in the US similar to the European ones. This will support the idea that the TTIP negotiations are not likely to modify substantially the regulatory standards set by the EU on cosmetic products because these standards are already met by an increasing number of manufacturers.

Background: In 2011-2013, >95% of the global opioid analgesics consumption occurred in three regions, accounting for 15% of the world population. Despite abundant literature on barriers to access, little is known on the correlation between actual access to opioid analgesics and barriers to access, including legal and regulatory barriers. Objective: This study aimed to evaluate the correlation between access to strong opioid analgesics and barriers to access in national legislation and regulations in 11 central and eastern European countries that participated in the Access to Opioid Medication in Europe (ATOME) project. Design: Two variables were contrasted to assess their correlation: the country level of access to strong opioid analgesics indicated by the Adequacy of Consumption Measure (ACM) and the number of potential legal and regulatory barriers identified by an external review of legislation and regulations. Measurements: A linear correlation was evaluated using a squared linear correlation coefficient. Results: Evaluation of the correlation between the ACM and the number of potential barriers produces an R2 value of 0.023 and a correlation plot trend line gradient of −0.075, indicating no correlation between access to strong opioid analgesics and the number of potential barriers in national legislation and regulations in the countries studied. Conclusions: No correlation was found, which indicates that other factors besides potential legal and regulatory barriers play a critical role in withholding prescribers and patients essential pain medication in the studied countries. More research is needed toward better understanding of the complex interplay of factors that determine access to strong opioid analgesics. [ABSTRACT FROM AUTHOR]

Energy storage has been identified as a priority technology for innovation. However, the rapidly developing family of storage technologies will find it difficult, under the current regulatory regimes, to compete with conventional generators for the provision of electricity system services, and this is likely to impede innovation. This paper analyses and categorizes 16 investment barriers hindering the near-term deployment of energy storage technologies in electricity markets, which are related to four regulatory and public attitudes barriers. The most important regulatory barrier is the current classification of storage as a generation asset, despite it being unable to provide a positive net flow of electricity, which is used to justify double network usage charges. The merit order design of balancing and ancillary markets hampers the ability of storage technologies to recoup their relatively high capital cost, while capacity markets penalize their limited discharge duration. Network companies are in the best position to realize the system value of storage, but their ownership may only be acceptable if system operation is made independent of network operation. Current initiatives to address these issues include flexible connection agreements and the development of enhanced frequency response and aggregate fast reserve services. However, to remove the identified barriers, a market structure that valued the flexibility offered by storage, viewing it as complementing rather than competing with network and generation assets, would be required. [ABSTRACT FROM AUTHOR]

Objective: The aim of this work within OptTEST by HiE has been to demonstrate the role of legal and regulatory barriers in hindering access to HIV testing, treatment and care across Europe and to produce tools to help dismantle them. Methods: An online survey to assess country‐specific data on legal and regulatory barriers distributed widely across the WHO Europe region. Literature reviews conducted in January‐October 2015 in English, in November 2015 in Russian, and updated in April 2017. Semi‐structured interviews were conducted with 25 key actors within the HIV field to feed into case studies and tip sheets on how to dismantle legal and regulatory barriers. Results: More than 160 individuals and organisations from 49 countries across the WHO European region provided responses which were analysed and cross checked with other data sources and a searchable database produced (legalbarriers.peoplewithhiveurope.org). The conducted literature reviews yielded 88 papers and reports which identify legal and regulatory barriers to key populations’ access to HV testing and care. Based on the interviews with key actors, ranging from PLHIV activists to government officials, on lessons‐learned, a series of tip sheets and ten case studies were written‐up intended to inform and inspire the HIV community to address and overcome existing barriers (opttest.eu/Tools). Conclusion: While some of the barriers identified may require major changes to wider health systems, or long term legal reform, many are open to a simple change in regulations or custom and practice. We have the tools. Why can't we finish the job? [ABSTRACT FROM AUTHOR]

Increasing environmental concerns are driving an evolution of the energy system in which electric vehicles (EVs) play an important role. Still, as the EV number increases, the adverse impact of charging is observed more widely, especially at the low-voltage level where high EV concentrations cause various detrimental effects due to the coincidence between EV charging and residential peak load. However, if managed properly, EVs become flexible resources which can improve the system operation, making them an attractive asset for the distribution system operator. With the recent technology development, new forms of local EV support can be developed, provided that an appropriate regulatory framework is established. Whereas the technical value of such EV distribution grid services has already been proven, integrating them into the European regulatory context is not straightforward. In the context where active distribution grid management schemes are still to be developed, it is important to recognise the barriers for active EV involvement in the early stage of the development. This manuscript focuses on identifying these barriers from a technology and infrastructure perspective as well as from the regulatory and market aspect. Various policy recommendations are provided for the stakeholders involved in the EV value chain. [ABSTRACT FROM AUTHOR]

Summary Rural electrification rates in India lag behind government goals, in part due to the inability of distribution companies (discoms) to fund central grid expansion. In the absence of central grid electrification, mini-grids offer significant potential for an immediate pathway toward rural electrification and the attendant gains in economic growth and productivity. Yet private investment in mini-grids has been virtually absent in India. Using a comprehensive life-cycle cost analysis, we find that mini-grids based on solar PV power and storage are more economical than incumbent energy services available to households without central grid connection. Under current law, a prospective entrepreneur in India does not require a license or certification in order to build a mini-grid and subsequently provide electricity services in the area covered by said installation. Conversely, there is no legal or regulatory framework that specifies what is to happen if the central grid were to be extended to an area that is already covered by a mini-grid. We report detailed survey evidence from interviews with entrepreneurs, analysts and policymakers whose assessments converge on the same point: mini-grid investments would be jeopardized in the event of central grid extension, precisely because discoms would, by regulatory order, provide electricity services at highly subsidized rates, well below their full economic cost. Our fieldwork suggests that the threat of central grid extension is a gateway barrier preventing mini-grid development in India. The issues associated with the gateway barrier have common elements with the so-called holdup problem as identified in the economics of organizations. There have been two recent federal policy guidelines and one actual state-level policy addressing the regulatory status of mini-grids. We examine the effectiveness of these policies/proposals in terms of an entrepreneur’s willingness to develop mini-grids in the future. [ABSTRACT FROM AUTHOR]

Inter-regional free trade agreements (FTAs) - notably between Asia and Latin America - are growing in numbers and complexity. There is an absence of an agreed methodology for empirical assessments on the content of FTAs and little research. This paper proposes a framework to assess liberalization in FTAs in goods and services and new trade policy issues relating to regulatory barriers. Next, it applies this framework to studying the 22 Asia-Latin America FTAs in existence. The findings suggest that Asia-Latin American FTAs have laid the foundations for inter-regional integration by liberalizing the trade in goods and services and reducing some regulatory barriers. Deepening FTAs and adopting structural reforms will enhance Asia-Latin American integration in the future.

There have been numerous investigations targeted at identifying whether a drug lag exists in the mature markets of the US, EU and Japan. This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical industry as a consequence of rapid economic and political development. The aims of this work are to ascertain whether a drug lag exists in the emerging markets and how it has changed over time from the 1960s to the 2000s. It will also highlight key regulatory barriers which may contribute to drug lag. The date of the marketing authorisation (MA) approval by the US Food and Drug Administration (FDA) was used as a reference point. A comparison against the company database regarding emerging market specific approval enabled the difference in time and thus the drug lag for that particular market to be calculated. This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; ′Western Approval′, local clinical development (LCD), Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), pricing approval, document authentication and harmonisation.

As the largest polity worldwide to legalize cannabis, California has implemented uniquely high environmental and land use standards for cannabis agriculture. To date, however, regulations have suffered from low compliance rates, especially among smaller, "legacy" farms that existed prior to legalization. Meanwhile, both licensed and unlicensed farms are increasing in size, thus increasing environmental pressures. Is there a way to achieve environmental objectives, farmer compliance, and an equitable transition away from illegal markets? In the largest US survey of cannabis farmers to date, we found farmers are open to strong environmental protections yet face significant barriers in meeting regulatory requirements. We present this opinion article to suggest several strategies to ameliorate compliance barriers by reducing associated learning, financial, and psychological costs. Taken together, these strategies present an unprecedented opportunity to model a new kind of agriculture centered on small-farm production and environmental stewardship—a model that indicates new directions for agriculture beyond cannabis. • California cannabis regulations have struggled to enroll and support farmers, particularly at smaller scales. • Barriers to and burdens of participation are key reason for non-participation. • Policy responses should lower barriers and burdens in ways that support equity and sustainability. • Policy responses should address financial, administrative, and psychological costs of legal market participation. • If successful, cannabis policy may be model for agricultural policy in time of socio-environmental crisis. [ABSTRACT FROM AUTHOR]

New maritime technologies -autonomous and uncrewed vessels- are already poised to revolutionize the shipping industry. However, they are virtually unregulated under the current maritime laws, which raises significant safety and social impact issues. Can their incorporation into the maritime legal order occur through a policy decision by the international community or are substantial amendments to existing laws or adoption of new international legal instruments necessary? While the possibility of expanding the notions of a master, seafarer, vessel and safe manning requirements under the existing international framework is analyzed, it is concluded that the adoption of a new, specialized autonomous and uncrewed vessels convention or a specialized code designed for those vessels seems a much easier and faster solution. [ABSTRACT FROM AUTHOR]