Search results for: legal and regulatory.

Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

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Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

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Authors: Hatim Elhag

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Banking and Financial Service Institutions are possibly the most advanced in terms of technology adoption and use it as a key differentiator. With high levels of business process automation, maturity in the functional portfolio, straight through processing and proven technology outsourcing benefits, Banking sector stand to benefit significantly from Cloud computing capabilities. Additionally, with complex Compliance and Regulatory policies, combined with expansive products and geography coverage, the business impact is even greater. While the benefits are exponential, there are also significant challenges in adopting this model– including Legal, Security, Performance, Reliability, Transformation complexity, Operating control and Governance and most importantly proof for the promised cost benefits. However, new architecture designed should be implemented to align this approach.

Keywords: security, cloud, banking sector, cloud computing

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Authors: Sami Adwan, Alaa Alhaj Ismail, Claudia Girardone

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This paper examines the changes in the value relevance of book value of equity and net income of financial firms over the crisis period. It also examines how these changes vary with three variables, namely, fair value exposure, ownership concentration, and regulatory capital ratios. Using a sample of financial firms operating in the European Economic Area over 2005-2011, our findings suggest that the value relevance of book value of equity increases while that of net income decreases during the financial crisis. We find that more exposure to fair value accounting mitigates the impact of the crisis on the value relevance of book value of equity and net income. We also find that more concentrated ownership appears to have a mitigating impact on the changes in the value relevance of both book value of equity and net income in times of financial crisis. Finally, we find evidence that the level of regulatory capital ratios tends to have an attenuating effect on the changes in the value relevance of net income (but not book value of equity) in times of financial crisis.

Keywords: value relevance, financial crisis, financial firms, fair value, ownership concentration, regulatory capital

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Authors: Oluchukwu P. Obioma, Amarachi R. Dike

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Competition law promotes market competition by regulating anti-competitive conduct by undertakings. There is a need for a third party to regulate the market for efficiency and supervision, since, if the market is left unchecked, it may be skewed against the consumers and the economy. Competition law is geared towards the protection of consumers from economic exploitation. It is the duty of every rational government to optimally manage its economic system by employing the best regulatory practices over the market to ensure it functions effectively and efficiently. The Nigerian government has done this by enacting the Federal Competition and Consumer Protection Act, 2018 (FCCPA). This is a comprehensive legal framework with the objective of governing competition issues in Nigeria. Prior to its enactment, the competition law regime in Nigeria was grossly inadequate despite Nigeria being the biggest economy in Africa. This latest legislation has become a bold step in the right direction. This study will use the doctrinal methodology in analyzing the FCCPA, 2018 in order to discover the extent to which the Act will guard against anti-competitive practices and promote competitive markets for the benefit of the Nigerian economy and consumers. The study finds that although the FCCPA, 2018 provides for the regulation of competition in Nigeria, there is a need to effectively tackle the challenges to the implementation of the Act and the development of anti-trust jurisprudence in Nigeria. This study concludes that incisive implementation of competition law in Nigeria will help protect consumers and create a conducive environment for economic growth, development, and protection of consumers from obnoxious competition practices.

Keywords: anti-competitive practices, competition law, competition regulation, consumer protection.

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Authors: Zsofia Patyi

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While empirical studies under socialism in Hungary focused on the lawyer society as a whole, current research deals with law students in specific. The change of regime and the mutation of legal education have influenced the motivation, efficiency, social background and self-concept of law students. This shift needs to be acknowledged, and the education system improved for students and together with students. A new law student society requires a different legal education system, different legal studies, or, at the minimum, a different approach to teaching law. This is to ensure that competitive lawyers be trained who understand the constantly changing nature of the law and, as a result, can potentially transform or create legislation themselves. A number of developments can affect law students’ awareness of legal relations in a democratic state. In today’s Hungary, these decisive factors are primarily the new regulation of the financing of law students, and secondly, the new Hungarian constitution (henceforth: Alaptörvény), which has modified the base of the Hungarian legal system. These circumstances necessitate a new, comprehensive, and empirical, investigation of law students. To this end, our research team (comprising a professor, a Ph.D. student, and two law students), is conducting a new type of study in February 2017. The first stage of the research project uses the desktop method to open up the research antecedents. Afterward, a structured questionnaire draft will be designed and sent to the Head of Department of Sociology and the Associate Professor of the Department of Constitutional Law at the University of Szeged to have the draft checked and amended. Next, an open workshop for students and teachers will be organized with the aim to discuss the draft and create the final questionnaire. The research team will then contact each Hungarian university with a Faculty of Law to reach all 1st- and 4th-year law students. 1st-year students have not yet studied the Alaptörvény, while 4th-year students have. All students will be asked to fill in the questionnaire (in February). Results are expected to be in at the end of February. In March, the research team will report the results and present the conclusions. In addition, the results will be compared to previous researches. The outcome will help us answer the following research question: How should legal studies and legal education in Hungary be reformed in accordance with law students and the future lawyer society? The aim of the research is to (1) help create a new student- and career-centered teaching method of legal studies, (2) offer a new perspective on legal education, and (3) create a helpful and useful de lege ferenda proposal for the attorney general as regards legal education as part of higher education.

Keywords: change, constitution, investigation, law students, lawyer society, legal education, legal studies, motivation, reform

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Authors: Mandeep Saini

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The rapid advancement of Artificial Intelligence (AI) is transforming various fields, including intellectual property law. This paper explores the emerging role of AI in interpreting patent claims, a critical and highly specialized area within intellectual property rights. Patent claims define the scope of legal protection granted to an invention, and their precise interpretation is crucial in determining the boundaries of the patent holder's rights. Traditionally, this interpretation has relied heavily on the expertise of patent examiners, legal professionals, and judges. However, the increasing complexity of modern inventions, especially in fields like biotechnology, software, and electronics, poses significant challenges to human interpretation. Introducing AI into patent claim interpretation raises several legal and ethical concerns. This paper addresses critical issues such as the reliability of AI-driven interpretations, the potential for algorithmic bias, and the lack of transparency in AI decision-making processes. It considers the legal implications of relying on AI, particularly regarding accountability for errors and the potential challenges to AI interpretations in court. The paper includes a comparative study of AI-driven patent claim interpretations versus human interpretations across different jurisdictions to provide a comprehensive analysis. This comparison highlights the variations in legal standards and practices, offering insights into how AI could impact the harmonization of international patent laws. The paper proposes policy recommendations for the responsible use of AI in patent law. It suggests legal frameworks that ensure AI tools complement, rather than replace, human expertise in patent claim interpretation. These recommendations aim to balance the benefits of AI with the need for maintaining trust, transparency, and fairness in the legal process. By addressing these critical issues, this research contributes to the ongoing discourse on integrating AI into the legal field, specifically within intellectual property rights. It provides a forward-looking perspective on how AI could reshape patent law, offering both opportunities for innovation and challenges that must be carefully managed to protect the integrity of the legal system.

Keywords: artificial intelligence (ai), patent claim interpretation, intellectual property rights, algorithmic bias, natural language processing, patent law harmonization, legal ethics

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Authors: Gianni Izzo

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The relation of Islam to its legal precepts, reflected in the various jurisprudential 'schools of thought' (madhahib), is one expressed in a version of 'positivism' (fiqh) providing the primary theory for deducing Qurʾan rulings and those from the narrations (hadith) of the Prophet Muhammad. Scholars of Islam, including Patricia Crone (2004) and others chronicled by Anver Emon (2005), deny the influence of natural law theories as extra-scriptural indices of revelation’s content. This paper seeks to dispute these claims by reference to historical and canonical examples within Shiʿa legal thought that emphasize the salient roles of ‘aql (reason), fitrah (primordial human nature), and lutf (divine grace). These three holistic features, congenital to every human, and theophanically reflected in nature make up a mode of moral intelligibility antecedent to prophetic revelation. The debate between the 'traditionalist' Akhbaris and 'rationalist' Usulis over the nature of deriving legal edicts in Islam is well-covered academic ground. Instead, an attempt is made to define and detail the built-in assumptions of natural law revealed in the jurisprudential summa of Imami Shiʿism, whether of either dominant school, that undergird its legal prescriptions and methods of deduction.

Keywords: Islam, fiqh, natural law, legal positivism, aql

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Authors: Mark Lokanan

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The paper analyzes the processing of complaints against investment brokers and dealer members through the Investment Industry Regulatory Organization of Canada (IIROC) from 2008 to 2017. IIROC is the self-regulatory organization (SRO) that is responsible for policing investment dealers and brokerage firms that trade in Canada’s securities market. Data from the study came from IIROC's enforcement annual reports for the years examined. The case processing is evaluated base on the misconduct funnel that was originally designed for street crime and applies to the enforcement of investment fraud. The misconduct funnel is used as a framework to examine IIROC’s claim that it brought in more complaints (funnel in) than government regulators and shows how these complaints are funneled out and funneled away as they are processed through IIROC’s enforcement system. The results indicate that IIROC is ineffective in disciplining its members and is unable to handle the more serious quasi-criminal and improper sales practices offenses. It is hard not to see the results of the paper being used by the legislator in Ottawa to show the importance of a federal securities regulatory agency such as the Securities and Exchange Commission (SEC) in the United States.

Keywords: investment fraud, securities regulation, compliance, enforcement

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Authors: Mohamed Aljarallah, Mohamed Nurullah, George Saridakis

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This paper aims and objectives are to investigate how the structural change of the financial regulatory bodies affect the financial supervision and how the regulators can design such a structure with taking into account; the Central Bank, the conduct of business and the prudential regulators, it will also consider looking at the structure of the international regulatory bodies and what barriers are found. There will be five questions to be answered; should conduct of business and prudential regulation be separated? Should the financial supervision and financial stability be separated? Should the financial supervision be under the Central Bank? To what extent the politician should intervene in changing the regulatory and supervisory structure? What should be the regulatory and supervisory structure when there is financial conglomerate? Semi structure interview design will be applied. This research sample selection contains a collective of financial regulators and supervisors from the emerged and emerging countries. Moreover, financial regulators and supervisors must be at a senior level at their organisations. Additionally, senior financial regulators and supervisors would come from different authorities and from around the world. For instance, one of the participants comes from the International Bank Settlements, others come from European Central Bank, and an additional one will come from Hong Kong Monetary Authority and others. Such a variety aims to fulfil the aims and objectives of the research and cover the research questions. The analysis process starts with transcription of the interview, using Nvivo software for coding, applying thematic interview to generate the main themes. The major findings of the study are as follow. First, organisational structure changes quite frequently if the mandates are not clear. Second, measuring structural change is difficult, which makes the whole process unclear. Third, effective coordination and communication are what regulators looking for when they change the structure and that requires; openness, trust, and incentive. In addition to that, issues appear during the event of crisis tend to be the reason why the structure change. Also, the development of the market sometime causes a change in the regulatory structure. And, some structural change occurs simply because of the international trend, fashion, or other countries' experiences. Furthermore, when the top management change the structure tends to change. Moreover, the structure change due to the political change, or politicians try to show they are doing something. Finally, fear of being blamed can be a driver of structural change. In conclusion, this research aims to provide an insight from the senior regulators and supervisors from fifty different countries to have a clear understanding of why the regulatory structure keeps changing from time to time through a qualitative approach, namely, semi-structure interview.

Keywords: financial regulation bodies, financial regulatory structure, global financial regulation, financial crisis

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Authors: Jumana Majdi Qutub

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Rationale: Cloud computing has rapidly developed the past few years. Because of the importance of providing protection for personal data used in cloud computing, the role of data protection in promoting trust and confidence in users’ data has become an important policy priority. This research examines key regulatory challenges rose by the growing use and importance of cloud computing with focusing on protection of individuals personal data. Methodology: Describing and analyzing governance challenges facing policymakers and industry in Saudi Arabia, with an account of anticipated governance responses. The aim of the research is to describe and define the regulatory challenges on cloud computing for policy making in Saudi Arabia and comparing it with potential complied issues rose in respect of transported data to EU member state. In addition, it discusses information privacy issues. Finally, the research proposes policy recommendation that would resolve concerns surrounds the privacy and effectiveness of clouds computing frameworks for data protection. Results: There are still no clear regulation in Saudi Arabia specialized in legalizing cloud computing and specialty regulations in transferring data internationally and locally. Decision makers need to review the applicable law in Saudi Arabia that protect information in cloud computing. This should be from an international and a local view in order to identify all requirements surrounding this area. It is important to educate cloud computing users about their information value and rights before putting it in the cloud to avoid further legal complications, such as making an educational program to prevent giving personal information to a bank employee. Therefore, with many kinds of cloud computing services, it is important to have it covered by the law in all aspects.

Keywords: cloud computing, cyber crime, data protection, privacy

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Authors: Pratyusha Das

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A paradigm shift has been noticed in the interpretation of DNA evidence for determining paternity. Sometimes DNA evidence has been accepted while sometimes it was rejected by the Indian Courts. Courts have forwarded various justifications for acceptance and rejection of such evidence through legal and scientific means. Laws have also been changed to accommodate the necessities of society. Balances between both the legal and scientific approaches are required, to make the best possible use of DNA evidence for the well-being of the society. Specifications are to be framed as to when such evidence can be used in the future by pointing out the pros and cons. Judicial trend is to be formulated to find out the present situation. The study of cases of superior courts of India using an analytical and theoretical approach is driving the questions regarding the shared identity of the legal and scientific approaches. To assimilate the differences between the two approaches, the basic differences between them have to be formulated. Revelations are required to access the favorable decisions using the DNA evidence. Reasons are to be forwarded for the unfavorable decisions and the approach preferred in such cases. The outcome of the two methods has to be assessed in relation to the parties to the dispute, the society at large, the researcher and from the judicial point of view. The dependability of the two methods is to be studied in relation to the justice delivery system. A highlight of the chronological study of cases along with the changes in the laws with the aid of presumptions will address the questions of necessity of a method according to the facts and situations. Address is required in this respect whether the legal and scientific forces converge somewhere pushing the traditional identification of paternity towards a fundamental change.

Keywords: cases, evidence, legal, scientific

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Authors: Amy Gooden, Meshandren Naidoo

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Genetic research and transfers of big data are not confined to a particular jurisdiction, but there is a lack of clarity regarding the legal requirements for importing and exporting such data. Using direct-to-consumer genetic testing (DTC-GT) as an example, this research assesses the status of data sharing into and out of South Africa (SA). While SA laws cover the sending of genetic data out of SA, prohibiting such transfer unless a legal ground exists, the position where genetic data comes into the country depends on the laws of the country from where it is sent – making the legal position less clear.

Keywords: cross-border, data, genetic testing, law, regulation, research, sharing, South Africa

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Authors: Andrew Thayer, Courtney Rondeau, Paraskevi Papadopoulou

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The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene-editing technologies have generated considerable discussion about the applications and ethics of their use. However, no consistent guidelines for using CRISPR technologies have been developed -nor common legislation passed related to gene editing, especially as it is connected to genetically modified organisms (GMOs) in the European Union. The recent announcement that the first babies with CRISPR-edited genes were born, along with new studies exploring CRISPR’s applications in treating thalassemia, sickle-cell anemia, cancer, and certain forms of blindness, have demonstrated that the technology is developing faster than the policies needed to control it. Therefore, it can be seen that a reasonable and coherent regulatory framework for the use of CRISPR in human somatic and germline cells is necessary to ensure the ethical use of the technology in future years. The European Union serves as a unique region of interconnected countries without a standard set of regulations or legislation for CRISPR gene-editing. We posit that the EU would serve as a suitable model in comparing the legislations of its affiliated countries in order to understand the practicality and effectiveness of adopting majority-approved practices. Additionally, we present a proposed set of guidelines which could serve as a basis in developing a consistent regulatory framework for the EU countries to implement but also act as a good example for other countries to adhere to. Finally, an additional, multidimensional framework of smart solutions is proposed with which all stakeholders are engaged to become better-informed citizens.

Keywords: CRISPR, ethics, regulatory framework, European legislation

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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Authors: Patrick M. Stanton, William R. McCumber

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Using a large dataset of more than 2,400 individual microfinance institutions (MFIs) from 120 countries from 1999 to 2016, this study finds that nearly half of the international MFIs operate as for-profit institutions. Formal institutions (business regulatory environment, property rights, social protection, and a developed financial sector) impact the likelihood of MFIs being for-profit across countries. Cultural differences across countries (power distance, individualism, masculinity, and indulgence) seem to be a factor in the legal status of the MFI (non-profit or for-profit). MFIs in countries with stronger formal institutions, a greater degree of power distance, and a higher degree of collectivism experience better financial and social performance.

Keywords: Hofstede cultural dimensions, international finance, microfinance institutions, non-profite

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Authors: Richard J. Sobelsohn

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Green Building and Sustainable Development help fight climate change, and protects the ozone, animal habitats, air quality, and ground water. The myriad of reasons to go Green has multiplied to the point that a developer that is building a ground-up or renovating/retrofitting a property has a plethora of choices to get to the green goal post. Sustainability not affects the bottom line but satisfies corporate mandates (ESG), consumer demand, market requirements, and the many laws dictating green building practices. The good news is that there are many paths a property owner can take to become green. The bad news is that there are many paths a property owner can take to become green, and they need to choose which direction to take. Certification of a building used to be the highest achievement in the Green building world. Now there are so many variables and laws with which a property owner must comply, and the legal analysis has mushroomed. Operation and Maintenance have also become one of the most important functions for a prudent Green Building owner. So adding to the “development/retrofit” parties involved in the sustainable building legal world, we now need to include all those people who keep the building green, and there are a lot of them!

Keywords: green building, sustainable development, legal issues, greenwashing, green cleaning, compliance, ESQ

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Authors: Umeda Junaydova

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Legal aid is a key element of access to justice. According to UN Principles and Guidelines on Access to Legal Aid in Criminal Justice Systems, state members bear the obligation to put in place accessible, effective, sustainable, and credible legal aid systems. Regarding this obligation, developing countries, such as Tajikistan, faced challenges in terms of financing this system. Thus, many developed nations have launched rule-of-law programs to support these states and ensure access to justice for all. Following independence from the Soviet Union, Tajikistan committed to introducing the rule of law and providing access to justice. This newly established country was weak, and the sudden outbreak of civil war aggravated the situation even more. The country needed external support and opened its door to attract foreign donors to assist it in its way to development. In 2015, Tajikistan, with the financial support of development partners, was able to establish a state-funded legal aid system that provides legal assistance to vulnerable and marginalized populations, including in criminal cases. In the beginning, almost the whole system was financed from donor funds; by that time, the contribution of the government gradually increased, and currently, it covers 80% of the total budget. All these governments' actions toward ensuring access to criminal legal aid for disadvantaged groups look promising; however, the reality is completely different. Currently, not all disadvantaged people are covered by these services, and their cases are most of the time considered without appropriate defense, which leads to violation of fundamental human rights. This research presents a comprehensive exploration of the interplay between donor assistance and the effectiveness of legal aid services in Tajikistan, with a specific focus on criminal cases involving vulnerable groups, such as women and children. In the context of Tajikistan, this study addresses a pressing concern: despite substantial financial support from international donors, state-funded legal aid services often fall short of meeting the needs of poor and vulnerable populations. The study delves into the underlying complexities of this issue and examines the structural, operational, and systemic challenges faced by legal aid providers, shedding light on the factors contributing to the ineffectiveness of legal aid services. Furthermore, it seeks to identify the root causes of these issues, revealing the barriers that hinder the delivery of adequate legal aid services. The research adopts a socio-legal methodology to ensure an appropriate combination of multiple methodologies. The findings of this research hold significant implications for both policymakers and practitioners, offering insights into the enhancement of legal aid services and access to justice for disadvantaged and marginalized populations in Tajikistan. By addressing these pressing questions, this study aims to fill the gap in legal literature and contribute to the development of a more equitable and efficient legal aid system that better serves the needs of the most vulnerable members of society.

Keywords: access to justice, legal aid, rule of law, rights for council

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Authors: Norbert Tribl

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European contemporary scientific public opinion considers the concept of constitutional identity as a highlighted issue. Some scholars interpret the matter as the manifestation of a conflict of Europe. Nevertheless, constitutional identity is a bridge between the Member States and the EU rather than a river that will wash away the achievements of the integration. In accordance with the opinion of the author, the main problem of constitutional identity in Europe is the undetermined nature: the exact concept of constitutional identity has not been defined until now. However, this should be the first step to understand and use identity as a legal institution. Having regard to this undetermined nature, the legal-theoretical examination of constitutional identity is the main purpose of this study. The concept of constitutional identity appears in the Anglo-Saxon legal systems by a different approach than in the supranational system of European Integration. While the interpretation of legal institutions in conformity with the constitution is understood under it, the European concept is applied when possible conflicts arise between the legal system of the European supranational space and certain provisions of the national constitutions of the member states. The European concept of constitutional identity intends to offer input in determining the nature of the relationship between the constitutional provisions of the member states and the legal acts of the EU integration. In the EU system of multilevel constitutionalism, a long-standing central debate on integration surrounds the conflict between EU legal acts and the constitutional provisions of the member states. In spite of the fact that the Court of Justice of the European Union stated in Costa v. E.N.E.L. that the member states cannot refer to the provisions of their respective national constitutions against the integration. Based on the experience of more than 50 years since the above decision, and also in light of the Treaty of Lisbon, we now can clearly see that EU law has itself identified an obligation for the EU to protect the fundamental constitutional features of the Member States under Article 4 (2) of Treaty on European Union, by respecting the national identities of member states. In other words, the European concept intends to offer input for the determination of the nature of the relationship between the constitutional provisions of the member states and the legal acts of the EU integration.

Keywords: constitutional identity, EU law, European Integration, supranationalism

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Authors: Vesali Naseh Morteza, Najafi Mohammad Hosein

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The possibility of trading in-game items for real money provides a high economic capacity for online games and turns them into a business model. Nowadays, the market for in-game item purchases and microtransactions or micropayments has been growing increasingly. Since the market should be legal, lawyers and lawmakers around the world have expressed concerns over the legality of online gaming and in-game transactions. The issue is highlighted by the recent emergence of an in-game business model in the name of loot boxes. Similarities between loot boxes gaming and gambling features activities have started a legal debate as to whether loot boxes constitute a form of gambling or whether the game’s use of loot boxes should be considered gambling. Hence, based on the relationship between loot boxes purchasing and problem gambling, the paper investigates the legal effect of the newly emergent phenomenon of loot boxes on online games from the perspective of Iranian law.

Keywords: serious games, loot boxes, online gambling, in-game purchase, virtual items

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Authors: Razieh Zarei, Hassan zm, Abolghasem Ajami, Darush Moslemi, Narges Afsary, Amrollah Mostafa-zade

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Introduction: IL-23 is responsible for the differentiation and expansion of Th17/ThIL-17 cells from naive CD4+ T cells. Therefore, may be IL-23/IL17 axis involve in a variety of allergic and autoimmune diseases, such as RA, MS, inflammatory bowel disease (IBD), and asthma. TGF-β is also share for the differentiation Th17 producing IL-17 and CD4+CD25+Foxp3hiT regulatory cells from naïve CD4+ T cells which are involved in the regulation of immune response, maintaining immunological self-tolerance and immune homeostasis ,and the control of autoimmunity and cancer surveillance. Therefore, T regulatory cells play a key role in autoimmunity, allergy, cancer, infectious disease, and the induction of transplantation tolerance. Vitamin A and it's derivatives (retinoids) inhibit or reverse the carcinogenic process in some types of cancers in oral cavity,head and neck, breast, skin, liver, and blood cells. Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, in vitro. Our purpose is whether simultaneous oral treatment vitamin A and shark cartilage can modulate IL-23/IL-17 and CD4CD25Foxp3 T regulatory cell/TGF-β pathways and Th1/Th2 immunity in patients with gastric cancer. Materials and Methods: First investigated an imbalanced supernatant of cytokines exist in patients with gastric cancer by ELISA. Associated with cytokines measuring such as IL-23,IL-17,TGF-β,IL-4 and γ-IFN, then flow cytometry was employed to determine whether the peripheral blood mononuclear cells such as CD4+CD25+Foxp3highT regulatory cells in patients with gastric cancer were changed correspondingly. Results: An imbalance between IL-17 secretion and TGF-β/Foxp3 t regulatory cell pathway and so, Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) was not seen in patients with gastric cancer treated by vitamin A and shark cartilage. But, the simultaneously presented down-regulation of IL-23 indicated, at least cytokine level. Conclusion: Il-23, as a pro-angiogenesis cytokine, probably, help to tumor growth. Hence, suggested that down-regulation of IL-23, at least cytokine level, is useful for anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4CD25Foxp3 T regulatory pathway, γ-IFN, IL-4, shark cartilage and gastric cancer

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Authors: Malcolm Richardson, Gabriele Richardson

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This paper illustrates how historical problems can be studied successfully using GIS even in cases in which data, in the modern sense, is fragmentary. The overall problem under investigation is how early (1300-1500) English schools of Common Law moved from apprenticeship training in random individual London inns run in part by clerks of the royal chancery to become what is widely called 'the Third University of England,' a recognized system of independent but connected legal inns. This paper focuses on the preparatory legal inns, called the Inns of Chancery, rather than the senior (and still existing) Inns of Court. The immediate problem studied in this paper is how the junior legal inns were organized, staffed, and located from 1292 to about 1500, and what maps tell us about the role of the chancery clerks as managers of legal inns. The authors first uncovered the names of all chancery clerks of the period, most of them unrecorded in histories, from archival sources in the National Archives, Kew. Then they matched the names with London property leases. Using ArcGIS, the legal inns and their owners were plotted on a series of maps covering the period 1292 to 1500. The results show a distinct pattern of ownership of the legal inns and suggest a narrative that would help explain why the Inns of Chancery became serious centers of learning during the fifteenth century. In brief, lower-ranking chancery clerks, always looking for sources of income, discovered by 1370 that legal inns could be a source of income. Since chancery clerks were intimately involved with writs and other legal forms, and since the chancery itself had a long-standing training system, these clerks opened their own legal inns to train fledgling lawyers, estate managers, and scriveners. The maps clearly show growth patterns of ownership by the chancery clerks for both legal inns and other London properties in the areas of Holborn and The Strand between 1450 and 1417. However, the maps also show that a royal ordinance of 1417 forbidding chancery clerks to live with lawyers, law students, and other non-chancery personnel had an immediate effect, and properties in that area of London leased by chancery clerks simply stop after 1417. The long-term importance of the patterns shown in the maps is that while the presence of chancery clerks in the legal inns likely created a more coherent education system, their removal forced the legal profession, suddenly without a hostelry managerial class, to professionalize the inns and legal education themselves. Given the number and social status of members of the legal inns, the effect on English education was to free legal education from the limits of chancery clerk education (the clerks were not practicing common lawyers) and to enable it to become broader in theory and practice, in fact, a kind of 'finishing school' for the governing (if not noble) class.

Keywords: GIS, law, London, education

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Authors: Xinchao Liu

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Regulating environmental and human rights damages caused by transnational corporations in host States is a core issue in the business and human rights discourse. In current regulatory practices, host States, which are territorially based and should bear primary regulation responsibility, face dual challenges at both domestic and international levels, leading to their continued marginalization. Specifically, host States as TNC damage regulators are constrained domestically by territorial jurisdiction limitations and internationally by the neoliberal international economic order exemplified by investment protection mechanisms. Taking China as a sample, it currently lacks a comprehensive regulation system to address TNC damages; while domestic constraints manifest as the marginalization of judicial regulation, the absence of corporate duty of care, and inadequate extraterritorial regulation effectiveness, international constraints are reflected in the absence of foreign investor obligations in investment agreements and the asymmetry of dispute resolution clauses, challenging regulatory sovereignty. As China continues to advance its policy of high-quality opening up, the risks of negative externalities from transnational capital will continue to increase, necessitating a focus on building and perfecting a regulation mechanism for TNC damages within the framework of international law. To address domestic constraints, it is essential to clarify the division of regulation responsibilities between judicial and administrative bodies, promote the normalization of judicial regulation, and enhance judicial oversight of governmental settlements. Improving the choice of law rules for cross-border torts and the standards for parent company liability for omissions, and enhancing extraterritorial judicial effectiveness through transnational judicial dialogue and cooperation mechanisms are also crucial. To counteract international constraints, specifying investor obligations in investment treaties and designing symmetrical dispute resolution clauses are indispensable to eliminate regulatory chill. Additionally, actively advancing the implementation of TNC obligations in business and human rights treaty negotiations will lay an international legal foundation for the regulation sovereignty of host States.

Keywords: transnational corporate damages, home state litigation, optimization limit, investor-state dispute settlement

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Authors: Muhammad Farhad Hosen

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This article examines the sustainability of offshore petroleum resource extraction and management in Bangladesh, focusing on international and regional frameworks. The analysis includes international conventions such as UNCLOS, IMO regulations, and SDGs, as well as regional cooperation through organizations like BIMSTEC and SAARC. The objective is to highlight the impact of these frameworks on sustainable extraction practices, address challenges, and offer recommendations for enhancing Bangladesh's legal and regulatory approaches to offshore resource management. The article underscores the need for harmonizing national laws with international standards, enhancing enforcement mechanisms, and promoting regional cooperation to ensure sustainable development.

Keywords: Bangladesh, international frameworks, offshore petroleum, regional framework, sustainability

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Authors: Fatimah Opebiyi

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Economic growth promotion, inflation reduction and consumer protection are among the core public interest aims of governments. Nevertheless, higher rates of default by consumers in relation to credit card loans and mortgages in recent times illustrate that government’s performance in balancing the protection of the economy and consumer is subpar. This thereby raises an important question on the role of government in protecting consumers during prolonged spells of inflation, particularly when such inflationary trends may be traceable to the acts of the government. Adopting a doctrinal research methodology, this article investigates the evolution of the concept of consumer protection in the United Kingdom and also brings to the fore the tensions and conflicts of interests in the aims and practices of the main regulators within the financial services industry. Relying on public interest theories of regulation and responsive regulatory theory, the article explores the limitations in the state’s ability to strike the right balance in meeting regulatory aims of the regulatory agencies at the opposite ends of the spectrum.

Keywords: financial regulation, consumer protection, prudential regulation, public interest theories of regulation, central bank

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Authors: Ibrahim A. Alhammad, Suleiman A. Al-Otaibi, Khalid S. Al-Gahtani, Naïf Al-Otaibi, Abdulaziz A. Bubshait

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In the last decade, the use of project delivery system of design build engineering contracts is increasing in North America due to the reasons of reducing the project duration and minimizing costs. The shift from traditional approach of Design-Bid-Build to Design-Build contracts have been attributed to many factors such as evolution of the regulatory and legal frameworks governing the engineering contracts and improvement in integrating design and construction. The aforementioned practice of contracting is more appropriate in North America; yet, it may not be the case in Saudi Arabia where the traditional approach of construction contracting remains dominant. The authors believe there are number of factors related to the gaps in the level of sophistication of the engineering and management of the construction projects in both countries. A step towards improving the Saudi construction practice by adopting the new trend of construction contracting, this paper identifies the reasons why Design/Build form of contracting are not frequently utilized. A field survey, which includes the questionnaire addressing the research problem, is distributed to three main parties of the construction contracts: clients, consultants, and contractors. The analyzed collected data were statistically sufficient to finding the reasons of not adopting the new trend of good practice of deign build approach in Saudi Arabia. In addition, the reasons are: (1) lack of regulation and legal framework; (2) absence of clear criteria of the owner for the trade-off between competing contractors, (3) and lack of experience, knowledge and skill.

Keywords: design built projects, Saudi Arabia, GCC, mega projects

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Authors: dr. Bendes Ákos

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Digital skepticism, a critical stance towards digital technology and its pervasive influence on society, presents significant challenges when analyzed from a legal philosophical perspective. This abstract aims to explore the intersection of digital skepticism and legal philosophy, emphasizing the implications for justice, rights, and the rule of law in the digital age. Digital skepticism arises from concerns about privacy, security, and the ethical implications of digital technology. It questions the extent to which digital advancements enhance or undermine fundamental human values. Legal philosophy, which interrogates the foundations and purposes of law, provides a framework for examining these concerns critically. One key area where digital skepticism and legal philosophy intersect is in the realm of privacy. Digital technologies, particularly data collection and surveillance mechanisms, pose substantial threats to individual privacy. Legal philosophers must grapple with questions about the limits of state power and the protection of personal autonomy. They must consider how traditional legal principles, such as the right to privacy, can be adapted or reinterpreted in light of new technological realities. Security is another critical concern. Digital skepticism highlights vulnerabilities in cybersecurity and the potential for malicious activities, such as hacking and cybercrime, to disrupt legal systems and societal order. Legal philosophy must address how laws can evolve to protect against these new forms of threats while balancing security with civil liberties. Ethics plays a central role in this discourse. Digital technologies raise ethical dilemmas, such as the development and use of artificial intelligence and machine learning algorithms that may perpetuate biases or make decisions without human oversight. Legal philosophers must evaluate the moral responsibilities of those who design and implement these technologies and consider the implications for justice and fairness. Furthermore, digital skepticism prompts a reevaluation of the concept of the rule of law. In an increasingly digital world, maintaining transparency, accountability, and fairness becomes more complex. Legal philosophers must explore how legal frameworks can ensure that digital technologies serve the public good and do not entrench power imbalances or erode democratic principles. Finally, the intersection of digital skepticism and legal philosophy has practical implications for policy-making. Legal scholars and practitioners must work collaboratively to develop regulations and guidelines that address the challenges posed by digital technology. This includes crafting laws that protect individual rights, ensure security, and promote ethical standards in technology development and deployment. In conclusion, digital skepticism provides a crucial lens for examining the impact of digital technology on law and society. A legal philosophical approach offers valuable insights into how legal systems can adapt to protect fundamental values in the digital age. By addressing privacy, security, ethics, and the rule of law, legal philosophers can help shape a future where digital advancements enhance, rather than undermine, justice and human dignity.

Keywords: legal philosophy, privacy, security, ethics, digital skepticism

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Authors: Mhd. Zakiul Fikri, M. Agus Maulidi

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Indonesia is a constitutional state. As the constitutional state, Indonesia is not only using a single legal system, but also adopting three legal systems consist of: The European continental legal system or positive law of Indonesia, adat law system, and legal system of religion. This study will discuss Marosok tradition in the process of buying and selling cattle in Payakumbuh: a comparative study between adat law and positive law of Indonesia. The objectives of this research are: First, to find the meaning of the philosophical of Marosok tradition in Payakumbuh. Second, to find the legal implications of the Marosok tradition reviewed aspects of adat law and positive law of Indonesia. Third, to find legal procedure in arbitrating the dispute wich is potentially appear in the post-process of buying and selling cattle based on positive law and adat law adopted in Indonesia. This research is empirical legal research that using two model approaches which are statute approach and conceptual approach. Data was obtained through interviews, observations, and documents or books. Then a method of data analysis used is inductive analysis. Finally, this study found that: First, tradition of Marosok contains the meaning of harmonization of social life that keep people from negative debate, envy, and arrogant. Second, Marosok tradition is one of the adat law in Indonesia; it is one of contract law in the process of buying and selling. If the comparison between the practice Marosok tradition as adat law with the provisions of Article 1320 book of civil code about the terms of the validity of a contract, the elements contained in the provisions of these regulations are met in practice Marosok. Thus, the practice of Marosok in buying and selling cattle process in Payakumbuh justified in view of the positive law of Indonesia. Last of all, all kinds of disputes arising due to contracts made by Marosok tradition can be resolved by positive law and adat law of Indonesia.

Keywords: Adat law, contract, Indonesia, Marosok

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Authors: Susanna Menis

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‘Unconscious’ bias is widespread, affecting society on all levels of decision-making and beyond. Placed in the law context, this study will explore the direct effect of the psycho-social and cultural evolution of unconscious bias on how a judicial decision was made. The aim of this study is to contribute to socio-legal scholarship by examining the formation of unconscious bias and its influence on the creation of legal rules that judges believe reflect social solidarity and protect against violence. The study seeks to understand how concepts like criminalization and unlawfulness are constructed by the common law. The study methodology follows two theoretical approaches: historical genealogy and emotions as sociocultural phenomena. Both methods have the ‘tracing back’ of the original formation of a social way of seeing and doing things in common. The significance of this study lies in the importance of reflecting on the ways unconscious bias may be formed; placing judges’ decisions under this spotlight forces us to challenge the status quo, interrogate justice, and seek refinement of the law.

Keywords: legal geneology, emotions, disgust, criminal law

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Authors: Aikaterini Tsalampouni

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The European Union has long been the most developed model of economic and political integration that has brought a common market, a common currency and a standardization of national policies in certain areas in consistent with EU values and principles. To this direction, there is a parallel process of social integration that effect public policy decisions of member states. Even though social policy, i.e. social protection and moreover healthcare policy, still remains in state's responsibility to develop, EU applies different mechanisms in order to influence health policy systems, since from a more federalist point of view, EU ought to expand its regulatory and legislative roles in as many policy areas as possible. Recently, the pandemic has become a turning point for health care provision and at the same time has also highlighted the need to strengthen the EU’s role in coordinating health care. This paper analyses the EU health policy in general, as well as the response to COVID-19 pandemic with an attempt to identify indications of interaction between EU policies and the promotion of sustainable and resilient health systems. More analytically, the paper investigates the EU binding legal instruments, non-binding legal instruments, monitoring and assessment instruments and instruments for co-financing concerning health care provision in member states and records the evolution of health policies before and during the COVID-19 pandemic. The paper concludes by articulating some remarks regarding the improvement of health policy in EU. Since the ability to deal with a pandemic depends on continuous and increased investment in health systems, the involvement of the EU can lead to a policy convergence, necessary for the resilience of the systems, maintaining at the same time, a strong health policy framework in Europe.

Keywords: EU health policy, EU response to COVID-19, European Health Union, health systems in Europe

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Authors: Neelam Kadyan

Abstract:

Global environmental change is happening at an alarming rate in the present world. Floods, Tsunamis’, Avalanches, Change in Weather patterns, Rise in sea temperature, Landslides, are only few evidences of this change. To regulate such alarming growth of global change in environment certain regulatory system or mechanism is required. Nuisance,negligence,absolute liability,strict liability and trespass are some of the effective common law principles which are helpful in environmental problems. What we need today is sufficient law and adequate machinery to enforce the legal standards. Without law environmental standards cannot be enforced and once again there is need to adopt the common law approach in solving the problem of environmental change as through this approach the affected person can get compensation and as the same time it puts check on wrongdoer.

Keywords: global environmental problems, nuisance, negligence, trespass, strict liability, absolute liability

Procedia PDF Downloads 566