Search results for: legal and regulatory framework

Authors: Dwitya Elvira, Eryati Darwin

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Background: Graves’ disease (GD) is an autoimmune thyroid disease. Imbalance of Th1/Th2 cells and T-regulatory (Treg)/Th17 cells was thought to play pivotal role in the pathogenesis of GD. Treg FoxP3 produced TGF-β to maintain regulatory function, and Th17 cells produced IL-17 as cytokines that were thought in mediating several autoimmune diseases. The aim of this study is to assess the role of IL-17 and TGF-β in the pathogenesis of GD and to investigate its correlation with Thyroid Stimulating Hormone Receptor Antibody (TRAb) and Treg FoxP3 expression. Method: 30 GD patients and 27 age and sex-matched controls were enrolled in this study. Diagnosis of GD was based on clinical and biochemical of GD. Serum IL-17, TGF-β, TRAb, and FoxP3 were measured by enzyme-linked immunosorbent assay (ELISA). Data were analyzed by using SPSS 21.0 (SPSS Inc.). Spearman rank correlation test was used for assessment of correlation. The statistical significance was accepted as P<0.05. Result: There was no significant correlation between IL-17 and TGF-β serum with expression of FoxP3 level in GD, but there was significant correlation between TGF-β and TRAb serum level (P<0.05). Serum levels of IL-17 and TGF-β were found to be elevated in patient group compared to control, where mean values of IL-17 were 14.43±2.15 pg/mL and TGF-β were 10.44±3.19 pg/mL in patients group; and in control group, level of IL-17 were 7.1±1.45 pg/mL and TGF-β were 4.95±1.35 pg/mL. Conclusion: Serum Il-17 and TGF-β were elevated in GD patients that reflect the role of inflammatory and regulatory cytokines activation in pathogenesis of GD. There was significant correlation between TGF-β and TRAb, revealing that Treg cytokines may play a role in pathogenesis of GD.

Keywords: IL-17, TGF-B, FoxP3, TRAb, Graves’ disease

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Authors: Sara Vora (Hoxha)

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The present article delves into the intricate matters concerning Intellectual Property Rights (IPR) and cross-border jurisdiction within the confines of the European Union (EU). The prevalence of cross-border intellectual property rights (IPR) disputes has increased in tandem with the globalization of commerce and the widespread adoption of technology. The European Union (EU) is not immune to this trend. The manuscript presents a comprehensive analysis of various forms of intellectual property rights (IPR), such as patents, trademarks, and copyrights, and the regulatory framework established by the European Union (EU) to oversee these rights. The present article examines the diverse approaches employed for ascertaining the appropriate jurisdiction within the European Union (EU), and their potential application in the sphere of cross-border intellectual property rights (IPR) conflicts. The article sheds light on jurisdictional issues and outcomes of significant cross-border intellectual property rights (IPR) disputes in the European Union (EU). Additionally, the document provides suggestions for effectively managing intellectual property rights conflicts across borders within the European Union, which encompasses the utilization of alternative methods for resolving disputes. The article highlights the significance of comprehending the relevant jurisdiction in the European Union for Intellectual Property Rights (IPR). It also offers optimal approaches for enterprises and individuals who aim to safeguard their intellectual property beyond national boundaries. The primary objective of this article is to furnish a thorough comprehension of Intellectual Property Rights (IPR) and the relevant jurisdiction in the European Union (EU). Additionally, it endeavors to provide pragmatic recommendations for managing cross-border IPR conflicts in this intricate and ever-changing legal milieu.

Keywords: intellectual property rights (IPR), cross-border jurisdiction, applicable laws and regulations, dispute resolution, best practices

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Authors: Maria João Mimoso, Bárbara Magalhães Bravo

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This study aims to analyse the phenomenon of arbitration as a paradigm in solving emerging controversies of foreign investment. We will present their benefits and demonstrate their contribution to greater legal certainty in economic relations. This article explores the legal relevant concepts under a strictly conceptual methodology, preparing future research to be developed under more developed comparative law methodologies. The review of national and international literature and jurisprudence will reveal the importance of arbitration in the field of international economic relations, presenting it as an alternative dispute resolution. Globalization imposes new forms of investment protection and appeals to other forms of dispute settlement, primarily to prevent, among other problems, the possible bias of the recipient country's investment tribunals. Characterization of foreign investment, its regulatory sources, their characteristics and the need for intervention of an entity capable of resolving disputes between the parties involved: State investor reception; Investor (of a nationality other than the latter); State of the investor's nationality, and sometimes a ‘subsidiary’ local foreign investor. The ICSID (International Settlement of Investment Disputes) arbitration as a means of resolving investment litigations covered by bilateral treaties (BIT) and investment contracts calls for a delimitation of these two figures in order to clarify the scope of the arbitration under the aegis of the World Bank and to make it more secure in the view of the sovereign power of the States.

Keywords: arbitration, contract, foreign, investment, disputes

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Authors: Wassamon Kun-Amornpong

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When a financial crisis occurs, there will be a law and regulatory reform in order to manage the turmoil and prevent a future crisis. One of the most important regulatory efforts to help cope with systemic risk and a financial crisis is the third version of the Basel Accord. Basel III has introduced some measures and tools (e.g., systemic risk buffer, countercyclical buffer, capital conservation buffer and liquidity risk) in order to mitigate systemic risk. Nevertheless, the effectiveness of these measures in Basel III in adequately addressing the problem of contagious runs that can quickly spread throughout the financial system is questionable. This paper seeks to contribute to the knowledge regarding the role of the Basel Accords in mitigating systemic risk. The research question is to what extent the Basel Accords can help control systemic risk in the financial markets? The paper tackles this question by analysing the concept of systemic risk. It will then examine the weaknesses of the Basel Accords before and after the Global financial crisis in 2008. Finally, it will suggest some possible solutions in order to improve the Basel Accord. The rationale of the study is the fact that academic works on systemic risk and financial crises are largely studied from economic or financial perspective. There is comparatively little research from the legal and regulatory perspective. The finding of the paper is that there are some problems in all of the three pillars of the Basel Accords. With regards to Pillar I, the risk model is excessively complex while the benefits of its complexity are doubtful. Concerning Pillar II, the effectiveness of the risk-based supervision in preventing systemic risk still depends largely upon its design and implementation. Factors such as organizational culture of the regulator and the political context within which the risk-based supervision operates might be a barrier against the success of Pillar II. Meanwhile, Pillar III could not provide adequate market discipline as market participants do not always act in a rational way. In addition, the too-big-to-fail perception reduced the incentives of the market participants to monitor risks. There has been some development in resolution measure (e.g. TLAC and MREL) which might potentially help strengthen the incentive of the market participants to monitor risks. However, those measures have some weaknesses. The paper argues that if the weaknesses in the three pillars are resolved, it can be expected that the Basel Accord could contribute to the mitigation of systemic risk in a more significant way in the future.

Keywords: Basel accords, financial regulation, risk-based supervision, systemic risk

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Authors: Aysha Alshehri

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This paper provides a literature review of the sources of women’s rights under the Saudi legal framework, taking account of the constitutional primacy of Sharia under the Saudi legal system as well as the state’s obligations under international law. Building on one of the central aims of the paper, it conducts an exploration of how Saudi Arabia already has or might be further able to more clearly delineate its position and reservations in the adoptions of international human rights agreements while preserving its core religious beliefs and societal practices in regard to women’s rights at the domestic level. In this regard, the paper will consider the apparent tension between certain jurisprudential and customary aspects on gender equality and contemporary discourses of women’s rights from within and outside the Muslim world. Particular attention will be devoted to the question of the causes behind the lack of direct application of women’s rights mentioned by international reports and any challenges this may bring in the contexts of Saudi Arabia’s evolving gender equality policies.

Keywords: Islamic Constitution, executive actions, gender equality, judicial review

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Authors: Mokgadi Julia Ngoepe-Ntsoane

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The article aims to make a case for a legislative framework for the fire sector in South Africa. Robust legislative framework is essential for empowering those with obligatory mandate within the sector. This article contributes to the body of knowledge in the field of policy reviews particularly with regards to the legal framework. It has been observed overtime that the scholarly contributions in this field are limited. Document analysis was the methodology selected for the investigation of the various legal frameworks existing in the country. It has been established that indeed the national legislation on the fire industry does not exist in South Africa. From the documents analysed, it was revealed that the sector is dominated by cartels who are exploiting the new entrants to the market particularly SMEs. It is evident that these cartels are monopolising the system as they have long been operating in the system turning it into self- owned entities. Commitment to addressing the challenges faced by fire services and creating a framework for the evolving role that fire brigade services are expected to execute in building safer and sustainable communities is vital. Legislation for the fire sector ought to be concluded with immediate effect. The outdated national fire legislation has necessitated the monopolisation and manipulation of the system by dominating organisations which cause a painful discrimination and exploitation of smaller service providers to enter the market for trading in that occupation. The barrier to entry bears long term negative effects on national priority areas such as employment creation, poverty, and others. This monopolisation and marginalisation practices by cartels in the sector calls for urgent attention by government because if left attended, it will leave a lot of people particularly women and youth being disadvantaged and frustrated. The downcast syndrome exercised within the fire sector has wreaked havoc and is devastating. This is caused by cartels that have been within the sector for some time, who know the strengths and weaknesses of processes, shortcuts, advantages and consequences of various actions. These people take advantage of new entrants to the sector who in turn find it difficult to manoeuvre, find the market dissonant and end up giving up their good ideas and intentions. There are many pieces of legislation which are industry specific such as housing, forestry, agriculture, health, security, environmental which are used to regulate systems within the institutions involved. Other regulations exist as bi-laws for guiding the management within the municipalities.

Keywords: sustainable job creation, growth and development, transformation, risk management

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Authors: Stefano Fantin

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The present analysis outcomes from the research undertaken in the course of the European-funded project EUNITY, which targets the gaps in research and development on cybersecurity and privacy between Europe and Japan. Under these auspices, the research presents a study on the policy approach of Japan, the EU and a number of Member States of the Union with regard to the handling and discovery of software vulnerabilities, with the aim of identifying methodological differences and similarities. This research builds upon a functional comparative analysis of both public policies and legal instruments from the identified jurisdictions. The result of this analysis is based on semi-structured interviews with EUNITY partners, as well as by the participation of the researcher to a recent report from the Center for EU Policy Study on software vulnerability. The European Union presents a rather fragmented legal framework on software vulnerabilities. The presence of a number of different legislations at the EU level (including Network and Information Security Directive, Critical Infrastructure Directive, Directive on the Attacks at Information Systems and the Proposal for a Cybersecurity Act) with no clear focus on such a subject makes it difficult for both national governments and end-users (software owners, researchers and private citizens) to gain a clear understanding of the Union’s approach. Additionally, the current data protection reform package (general data protection regulation), seems to create legal uncertainty around security research. To date, at the member states level, a few efforts towards transparent practices have been made, namely by the Netherlands, France, and Latvia. This research will explain what policy approach such countries have taken. Japan has started implementing a coordinated vulnerability disclosure policy in 2004. To date, two amendments can be registered on the framework (2014 and 2017). The framework is furthermore complemented by a series of instruments allowing researchers to disclose responsibly any new discovery. However, the policy has started to lose its efficiency due to a significant increase in reports made to the authority in charge. To conclude, the research conducted reveals two asymmetric policy approaches, time-wise and content-wise. The analysis therein will, therefore, conclude with a series of policy recommendations based on the lessons learned from both regions, towards a common approach to the security of European and Japanese markets, industries and citizens.

Keywords: cybersecurity, vulnerability, European Union, Japan

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Authors: Kurt Willems

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The right to education is a fundamental human right, which has been entrenched in many international and regional treaties and national constitutions. Nevertheless, practice shows that many obstacles impede easy access to quality education for refugees. Overall, the material effects of international human rights legislation on improving (irregular) migrants’ access to social rights in the European countries have remained limited due to the lack of guarantees on effective incorporation in the municipal legal order and due to the lack of effective enforcement mechanisms. After the recent refugee crisis in Europe, this issue has grown in importance. The presentation aims to give a brief overview of the most important issues impeding the effective enforceability of the right to education for refugees. I. Do refugees fall within the scope of application of the relevant human rights treaties and to which extent can they invoke human rights treaties in domestic courts to set aside domestic legislation? II. How is the justiciability of the right to education organized in those treaties? III. What is the legal answer to questions raised in practice when dealing with the influx of refugees in Europe: (i) can refugees be placed in separate schools or classes until they can follow the regular curriculum?; (ii) can higher school fees be asked from pupils without legal documents?; (iii) do refugees have a right to be taught in their own native language until they learn to speak the national language? To answer the above questions, the doctrinal and comparative legal method will be used. The normative framework, as interpreted within Europe, will be distilled from the recent and relevant international treaties and European law instruments (in particular the Convention on the Rights of the Child, the European Convention on human rights, the European Social Charter and the International Covenant on Economic, Social and Cultural Rights) and their underlying policy documents, the legal literature, the (limited) European jurisprudence, and the general comments to those treaties. The article is mainly descriptive in nature. Its aim is to serve as a summary of the legal provisions, case law and legal literature on the topic of the right to education for refugees. The research shows that the reasons for the delicate enforceability of the rights to and the rights in education are multifold. The research will categorize the different contributing factors under the following headings: (i) problems related to the justiciability of international law as such; (ii) problems specifically related to the educational field; (iii) problems related to policy issues in the refugee debate. By categorizing the reasons contributing to the difficult enforceability of the right to education and the rights in education for refugees, this research hopes to facilitate the search for solutions to this delicate problem.

Keywords: right to education, refugees, discrimination, enforceability of human rights

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Authors: William Thomas Worster

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Diplomatic assurances issued by states declaring that they will not mistreat individuals returned to them occupy a strange middle ground between being legal and non-legal obligations. States assert that they are non-binding, yet at other times that they are binding. However, this assertion may not be the end of the discussion. The International Court of Justice and other tribunals have concluded that similar instruments were binding, states have disagreed that certain similar instruments were binding, and the Vienna Convention on the Law of Treaties and its travaux prépératoires do not appear to contemplate non-binding instruments. This paper is a case study of diplomatic assurances but, by necessity, touches on the delicate question of whether certain texts are treaties, promises, or non-binding political statements. International law, and law in general, requires a binary approach to obligation. All communications must be binding or not, even if the fit is not precise. Through this study, we will find that some of the obligations in certain assurances can be understood as legal and some not. We will attempt to state the current methodology for determining which obligations are legal under the law of treaties and law on binding unilateral promises. The paper begins with some background of the legal environment of diplomatic assurances and their use in cases of expulsion. The paper then turns to discuss the legal nature of diplomatic assurances, proceeding to address various possibilities for legal value as treaties and as binding unilateral statements. This paper will not examine the legal value of diplomatic assurances solely under customary international law other than the way in which customary international law might further refine the treaty definition. In order to identify whether any assurances are contained in legal acts, this study identifies a pool of relevant assurances and qualitatively analyzes whether any of those are contained in treaties or binding unilateral statements. To the author’s best knowledge, this study is the first large-scale, qualitative qualitative analysis of assurances as a group of instruments that accounts for their heterogenous nature. It is also the first study to identify the indicators of whether an instrument is a treaty or promise.

Keywords: diplomatic assurances, deportation, extradition, expulsion, non-refoulement, torture, persecution, death penalty, human rights, memorandum of understanding, promises, secret, monitoring, compliance, enforcement

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Authors: Rahmi Kopar

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Legitimate expectations principle is considered one of the most dominant elements of the Fair and Equitable Treatment Standard which is today’s most relied upon treaty standard. Since its utilization by arbitral tribunals is relatively new, the contours of the legitimate expectations concept under investment treaty law have not been precisely defined yet. There are various fragmented views arising both from arbitral tribunals and scholarly writings with respect to its limits and use even though the principle is ‘firmly rooted in arbitral practice.’ International energy investments, due to their characteristics, are more prone to certain types of risks, especially the political risks. Thus, there are several mechanisms to protect an energy investment against those risks. Stabilisation is one of these investment protection methods. Stability provisions can be found under domestic legislations, as a contractual clause, or as a separate legal stability agreement. This paper will start by examining the roots of the contentious concept of legitimate expectations with reference to its application in domestic legal systems from where the doctrine under investment treaty law context was transplanted. Then the paper will turn to the investment treaty law and analyse the main contours of the doctrine as understood and applied by arbitral tribunals. 'What gives rise to the investor’s legitimate expectations?' question is answered mainly by three categories of sources: the general legal framework prevalent in a host state, the representations made by the officials or organs of a host state, and the contractual commitments. However, there is no unanimity among the arbitral tribunals and the scholars with respect to the form these sources should take. At this point, the study will discuss the sources of a stability provision and the effect of these stability provisions found in various legal sources in creating a legitimate expectation for the investor. The main questions to be discussed in this paper are as follows: a) Do the stability provisions found under different legal sources create a legitimate expectation on the investor side? b) If yes, what levels of legitimate expectations do they create? These questions will be answered mainly by reference to investment treaty jurisprudence.

Keywords: fair and equitable treatment standard, international energy investments, investment protection, legitimate expectations, stabilization

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Authors: Abel Sichinava

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The need for organ transplantation is vigorously increasing worldwide. The numbers on the waiting lists grow, but the number of donors is not keeping up with the demand even though there is a legal possibility of decreasing the gap between the demand and supply. Most countries around the globe are facing an organ donation problem (living or deceased); however, the extent of the problem differs based on how well developed a country is. The determining issues seem to be centered on how aware the society is about the concept of organ donation, as well as cultural and religious factors. Even if people are aware of the benefits of organ donation, they may still have fears that keep them from being in complete agreement with the idea. Some believe that in the case of deceased organ donation: “the brain dead human body may recover from its injuries” or “the sick might get less appropriate treatment if doctors know they are potential donors.” In the case of living organ donations, people sometimes fear that after the donation, “it might reduce work efficiency, cause health deterioration or even death.” Another major obstacle in the organ shortage is a lack of a well developed ethical framework. In reality, there are truly an immense number of people on the waiting list, and they have only two options in order to receive a suitable organ. First is the legal way, which is to wait until their turn. Sadly, numerous patients die while on the waiting list before an appropriate organ becomes available for transplant. The second option is an illegal way: seeking an organ in a country where they can possibly get. To tell the truth, in people’s desire to live, they may choose the second option if their resources are sufficient. This process automatically involves “organ brokers.” These are people who get organs from vulnerable poor people by force or betrayal. As mentioned earlier, the high demand and low supply leads to human trafficking. The subject of the study was the large number of society from different backgrounds of their belief, culture, nationality, level of education, socio-economic status. The great majority of them interviewed online used “Google Drive Survey” and others in person. All statistics and information gathered from trusted sources annotated in the reference list and above mentioned considerable testimonies shared by the respondents are the fundamental evidence of a lack of the well developed ethical framework. In conclusion, the continuously increasing number of people on the waiting list and an irrelevant ethical framework, lead people to commit to atrocious, dehumanizing crimes. Therefore, world society should be equally obligated to think carefully and make vital decisions together for the advancement of an organ donations and its ethical framework.

Keywords: donation, ethical framwork, organ, transplant

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Authors: Taner Cindik, Ferya Tas Ciftci

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Mobbing in the public sector and specific issues (i.e., the demand for non-pecuniary damages) regarding mobbing have become very important in the light of the precedents constituted by the Turkish Council of State in 2010. The legal scope of mobbing is not able to be determined since the concept of mobbing is not defined in Turkish law system. This study aims to reveal three major problems caused by the lack of laws related to mobbing in the Turkish legal system. First, the absence of an arrangement for disciplinary penalties leads that general provisions in the disciplinary law are implemented. This situation, therefore, causes difficulties in practice. Second, not being drawn of the lines in the topic concerning mobbing in public sector leads confusions in being direction of hostility. Third, the fact that there is a legal gap on seeking non-pecuniary compensation when employees in public sector are exposed to mobbing might make it difficult to obtain non-pecuniary compensation. Within the context of these major problems, civil servants in Turkey do not have enough protection mechanism. However, some possible legal arrangements will help civil servants to protect against mobbing. This study may be considered important because of the fact that mobbing in the public sector is at a significant level and has not been evaluated in this context before. This research is mainly a study of Turkish legal system and evaluates critically law case to determine legal problems. As a result of this study, three main problems might be identified because there is legal gap regarding mobbing in the public sector. In conclusion, the introduction of the major problems related to mobbing in this study might shed light on making the proper regulations of this subject in Turkish law system. In this respect, the plaintiff will be provided convenience in the point of non-pecuniary damages and this study will guide the assessment of legal liability of those who implement mobbing.

Keywords: human rights violations, mobbing, public sector, direction of hostility, non-pecuniary compensation, disciplinary law

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Authors: Amy Gooden

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Despite its prevalence, direct-to-consumer genetic testing (DTC-GT) remains under-investigated in South Africa (SA), and the issue of regulation is yet to be examined. Therefore, this research maps the current legal landscape relating to DTC-GT in SA through a legal analysis of the extant law relevant to the industry and the issues associated therewith – with the intention of determining if and how DTC-GT is legally governed. This research analyses: whether consumers are legally permitted to collect their saliva; whether DTC-GT are medical devices; licensing, registering, and advertising; importing and exporting; and genetic research conducted by companies.

Keywords: direct-to-consumer genetic testing, genetic testing, health, law, regulation, South Africa

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Authors: Anisa Duraj

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As usually acknowledged, cultural heritage is the weakest component in EIA studies. The role of heritage impact assessment (HIA) in development projects is not often accounted for, and in those cases where it is, HIA is considered as a reactive response and not as a solutions provider. Because of continuous development projects, in most cases, heritage is unconsidered and often put under threat. Cultural protection and development challenges ask for prudent legal regulation and appropriate policy implementation. The challenges become even more peculiar in underdeveloped countries or endangered areas, which are generally characterized by numerous legal constraints. Therefore, the need for strategic proposals for HIA is of high importance. In order to trigger HIA as a proactive operation in the IA process and make sure to cover cultural heritage in the whole EIA framework, an appropriate system of evaluation of impacts should be provided. To obtain the required results for HIA, this last must be part of a regional policy, which will address and guide development projects toward a proper evaluation of their impacts affecting heritage. In order to get a clearer picture of existing gabs but also new possibilities for HIA, this paper will focus on the Western Balkans region and the undergoing changes that it faces. Concerning continuous development pressure in the region and within the aspiration of the Western Balkans countries to join the European Union (EU) as member states, attention should be paid to new development policies under the EU directives for conducting EIAs, and accurate support is required for the restructuration of existing policies as well as for the implementation of the UN Agenda for SDGs. In the framework of new emerging needs, if HIA is taken into account, the outcome would be an inclusive regional program that would help to overcome marginality issues of spaces and people.

Keywords: cultural heritage, impact assessment, SDGs, urban development, western Balkans, regional policy, HIA, EIA

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Authors: Luisa Perez-Mujica

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Traditionally, non-compliance in water regulation has been understood to be attributable to lack of information or knowledge of regulations. In other words, it is confusing behavioural change and education with communication or regulations. However, compliance is a complex response to water regulation factors including 1) knowledge and understanding of regulations; 2) perception that resources are overregulated; 3) presence of regulatory officers in the field; 4) accurate communication of what is being protected; 5) time lag between behavioral change projects and observation of outcomes and 6) how success of behavioral change is measured and evaluated. This paper presents a framework for designing education and behavioral change projects by understanding non-compliance in terms of the interaction of its factors, including a process for prioritizing projects, actions, evaluation and monitoring of outcomes. By taking a systemic approach to compliance, a more directed type of actions can be efficiently identified and prioritized, preventing the reactive nature of education and behavioral change projects.

Keywords: water regulation, compliance, behaviour change, systems thinking

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Authors: B. Unnikrishnan, Tanuj Kanchan, Ramesh Holla, Nithin Kumar

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Euthanasia has been debated for the ethical, legal, social, and religious implications associated with it. The present research was conducted to study the perceptions of doctors and nurses about ethical and legal aspects of Euthanasia in Indian scenario. The study was carried out at three tertiary care hospitals of Kasturba Medical College (KMC), Mangalore, India. Practicing doctors and nurses working in the hospitals associated with KMC were included in the study after taking written informed consent from the participants. The data was analyzed using SPSS version 11.5. Mann-Whitney U test was used to compare the responses of doctors and nurses. P-value of <0.05 was taken as statistically significant. A total of 144 doctors and nurses participated in the study. Both doctors and nurses agreed that if a terminally ill patient wishes to die, the wish cannot be honored ethically and legally. A significantly larger number of nurses agreed that patient’s wish for euthanasia cannot be honored ethically and legally when compared to the doctors. Though the doctors and nurses were broadly in agreement with the existing legal and ethical views on the issue, their knowledge on the issue with regard to the legal status of euthanasia in India and ethical aspects relating to it needs to be strengthened.

Keywords: euthanasia, ethical aspects, legal aspects, India

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Authors: Magda Olesiuk-Okomska

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The degree of international interdependence has grown significantly. Poland is a party to nearly 1000 binding multilateral treaties, including international legal instruments devoted to criminal matters and obliging the state to penalize certain crimes. The paper presents results of a theoretical research conducted as a part of doctoral research. The main hypothesis assumed that there was a separate category of crimes to penalization of which Poland was obliged under international legal instruments; that a catalogue of such crimes and a catalogue of international legal instruments providing for Poland’s international obligations had never been compiled in the domestic doctrine, thus there was no mechanism for monitoring implementation of such obligations. In the course of the research, a definition of transnational crimes was discussed and confronted with notions of international crimes, treaty crimes, as well as cross-border crimes. A list of transnational crimes penalized in the Polish Penal Code as well as in non-code criminal law regulations was compiled; international legal instruments, obliging Poland to criminalize and penalize specific conduct, were enumerated and catalogued. It enabled the determination whether Poland’s international obligations were implemented in domestic legislation, as well as the formulation of de lege lata and de lege ferenda postulates. Implemented research methods included inter alia a dogmatic and legal method, an analytical method and desk research.

Keywords: international criminal law, transnational crimes, transnational criminal law, treaty crimes

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Authors: Dalia Perkumiene

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The process of globalization has several unforeseen negative effects on the quality of the environment, including increased pollution, climate change, and the depletion and destruction of natural resources. The impact of these processes makes it difficult to guarantee citizens' rights to a clean environment, and complex legal solutions are needed to implement this right. In order to implement human rights in a clean and safe environment, international legal documents and court rulings are analyzed. It is important to find a balance between the legal context: the right to a clean environment and environmental challenges such as climate change and global warming. Research Methods: The following methods were used in this study: analytical, analysis, and synthesis of scientific literature and legal documents, comparative analysis of legal acts, and generalization. Major Findings: It is difficult to implement the right to a clean, safe and sustainable environment. The successful implementation of this right depends on the application of various complex ideas and rational, not only legal solutions. Legislative measures aim to maximize the implementation of citizens' rights in the face of climate change and other environmental challenges. This area remains problematic, especially in international law. Concluding Statement: The right to a clean environment should allow a person to live in a harmonious system, where environmental factors do not pose a risk to human health and well-being.

Keywords: clean and safe and clean environmen, environmen, persons’ rights, right to a clean and safe and clean environment

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Authors: Fatemeh Noori

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The fashion industry is a dynamic and ever-evolving realm that continuously shapes societal perceptions of beauty and style. Within this industry, fashion modeling plays a crucial role, acting as the visual representation of brands and designers. However, behind the glamorous façade lies a complex web of legal considerations that govern the rights, responsibilities, and ethical practices within the field. This paper aims to explore the legal landscape surrounding fashion modeling, shedding light on key issues such as contract law, intellectual property, labor rights, and the increasing importance of ethical considerations in the industry. Fashion modeling involves the collaboration of various stakeholders, including models, designers, agencies, and photographers. To ensure a fair and transparent working environment, it is imperative to establish a comprehensive legal framework that addresses the rights and obligations of each party involved. One of the primary legal considerations in fashion modeling is the contractual relationship between models and agencies. Contracts define the terms of engagement, including payment, working conditions, and the scope of services. This section will delve into the essential elements of modeling contracts, the negotiation process, and the importance of clarity to avoid disputes. Models are not just individuals showcasing clothing; they are integral to the creation and dissemination of artistic and commercial content. Intellectual property rights, including image rights and the use of a model's likeness, are critical aspects of the legal landscape. This section will explore the protection of models' image rights, the use of their likeness in advertising, and the potential for unauthorized use. Models, like any other professionals, are entitled to fair and ethical treatment. This section will address issues such as working conditions, hours, and the responsibility of agencies and designers to prioritize the well-being of models. Additionally, it will explore the global movement toward inclusivity, diversity, and the promotion of positive body image within the industry. The fashion industry has faced scrutiny for perpetuating harmful standards of beauty and fostering a culture of exploitation. This section will discuss the ethical responsibilities of all stakeholders, including the promotion of diversity, the prevention of exploitation, and the role of models as influencers for positive change. In conclusion, the legal considerations in fashion modeling are multifaceted, requiring a comprehensive approach to protect the rights of models and ensure ethical practices within the industry. By understanding and addressing these legal aspects, the fashion industry can create a more transparent, fair, and inclusive environment for all stakeholders involved in the art of modeling.

Keywords: fashion modeling contracts, image rights in modeling, labor rights for models, ethical practices in fashion, diversity and inclusivity in modeling

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Authors: Rukhsana Shaheen, Tahira Ifraq

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Interest based transactions led the advent of Islamic banking. In order to provide an alternative to Interest based banking, financial transactions found in classical books of fiqh were employed. Musharakah, Mudarabah, Murabahah Salam, Ijara, and some other modes were adopted. These modes were modified so that they can be adopted for banking and satisfy the needs of customers. Since the inception of Islamic banking, these modes are being used and with the passage of time, are being molded and experimented with to cater different kinds of customers and requirements. Human efforts cannot be errorless. These modes too bear legal defects which need an in-depth scrutiny and refinement. The aim of this paper is to dig the basis and rulings of these modes in classical books of fiqh and analyze its modification and adoption in Islamic banking and the legal defects that these modes are bearing. Paper will prove itself fruitful by providing remedies for the legal defects.

Keywords: financial instruments, legal defects, remedies, Islamic banking

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Authors: Prathyusha Samvedam, Hiranmaya Nanda

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Doping refers to the practice of using drugs or practices that enhance an athlete's performance. This is a problem that occurs on a worldwide scale and compromises the fairness of athletic tournaments. There are rules that have been created on both the national and international levels in order to prevent doping. However, these rules sometimes contradict one another, and it is possible that they don't do a very good job of prohibiting people from using PEDs. This study will contend that India's inability to comply with specific Code criteria, as well as its failure to satisfy "best practice" standards established by other countries, demonstrates a lack of uniformity in the implementation of anti-doping regulations and processes among nations. Such challenges have the potential to undermine the validity of the anti-doping system, particularly in developing nations like India. This article on the legislative framework in India governing doping in sports is very important. To begin, doping in sports is a significant problem that affects the spirit of fair play and sportsmanship. Moreover, it has the potential to jeopardize the integrity of the sport itself. In addition, the research has the potential to educate policymakers, sports organizations, and other stakeholders about the current legal framework and how well it discourages doping in athletic competitions. This article is divided into four distinct sections. The first section offers an explanation of what doping is and provides some context about its development throughout time. Followed the role of anti-doping authorities and the responsibilities they perform are investigated. Case studies and the research technique that will be employed for the study are in the third section; finally, the results are presented in the last section. In conclusion, doping is a severe problem that endangers the honest competition that exists within sports.

Keywords: sports law, doping, NADA, WADA, performance enhancing drugs, anti-doping bill 2022

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Authors: Razieh Zareia, Hassan ZMB, Darush Moslemic, Amrollah Mostafa-Zaded

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Introduction: Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, at least, in vitro. The purpose of our research was to evaluate the immune-effectiveness on imbalance between IL-23/IL-17 axis, as an inflammatory pathway and TGF/Foxp3 T regulatory as a inhibitory pathway of commercial shark cartilage that is available as a non-common dietary supplement in IRAN. 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: The simultaneously presented up-regulation IL-17A indicated, at least cytokine level without changing in TGF-β amount or CD4+CD25+Foxp3 T regulatory cells, that there are not a direct correlation between IL-23/IL-17 axis and Treg/TGF-β pathway in patients with gastric cancer treated by shark cartilage, but IL-23 was not expressed differentially in this group. So, accompany these changes, an imbalance between Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) evaluated in patients with gastric cancer treated by shark cartilage. Conclusion: On the basis of results, we propose that shark cartilage, by reducing IL-4, decreasing IL-17 a central cytokine in angiogenesis and increasing γ-IFN amplify anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4+CD25+Foxp3high T regulatory pathway, γ-IFN, IL-4, shark cartilage, gastric cancer

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Authors: Amy Williamson, Kerry Armstrong, Jason Edwards, Patricia Obst

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Australian national policy endorses a responsive approach to work health and safety (WHS) regulation, combining positive motivators (education and guidance), with compliance monitoring and enforcement to encourage and secure compliance with legislation. Despite theoretical support for responsive regulation, there is limited evidence regarding how to achieve best results in practice. Using positive psychology as a novel paradigm, this study aims to investigate how non-punitive regulatory interactions can be improved to further encourage regulatory compliance in the construction industry. As part of a larger project, semi-structured interviews were conducted with 35 inspectorate staff and 11 managers in the Australian (Queensland) construction industry. Using an inductive, grounded approach, an in-depth qualitative investigation was conducted to identify the positive psychological principles which underpin effective use of the non-punitive aspects of responsive regulation. Results highlighted the importance of effective engagement between inspectors and industry managers. This involved the need to interact cooperatively and encourage compliance with WHS legislation. Several strategies were identified that assisted regulatory interactions and the ability of inspectors to engage. The importance of communication and interpersonal skills was reported to be critical to any interaction, regardless of the nature of the visit and regulatory tools used. In particular, the use of clear and open communication fostered trust and rapport which facilitated more positive interactions. The importance of respect and empathy was also highlighted. The need for provision of guidance and direction on how to achieve compliance was also reported. This related to ensuring companies understand their WHS obligations, providing specific advice regarding how to rectify a breach and meet compliance requirements, and ensuring sufficient follow up to confirm that compliance is successfully achieved. In the absence of imminent risk, allowing companies the opportunity to comply before further action is taken was also highlighted. Increased proactive engagement with industry to educate and promote the vision of safety at work was also reported. Finally, provision of praise and positive feedback was reported to assist interactions and encourage the continuation of good practices. Evidence from positive psychology and organisational psychology was obtained to support the use of each strategy in practice. In particular, the area of positive leadership provided a useful framework to consider the factors and conditions that drive positive interactions within the context of work health and safety and the specific relationship between inspectors and industry managers. This study provides fresh insight into key psychological principles which support non-punitive regulatory interactions in the area of workplace health and safety. The findings of this research contribute to a better understanding of how inspectors can enhance the efficacy of their regulatory interactions to improve compliance with legislation. Encouraging and assisting compliance through effective non-punitive activity offers a sustainable pathway for promoting safety and preventing fatalities and injuries in the construction industry.

Keywords: engagement, non-punitive approaches to compliance, positive interactions in the workplace, work health and safety compliance

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Authors: Rodrigo Zepeda

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Transaction cost analysis (TCA) is a way of analyzing the relative performance of different intermediaries and different trading strategies for trades undertaken in financial instruments. It is a way for an investor to determine the overall quality of execution of a particular trade, and there are many different approaches to undertaking TCA. Under the updated Markets in Financial Instruments Directive (2014/65/EU) (MiFID II), investment firms are required when executing orders, to take all sufficient steps to obtain the best possible result for their clients. This requirement for 'Best Execution' must take into account price, costs, speed, likelihood of execution and settlement, size, nature or any other consideration relevant to the execution of the order. The new regulatory compliance framework under MiFID II will now also apply across a very broad range of financial instruments. This article will provide a comprehensive technical analysis of how TCA and Best Execution will significantly change under MiFID II. It will also explain why harmonization of post-trade reporting requirements under MiFID II could potentially support the development of peer group analysis, which in turn could provide a new and highly advanced framework for TCA that could more effectively support Best Execution requirements under MiFID II. The study is significant because there are no studies that have dealt with TCA and Best Execution under MiFID II in the literature.

Keywords: transaction cost analysis, execution quality, best execution, MiFID II, financial instruments

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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: Muhammad Ilham Agus Salim, Saufa Ata Taqiyya

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In many Muslim countries, secularization has successfully reduced the role of Islamic law as a formal legal source during this last century. The most obvious fact was the reform of Daulah Utsmaniyah to be Secular Republic of Turkey. Religion is strictly separated from the state authorities in many countries today. But these last decades in Indonesia, a remarkable fact is apparent. Islamic law has expanded its role in Indonesian legal system, especially in districts regulations. In Aceh province, as a case in point, shariah has been the basic source of law in all regulations. There are more provinces in Indonesia which adopted Islamic law as a formal legal source by the end of 2014. Different from some other countries which clearly stipulates the status of Islam in formal ways, Indonesian constitution formally does not render any recognition for Islam to be the formal religion of the state. But in this Muslim majority country, Islamic law takes a place in democratic way, namely on the basis of the voice of majority. This paper will analyze how this reality increases significantly since what so called by Indonesian reformation era (end of nineties). Some causes will be identified regarding this tendency of expansion of role. Some lessons learned also will be recommended as the concluding remarks by the end of the paper.

Keywords: Islamic law, Indonesia, legal reform, Syariah local regulation

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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: Deeksha Karunakar

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The gaming industry is one of the biggest industries in the world. Video games are interactive works of authorship that require the execution of a computer programme on specialized hardware but which also incorporate a wide variety of other artistic mediums, such as music, scripts, stories, video, paintings, and characters, into which the player takes an active role. Therefore, video games are not made as singular, simple works but rather as a collection of elements that, if they reach a certain level of originality and creativity, can each be copyrighted on their own. A video game is made up of a wide variety of parts, all of which combine to form the overall sensation that we, the players, have while playing. The entirety of the components is implemented in the form of software code, which is then translated into the game's user interface. Even while copyright protection is already in place for the coding of software, the work that is produced because of that coding can also be protected by copyright. This includes the game's storyline or narrative, its characters, and even elements of the code on their own. In each sector, there is a potential legal framework required, and the gaming industry also requires legal frameworks. This represents the importance of intellectual property laws in each sector. This paper will explore the beginnings of video games, the various aspects of game copyrights, and the approach of the courts, including examples of a few different instances. Although the creative arts have always been known to draw inspiration from and build upon the works of others, it has not always been simple to evaluate whether a game has been cloned. The video game business is experiencing growth as it has never seen before today. The majority of today's video games are both pieces of software and works of audio-visual art. Even though the existing legal framework does not have a clause specifically addressing video games, it is clear that there is a great many alternative means by which this protection can be granted. This paper will represent the importance of copyright and trademark laws in the gaming industry and its regulations with the help of relevant case laws via utilizing doctrinal methodology to support its findings. The aim of the paper is to make aware of the applicability of intellectual property laws in the gaming industry and how the justice system is evolving to adapt to such new industries. Furthermore, it will provide in-depth knowledge of their relationship with each other.

Keywords: copyright, DMCA, gaming industry, trademark, WIPO

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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: Jacob Livingston Slosser, Naja Holten Moller, Thomas Troels Hildebrandt, Henrik Palmer Olsen

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In this paper, we propose a model for human-AI interaction in public administration that involves legal decision-making. Inspired by Alan Turing’s test for machine intelligence, we propose a way of institutionalizing a continuous working relationship between man and machine that aims at ensuring both good legal quality and higher efficiency in decision-making processes in public administration. We also suggest that our model enhances the legitimacy of using AI in public legal decision-making. We suggest that case loads in public administration could be divided between a manual and an automated decision track. The automated decision track will be an algorithmic recommender system trained on former cases. To avoid unwanted feedback loops and biases, part of the case load will be dealt with by both a human case worker and the automated recommender system. In those cases an experienced human case worker will have the role of an evaluator, choosing between the two decisions. This model will ensure that the algorithmic recommender system is not compromising the quality of the legal decision making in the institution. It also enhances the legitimacy of using algorithmic decision support because it provides justification for its use by being seen as superior to human decisions when the algorithmic recommendations are preferred by experienced case workers. The paper outlines in some detail the process through which such a model could be implemented. It also addresses the important issue that legal decision making is subject to legislative and judicial changes and that legal interpretation is context sensitive. Both of these issues requires continuous supervision and adjustments to algorithmic recommender systems when used for legal decision making purposes.

Keywords: administrative law, algorithmic decision-making, decision support, public law

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