Search results for: regulatory changes

Authors: Olia Kanevskaia

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Standardization has been in the limelight of numerous academic studies. Typically described as ‘any set of technical specifications that either provides or is intended to provide a common design for a product or process’, standards do not only set quality benchmarks for products and services, but also spur competition and innovation, resulting in advantages for manufacturers and consumers. Their contribution to globalization and technology advancement is especially crucial in the Information and Communication Technology (ICT) and telecommunications sector, which is also characterized by a weaker state-regulation and expert-based rule-making. Most of the standards developed in that area are interoperability standards, which allow technological devices to establish ‘invisible communications’ and to ensure their compatibility and proper functioning. This type of standard supports a large share of our daily activities, ranging from traffic coordination by traffic lights to the connection to Wi-Fi networks, transmission of data via Bluetooth or USB and building the network architecture for the Internet of Things (IoT). A large share of ICT standards is developed in the specialized voluntary platforms, commonly referred to as Standards Development Organizations (SDOs), which gather experts from various industry sectors, private enterprises, governmental agencies and academia. The institutional architecture of these bodies can vary from semi-public bodies, such as European Telecommunications Standards Institute (ETSI), to industry-driven consortia, such as the Internet Engineering Task Force (IETF). The past decades witnessed a significant shift of standard setting to those institutions: while operating independently from the states regulation, they offer a rather informal setting, which enables fast-paced standardization and places technical supremacy and flexibility of standards above other considerations. Although technical norms and specifications developed by such nongovernmental platforms are not binding, they appear to create significant regulatory impact. In the United States (US), private voluntary standards can be used by regulators to achieve their policy objectives; in the European Union (EU), compliance with harmonized standards developed by voluntary European Standards Organizations (ESOs) can grant a product a free-movement pass. Moreover, standards can de facto manage the functioning of the market when other regulative alternatives are not available. Hence, by establishing (potentially) mandatory norms, SDOs assume regulatory functions commonly exercised by States and shape their own legal order. The purpose of this paper is threefold: First, it attempts to shed some light on SDOs’ institutional architecture, focusing on private, industry-driven platforms and comparing their regulatory frameworks with those of formal organizations. Drawing upon the relevant scholarship, the paper then discusses the extent to which the formulation of technological standards within SDOs constitutes a private legal order, operating in the shadow of governmental regulation. Ultimately, this contribution seeks to advise whether a state-intervention in industry-driven standard setting is desirable, and whether the increasing regulatory importance of SDOs should be addressed in legislation on standardization.

Keywords: private order, standardization, standard-setting organizations, transnational law

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Authors: Paschal Ohalehi

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Purpose - The purpose of this paper, which is part of a PhD thesis is to examine the role of risk based approach in minimising financial crime in the charity sector as well as offer recommendations to improving the quality of charity regulation whilst still retaining risk based approach as a regulatory framework and also making a case for a new regulatory model. Increase in financial crimes in the charity sector has put the role of regulation in minimising financial crime up for debates amongst researchers and practitioners. Although previous research has addressed the regulation of charities, research on the role of risk based approach to minimising financial crime in the charity sector is limited. Financial crime is a concern for all organisation including charities. Design/methodology/approach - This research adopts a social constructionist’s epistemological position. This research is carried out using semi structured in-depth interviews amongst randomly selected 24 charity trustees divided into three classes: 10 small charities, 10 medium charities and 4 large charities. The researcher also interviewed 4 stakeholders (NFA, Charity Commission and two different police forces in terms of size and area of coverage) in the charity sector. Findings - The results of this research show that reliance on risk based approach to financial crime in the sector is weak and fragmented with the research pointing to a clear evidence of disconnect between the regulator and the regulated leading to little or lack of regulation of trustees’ activities, limited monitoring of charities and lack of training and awareness on financial crime in the sector. Originality – This paper shows how regulation of charities in general and risk based approach in particular can be improved in order to meet the expectations of the stakeholders, the public, the regulator and the regulated.

Keywords: risk, risk based approach, financial crime, fraud, self-regulation

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Authors: Cyoung-Huei Huang, Chiu-Li Yeh, Man-Hui Pai, Sung-Ling Yeh

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This study evaluated the effect of different dietary n-6/n-3 polyunsaturated fatty acid (PUFA) ratios on modulating helper T (Th) and regulatory T (Treg) lymphocytes in mice with dextran sulfate sodium (DSS)-induced colitis. There were 3 control and 3 colitis groups in this study. Mice were fed for 24 d with an AIN-93G diet either with soybean oil (S), a mixture of soybean oil and low fish oil content (LF) or high fish oil content (HF). The ratio of n-6/n-3 PUFA in the LF diet was 4:1, and that in the HF diet was 2:1. The control groups drank distilled water while colitis groups provided 2% DSS in drinking water during day 15-19. All mice drank distilled water from day 20-24 for recovery and sacrificed on day 25. The results showed that colitis resulted in higher Th1, Th2, and Th17 and lower Treg percentages in the blood. Also, plasma haptoglobin and proinflammatory chemokines were elevated in colon lavage fluid. Colitic groups with fish oil had lower inflammatory mediators in the plasma and colon lavage fluid. Further, the percentages of Th1, Th2, and Th17 cells in the blood were lower, whereas Treg cell percentages were higher than those in the soybean oil group. The colitis group with n-6/n-3 PUFA ratio 2:1 had more pronounce effects than ratio 4:1. These results suggest that diets with an n-6/n-3 PUFA ratio of 2:1 or 4:1 regulate the Th/Treg balance and attenuate inflammatory mediator production in colitis. Compared to the n-6/n-3 PUFA ratio 4:1, the ratio of 2:1 was more effective in reducing inflammatory reactions in DSS-induced colitis.

Keywords: inflammatory bowel disease, n-3 polyunsaturated fatty acids, helper T lymphocyte, regulatory T lymphocyte

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Authors: Omogboyega Abe

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This paper examines the relationships between socio-economic inequalities of power, race, wealth engendered by corporate structure, and domination in postcolonial Africa. The paper further considers how land as an epitome of property and power for the locals paved the way for capitalist accumulation and control in the hands of transnational corporations. European colonization of Africa was contingent on settler colonialism, where properties, including land, were re-modified as extractive resources for primitive accumulation. In developing Africa's extractive resources, transnational corporations (TNCs) usurped states' structures and domination over native land. The usurpation/corporate capture that exists to date has led to remonstrations and arguably a counter-productive approach to development projects. In some communities, the mention of extractive companies triggers resentment. The paradigm of state capture and state autonomy is simply inadequate to either describe or resolve the play of forces or actors responsible for severe corporate-induced human rights violations in emerging markets. Moreover, even if the deadly working conditions are conceived as some regulatory failure, it is tough to tell whose failure. The analysis in this paper is that the complexity and ambiguity evidenced by the multiple regimes and political and economic forces shaping production, consumption, and distribution of socio-economic variables are not exceptional in emerging markets. Instead, the varied experience in developing countries provides a window for seeing what we face in understanding and theorizing the structure and operation of the global economic and regulatory order in general.

Keywords: colonial, emerging markets, business, human rights, corporation

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Authors: Neslihan Cetin

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In this study, we will aim to analyze how the period of the state of emergency in Turkey lead to gaps in law and the formation of areas in which there was a complete lack of supervision. The state of emergency that was proclaimed following the coup attempt of July 15, 2016, continued until July 18, 2018, that is to say, 2 years, without taking into account whether the initial circumstances persisted. As part of this work, we claim that the state of emergency provided the executive power with important tools for governing, which it took constant use. We can highlight how the concern for security at the center of the basic considerations of the people in a city was exploited as a foundation by the military power in Turkey to interfere in the political, legal, and social spheres. The constitutions of 1924, 1961, and 1982 entrusted the army with the role of protector of the integrity of the state. This became an instrument at the hands of the military to legitimize their interventions in the name of public security. Its interventions in the political field are indeed politically motivated. The constitution, the legislative, and regulatory systems are modified and monopolized by the military power that dominates the legislative, regulatory, and judicial power, leading to a state of exception. With the political convulsions over a decade, the government was able to usurp the instrument called the state of exception. In particular, the decree-laws of the state of emergency, which the executive makes frequent and generally abusive use, became instruments in the hands of the government to take measures that it wishes to escape from the rules and the pre-established control mechanisms. Thus the struggle against the political opposition becomes more unbalanced and destructive. To this must also be added the ineffectiveness of ex-post controls and domestic remedies. This research allows us to stress how a legal concept, such as ‘the state of emergency’ can be politically exploited to make it a legal weapon that continues to produce victims.

Keywords: constitutional law, state of emergency, rule of law, instrumentalization of law

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Authors: Gerhard Grebe, Johan Marx

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The aim of the study is to assess the state of operational risk management and the adoption of an appropriate risk culture in Ghanaian banks. The Bank of Ghana (BoG) joined the Basel Consultative Group (BCG) of the Basel Committee on Bank Supervision (BCBS) in 2021 and is proceeding with the implementation of the Basel III international regulatory framework for banks. The BoG’s Directive about risk management encourages, inter alia, the creation of an appropriate risk culture by Ghanaian banks. However, it is not evident how the risk management staff of Ghanaian banks experience the risk culture and the implementation of operational risk management in the banks where they are employed. Ghana is a developing economy, and it is addressing challenges with its organisational culture. According to Transparency International, successive Ghanaian governments claim to be fighting corruption, but little success has been achieved so far. This points to a possible lack of accountability, transparency, and integrity in the environment in which Ghanaian banks operate and which could influence their risk culture negatively. Purposive sampling was used for the survey, and the questionnaire was completed byGhanaian bank personnel who specializesin operational risk management, risk governance, and compliance, bank supervision, risk analyses, as well as the implementation of the operational risk management requirements of the Basel regulatory frameworks. The respondents indicated that they are fostering a risk culture and implementing monitoring and reporting procedures; the three lines of defence (3LOD); compliance; internal auditing; disclosure of operational risk information; and receiving guidance from the bank supervisor in an attempt to improve their operational risk management practices. However, the respondents reported the following challenges with staff members who are not inside the risk management departments(in order of priority), namelydemonstrating a risk culture, training and development; communication; reporting and disclosure; roles and responsibilities; performance appraisal; and technological and environmental barriers. Recommendations to address these challenges are provided

Keywords: ghana, operational risk, risk culture, risk management

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Authors: S. Shakibaei, P. Alpkokin

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The railway network is one of the major components of a transportation system in a country which may be an indicator of the country’s level of economic improvement. Since 2000s on, revival of national railways and development of High Speed Rail (HSR) lines are one of the most remarkable policies of Turkish government in railway sector. Within this trend, the railway age is to be revived and coming decades will be a golden opportunity. Indubitably, major infrastructures such as road and railway networks require sizeable investment capital, precise maintenance and reparation. Traditionally, governments are held responsible for funding, operating and maintaining these infrastructures. However, lack or shortage of financial resources, risk responsibilities (particularly cost and time overrun), and in some cases inefficacy in constructional, operational and management phases persuade governments to find alternative options. Financial power, efficient experiences and background of private sector are the factors convincing the governments to make a collaboration with private parties to develop infrastructures. Public-Private Partnerships (PPP or 3P or P3) and related regulatory issues are born considering these collaborations. In Turkey, PPP approaches have attracted attention particularly during last decade and these types of investments have been accelerated by government to overcome budget limitations and cope with inefficacy of public sector in improving transportation network and its operation. This study mainly tends to present a comprehensive overview of PPP concept, evaluate the regulatory procedure in Europe and propose a general framework for Turkish State Railways (TCDD) as an outlook on privatization, liberalization and deregulation of railway network.

Keywords: deregulation, high-speed railway, liberalization, privatization, public-private partnership

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Authors: Ponshano Kaselekela, Simooya O. Oscar, Lunshano Boyd

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The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.

Keywords: adverse drug reactions, drug safety, monitoring, pharmacovigilance

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Authors: Lucas Bublitz, Michael Herdrich

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By achieving the first commercialization approval in San Francisco the Autonomous Driving (AD) industry proves the technology maturity of the SAE L4 AD systems and the corresponding software and hardware stack. This milestone reflects the upcoming phase in the industry, where the focus is now about scaling and supervising larger autonomous vehicle (AV) fleets in different operation areas. This requires an operation framework, which organizes and assigns responsibilities to the relevant AV technology and operation stakeholders from the AV system provider, the Remote Intervention Operator, the MaaS provider and regulatory & approval authority. This holistic operation framework consists of technological, processual, and organizational activities to ensure safe operation for fully automated vehicles. Regarding the supervision of large autonomous vehicle fleets, a major focus is on the continuous field monitoring. The field monitoring approach must reflect the safety and security criticality of incidents in the field during driving operation. This includes an automatic containment approach, with the overall goal to avoid safety critical incidents and reduce downtime by a malfunction of the AD software stack. An End-to-end (E2E) field monitoring approach detects critical faults in the field, uses a knowledge-based approach for evaluating the safety criticality and supports the automatic containment of these E/E faults. Applying such an approach will ensure the scalability of AV fleets, which is determined by the handling of incidents in the field and the continuous regulatory compliance of the technology after enhancing the Operational Design Domain (ODD) or the function scope by Functions on Demand (FoD) over the entire digital product lifecycle.

Keywords: field monitoring, incident management, multicompliance management for AI in AD, root cause analysis, database approach

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Authors: Anjan Hazra, Nirjhar Dasgupta, Chandan Sengupta, Sauren Das

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Tea (Camellia sinensis) has received substantial attention from the scientific world time to time, not only for its commercial importance, but also for its demand to the health-conscious people across the world for its extensive use as potential sources of antioxidant supplement. These health-benefit traits primarily rely on some regulatory networks of different metabolic pathways. Development of microsatellite markers from the conserved genomic regions is being worthwhile for studying the genetic diversity of closely related species or self-pollinated species. Although several SSR markers have been reported, in tea the trait-specific Simple Sequence Repeats (SSRs) are yet to be identified, which can be used for marker assisted breeding technique. MicroRNAs are endogenous, noncoding, short RNAs directly involved in regulating gene expressions at the post-transcriptional level. It has been found that diversity in miRNA gene interferes the formation of its characteristic hair pin structure and the subsequent function. In the present study, the precursors of small regulatory RNAs (microRNAs) has been fished out from tea Expressed Sequence Tag (EST) database. Furthermore, the simple sequence repeat motifs within the putative miRNA precursor genes are also identified in order to experimentally validate their existence and function. It is already known that genic-SSR markers are very adept and breeder-friendly source for genetic diversity analysis. So, the potential outcome of this in-silico study would provide some novel clues in understanding the miRNA-triggered polymorphic genic expression controlling specific metabolic pathways, accountable for tea quality.

Keywords: micro RNA, simple sequence repeats, tea quality, trait specific marker

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Authors: George Kyriakopoulos, Photini Pazartzis, Anthi Koskina, Crystalie Bourcha

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The need for securing safe access to and return from outer space, as well as ensuring the viability of outer space operations, maintains vivid the debate over the promotion of organization of space traffic through a Space Traffic Management System (STM). The proliferation of outer space activities in recent years as well as the dynamic emergence of the private sector has gradually resulted in a diverse universe of actors operating in outer space. The said developments created an increased adverse impact on outer space sustainability as the case of the growing number of space debris clearly demonstrates. The above landscape sustains considerable threats to outer space environment and its operators that need to be addressed by a combination of scientific-technological measures and regulatory interventions. In this context, recourse to recent technological advancements and, in particular, to Artificial Intelligence (AI) and machine learning systems, could achieve exponential results in promoting space traffic management with respect to collision avoidance as well as launch and re-entry procedures/phases. New technologies can support the prospects of a successful space traffic management system at an international scale by enabling, inter alia, timely, accurate and analytical processing of large data sets and rapid decision-making, more precise space debris identification and tracking and overall minimization of collision risks and reduction of operational costs. What is more, a significant part of space activities (i.e. launch and/or re-entry phase) takes place in airspace rather than in outer space, hence the overall discussion also involves the highly developed, both technically and legally, international (and national) Air Traffic Management System (ATM). Nonetheless, from a regulatory perspective, the use of AI for the purposes of space traffic management puts forward implications that merit particular attention. Key issues in this regard include the delimitation of AI-based activities as space activities, the designation of the applicable legal regime (international space or air law, national law), the assessment of the nature and extent of international legal obligations regarding space traffic coordination, as well as the appropriate liability regime applicable to AI-based technologies when operating for space traffic coordination, taking into particular consideration the dense regulatory developments at EU level. In addition, the prospects of institutionalizing international cooperation and promoting an international governance system, together with the challenges of establishment of a comprehensive international STM regime are revisited in the light of intervention of AI technologies. This paper aims at examining regulatory implications advanced by the use of AI technology in the context of space traffic management operations and its key correlating concepts (SSA, space debris mitigation) drawing in particular on international and regional considerations in the field of STM (e.g. UNCOPUOS, International Academy of Astronautics, European Space Agency, among other actors), the promising advancements of the EU approach to AI regulation and, last but not least, national approaches regarding the use of AI in the context of space traffic management, in toto. Acknowledgment: The present work was co-funded by the European Union and Greek national funds through the Operational Program "Human Resources Development, Education and Lifelong Learning " (NSRF 2014-2020), under the call "Supporting Researchers with an Emphasis on Young Researchers – Cycle B" (MIS: 5048145).

Keywords: artificial intelligence, space traffic management, space situational awareness, space debris

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Authors: S. K. Balashanmugam, Padmavati Manchikanti, S. R. Subramanian

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The question of legal liability over injury arising out of the import and the introduction of GM food emerges as a crucial issue confronting to promote GM food and its derivatives. There is a greater possibility of commercialized GM food from the exporting country to enter importing country where status of approval shall not be same. This necessitates the importance of fixing a liability mechanism to discuss the damage, if any, occurs at the level of transboundary movement or at the market. There was a widespread consensus to develop the Cartagena Protocol on Biosafety and to give for a dedicated regime on liability and redress in the form of Nagoya Kuala Lumpur Supplementary Protocol on the Liability and Redress (‘N-KL Protocol’) at the international context. The national legal frameworks based on this protocol are not adequately established in the prevailing food legislations of the developing countries. The developing economy like India is willing to import GM food and its derivatives after the successful commercialization of Bt Cotton in 2002. As a party to the N-KL Protocol, it is indispensable for India to formulate a legal framework and to discuss safety, liability, and regulatory issues surrounding GM foods in conformity to the provisions of the Protocol. The liability mechanism is also important in the case where the risk assessment and risk management is still in implementing stage. Moreover, the country is facing GM infiltration issues with its neighbors Bangladesh. As a precautionary approach, there is a need to formulate rules and procedure of legal liability to discuss any kind of damage occurs at transboundary trade. In this context, the proposed work will attempt to analyze the liability regime in the existing Food Safety and Standards Act, 2006 from the applicability and domestic compliance and to suggest legal and policy options for regulatory authorities.

Keywords: commercialization, food safety, FSSAI, genetically modified foods, India, liability

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Authors: Mohammadjavad Sotoudeheian, Soroush Nematollahi

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Crohn’s disease (CD) is a chronic gastrointestinal segment inflammation encompassing immune dysregulation in a genetically susceptible individual in response to the environmental triggers and interaction between the microbiome and immune system. Uncontrolled inflammation leads to long-term complications, including fibrotic strictures and enteric fistulae. Increased production of Th1 and Th17-cell cytokines and defects in T-regulatory cells have been associated with CD. Th17-cells are essential for protection against extracellular pathogens, but their atypical activity can cause autoimmunity. Intrinsic defects in the control of programmed cell death in the mucosal T-cell compartment are strongly implicated in the pathogenesis of CD. The apoptosis defect in mucosal T-cells in CD has been endorsed as an imbalance of the Bcl-2 and the Bax. The immune system encounters foreign antigens through microbial colonization of mucosal surfaces or infections. In addition, FOSL downregulated IL-26 expression, a cytokine that marks inflammatory Th17-populations in patients suffering from CD. Furthermore, the expression of IL-23 is associated with the transcription factor primary leucine zipper transcription factor ATF-like (Batf). Batf-deficiency demonstrated the crucial role of Batf in colitis development. Batf and IL-23 mediate their effects by inducing IL-6 production. Strong association of IL-23R, Stat3, and Stat4 with IBD susceptibility point to a critical involvement of T-cells. IL-23R levels in transfer fistula were dependent on the AP-1 transcription factor JunB that additionally controlled levels of RORγt by facilitating DNA binding of Batf. T lymphocytes lacking JunB failed to induce IL-23- and Th17-mediated experimental colitis highlighting the relevance of JunB for the IL-23/ Th17 pathway. The absence of T-bet causes unrestrained Th17-cell differentiation. T-cells are central parts of immune-mediated colon fistula. Especially Th17-cells were highly prevalent in inflamed IBD tissues, as RORγt is effective in preventing colitis. Intraepithelial lymphocytes (IEL) contain unique T-cell subsets, including cells expressing RORγt. Increased activated Th17 and decreased T-regulatory cells in inflamed intestinal tissues had been seen. T-cells differentiate in response to many cytokines, including IL-1β, IL-6, IL-23, and TGF-β, into Th17-cells, a process which is critically dependent on the Batf. IL-23 promotes Th17-cell in the colon. Batf manages the generation of IL-23 induced IL-23R+ Th17-cells. Batf is necessary for TGF-β/IL-6-induced Th17-polarization. Batf-expressing T-cells are the core of T-cell-mediated colitis. The human-specific parts of three AP-1 transcription factors, FOSL1, FOSL2, and BATF, are essential during the early stages of Th17 differentiation. BATF supports the Th17 lineage. FOSL1, FOSL2, and BATF make possession of regulatory loci of genes in the Th17 lineage cascade. The AP1 transcription factor Batf is identified to control intestinal inflammation and seems to regulate pathways within lymphocytes, which could theoretically control the expression of several genes. It shows central regulatory properties over Th17-cell development and is intensely upregulated within IBD-affected tissues. Here, we demonstrated that targeting Batf in IBD appears as a therapeutic approach that reduces colitogenic T-cell activities during fistula formation while aiming to affect inflammation in the gut epithelial cells.

Keywords: immune system, Crohn’s Disease, BATF, T helper cells, Bcl, interleukin, FOSL

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Authors: Qingxin Chen, Liben Jiang, Andrew Smith, Karim Hadjri

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Since 2007, the Chinese food industry has undergone serious food contamination in the baby dairy industry, especially milk powder contamination. One of the milk powder products was found to contain melamine and a significant number (294,000) of babies were affected by kidney stones. Due to growing concerns among consumers about food safety and protection, and high pressure from central government, companies must take radical action to ensure food quality protection through the use of an appropriate quality management system. Previously, though researchers have investigated the health and safety aspects of food industries and products, quality issues concerning food products in China have been largely over-looked. Issues associated with baby dairy products and their quality issues have not been discussed in depth. This paper investigates the impact of quality management systems on the Chinese baby dairy product industry. A literature review was carried out to analyse the use of quality management systems within the Chinese milk power market. Moreover, quality concepts, relevant standards, laws, regulations and special issues (such as Melamine, Flavacin M1 contamination) have been analysed in detail. A qualitative research approach is employed, whereby preliminary analysis was conducted by interview, and data analysis based on interview responses from four selected Chinese baby dairy product companies was carried out. Through the analysis of literature review and data findings, it has been revealed that for quality management system that has been designed by many practitioners, many theories, models, conceptualisation, and systems are present. These standards and procedures should be followed in order to provide quality products to consumers, but the implementation is lacking in the Chinese baby dairy industry. Quality management systems have been applied by the selected companies but the implementation still needs improvement. For instance, the companies have to take measures to improve their processes and procedures with relevant standards. The government need to make more interventions and take a greater supervisory role in the production process. In general, this research presents implications for the regulatory bodies, Chinese Government and dairy food companies. There are food safety laws prevalent in China but they have not been widely practiced by companies. Regulatory bodies must take a greater role in ensuring compliance with laws and regulations. The Chinese government must also play a special role in urging companies to implement relevant quality control processes. The baby dairy companies not only have to accept the interventions from the regulatory bodies and government, they also need to ensure that production, storage, distribution and other processes will follow the relevant rules and standards.

Keywords: baby dairy product, food quality, milk powder contamination, quality management system

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Authors: Thanusha D. Abeywickrama, Inoka C. Perera, Genji Kurisu

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Tuberculosis, considered being as the ninth leading cause of death worldwide, cause from a single infectious agent M. tuberculosis and the drug resistance nature of this bacterium is a continuing threat to the world. Therefore TB preventing treatment is expanding, where this study designed to analyze the regulatory mechanism of GntR transcriptional regulator gene Rv0792c, which lie between several genes codes for some hypothetical proteins, a monooxygenase and an oxidoreductase. The gene encoding Rv0792c was cloned into pET28a and expressed protein was purified to near homogeneity by Nickel affinity chromatography. It was previously reported that the protein binds within the intergenic region (BS region) between Rv0792c gene and monooxygenase (Rv0793). This resulted in binding of three protein molecules with the BS region suggesting tight control of monooxygenase as well as its own gene. Since monooxygenase plays a key role in metabolism, this gene may have a global regulatory role. The natural ligand for this regulator is still under investigation. In relation to the Rv0792 protein structure, a Circular Dichroism (CD) spectrum was carried out to determine its secondary structure elements. Percentage-wise, 17.4% Helix, 21.8% Antiparallel, 5.1% Parallel, 12.3% turn and 43.5% other were revealed from CD spectrum data under room temperature. Differential Scanning Calorimetry (DSC) was conducted to assess the thermal stability of Rv0792, which the melting temperature of protein is 57.2 ± 0.6 °C. The graph of heat capacity (Cp) versus temperature for the best fit was obtained for non-two-state model, which concludes the folding of Rv0792 protein occurs through stable intermediates. Peak area (∆HCal ) and Peak shape (∆HVant ) was calculated from the graph and ∆HCal / ∆HVant was close to 0.5, suggesting dimeric nature of the protein.

Keywords: CD spectrum, DSC analysis, GntR transcriptional regulator, protein structure

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Authors: Ian Kingsbury

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The rapid expansion of charter schools (public schools that receive government but do not face the same regulations as traditional public schools) over the preceding two decades has raised concerns over the potential for graft and fraud. These concerns are largely justified: Incidents of financial crime and mismanagement are not unheard of, and the charter sector has become a darling of hedge fund managers. In response, several states have strengthened their charter school regulatory regimes. Imposing regulations and attempting to increase accountability seem like sensible measures, and perhaps they are necessary. However, increased regulation may come at the cost of imposing barriers to entry. Specifically, increased regulation often entails evidence for a high likelihood of fiscal solvency. That should theoretically entail access to capital in the short-term, which may systematically preclude Black or Hispanic applicants from opening charter schools. Moreover, increased regulation necessarily entails more red tape. The institutional wherewithal and the number of hours required to complete an application to open a charter school might favor those who have partnered with an education service provider, specifically a charter management organization (CMO) or education management organization (EMO). These potential barriers to entry pose a significant policy concern. Just as policymakers hope to increase the share of minority teachers and principals, they should sensibly care whether individuals who open charter schools look like the students in that school. Moreover, they might be concerned if successful applications in states with stringent regulations are overwhelmingly affiliated with education service providers. One of the original missions of charter schools was to serve as a laboratory of innovation. Approving only those applications affiliated with education service providers (and in effect establishing a parallel network of schools rather than a diverse marketplace of schools) undermines that mission. Data and methods: The analysis examines more than 2,000 charter school applications from 15 states. It compares the outcomes of applications from states with a strong regulatory environment (those with high scores) from NACSA-the National Association of Charter School Authorizers- to applications from states with a weak regulatory environment (those with a low NACSA score). If the hypothesis is correct, applicants not affiliated with an ESP are more likely to be rejected in high-regulation states compared to those affiliated with an ESP, and minority candidates not affiliated with an education service provider (ESP) are particularly likely to be rejected. Initial returns indicate that the hypothesis holds. More applications in low NASCA-scoring Arizona come from individuals not associated with an ESP, and those individuals are as likely to be accepted as those affiliated with an ESP. On the other hand, applicants in high-NACSA scoring Indiana and Ohio are more than 20 percentage points more likely to be accepted if they are affiliated with an ESP, and the effect is particularly pronounced for minority candidates. These findings should spur policymakers to consider the drawbacks of charter school accountability and consider accountability regimes that do not impose barriers to entry.

Keywords: accountability, barriers to entry, charter schools, choice

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Authors: Yiling Shao, Megan Dai

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This paper attempts to explore whether the cultural infrastructure supported by the Chinese government is still subject to a logic of “strict regulation”.Previous studies have pointed out that the "paternalism" tendency of China's cultural policy always leads to excessive government intervention in cultural development, while Chinese cultural practitioners can only seek cultural autonomy in the cracks of supervision. This can also explain why Chinese cultural policies sometimes have different effects than the official expectations.But this only reflects one aspect of China's cultural policy. In fact, the welfare cultural infrastructure funded by the government seems to highlight the principles of "safeguarding citizens' cultural rights" and "citizens' voluntary" rather than "indoctrination" and "enlightenment", What new features of China's cultural policy are reflected behind this policy orientation that is completely different from the logic of "regulation", which has also become an important issue in this paper. Based on the field survey of a cultural infrastructure (Gao ming District Cultural Center) in Gao ming District, Fo shan City, Guangdong Province, China, for nearly one year, the authors have obtained many text and picture materials.The paper discusses the dual role of cultural centers in China's cultural policy -both as a formal commitment by the state to protect citizens' basic cultural rights and as a social space for citizens to use preferential policies to obtain cultural capital. All in all, the author have conclued three operational logics of the cultural infrastructure currently supported by the Chinese government (at least in developed areas): first, the cultural center has become a versatile cultural space; second, grass-roots cultural cadres can be described as "policy entrepreneurs"; third, ordinary citizens will use the officially supported cultural infrastructure to increase cultural capital. This paper argues that, in comparison to the common “regulatory hand” in the field of cultural industries, in cultural infrastructure supported by state, the authorities and citizens are not in conflict. On the contrary, authorities must adopt a de-regulatory "pleasing" strategy to gain the support of citizens.

Keywords: cultural infrastructure, cultural capital, deregulation, policy entrepreneur

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Authors: S. Lemoussu, J. C. Chaudemar, R. A. Vingerhoeds

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The aeronautics sector is currently living an unprecedented growth largely due to innovative projects. In several cases, such innovative developments are being carried out by Small and Medium sized-Enterprises (SMEs). For instance, in Europe, a handful of SMEs are leading projects like airships, large civil drones, or flying cars. These SMEs have all limited resources, must make strategic decisions, take considerable financial risks and in the same time must take into account the constraints of safety, cost, time and performance as any commercial organization in this industry. Moreover, today, no international regulations fully exist for the development and certification of this kind of projects. The absence of such a precise and sufficiently detailed regulatory framework requires a very close contact with regulatory instances. But, SMEs do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses additional challenges for those SMEs that have system integration responsibilities and that must provide all the necessary means of compliance to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The final objective of our research is thus to provide a methodological framework supporting SMEs in their development taking into account recent innovation and institutional rules of the sector. We aim to provide a contribution to the problematic by developing a specific Model-Based Systems Engineering (MBSE) approach. Airspace regulation, aeronautics standards and international norms on systems engineering are taken on board to be formalized in a set of models. This paper presents the on-going research project combining Systems Engineering and Project Management process modeling and taking into account the metamodeling problematic.

Keywords: aeronautics, certification, process modeling, project management, SME, systems engineering

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Authors: Pradeep Kulshrestha, Maulana Ayoub Ali

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The concept of financial inclusion has been tabled in the whole world where practitioners, academicians, policy makers and economists are working hard to look for the best possible opportunities in order to enable the whole society to be in the banking cycle. The Islamic banking system is considered to be one of the said opportunities. Countries like the United Kingdom, United States of America, Malaysia, Saudi Arabia, the whole of the United Arab Emirates and many African countries have accommodated the aspect of Islamic banking in the conventional banking system as one of the financial inclusion strategies. This paper tries to analyse the current state of affairs of the Islamic Banking system in Tanzania in order to understand the improvement of the provision of Islamic banking products and services in the said country. The paper discusses the historical background of the banking system in Tanzania, the level of penetration of banking products and services and the coming of the Islamic banking system in the country. Furthermore, the paper discusses banking regulatory bodies, legal instruments governing banking operations as well as number of legal challenges facing Islamic banking operations in the country. Following a critical literature review, the paper discovered that there is no legal instrument which talks about the introduction and provision of Islamic banking system in Tanzania. Furthermore, the Islamic banking system was considered as a banking product which is absolutely incorrect because Islamic banking is considered to be as a banking system of its own. In addition to that, it has been discovered that lack of a proper regulatory system and legal instruments to harmonize the conventional and Islamic banking systems has resulted in the closure of one Islamic window in the country, which in the end affects the credibility of the newly introduced banking system. In its conclusive remarks, the paper suggests that Tanzania should work on all legal challenges affecting the smooth operations of the Islamic banking system. This can be in a way of adopting various Islamic banking legal models which are used in countries like Malaysia and others, or a borrowing legal harmonization process which has been adopted by the UK, Uganda, Nigeria and Kenya.

Keywords: Islamic banking, Islamic windows, regulations, banks

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Authors: Anurag Devkota

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Foreign employment serves to be the strongest pillar in engendering employment options for a large number of the young Nepali population. Nepali workers are forced to leave the comfort of their homes and are exposed to precarious conditions while on a journey to earn enough money to live better their lives. The exponential rise in foreign labour migration has produced a snowball effect on the economy of the nation. The dramatic variation in the economic development of the state has proved to establish the fact that migration is increasingly significant for livelihood, economic development, political stability, academic discourse and policy planning in Nepal. The foreign employment practice in Nepal largely incorporates the role of individual agents in the entire process of migration. With the fraudulent acts and false promises of these agents, the problems associated with every Nepali migrant worker starts at home. The workers encounter tremendous pre-departure malpractice and exploitation at home by different individual agents during different stages of processing. Although these epidemic and repetitive ill activities of intermediaries are dominant and deeply rooted, the agents have been allowed to walk free in the absence of proper laws to curb their wrongdoings and misconduct. It has been found that the existing regulatory mechanisms have not been utilised to their full efficacy and often fall short in addressing the actual concerns of the workers because of the complex legal and judicial procedures. Structural changes in the judicial setting will help bring perpetrators under the law and victims towards access to justice. Thus, a qualitative improvement of the overall situation of Nepali migrant workers calls for a proper 'regulatory' arrangement vis-à-vis these brokers. Hence, the author aims to carry out a doctrinal study using reports and scholarly articles as a major source of data collection. Various reports published by different non-governmental and governmental organizations working in the field of labour migration will be examined and the research will focus on the inductive and deductive data analysis. Hence, the real challenge of establishing a pro-migrant worker regime in recent times is to bring the agents under the jurisdiction of the court in Nepal. The Gulf Visit Study Report, 2017 prepared and launched by the International Relation and Labour Committee of Legislature-Parliament of Nepal finds that solving the problems at home solves 80 percent of the problems concerning migrant workers in Nepal. Against this backdrop, this research study is intended to determine the ways and measures to curb the role of agents in the foreign employment and labour migration process of Nepal. It will further dig deeper into the regulatory mechanisms of Nepal and map out essential determinant behind the impunity of agents.

Keywords: foreign employment, labour migration, human rights, migrant workers

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Authors: Ogunlana Olarewaju Fatai, Kelani Fatai Adeshina

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The interplay of corruption and institutional quality determines how effective and efficient an economy progresses. An efficient institutional quality is a key requirement for economic stability. Institutional quality in most cases has been used interchangeably with Governance and these have given room for proxies that legitimized Governance as measures for institutional quality. A poorly-tailored institutional quality has a penalizing effect on corruption and economic growth, while defective institutional quality breeds corruption. Corruption is a hydra-headed phenomenon as it manifests in different forms. The most celebrated definition of corruption is given as “the use or abuse of public office for private benefits or gains”. It also denotes an arrangement between two mutual parties in the determination and allocation of state resources for pecuniary benefits to circumvent state efficiency. This study employed Barro (1990) type augmented model to analyze the nexus among corruption, institutional quality and economic growth in Nigeria using annual time series data, which spanned the period 1996-2019. Within the analytical framework of Johansen Cointegration technique, Error Correction Mechanism (ECM) and Granger Causality tests, findings revealed a long-run relationship between economic growth, corruption and selected measures of institutional quality. The long run results suggested that all the measures of institutional quality except voice & accountability and regulatory quality are positively disposed to economic growth. Moreover, the short-run estimation indicated a reconciliation of the divergent views on corruption which pointed at “sand the wheel” and “grease the wheel” of growth. In addition, regulatory quality and the rule of law indicated a negative influence on economic growth in Nigeria. Government effectiveness and voice & accountability, however, indicated a positive influence on economic growth. The Granger causality test results suggested a one-way causality between GDP and Corruption and also between corruption and institutional quality. Policy implications from this study pointed at checking corruption and streamlining institutional quality framework for better and sustained economic development.

Keywords: institutional quality, corruption, economic growth, public policy

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Authors: Mayada Mazher, Ahmed Moustafa, Ahmed Abdellatif

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Background: Autophagy is a eukaryotic, highly conserved catabolic process implicated in many pathophysiologies such as wound healing. Autophagy-associated genes serve as a scaffolding platform for signal transduction of macrophage polarization during the inflammatory phase of wound healing and tissue repair process. In the current study, we report a model for the interplay between autophagy-associated genes and macrophages polarization associated genes. Methods: In silico analysis was performed on 249 autophagy-related genes retrieved from the public autophagy database and gene expression data retrieved from Gene Expression Omnibus (GEO); GSE81922 and GSE69607 microarray data macrophages polarization 199 DEGS. An integrated protein-protein interaction network was constructed for autophagy and macrophage gene sets. The gene sets were then used for GO terms pathway enrichment analysis. Common transcription factors for autophagy and macrophages' polarization were identified. Finally, microRNAs enriched in both autophagy and macrophages were predicated. Results: In silico prediction of common transcription factors in DEGs macrophages and autophagy gene sets revealed a new role for the transcription factors, HOMEZ, GABPA, ELK1 and REL, that commonly regulate macrophages associated genes: IL6,IL1M, IL1B, NOS1, SOC3 and autophagy-related genes: Atg12, Rictor, Rb1cc1, Gaparab1, Atg16l1. Conclusions: Autophagy and macrophages' polarization are interdependent cellular processes, and both autophagy-related proteins and macrophages' polarization related proteins coordinate in tissue remodelling via transcription factors and microRNAs regulatory network. The current work highlights a potential new role for transcription factors HOMEZ, GABPA, ELK1 and REL in wound healing.

Keywords: autophagy related proteins, integrated network analysis, macrophages polarization M1 and M2, tissue remodelling

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Authors: Ankan Roy, Niharika, Samir Kumar Patra

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Anomalous nexus of complex topological assemblies and spatiotemporal epigenetic choreography at chromosomal territory may forms the most sophisticated regulatory layer of gene expression in cancer. Colon cancer is one of the leading malignant neoplasms of the lower gastrointestinal tract worldwide. There is still a paucity of information about the complex molecular mechanisms of colonic cancerogenesis. Bioinformatics prediction and analysis helps to identify essential genes and significant pathways for monitoring and conquering this deadly disease. The present study investigates and explores potential hub genes as biomarkers and effective therapeutic targets for colon cancer treatment. Colon cancer patient sample containing gene expression profile datasets, such as GSE44076, GSE20916, and GSE37364 were downloaded from Gene Expression Omnibus (GEO) database and thoroughly screened using the GEO2R tool and Funrich software to find out common 2 differentially expressed genes (DEGs). Other approaches, including Gene Ontology (GO) and KEGG pathway analysis, Protein-Protein Interaction (PPI) network construction and hub gene investigation, Overall Survival (OS) analysis, gene correlation analysis, methylation pattern analysis, and hub gene-Transcription factors regulatory network construction, were performed and validated using various bioinformatics tool. Initially, we identified 166 DEGs, including 68 up-regulated and 98 down-regulated genes. Up-regulated genes are mainly associated with the Cytokine-cytokine receptor interaction, IL17 signaling pathway, ECM-receptor interaction, Focal adhesion and PI3K-Akt pathway. Downregulated genes are enriched in metabolic pathways, retinol metabolism, Steroid hormone biosynthesis, and bile secretion. From the protein-protein interaction network, thirty hub genes with high connectivity are selected using the MCODE and cytoHubba plugin. Survival analysis, expression validation, correlation analysis, and methylation pattern analysis were further verified using TCGA data. Finally, we predicted COL1A1, COL1A2, COL4A1, SPP1, SPARC, and THBS2 as potential master regulators in colonic cancerogenesis. Moreover, our experimental data highlights that disruption of lipid raft and RAS/MAPK signaling cascade affects this gene hub at mRNA level. We identified COL1A1, COL1A2, COL4A1, SPP1, SPARC, and THBS2 as determinant hub genes in colon cancer progression. They can be considered as biomarkers for diagnosis and promising therapeutic targets in colon cancer treatment. Additionally, our experimental data advertise that signaling pathway act as connecting link between membrane hub and gene hub.

Keywords: hub genes, colon cancer, DNA methylation, epigenetic engineering, bioinformatic predictions

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Authors: Maria Krambia-Kapardis, Andreas Kapardis

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The paper discusses regulatory and legislative measures implemented by various nations in an effort to avert another financial crisis. More specifically, to address the financial crisis, the European Commission followed the practice of other developed countries and implemented a European Economic Recovery Plan in an attempt to overhaul the regulatory and supervisory framework of the financial sector. In 2010 the Commission introduced the European Systemic Risk Board and in 2011 the European System of Financial Supervision. Some experts advocated that the type and extent of financial regulation introduced in the European crisis in the wake of the 2008 crisis has been excessive and counterproductive. In considering how different countries responded to the financial crisis, global regulators have shown a more focused commitment to combat industry misconduct and to pre-empt abusive behavior. Regulators have also increased funding and resources at their disposal; have increased regulatory fines, with an increasing trend towards action against individuals; and, finally, have focused on market abuse and market conduct issues. Financial regulation can be effected, first of all, through legislation. However, neither ex ante or ex post regulation is by itself effective in reducing systemic risk. Consequently, to avert a financial crisis, in their endeavor to achieve both economic efficiency and financial stability, governments need to balance the two approaches to financial regulation. Fiduciary duty is another means by which the behavior of actors in the financial world is constrained and, thus, regulated. Furthermore, fiduciary duties extend over and above other existing requirements set out by statute and/or common law and cover allegations of breach of fiduciary duty, negligence or fraud. Careful analysis of the etiology of the 2008 financial crisis demonstrates the great importance of corporate governance as a way of regulating boardroom behavior. In addition, the regulation of professions including accountants and auditors plays a crucial role as far as the financial management of companies is concerned. In the US, the Sarbanes-Oxley Act of 2002 established the Public Company Accounting Oversight Board in order to protect investors from financial accounting fraud. In most countries around the world, however, accounting regulation consists of a legal framework, international standards, education, and licensure. Accounting regulation is necessary because of the information asymmetry and the conflict of interest that exists between managers and users of financial information. If a holistic approach is to be taken then one cannot ignore the regulation of legislators themselves which can take the form of hard or soft legislation. The science of averting a financial crisis is yet to be perfected and this, as shown by the preceding discussion, is unlikely to be achieved in the foreseeable future as ‘disaster myopia’ may be reduced but will not be eliminated. It is easier, of course, to be wise in hindsight and regulating unreasonably risky decisions and unethical or outright criminal behavior in the financial world remains major challenges for governments, corporations, and professions alike.

Keywords: financial crisis, legislation, regulation, financial regulation

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Authors: Maria Ashitko

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The Constitution of the Republic of Belarus is based on the principle of the unity of rights and obligations, including those of the child. The constitutional status of the child is aspecific system of constitutional elements established and guaranteed by the state through the current legislation and regulatory acts that ensure the special legal status of the child, his or her constitutional legal capacity, implementation of the principles of the constitutional and legal status of the child, constitutional rights of the child and their safeguards. Under the principles of the constitutional status of the child, we consider the general, normative, social-volitional rules of behavior established by the Constitution of the Republic of Belarus, laws and other regulatory acts that determine the content and social purpose of the legal status of the child. The constitutional and legal status of the child is characterized by the following special principles, which form a feature of the state legal system:1) Ensuring the interests of the child means providing for the child in accordance with his or her age, state of health, characteristics of development, life experience, family life, cultural traditions, ethnicity. 2) The principle of equal responsibility of both parents or their substitutes characterized by caring for the next generation as one of the priority tasks of the state and society, and all issues related to the implementation of children’s rights should be addressed at the constitutional level. 3) We would like to highlight such a special principle as the subprinciple of safeguards, which is the principle of ensuring the safety of the child. It is also worth noting that in legal studies, there is no relationship between safety and constitutional rights as general safeguards of individual rights and freedoms, and as special safeguards for the right to life. 4) The principle of justice is expressed by the fact that in modern conditions, the quality of life is determined not only by material wealth but also by the ability of the state to ensure the harmonization of social relations and social harmony on the basis of humanism and justice. Thus, the specificity of the constitutional status of the child is the age boundary between adulthood and minority; therefore, we propose to highlight the age characteristics of the child as an additional element. It is advisable to highlight such a special principle as the subprinciple of safeguards, which is the principle of ensuring the safety of the child.

Keywords: children’s rights, constitutional status, constitutional principles, constitutional rights

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Authors: Liya Abraham

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Eritrea is located along the Red Sea, north of the Horn of Africa, between Djibouti and Sudan and has a population of about 3.2 million as of 2010. It has six administrative regions; Anseba, Debub, Debubawi K’eyih Bahri, Gash-Barka, Ma'akel, and Semenawi K’eyih Bahri. Eritrea has got its independence in 1991 after 30 years war of liberation. The country is blessed with various medicinal flora and fauna, and marine and terrestrial biodiversity. Traditional Medicine (TM) has been an integral part of the Eritrean culture for centuries. So far, more than 19 TM modalities have been recognized, and are broadly categorized as; herbal, procedure-based and spiritual. Despite the availability of modern medicine to the majority of the population, TM is still widely practiced. The rationale behind widespread use is accessibility, affordability and cultural acceptability. Hence, TM is of great contribution to the Eritrean health care system. As a matter of fact, harnessing the potential contribution of effective and safe TM in order to attain Universal Health Coverage (UHC) has been emphasized in the WHO TM strategy 2014-2023. The Eritrean TM, however, was operating without regulation and reliable scientific justification behind its safety and efficacy. Thus, the Ministry of Health (MoH), in recognition of the role of TM in primary healthcare and safeguard public health, established a regulatory body for TM so-called as Traditional Medicine Unit (TMU) in 2012. The mission of the unit is to ensure rational TM use through an integrated health service delivery system and contribute to the country’s economic and social development. The unit has established its national TM policy in 2017. The activities of the unit are guided by the National TM Advisory Committee (TMAC), responsible for the provision of technical assistance and advisory role. Moreover, the Legal Framework and Code of Ethics and Practice which provide a legal basis for the regulation of TM have also been drafted. In recognition of the importance of TM research and development, the unit launched a nationwide TM survey in 2017 and had surveyed two zones (Gash-Barka and Debub). The findings of the survey were subjected to a research dissemination workshop and publication in international journals. Furthermore, TM-related adverse events reporting tool (Green Form) aiming to guide regulatory interventions and researches have been established by the unit, and ever since reports are flowing. The unit has also been offering training to THPs, pharmacy students and health care professionals regarding TM and its regulatory activities. In addition, as part of the establishment of the national medicinal plants' database and herbal monograph, more than 329 and 30 medicinal plants, have been compiled respectively. In conclusion, TM is still widely accepted and practiced in Eritrea. The TMU ever since its establishment is endeavoring to ensure the safety and efficacy of the TM, and its integration in the mainstream health service delivery system.

Keywords: efficacy, regulation, safety, traditional medicine, traditional medicine unit, universal health coverage

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Authors: Chrysthia Papacleovoulou

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The era of de-regulation, off-shore and tax haven jurisdictions, and shelf companies has come to an end. The usage of complex corporate structures involving trust instruments, special purpose vehicles, holding-subsidiaries in offshore haven jurisdictions, and taking advantage of tax treaties is soaring. States which raced to introduce corporate friendly legislation, tax incentives, and creative international trust law in order to attract greater FDI are now faced with regulatory challenges and are forced to revisit the corporate form and its tax treatment. The fiduciary services industry, which dominated over the last 3 decades, is now striving to keep up with the new regulatory framework as a result of a number of European and international legislative measures. This article considers the challenges to the company and the corporate form as a result of the legislative measures on tax planning and tax avoidance, CRS reporting, FATCA, CFC rules, OECD’s BEPS, the EU Commission's new transparency rules for intermediaries that extends to tax advisors, accountants, banks & lawyers who design and promote tax planning schemes for their clients, new EU rules to block artificial tax arrangements and new transparency requirements for financial accounts, tax rulings and multinationals activities (DAC 6), G20's decision for a global 15% minimum corporate tax and banking regulation. As a result, states are found in a race of over-regulation and compliance. These legislative measures constitute a global up-side down tax-harmonisation. Through the adoption of the OECD’s BEPS, states agreed to an international collaboration to end tax avoidance and reform international taxation rules. Whilst the idea was to ensure that multinationals would pay their fair share of tax everywhere they operate, an indirect result of the aforementioned regulatory measures was to attack private clients-individuals who -over the past 3 decades- used the international tax system and jurisdictions such as Marshal Islands, Cayman Islands, British Virgin Islands, Bermuda, Seychelles, St. Vincent, Jersey, Guernsey, Liechtenstein, Monaco, Cyprus, and Malta, to name but a few, to engage in legitimate tax planning and tax avoidance. Companies can no longer maintain bank accounts without satisfying the real substance test. States override the incorporation doctrine theory and apply a real seat or real substance test in taxing companies and their activities, targeting even the beneficial owners personally with tax liability. Tax authorities in civil law jurisdictions lift the corporate veil through the public registries of UBO Registries and Trust Registries. As a result, the corporate form and the doctrine of limited liability are challenged in their core. Lastly, this article identifies the development of new instruments, such as funds and private placement insurance policies, and the trend of digital nomad workers. The baffling question is whether industry and states can meet somewhere in the middle and exit this over-regulation frenzy.

Keywords: company, regulation, TAX, corporate structure, trust vehicles, real seat

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Authors: A. Md. Bayejid Hosen, B. M Zakir Hossain Howlader, C. Yearul Kabir

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Contamination of soil and agricultural products by heavy metals resulting from rapid industrial development has caused major concern. Dietary exposure to heavy metals has been associated with toxic and adverse health effects. The main threats to human health from heavy metals are associated with exposure to Pb, Cd and Hg. The aim of this study was to monitor the presence of heavy metals in cereals collected from different wholesale markets of Dhaka City. One hundred and sixty cereal samples were collected and analyzed for determination of heavy metals. Heavy metals were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). A total of six heavy metals– lead, chromium, cadmium, mercury, arsenic and antimony were estimated. The average concentrations of heavy metals in cereals fall within the safe limit established by regulatory organizations except for Pb (152.4 μg/100g) and Hg (15.13 μg/100g) which exceeded the safe limits. BARI gom-26 was the highest source of Pb (304.1 μg/100g) whereas Haski-29 rice variety contained the highest amount of Hg (60.85 μg/100g). Though all the cereal varieties contained approximately same amount of Cr the naizer sail varieties contained huge amount of Cr (171.8 μg/100g). Among all the cereal samples miniket rice varieties contained the least amount of heavy metals. The concentration of Cr (63.24 μg/100g), Cd (5.54 μg/100g) and As (3.26 μg/100g) in all cereals were below the safe limits. The daily intake of heavy metals was determined using the total weight of cereals consumed each day multiplied by the concentrations of heavy metals in cereals. The daily intake was compared with provisional maximum tolerable daily intake set by different regulatory organizations. The daily intake of Cd (23.0 μg), Hg (63.0 μg) and as (13.6 μg) through cereals were below the risk level except for Pb (634.0 μg) and Cr (263.1 μg). As the main meal of average Bangladeshi people is boiled rice served with some sorts of vegetables, our findings indicate that the residents of Dhaka City are at risk from Pb and Cr contamination. Potential health risks from exposure to heavy metals in self-planted cereals need more attention.

Keywords: contamination, dietary exposure, heavy metals, human health, ICP-MS

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Authors: Mengjia Zhi, Xingmei Wei, Xiang Gao, Shiyang Liu, Zhiran Huang, Li Yang, Jing Sun

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Background: To understand the consumption trend of opioid analgesics and the consumption adequacy of opioid analgesic treatment for moderate to severe pain in China, as well as the pain control level of China with international perspective. Importance: To author’s best knowledge, this is the first study in China to measure the adequacy of opioid analgesic treatment for moderate to severe pain considering disease pattern and with the standardized pain treatment guideline. Methods: A retrospective analysis was carried out to show the consumption frequency (daily defined doses, DDDs) of opioid analgesics and its trend in China from 2006 to 2016. Adequacy of consumption measure (ACM) was used to measure the number of needed morphine equivalents and the overall adequacy of opioid analgesic treatment of moderate to severe pain in China, and compared with international data. Results: The consumption frequency of opioid analgesics (DDDs) in China increased from 13,200,000 DDDs in 2006 to 44,200,000 DDDs in 2016, and showed an increasing trend. The growth rate was faster at first, especially in 2013, then slowed down, decreased slightly in 2015. The ACM of China increased from 0.0032 in 2006 to 0.0074 in 2016, with an overall trend of growth. The ACM level of China has been always a very poor level during 2006-2016. Conclusion: The consumption of opioid analgesics for the treatment of moderate to severe pain in China has always been inadequate. There is a huge gap between China and the international level. There are many reasons behind this problem, which lie in different aspects, including medical staff, patients and the public, health systems and social & cultural aspects. It is necessary to strengthen the training and education of medical staff and the patients, to use mass media to disseminate scientific knowledge of pain management, to encourage communications between doctors and patients, to improve regulatory system for the controlled medicines and the overall health systems, and to balance the regulatory goal for avoidance of abuse, and the social goal of meeting the increasing needs of the people for better life.

Keywords: opioid analgesics, adequate consumption measure, pain control, China

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Authors: M. Miljkovic, A. Urakpo, M. Simic-Koumoutsaris

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Benefit-risk assessment (BRA) is a valuable tool that takes place in multiple stages during a medicine's lifecycle, and this assessment can be conducted in a variety of ways. The aim was to summarize current BRA methods used during approval decisions and in post-approval settings and to see possible future directions. Relevant reviews, recommendations, and guidelines published in medical literature and through regulatory agencies over the past five years have been examined. BRA implies the review of two dimensions: the dimension of benefits (determined mainly by the therapeutic efficacy) and the dimension of risks (comprises the safety profile of a drug). Regulators, industry, and academia have developed various approaches, ranging from descriptive textual (qualitative) to decision-analytic (quantitative) models, to facilitate the BRA of medicines during the product lifecycle (from Phase I trials, to authorization procedure, post-marketing surveillance and health technology assessment for inclusion in public formularies). These approaches can be classified into the following categories: stepwise structured approaches (frameworks); measures for benefits and risks that are usually endpoint specific (metrics), simulation techniques and meta-analysis (estimation techniques), and utility survey techniques to elicit stakeholders’ preferences (utilities). All these approaches share the following two common goals: to assist this analysis and to improve the communication of decisions, but each is subject to its own specific strengths and limitations. Before using any method, its utility, complexity, the extent to which it is established, and the ease of results interpretation should be considered. Despite widespread and long-time use, BRA is subject to debate, suffers from a number of limitations, and currently is still under development. The use of formal, systematic structured approaches to BRA for regulatory decision-making and quantitative methods to support BRA during the product lifecycle is a standard practice in medicine that is subject to continuous improvement and modernization, not only in methodology but also in cooperation between organizations.

Keywords: benefit-risk assessment, benefit-risk profile, product lifecycle, quantitative methods, structured approaches

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