Regulatory Deficiencies Research Articles

Los concursos infraccionales en el derecho administrativo sancionador chileno

The paper analyzes the problems of concurrent contraventions in Chile. It makes a relation with the doctrine and penal norms, the sectorial regulations and the criteria of the jurisprudence. The bases of a system applicable to the competitions are proposed to attenuate the mathematical accumulation considering the existing regulatory deficiencies. 

Unveiling the guidance heterogeneity for genome-informed drug treatment interventions among regulatory bodies and research consortia

Pharmacogenomics and personalized medicine interventions hold promise to optimize drug treatment modalities and hence, improve the quality of life of the patients by minimizing the occurrence of adverse drug reactions and/or maximizing drug treatment efficacy. To this end, proper guidance for accurately prescribing the correct drug at the right dose is empowered by major regulatory bodies, namely the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and well-recognized research consortia, like the Clinical Pharmacogenetics Implementation Consortium (CPIC), that propose therapeutic recommendations after the thorough evaluation of the existing scientific evidence base. In this context, the consistency of these recommendations is crucial for smoothly integrating pharmacogenomics into the clinic. Here, we collected all of the important and clinically actionable pharmacogenomics information provided by the aforementioned renowned sources and documented it in order to assess potential similarities and, most importantly, differences. Our data show that the level of concordance regarding the guidance provided for the same drug-gene association pairs varies significantly, despite the fact that it all derives from a single evidence base. In particular, apart from the expected similarities in a number of association pairs, especially the ones related to cancer genomics, there are still major discrepancies that create confusion as to which guidance should be followed in order to properly inform drug prescribing. This regulatory deficiency calls for the fruitful engagement of the regulatory agencies involved with the contribution of other experts engaged in the field of pharmacogenomics in an effort to harmonize the existing arsenal of guidance for genome-informed drug prescription. The achievement of harmonization would in turn expedite bringing personalized medicine closer to clinical fruition.

Análisis comparativo de la legislación iberoamericana en materia de transparencia y derecho de acceso a la información

La implementación de la legitimidad constitucional para la credibilidad y confianza en los sistemas democráticos iberoamericanos se desarrolla a través de la transparencia legal e institucional. Su consolidación como derecho constitucional impide el menoscabo de las garantías de otros derechos fundamentales conexos como la participación o la libertad de información. El análisis de las deficiencias regulativas de la transparencia desde un prisma territorial, subjetivo, objetivo y con relación a los límites, plantea retos jurídicos a su aplicación en el contexto iberoamericano.

Factores principales de ineficacia de la ley de relaciones colectivas de trabajo en la región Tacna 2001-2015

El estudio ha permitido relacionar las variables dependiente e independiente en el contexto social de un periodo de tiempo extenso para determinar su comportamiento y correlación, planteándose el objetivo de determinar el grado de inflexión entre ambas variables que afecte significativamente el clima laboral colectivo en la ciudad de Tacna; así como de obtener información oficial y analizar comparativamente los efectos y características que plantea el cumplimiento de la normatividad vigente en materia de relaciones colectivas de trabajo en la región de Tacna. Se ha utilizado el método científico y dentro de él el método inductivo-deductivo. El tipo de investigación es cualitativo y el nivel explicativo de corte transversal. En cuanto al diseño es no experimental obteniéndose la información de la observación directa. La población del estudio es la referida a la ciudad de Tacna tomándose la muestra de las organizaciones sindicales de la región para determinar el comportamiento y grado de eficacia de la norma. Los instrumentos utilizados fueron la entrevista y cuestionario. El estudio concluye que entre las variables independientes de normatividad y relaciones colectivas débiles existe correlación con los efectos que ha tenido la crisis sindical en el Perú desde la década del noventa, ello porque las normas que regulan las Relaciones Colectivas de Trabajo no promueven el adecuado ejercicio del derecho colectivo de los trabajadores sino su debilitamiento. Se han podido establecer deficiencias normativas en cuanto al grado de cumplimiento de las recomendaciones de la Organización Internacional del Trabajo y a la ausencia de políticas de promoción de la negociación colectiva en el ámbito estatal, lo que ha generado consecuencias económico-sociales directas en la población sindicalizada y no sindicalizada. La modificación normativa en esta materia resulta entonces de urgente necesidad, presentando una primera propuesta.

A case of recurrent spontaneous parthenogenetic oocyte activation

Oocytes obtained during in vitro fertilization (IVF) cycles ideally are arrested in metaphase II (MII), which are characterized by the presence of a single polar body. They remain in arrest until after fertilization when time meiosis is resumed in a calcium-dependent manner. We present a case of a 23 year old gravida 0 with polycystic ovarian syndrome who presented for evaluation at our center after previously having failed two IVF cycles elsewhere. The patient subsequently underwent three controlled ovarian hyperstimulation cycles with either an antagonist or low dose luteal lupron down-regulation protocol. Vaginal oocyte retrieval (VOR) was performed 36 hours after administration of gonadotropin releasing hormone agonist (GnRHa) or human chorionic gonadotropin trigger. Cycle outcomes are demonstrated in Figure 1 . Oocytes were fertilized by intracytoplasmic sperm injection (ICSI) according to standard laboratory protocol. Embryos were cultured until day 7 of development. A substantial proportion of oocytes were noted to have one pronucleus (1PN) and two polar bodies (PB) at the time that the cumulus complex was denuded prior to ICSI ( Figure 2 ). The parthenogenetic oocytes were re-examined on the morning following VOR and were noted to have undergone cell division, with many that appeared similarly to cleavage stage embryos. In each cycle, there was complete embryo arrest prior to the blastocyst stage and no embryos were available for transfer. This case of recurrent parthenogenesis, accelerated cell division and complete developmental arrest highlights what potentially could be a rare genetic contribution to a cell-cycle regulatory deficiency. It has been suggested that defects in the c-mos/mitogen-activated protein kinase (MAPK) pathway in oocytes exhibit failure to arrest and premature activation ( 1 ). EMI2 is an additional regulatory factor that has been implicated in maintenance of arrest ( 2 ). It is unclear whether there is a failure of MII arrest due to functional deficiencies of MAPK and EMI2 or if there is an unidentified stimulus for escape which overrides these checkpoints. Attempts at fertilization of prematurely activated 1PNs have previously failed ( 3 ). Enhanced understanding of cell-cycle regulatory measures in oocytes and human preimplantation embryos may yield insight regarding diagnostic and therapeutic modalities for similar rare cases of spontaneous parthenogenesis.

Molecular Genetic Anatomy and Risk Profile of Hirschsprung’s Disease

BackgroundHirschsprung’s disease, or congenital aganglionosis, is a developmental disorder of the enteric nervous system and is the most common cause of intestinal obstruction in neonates and infants. The disease has more than 80% heritability, including significant associations with rare and common sequence variants in genes related to the enteric nervous system, as well as with monogenic and chromosomal syndromes.MethodsWe genotyped and exome-sequenced samples from 190 patients with Hirschsprung’s disease to quantify the genetic burden in patients with this condition. DNA sequence variants, large copy-number variants, and karyotype variants in probands were considered to be pathogenic when they were significantly associated with Hirschsprung’s disease or another neurodevelopmental disorder. Novel genes were confirmed by functional studies in the mouse and human embryonic gut and in zebrafish embryos.ResultsThe presence of five or more variants in four noncoding elements defined a widespread risk of Hirschsprung’s disease (48.4% of patients and 17.1% of controls; odds ratio, 4.54; 95% confidence interval [CI], 3.19 to 6.46). Rare coding variants in 24 genes that play roles in enteric neural-crest cell fate, 7 of which were novel, were also common (34.7% of patients and 5.0% of controls) and conferred a much greater risk than noncoding variants (odds ratio, 10.02; 95% CI, 6.45 to 15.58). Large copy-number variants, which were present in fewer patients (11.4%, as compared with 0.2% of controls), conferred the highest risk (odds ratio, 63.07; 95% CI, 36.75 to 108.25). At least one identifiable genetic risk factor was found in 72.1% of the patients, and at least 48.4% of patients had a structural or regulatory deficiency in the gene encoding receptor tyrosine kinase (RET). For individual patients, the estimated risk of Hirschsprung’s disease ranged from 5.33 cases per 100,000 live births (approximately 1 per 18,800) to 8.38 per 1000 live births (approximately 1 per 120).ConclusionsAmong the patients in our study, Hirschsprung’s disease arose from common noncoding variants, rare coding variants, and copy-number variants affecting genes involved in enteric neural-crest cell fate that exacerbate the widespread genetic susceptibility associated with RET. For individual patients, the genotype-specific odds ratios varied by a factor of approximately 67, which provides a basis for risk stratification and genetic counseling. (Funded by the National Institutes of Health.)

Magic realism: a Latin American paradigm for stem cell research & development?

Rigorous testing of cell therapies in South America struggles with emerging opportunities and regulatory deficiencies. As in other continents, these tend to be permissive with commercial opportunism but stifling for research. We describe a successful biotechnological entrepreneurship, born from within an academic institution, to foster science and promote translational research. Sustainability, however, requires a more complex niche, and realistic contributions from investors, state agencies, and legislators. An added level of complexity is required to enable multicentric studies. Herein we succinctly describe some of the most urgent challenges that the deployment of cell therapy faces in Chile. If this is truly an aspiration, fantasy should not be allowed to direct regulatory agents or legislators, and our Latin American Magic realism should remain within the realm of literary fiction.

Software Consistency Checking Method for Distribution Terminal based on Chaotic Map

Distribution terminal system software is the core carrier of its function realization and performance stability. In the process of development and operation and maintenance of distribution terminals, software versions are confusing and inconsistent with the archived versions due to technical upgrades, version management, and regulatory deficiencies. It makes some functions unable to operate normally, performance indicators can not be met, equipment on-line rate decreased, and seriously affecting the operation and maintenance and practicality of distribution automation system. In order to strengthen the software version control of distribution automation terminal equipment, the feature information of software version was extracted by analysing the executable files of terminal software, and then the priority was divided according to the feature information. The MD5 algorithm and CRC32 checking algorithm were used to calculate the comparison factor, which then was encrypted by using pseudo random code generated by Logistic chaotic map. The model and method of software version consistency detection for distribution terminal were established.

It Takes a Village: Civil Society Regulation of Employment Standards for Temporary Migrant Workers in Australian Horticulture

How can civil society actors address regulatory deficiencies in complex systems? The challenge of regulating employment standards in non-unionised industries is shared by many developed countries. In industries like horticulture, violation of minimum employment standards for vulnerable temporary migrant workers is widespread and state employment regulators struggle to enforce laws. This article examines the challenge at a system level incorporating a range of civil society stakeholders. It conceptualises a regional town and its surrounding horticulture-dependent economy and society as a complex system in which stakeholders face the challenge of reputational damage among temporary migrant farm workers, threatening future labour supply. This ‘tragedy of the commons’ was created by some stakeholders acting solely in their individual interests by underpaying and otherwise mistreating the workers. Using a qualitative approach including 30 interviews, focusing on a single farming region in Queensland, Australia, this article identifies the conditions in which civil society stakeholders in a horticulture system regulate employment standards through orienting and connecting with one another to advance both individual and shared interests.

Holistic Biodiversity Conservation in the Anthropocene: A Southern African Perspective

In the Anthropocene the loss of biodiversity is set to become increasingly critical. Our law and governance institutions have been unable to halt this worrying trend. One of the reasons for this regulatory deficiency is that global law and governance pertaining to biodiversity are fragmented. In response to the need for a greater integration of law and governance directed at the protection of an integrated biosphere and as a measure to counter fragmentation, we argue that global biodiversity law and governance should be based on the connectivity conservation approach. While the debate about connectivity could occur in various geographical contexts, we focus for our present purposes on regional biodiversity governance in Southern Africa. It is our central hypothesis that adopting a holistic approach to biodiversity conservation in this region might go a long way towards preventing the human encroachment on biodiversity that typifies the Anthropocene.

Фінансова інклюзія як чинник соціоекономічного розвитку

Paper dwells upon approaches to understanding the concept and role of financial inclusion. It is established that financial inclusion is one of the factors for economic development; the study of the role of financial inclusion among the factors for socio-economic development is substantiated. The evolution of the term “inclusion” has been traced from the area of social processes analysis at the social groups’ level, including various social relations, to the macroeconomic level. It has been revealed that a consistent definition of “financial inclusion” by key standards-setting institutions has been extended by financial market experts: interpretations of the term “financial inclusion” include its definition as “process”, “stage” (of development) or “state” (of development). Authors define the concept of financial inclusion as a process of interaction between financial market entities and financial services’ consumers, which, by providing equal access to financial services, offers a level of participation of financial services’ consumers in the financial relations, which contributes to the sustainability of financial institutions and increase of social welfare. There is an alternative view of the financial inclusion definition through its opposite concept of financial exclusion, which is either voluntary or forced, and is determined by four groups of reasons. It has been found that the most crucial is the need to reduce the fourth group of reasons, which are subject to compulsory exclusion, since this category of users is excluded from the financial system because of regulatory deficiencies or market barriers. Authors analyses consensus offered in the scientific literature regarding the three main aspects of financial inclusion: coverage, use and quality of financial services. Positive factors and risks of financial inclusion development, as well as negative aspects of financial exclusion are highlighted.

Tregopathies: Monogenic diseases resulting in regulatory T-cell deficiency

Tregopathies: Monogenic diseases resulting in regulatory T-cell deficiency

Metals in select beers commercially available in the US: Unmonitored sources of concerning exposure

Stemming from the need to inform US consumers about the potential health hazards originating from regulatory deficiencies and an inadequate capacity to conduct the complete screening of beverage products entering the US, this study aimed to answer two questions: (1) how do concerning metal concentrations of beers imported to the US market compare to those in US produced beers; and (2) do imported and domestic beers exhibit concerning metal concentrations below the existing US primary drinking water standards. To address this aim: (1) beers manufactured worldwide, which were commercially available on the US market were obtained; (2) the concentration of concerning metals in the beers was analyzed; and (3) data were examined and correlated to explore any US maximum contaminant level (MCL) exceedances and determine whether geographic or grain-related trends exist. The results showed that there are no significant differences between the concerning metal concentrations of imported vs. domestic beers in the US market. Some specific heavy metals, like arsenic, are present in both imported and domestic beers in concentrations that exceed the national primary drinking water standards MCLs. Although water quality may be a factor contributing to the elevated concentrations of concerning metals in beers, it is more likely that the grain ingredients are greater contributors to the observed trends.

Deficyty obowiązującej w prawie polskim regulacji w zakresie reklamy i innych technik marketingowych dotyczących produktów relewantnych dla ochrony karmienia piersią, ze szczególnym uwzględnieniem preparatów do początkowego żywienia niemowląt. Zarys problematyki

THE REGULATORY DEFICIENCIES OF POLISH REGULATION CONCERNING ADVERTISEMENT AND OTHER MARKETING TECHNIQUES RELATING TO PRODUCTS RELEVANT TO PROTECTION OF BREASTFEEDING, WITH SPECIAL REGARD TO THE INFANT FORMULAE. AN OUTLINE OF THE ISSUESThe aim of this article is to draw attention to the regulatory deficiencies of Polish regulation concerning advertisement and other marketing techniques related to products relevant to protection of breastfeeding, with special regard to infant formulas, and the evaluation of its effectiveness for breastfeeding protection. This regulation is non-transparent, heterogeneous and to a great extent unclear. It is also ineffective and insufficient for the protection of breastfeeding. It is much less rigorous than the standard established by the International Code of Marketing of Breast-Milk Substitutes i.e. WHO Code. The main conclusion is that irrespective of the need for improvement of the promotion of breastfeeding, including lactation education of medical staff and parents, legislative changes are necessary in the field of the marketing of food intended for infants and young children, feeding bottles and teats. The best solution would be the full implementation of the WHO Code including subsequent WHA resolutions.

Drivers and Consequences of Recurrent Conflicts between Farmers and Pastoralists in Kilosa and Mvomero Districts, Tanzania

Recurrent conflicts between farmers and pastoralists have brought significant impacts on both groups. In response to this situation, the government and other actors have taken several measures to mitigate such conflicts with little success. This paper examined drivers and consequences of recurrent conflicts between farmers and pastoralists in Kilosa and Mvomero districts. Covering a sample size of 203 respondents, data was collected using interview, documentary review, and focus group discussions. Collected data was analyzed using both qualitative and quantitative analysis. The findings revealed that weak governance structures associated with unethical behavior, regulatory deficiencies, socio-economic and environmental factors are responsible for the recurrence of conflicts between farmers and pastoralists. Consequently, the recurrent conflicts have resulted into major socio-economic impact that includes loss of lives and properties to both farmers and pastoralists. Drawing from conflict and conflict resolution theories, which advocates use of coercive power and participatory approaches to restore peace, respectively; this paper conclude that no single strategy fits all conflicts given the complexity in which such conflicts occurs. In the light of the results this paper recommends that the effective way to address farmers-pastoralists conflicts; actors should use both lenses of coercive and participatory approaches and the choice of appropriate strategy will depends on the context since no single approach fits all types of conflicts...

Human factors analysis and classification system for the oil and gas industry (HFACS-OGI)

The oil and gas industry has been beset with several catastrophic accidents, most of which have been attributed to organisational and operational human factor errors. The current HFACS developed for the aviation industry, cannot be used to simultaneously analyse regulatory deficiencies and emerging violation issues, such as sabotage in the oil and gas industry. This paper presents an attempt to improve the existing HFACS investigation tool and proposes a novel HFACS named the Human Factors Analysis and Classification System for the Oil and Gas Industry (HFACS-OGI). Results found the HFACS-OGI system to be suitable for categorising accidents, following the analysis of 11 accident reports from the US Chemical Safety Board (US CSB). The HFACS-OGI system moreover revealed some significant relationships between the different categories. Furthermore, the results indicated that failures in national and international industry regulatory standards would automatically create the preconditions for accidents to occur.

Explaining urban economic governance: The City of Macao

This paper traces the root causes of the Macao Special Administrative Region (SAR) government's inability to regulate the city's major economic issues. This regulatory deficiency can be partly attributed to the city's 500years of Portuguese colonial rule, although some of the problems have been caused by the casino boom, which began with the liberalization of Macao's gaming industry, and the government's failure to cope with ensuing dramatic changes. From a historical and institutional perspective, the author illustrates and analyzes the dynamic relationship between economic regulation and urban politics on a rapidly growing urban island facing various governance challenges.

A qualitative study of outsourced aeronautical maintenance: The case of Brazilian organizations

The outsourcing of aeronautical maintenance has been criticized for the quality of services offered. According to the literature, airlines have contracted repair stations to perform maintenance activities on their aircraft or parts when attempting to optimize resources (time, facilities, personnel, money). The attempt to reduce costs in maintenance activities and regulatory deficiencies can lead to maintenance management practices that could threaten equipment airworthiness. Therefore, the aim of this research was to evaluate whether outsourced aeronautical maintenance is aligned to common industrial maintenance management practices. To achieve this goal, qualitative exploratory research was conducted on Brazilian repair stations. For data collection, a questionnaire was developed based on seven factors related to aircraft maintenance. The data revealed that a mismatch exists between the best maintenance management practices and expected repair station performance.

Contra el viento: regulación, crisis social y cambio institucional en el Corredor Eólico del Istmo

En este artículo se analizan las fallas de regulación que agravan el conflicto entre los habitantes rurales y las empresas desarrolladoras del proyecto eólico de Gas Natural Fenosa (GNF), Bií Hioxo en el Istmo de Tehuantepec, Oaxaca. El objetivo de esta investigación es demostrar los efectos, principalmente sociales, así como las fallas institucionales que impiden una evolución normativa que proponga beneficios para las comunidades en las que habrán de instalarse estas empresas. Finalmente, se hace un análisis de cómo la reforma energética de 2013, podría resolver el conflicto citado sin que este cambio normativo lo haya logrado.

Inflammatory monocyte activation is associated with natural T regulatory cell deficiencies and co-occurs with cellular immune defects in major depressive disorder

Inflammatory monocyte activation is associated with natural T regulatory cell deficiencies and co-occurs with cellular immune defects in major depressive disorder