Journal articles on the topic 'Implied Authorization'

This study aimed at exploring legitimation strategies used by two members of the Indonesian Solidarity Party (or Partai Solidaritas Indonesia, abbreviated as PSI) in justifying their party leader’s controversial statement on the abandonment of Sharia Law. To do so, it employed critical discourse analysis (CDA) with Leeuwen’s legitimation strategies (2007, 2008) as its analytical tool. The data were obtained from two separate interviews with PSI members aired on two different Indonesian TV channels. The interviews were transcribed and translated. From this process, a 1.170-word corpus, from which the data were derived, was generated. The findings showed that moral evaluation is the most dominant legitimation strategy, followed by rationalization and authorization. In moral evaluation, abstraction occurs most often, followed by evaluation and analogy. In rationalization, theoretical rationalization is used more often than instrumental rationalization. Finally, in authorization, PSI utilized impersonal authority to reject the Sharia Law by referring to academic studies and legal documents which assess the law as being negative. Meanwhile, expert authority was used to build legitimation by reference to experts who support the negative effects of the law. This study implies the power of language to legitimize a controversial activity by using different linguistics strategies.

The paper presents an overview of the European and Italian Regulation on Orphan Medicinal Products (OMPs), along with some data on the OMPs licensed in the EU from 2000 to 2012. The EU legislation encourages pharmaceutical companies to develop drugs for rare diseases, so-called “orphan drugs”. The European Medicine Agency recognizes orphan drug status mainly on the basis of the prevalence of the disease (≤ 5/10,000), and potential benefit. Orphan status implies incentives for pharmaceutical companies. From 2000 up to 2012 890 candidate orphan drug designations received a positive opinion and the marketing authorization was granted to 72 OMPs corresponding to 80 different indications. Currently, 59 OMPs are available to Italian patients either because licensed to the market by the AIFA or included in the list of the L. 648/96. Despite of an encouraging regulation nearly all the currently estimated rare diseases still await treatments.

This article analyses the politics of medical translation and shows the complexity of knowledge production and circulation in the intercultural and multiethnic contexts of the Habsburg Monarchy. It argues that medical translations, including books, manuals, and brochures, were one of the important tools that contributed to the standardization of medical knowledge and practices in this region. Most of these books were authored by physicians and professors at medical schools in Vienna. They had a great influence upon medical knowledge and practices, thus Vienna was the authority approving what was taught and published. The usage of the same manuals and books implies that more or less the same medical knowledge was shared by the medical practitioners in the Habsburg Monarchy. The medical theories and practices transmitted reflect also the games of influence and power exercised by protomedici and professors at the Vienna University. It was a process of authorization and dissemination of knowledge from the “center” to the provinces.

The responsibility to protect was invoked by the United Nations (UN) Security Council in support of its authorization of a military intervention in Libya in 2011. In the wake of the intervention, Brazil approached the UN with a new doctrine: the responsibility while protecting. The responsibility while protecting implies a greater degree of caution on the part of the international community in its exercise of the responsibility to protect. Intentionally or unintentionally, Brazil mixes aspects of the jus ad bellum with aspects of the jus in bello in the new doctrine. This is controversial and potentially detrimental to both areas of law. An additional layer of limitations on the use of armed force in multinational peace operations is introduced beyond the existing restrictions on warfare following from international humanitarian law. A lack of clarity pertaining to the use of force and to the respective roles of the Security Council and the General Assembly in this respect in the exercise of the responsibility to protect contribute to making the responsibility while protecting seem increasingly enigmatic. Interpreted constructively, however, the responsibility while protecting simply urges the international community to follow international law. This would be good.

E-commerce implies an electronic purchasing and marketing process online by using typical Web browsers. As e-commerce is quickly developing on the planet, particularly in recent years, many areas of life are affected, particularly the improvement in how individuals regulate themselves non-financially and financially in different transactions. In electronic payment or e-commerce payment, the gateway is a major component of the structure to assure that such exchanges occur without disputes, while maintaining the common security over such systems. Most Internet payment gateways in e-commerce provide monetary information to customers using trusted third parties directly to a payment gateway. Nonetheless, it is recognized that the cloud Web server is not considered a protected entity. This article aims to develop an efficient and secure electronic payment protocol for e-commerce where consumers can immediately connect with the merchant properly. Interestingly, the proposed system does not require the customer to input his/her identity in the merchant’s website even though the customer can hide his/her identity and make a temporary identity to perform the service. It has been found that our protocol has much improved security effectiveness in terms of confidentiality, integrity, non-repudiation, anonymity availability, authentication, and authorization.

Purpose The purpose of this paper is to propose cold spraying and laser cladding processes as alternatives to cadmium and chromium electroplating, respectively. There are many substances or chemicals within the coating technology that can be identified as substances of very high concern because of their carcinogenic or mutagenic nature. Cadmium and chromium undoubtedly belong to these items and are the basic constituents of electrolytic coating processes. Finding an alternative and adapting to the existing restrictions of the usage of such hazardous products stands for many to be or not to be in the market. Design/methodology/approach The research work was focused on down selecting the appropriate materials, producing the coating samples, testing their properties and optimizing process parameters by statistical method. On the one hand, the high-pressure cold spray system and spraying of the titanium coating on the landing gear component, and on the other hand, the high-energy laser cladding facility and the wear resistant cobalt-based coating deposited onto the shock absorber piston. Substrates of these two applications were made of the same material, 4330 – high-strength low-carbon steel. Findings Meeting the requirements of Registration, Evaluation, Authorization and Restriction of Chemicals implies undertaking research and implementation work to identify alternative processes. The work provides the technical characteristics of new coatings justifying application readiness of the researched processes. Originality/value Taguchi’s design of experiment method was combined with the measurements and analysis of specified coating properties for the optimization of the cold spray process parameters. There is also laser cladding process development presented as a fast rate technology generating coatings with the unique properties.

e14034 Background: Cancer patients under cytotoxic treatment with fever used to have an average time of antibiotics administration of 11h (median 3h43min) when admitted and identified at the Emergency Room Service in the third level Central University Hospital of Asturias. International guidelines recommend antibiotic administration in the first hour: the so called “Golden Hour”. This delay implies an increase in patient morbidity as well as the cost of managing this complication. Methods: Data was collected from our electronic registry after proper authorization and corresponding anonymization. Pareto and fishbone diagrams were built to point out the possible causes and to stratify them in related subgroups. We measured: Number of visits to ER with fever and Number of inpatients with Febrile Neutropenia diagnosis, Time from the admission to antibiotic administration, Average stay of inpatients with Febrile Neutropenia diagnosis. A protocol associated to electronic tools and validated international scores was designed for patients at Febrile Neutropenia risk and launched on March 2019. Results: 66 patients were included since January 2018. Baseline data showed that the median time to antibiotics indication was 3h50min (average 4h38min) with a median delay of 18min to the administration (average 1h06min), a median of 3h54min (average 10h09min) time to antibiotic administration. When the protocol was activated, median time to antibiotic indication was 30min (average (1h08min) with a median 41min (average 40min) delay in administration, and a median of 1h30min (average 1h42min) time to antibiotic administration. Those with activation of the protocol had average length of stay of 1d13h40min vs. 5d11h18min in those to whom this protocol was not applied. Conclusions: A continuous evaluation effort and the design of appropriate protocols and interventions will increase the efficiency of the oncology patient care process with febrile neutropenia, by reducing unnecessary variability and costs.

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

The relevance of the research. The article is devoted to the study of the specifics of operational-search measures aimed at disclosing criminal acts that infringe on the constitutional rights and freedoms of man and citizen. The study of the methods used in order to disclose crimes of this category as well as other features of the ongoing operational-search actions, contributes to a more rational work of the operational units of the Internal Affairs Directorate. Articulation of issue. Activity of law enforcement agencies on solving crimes that infringe on the constitutional rights and freedoms of a person and a citizen, in addition to the procedural form, implies the use of operational-search forces, means and methods. The key elements of their application are the subject of discussions regarding their normative regulation, as well as issues of the admissibility of overt and covert methods, technical means, the use of operatively significant information, the admissibility of using the results of operational-search measures in criminal process. Objectives and methodology. The purpose of the study is to identify the characteristic features of operational-search measures carried out in order to disclose crimes against the constitutional rights and freedoms of man and citizen. The methodological basis of this research is represented by the general scientific system method, empirical methods of description and interpretation, as well as methods of legal research. Results and key findings. Crimes against constitutional human and civil rights and freedoms are characterized as socially dangerous acts, carefully hidden from law enforcement agencies. In order to effectively disclose these crimes, a significant role is assigned to operational-search measures with focus on the use of various technical means, a wide selection of sources of operational significant information, the use of overt and covert techniques and methods. However, these criminal acts imply operational-search measures that require departmental authorization, which makes it possible to effectively identify phenomena and processes that are carefully hidden from the public.

Введение. С функционально-стилистических позиций рассматривается смысловая структура научного текста в аспекте выражения в нем нового знания. Понятие политекстуальности научного текста. С учетом экстралингвистической обусловленности разноаспектным содержанием познавательной деятельности научный текст определяется как система субтекстов. Под субтекстом понимается структурно-смысловая единица текста, репрезентирующая определенный аспект эпистемической ситуации – онтологический, методологический, аксиологический, коммуникативно-прагматический. В монографиях и статьях по разным наукам зафиксированы следующие типы субтекстов: субтекст нового знания, субтекст старого знания, методологический субтекст, субтекст оценки, субтекст авторизации, субтекст адресации, периферийный субтекст. Взаимодействие субтекстов обусловливает особое качество смысловой структуры научного текста – политекстуальность. Политекстуальность предполагает иерархические отношения между субтекстами. Наибольшей коммуникативной значимостью обладают два субтекста – субтекст нового знания и методологический субтекст, которые репрезентируют онтологическое содержание нового знания, заключенное в форму понятий, гипотез, теорем, доказательств и др. Остальные субтексты являются дополнительными и формируют эпистемический контекст нового знания. Характеристика субтекста нового знания. Субтекст нового знания является стержнем смысловой структуры научного текста. Развертывание данного субтекста эксплицирует динамику научно-познавательной деятельности автора, представленную последовательностью этапов получения нового знания в составе проблемной ситуации, проблемы, идеи или гипотезы, аргументации, вывода. Благодаря субтексту нового знания содержание каждого из этапов получает речевую репрезентацию. В научной коммуникации сформировался стилистический стандарт субтекста нового знания, включающего обоснование проблемы или постановку задачи, характеристику изучаемого объекта, представление идеи или гипотезы, определение понятий, аргументацию или доказательство гипотезы, экспликацию результатов и выводов. Рассматриваются различные варианты развертывания субтекста нового знания в текстах по лингвистике, математике, физике, химии, философии. Особое внимание уделяется анализу композиционной структуры субтекста нового знания в авторефератах диссертаций. Репрезентация нового знания в этом жанре «зеркально» отражает все этапы познавательной деятельности автора. Заключение. Интерпретация смысловой структуры научного текста как политекстуального целого с доминирующей ролью субтекста нового знания позволяет обобщенно представить типовую стилистико-речевую организацию научного текста. Introduction. From the functional-stylistic positions, the semantic structure of the scientific text is considered in the aspect of the expression of new knowledge in it. Results and discussion. Taking into account the extralinguistic conditionality of the diverse content of cognitive activity, a scientific text is defined as a system of subtexts. A subtext is a structural and semantic unit of a text that represents a certain aspect of an epistemic situation – ontological, methodological, axiological, communicative and pragmatic. The following types of subtexts are recorded in monographs and articles on various sciences: the new knowledge subtext, the old knowledge subtext, the methodological subtext, the evaluation subtext, the authorization subtext, the addressing subtext, and the peripheral subtext. The interaction of subtexts determines a special quality of the semantic structure of a scientific text – polytextuality. Polytextuality implies hierarchical relationships between subtexts. Two subtexts have the greatest communicative significance – the new knowledge subtext and the methodological subtext. It is these subtexts that represent the ontological content of the new knowledge, enclosed in the form of concepts, hypotheses, theorems, proofs, etc. Other subtexts form the epistemic context of the new knowledge. The subtext of new knowledge is the core of the semantic structure of a scientific text. The deployment of this subtext explicates the dynamics of scientific and cognitive activity of the author, represented by a sequence of stages of obtaining new knowledge. The cognitive stages include: problem situation, problem, idea or hypothesis, argument, conclusion. Due to the subtext of the new knowledge, the content of each of these stages receives a speech representation. In scientific communication has formed new knowledge stylistic standard, comprising the following composition units: problem or problem statement, characteristics of the studied object, a representation of the ideas or hypotheses, definition of concepts, reasoning or prove the hypothesis, explication of the results and conclusions. Variants of the deployment of the new knowledge subtext in academic texts on linguistics, mathematics, physics, chemistry, and philosophy are considered. Special attention is paid to the analysis of the compositional structure of the new knowledge subtext in the dissertation abstracts. The representation of new knowledge in this genre “mirrors” all stages of the author’s cognitive activity. Conclusion. Interpretation of the semantic structure of a scientific text as a polytextual structure with the dominant role of the subtext of new knowledge allows us to generalize the typical stylistic and speech organization of a scientific text.

Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare public and household healthcare expenditures in Bulgaria during the period 2015–2019, as well as present the major cost-containment measures implied by the government and their probable influence on the overall health care cost. Regulatory analysis of the endorsed cost-containment measures, budget analysis of public and household health care expenditures, and their extrapolations were performed. The regulatory analysis reveals that a large number of measures are introduced and valid until January 2021, considering pharmaceuticals, medical devices, and negotiations between the National Health Insurance Fund (NHIF) and Marketing authorization holders (MAHs). NHIF costs due to pharmaceuticals, food supplements, and medical devices are rising from 2015 to 2019. The overall health expenditures average per household and the average per person also grow in this period. The cost extrapolation reveals that an increase in 3-year periods is expected. Despite the implementation of variety of cost-containment measures in Bulgaria, such as HTA, ERP, discounts, and annual negotiations, The National Health Insurance Fund's (NHIF) spending on pharmaceuticals continues to rise in recent years, and further increases are expected in the next 3 years. The average expenditure per household and per person also increased, which confirms the global trend of rising medicine and outpatient services value.

AbstractThe article explores the extent to which the Security Council has the legal authority to authorize regional (defence) organizations to enforce military measures on its behalf. In the process it identifies Article 53(1) of the Charter, as well as Articles 42 and 48(2) as the clauses that could facilitate such action. Whereas the first enables enforcement action between the regional organization and its members, the latter two allow for the military utilization of regional organizations outside of their territory and/or against non-members, as well as the military utilization of other organizations such as regional defence organizations. Thereafter, it explains how the centralization of the use of force within the Charter structure requires the Security Council to remain in overall control of the authorization. This factor, in combination with the `opt-in' character of Chapter VII decisions, necessitates the explicit and prior nature of the authorization. In addition, it implies that authorizations that are not subjected to an explicit time limit and from which no functional limitation can be derived, will only remain legal as long as they are supported by all five permanent members of the Security Council. The potential implications of these principles are illustrated with reference to the practise of Security Council with respect to ECOWAS in Liberia and Sierra Leone, as well as NATO in former Yugoslavia.

AbstractThe novel coronavirus disease 2019 (COVID-19) has infected more than 100 million people globally within the first year of the pandemic. With a death toll surpassing 500,000 in the United States alone, containing the pandemic is predicated on achieving herd immunity on a global scale. This implies that at least 70-80 % of the population must achieve active immunity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), either as a result of a previous COVID-19 infection or by vaccination against SARS-CoV-2. In December 2020, the first two vaccines were approved by the FDA through emergency use authorization in the United States. These vaccines are based on the mRNA vaccine platform and were developed by Pfizer/BioNTech and Moderna. Published safety and efficacy trials reported high efficacy rates of 94-95 % after two interval doses, in conjunction with limited side effects and a low rate of adverse reactions. The rapid pace of vaccine development and the uncertainty of potential long-term adverse effects raised some level of hesitation against mRNA vaccines in the global community. A successful vaccination campaign is contingent on widespread access to the vaccine under appropriate storage conditions, deployment of a sufficient number of vaccinators, and the willingness of the population to be vaccinated. Thus, it is important to clarify the objective data related to vaccine safety, including known side effects and potential adverse reactions. The present review was designed to provide an update on the current state of science related to the safety and efficacy of SARS-CoV-2 mRNA vaccines.

Abstract Issue Innovative contracting models are developed to ease price-setting negotiations in case an extremely expensive drug has not proven sufficient efficiency in clinical trials. As disruptive HIV treatments are expected in the near future, French patient organizations evaluated the ability of these innovative contracts to ensure accessible medicines at a fair price. Description Performance-based schemes condition prices paid by the State to the efficiency of the medicine observed through real-world data. In France, thirteen performance-based contracts have been concluded between 2008 and 2015. They are presented as a triple solution: innovative treatments are available to patients, manufacturers access markets, and states ensure healthcare within limited budgets. Establishing the added value of these models implies determining if they allow rapid access to treatments with substantial savings for payers, while ensuring rigorous price and cost transparency. Results Performance-based contracts indeed ensure patient access to treatments, but other mechanisms (such as temporary use authorizations) already serve this purpose. Regarding expenditure reduction however, these schemes have not proven their worth. The Court of Auditors' evaluation showed they do not generate substantial savings, as final prices correspond to those that would have applied with the European price guarantee. Lastly, as contracts are protected by business secrecy, the public cannot access neither to actual prices negotiated by payers, nor the amount of public investment that have been used for the research and development of the drug. Lessons The derogatory nature of performance contracts invites us to consider them on a case-by-case basis if ensuring access to a specific innovation is necessary. These contracts are certainly innovative, but they cannot be presented as technologies providing access at a fair price. Finally, their contractual and derogatory nature raises serious transparency issues. Key messages Performance-based contracts should be considered as alternatives to existing administrative channels provided that they lead to substantial savings and are drawn up in full transparency. Patient organizations need to assess innovative schemes such as performance-based contracting to ensure access to treatments without undermining historical struggles for fair and transparent pricing.