970 resultados para Regulatory framework


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This Practical Note examines the nascent micro-insurance sector in West Bengal, paying particular attention to the corporate- NGO partnership model for micro-insurance distribution,which has been enabled by India's unique regulatory framework. We challenge the popularconstruction of this model as a 'win - win' for all parties by analysing conflicting understandings of micro-insurance schemes and their purposes by insurance companies, NGOs, and poorvillagers. The article also considers the role of the specific political context of West Bengal inconstricting corporate- NGO micro-insurance

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This is the report of the first workshop on Incorporating In Vitro Alternative Methods for Developmental Neurotoxicity (DNT) Testing into International Hazard and Risk Assessment Strategies, held in Ispra, Italy, on 19-21 April 2005. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and jointly organized by ECVAM, the European Chemical Industry Council, and the Johns Hopkins University Center for Alternatives to Animal Testing. The primary aim of the workshop was to identify and catalog potential methods that could be used to assess how data from in vitro alternative methods could help to predict and identify DNT hazards. Working groups focused on two different aspects: a) details on the science available in the field of DNT, including discussions on the models available to capture the critical DNT mechanisms and processes, and b) policy and strategy aspects to assess the integration of alternative methods in a regulatory framework. This report summarizes these discussions and details the recommendations and priorities for future work.

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Nanotechnology encompasses the design, characterisation, production and application of materials and systems by controlling shape and size at the nanoscale (nanometres). Nanomaterials may differ from other materials because of their relatively large specific surface area, such that surface properties become particularly important. There has been rapid growth in investment in nanotechnology by both the public and private sectors worldwide. In the EU, nanotechnology is expected to become an important strategic contributor to achieving economic gain and societal and individual benefits. At the same time there is continuing scientific uncertainty and controversy about the safety of nanomaterials. It is important to ensure that timely policy development takes this into consideration. Uncertainty about safety may lead to polarised public debate and to business unwillingness to invest further. A clear regulatory framework to address potential health and environmental impacts, within the wider context of evaluating and communicating the benefit-risk balance, must be a core part of Europe's integrated efforts for nanotechnology innovation. While a number of studies have been carried out on the effect of environmental nanoparticles, e.g. from combustion processes, on human health, there is yet no generally acceptable paradigm for safety assessment of nanomaterials in consumer and other products. Therefore, a working group was established to consider issues for the possible impact of nanomaterials on human health focussing specifically on engineered nanomaterials. This represents the first joint initiative between EASAC and the Joint Research Centre of the European Commission. The working group was given the remit to describe the state of the art of benefits and potential risks, current methods for safety assessment, and to evaluate their relevance, identify knowledge gaps in studying the safety of current nanomaterials, and recommend on priorities for nanomaterial research and the regulatory framework. This report focuses on key principles and issues, cross-referencing other sources for detailed information, rather than attempting a comprehensive account of the science. The focus is on human health although environmental effects are also discussed when directly relevant to health

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Summary and conclusion: One of the main challenges facing the Swiss health care system remains continued fragmentation as a consequence of the federal structure and the division of responsibilities. This constitutes a major barrier for the implementation of a nationwide public health strategy and a more rational organization of health care. Much of the health reform agenda during the past decade was driven by cost-containment efforts. Despite the absence of a national regulatory framework targeting prevention and care of chronic diseases, national strategies and programmes have been developed within a growing recognition of the need to address chronic disease in the health care system. In addition, several small-scale pilot and preliminary structured care programmes have been implemented in selected localities. The latter are however still too few and limited in scope to cover the needs of the majority of patients with chronic diseases residing in Switzerland. Given the continued high satisfaction with the system among health care users, of around 80%, pressure to actually initiate larger scale changes might not yet be sufficiently strong.

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After the restructuring process of the power supply industry, which for instance in Finland took place in the mid-1990s, free competition was introduced for the production and sale of electricity. Nevertheless, natural monopolies are found to be the most efficient form of production in the transmission and distribution of electricity, and therefore such companies remained franchised monopolies. To prevent the misuse of the monopoly position and to guarantee the rights of the customers, regulation of these monopoly companies is required. One of the main objectives of the restructuring process has been to increase the cost efficiency of the industry. Simultaneously, demands for the service quality are increasing. Therefore, many regulatory frameworks are being, or have been, reshaped so that companies are provided with stronger incentives for efficiency and quality improvements. Performance benchmarking has in many cases a central role in the practical implementation of such incentive schemes. Economic regulation with performance benchmarking attached to it provides companies with directing signals that tend to affect their investment and maintenance strategies. Since the asset lifetimes in the electricity distribution are typically many decades, investment decisions have far-reaching technical and economic effects. This doctoral thesis addresses the directing signals of incentive regulation and performance benchmarking in the field of electricity distribution. The theory of efficiency measurement and the most common regulation models are presented. The chief contributions of this work are (1) a new kind of analysis of the regulatory framework, so that the actual directing signals of the regulation and benchmarking for the electricity distribution companies are evaluated, (2) developing the methodology and a software tool for analysing the directing signals of the regulation and benchmarking in the electricity distribution sector, and (3) analysing the real-life regulatory frameworks by the developed methodology and further develop regulation model from the viewpoint of the directing signals. The results of this study have played a key role in the development of the Finnish regulatory model.

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Nanotechnology developments continue to be produced at exponential rates for a wide and diverse range of applications. In this paper was done a study of technological forecasting in nanotechnology applied to health, based on information drawn in Brazil from 1991 to 2010. The longitudinal evolutions of the number of patent applications, their topics, and their respective patent families have been evaluated for the total global activity. There were obtained 1352 patent applications in this period. It were analyzed the legal nature of the depositors, the year of deposit, depositors' home countries and processes. It has been a goal subsidizes the policy-makers to adapt and modernize the regulatory framework on nanotechnology and risks involving health as a strategic area in the politics of Science.

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The renewable energy industry in Zambia is poised for growth and offers many possibilities for Finnish firms willing to enter the market. The Zambian government’s deliberate policy measures aim at attracting foreign direct investment (FDI) into this sector. This study rationalises that this could be the pull factor for Finnish firms. The thesis gives an overview of the industry and investigates an appropriate mode of entry, basing its arguments on the comparison analysis of the two economies with the use of the world forum’s stages of economic development as a framework. The theoretical part of the study examines internationalisation theories, entry mode choice and factors influencing the choice. The multiple case study approach is implored, analysing four case companies from Finland with the use of extant literature on internationalisation relevant to the study. The research design involves the use of documentation, secondary data, interviews and observation. The results of the case analyses show that the Finnish firm’s most preferred entry mode initially is exporting because it is considered to be less risky. Additionally, the findings also reveal that the selection of a suitable mode of entry is dependent on the firms’ size, orientation and international experience and could therefore be considered to be subjective. Paramount is the act of gaining market knowledge. The study shows that only hydro-electrical, solar energies and biomass are by far the most used and known forms of renewable energy in Zambia, while other alternative sources still remain un-exploited thus highlighting a growth potential. However, policy formulation and the regulatory framework in the renewable energy sector were found to be wanting.

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The research towards efficient, reliable and environmental-friendly power supply solutions is producing growing interest to the “Smart Grid” approach for the development of the electricity networks and managing the increasing energy consumption. One of the novel approaches is an LVDC microgrid. The purpose of the research is to analyze the possibilities for the implementation of LVDC microgrids in public distribution networks in Russia. The research contains the analysis of the modern Russian electric power industry, electricity market, electricity distribution business, regulatory framework and standardization, related to the implementation of LVDC microgrid concept. For the purpose of the economic feasibility estimation, a theoretical case study for comparing low voltage AC and medium voltage AC with LVDC microgrid solutions for a small settlement in Russia is presented. The results of the market and regulatory framework analysis along with the economic comparison of AC and DC solutions show that implementation of the LVDC microgrid concept in Russia is possible and can be economically feasible. From the electric power industry and regulatory framework point of view, there are no serious obstacles for the LVDC microgrids in Russian distribution networks. However, the most suitable use cases at the moment are expected to be found in the electrification of remote settlements, which are isolated from the Unified Energy System of Russia.

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Operational excellence of individual tramp shipping companies is important in today’s market, where competition is intense, freight revenues are modest and capital costs high due to global financial crisis, and tighter regulatory framework is generating additional costs and challenges to the industry. This thesis concentrates on tramp shipping, where a tramp operator in a form of an individual case company, specialized in short-sea shipping activities in the Baltic Sea region, is searching ways to map their current fleet operations and better understand potential ways to improve the overall routing and scheduling decisions. The research problem is related to tramp fleet planning where several cargoes are carried on board at the same time, which are here systematically referred to as part cargoes. The purpose is to determine the pivotal dimensions and characteristics of these part cargo operations in tramp shipping, and offer both the individual case company and wider research community better understanding of potential risks and benefits related to utilization of part cargo operations. A mixed method research approach is utilized in this research, as the objectives are related to complex, real-life business practices in the field of supply chain management and more specifically, maritime logistics. A quantitative analysis of different voyage scenarios is executed, including alternative voyage legs with varying cost structure and customer involvement. An on-line-based questionnaire designed and prepared by case company’s decision group again provides desired data of predominant attitudes and views of most important industrial customers regarding the part cargo-related operations and potential future utilization of this business model. The results gained from these quantitative methods are complied with qualitative data collection tools, along with suitable secondary data sources. Based on results and logical analysis of different data sources, a framework for characterizing the different aspects of part cargo operations is developed, utilizing both existing research and empirical investigation of the phenomenon. As conclusions, part cargoes have the ability to be part of viable fleet operations, and even increase flexibility among the fleet to a certain extent. Naturally, several hinderers for this development is recognized as well, such as potential issues with information gathering and sharing, inefficient port activities, and increased transit times.

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The privileges arising from patent protection on pharmaceutical products often prevent the full realization of the right to health, especially in developing countries with scarce resources. This thesis first identifies the international agreements that have established the right to health in international law, obligations and violations associated with it, the problems encountered in the implementation of human rights on the field, compared with the implementation and sanctions associated with economic rights from the World Trade Organization regulatory framework. A comparative study of the legislative frameworks of both developed and developing countries will reveal to what extent Canada, the United States, the European Union, Brazil, India, and South Africa conformed with patent protection exceptions arising from international patent law to protect public health. Finally, the author identifies the crucial indicators that need to be considered in order to assess the conformity of a given approach with the right to health, before he underscores the temporary character of the relevant WTO measures, and the future stakes concerning an increased access to essential medicines.

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This article examines the current legal regime applicable to animal-human combinations under the Assisted Human Reproduction Act (Canada). The Act prohibits as criminal offences the use of non-human reproductive material in humans, the use in humans of human reproductive material previously transplanted into a non-human life form, the creation of chimeras made from human embryos, and the creation for reproductive purposes of human/non-human hybrids. Additional animal-human combinations, such as transgenic life forms, may be regulated pursuant to section 11 of the Act in the future. The underlying concerns of the Act in establishing this regime appear to be the protection of human health and safety, human dignity and individuality, and the human genome. The Act seems calibrated to prohibit the creation of animal-human combinations that are currently unsafe and scientifically and ethically problematic, while leaving open the possibility of regulating other such combinations with more immediate scientific potential, although these also raise ethical questions. Currently, certain differences subsist in Canada between what is permissible for researchers and institutions funded by federal agencies and those in privately funded research. The development of the regulatory framework under the Act will reveal how freedom of research will be balanced against the need for scientifically valid and ethically justifiable research, and whether these differences will continue to apply.

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Dans un contexte d'instabilité économique, force est de constater que les remises en question du libéralisme économique s'intensifient, mettant ainsi l'accent sur l'importance de la réglementation pour la protection des investisseurs ainsi que l'efficience des marchés financiers. Souvent associés aux conséquences d'un manque d'encadrement, les fonds de couverture représentent des cibles de choix pour ceux qui cherchent à expliquer l'effondrement majeur des marchés, tout en prônant un interventionnisme accru des autorités gouvernementales. Pour mieux comprendre les tenants et aboutissants de cette industrie, la présente étude propose une vue d'ensemble des caractéristiques fondamentales des fonds de couverture, tant sous l'angle de leur structure organisationnelle que de leur encadrement réglementaire. À cet égard, il importe de jauger les principaux enjeux découlant des règles applicables à l'administration d'un fonds, particulièrement sur le plan de la transparence informationnelle et au niveau de la gouvernance interne. Ces deux éléments constituant les pierres angulaires de la présente analyse, notre étude offrira finalement une réflexion sur l'approche réglementaire à privilégier, et ce, en tenant compte des particularités des fonds de couverture. Dans un même ordre d'idées, le rôle des divers intermédiaires professionnels sera abordé afin d'élargir notre compréhension de la question sous étude. L'objet de cette étude n'est pas d'apporter une solution complète et définitive à ces enjeux, mais bien d'offrir des pistes de réflexions pouvant servir de balises à une étude subséquente de la question, laquelle devra par ailleurs tenir compte du rôle assumé par les fonds de couverture ainsi que du statut particulier qu'ils occupent sur les marchés financiers.

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Les raves sont des événements festifs dédiés à la musique techno et à la danse qui se distinguent des autres lieux de rassemblement tels que les bars et les discothèques notamment par le fait qu’ils se déroulent toute la nuit dans un lieu aménagé pour l’occasion et qu’il n’y a généralement pas de vente d’alcool. La consommation de drogues de synthèse telles que l’ecstasy et les speeds y est toutefois largement répandue. La tenue de ces rassemblements pose une série de problèmes du point de vue des autorités policières, tels que la présence de trafiquants de drogues ainsi que la sécurité des lieux où se déroulent les raves. Dans le contexte particulier de ces événements, les pratiques de contrôle social sont soumises à un certain nombre d’ambiguïtés. Le but général de l’étude est de permettre une compréhension de la façon dont se déterminent et s’appliquent les règles qui visent à encadrer la tenue de ce type de rassemblements. Trois objectifs spécifiques sont poursuivis, soit 1) de comprendre comment on a tenté de réguler ce type d’événements à Montréal, 2) de comprendre comment les différents acteurs responsables de l’organisation et du bon déroulement des événements établissent une série de règles, aussi bien formelles qu’informelles, et négocient leur application dans le cadre de leur pratique, et 3) de comprendre comment ces acteurs identifient certaines situations comme constituant un problème et éventuellement, y réagissent. La principale méthode de recueil des données a consisté à réaliser des entretiens semi-dirigés avec des promoteurs d’événements rave, des agents de sécurité ainsi que d’autres personnes impliquées dans le milieu telles que policier, pompier, artistes de la scène rave et intervenants. L’observation participante lors d’événements rave fut utilisée comme méthode complémentaire. L’étude démontre comment le service de police s’est vu confronté avec les raves à un vide juridique et comment l’encadrement de ce type d’événements s’est plutôt exercé par le service de prévention des incendies. Les autorités ont également tenté d’encadrer le phénomène par des modifications à certaines règlementations, dont celles sur les permis d’alcool. L’étude démontre également de quelle manière et en fonction de quoi les différents acteurs du milieu négocient les règles en cours d’action dans un contexte où la frontière entre le licite et l’illicite est floue.

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Le génie tissulaire est un domaine interdisciplinaire qui applique les principes du génie et des sciences de la vie (notamment la science des cellules souches) dans le but de régénérer et réparer les tissus et organes lésés. En d'autres mots, plutôt que de remplacer les tissus et les organes, on les répare. La recherche en génie tissulaire est considérable et les ambitions sont grandes, notamment celle de mettre fm aux listes d'attente de dons d'organes. Le génie tissulaire a déjà commencé à livrer des produits thérapeutiques pour des applications simples, notamment la peau et le cartilage. Les questions sur la façon de réglementer les produits thérapeutiques qui sont issus du génie tissulaire sont soulevées à chaque nouveau produit. À ce jour, ces questions ont reçu peu d'attention comparativement aux questions éthiques associées aux recherches avec les cellules souches et les risques qu'engendrent les produits biologiques. Il est donc important d'examiner si le cadre normatif qui entoure la mise en marché des produits issus du génie tissulaire est approprié puisque de tels produits sont déjà disponibles sur le marché et plusieurs autres sont en voie de l'être. Notre analyse révèle que le cadre canadien actuel n'est pas approprié et le moment d'une reforme est arrivé. Les États-Unis et l'Union européenne ont chacun des approches particulières qui sont instructives. Nous avons entrepris une revue des textes réglementaires qui encadrent la mise en marché des produits issus du génie tissulaire au Canada, aux États-Unis et dans l'Union européenne et formulons quelques suggestions de réforme.

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L’objet de ce travail vise à déterminer si le transport aérien en Europe relève d’une compétence partagée entre l’Union européenne (UE) et les États membres, ou s’il s’agit plutôt d’une occupation du terrain par l’UE dans cette matière ? Ainsi, nous verrons en quoi consiste le cadre règlementaire communautaire portant sur le transport aérien en Europe. Dans un premier temps, nous porterons notre attention sur des aspects généraux entourant l’aviation en Europe, comme par exemple la mise en place d’un marché unique de l’aviation ainsi que les ententes « ciel ouvert ». Puis, dans un second temps nous procéderons à l’analyse du cadre règlementaire spécifique portant sur des aspects tels que l’environnement, les droits des passagers aériens, la sécurité et la sûreté.