Spelling suggestions: "subject:"harmonization""
21 |
Coopération internationale et harmonisation de la réglementation pharmaceutique / International cooporation and harmonisation of the pharmaceutical regulationLezotre, Pierre-Louis 21 December 2012 (has links)
La mondialisation est une réalité du XXIe siècle. Le développement, la fabrication et la distribution des médicaments ont été internationalisés. Cette mondialisation croissante a fondamentalement changé l‟environnement pharmaceutique et induit des nouveaux défis pour tous les acteurs du système. Le paradigme réglementaire est en effet passé du plan national au plan international; les normes pharmaceutiques internationales sont donc plus importantes que jamais auparavant. La coopération et l‟harmonisation de la réglementation pharmaceutique sont devenues la seule solution évidente pour satisfaire le droit fondamental de l‟Homme de pouvoir accéder à des médicaments de bonne qualité, sûrs et efficaces, à la fois dans les pays développés et dans les pays en voie de développement.Dans ce contexte, de nombreuses initiatives de coopération ont été initiées aux niveaux bilatéral, régional et mondial et les efforts d‟harmonisation ont été renforcés. L‟éventail des collaborations va de la simple coopération technique à une intégration pleine et entière des systèmes et des règlementations.Ce document présente la situation actuelle de ce phénomène large et complexe de coopération et d‟harmonisation dans le secteur pharmaceutique (Partie I), il examine de manière exhaustive sa valeur ajoutée, ses paramètres critiques ainsi que ses facteurs d‟influence (Partie II) dans le but de recommander des actions et des mesures destinées à soutenir les prochaines étapes de coopération et d‟harmonisation (Partie III). Toutes ces recommandations supportent la création d‟un système pharmaceutique mondial mieux coordonné. Celui-ci représente l‟alternative la plus réaliste pour atteindre l‟objectif : Etablir une coalition mondiale d’autorités de santé et répondre à une demande exigeant davantage de coopération et d’harmonisation dans le secteur pharmaceutique. Ce système s‟appuie sur les réalisations accomplies jusque-là et utilise comme base les innombrables projets d‟harmonisation et de coopération développés au cours des années. Il présente des avantages pour tous les acteurs du système et fournirait également une valeur ajoutée significative pour la promotion et la protection de la santé publique mondiale. / Globalisation is a reality of the 21st century. The development, manufacture and distribution of medicines have been internationalised. This increased globalisation has fundamentally changed the environment for regulating medicines and created unique regulatory challenges for all stakeholders. The regulatory paradigm has indeed changed from national to international and international pharmaceutical norms and standards are more important than ever before. International cooperation and harmonisation of the pharmaceutical regulation has became the only clear choice to meet the fundamental human right to have access to high quality, safe and effective medicines in both developed and developing countries.In this context, many cooperative initiatives have been established at the bilateral, regional and global levels and harmonisation efforts have been enhanced. All these initiatives have taken a variety of forms, from informal cooperation to full integration of regulatory systems.This document provides the current status of this complex and broad phenomenon of cooperation and harmonisation in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation and harmonisation (Part III). All these recommendations support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfil the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all the on-going positive cooperation initiatives and uses as foundations all the numerous harmonisation projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.
|
22 |
The international aspects of the European common consolidated corporate tax base (CCCTB) and their interaction with third countriesAli, Eid Ashry Gaber January 2013 (has links)
The thesis examines the international taxation rules of the Common Consolidated Corporate Tax Base (CCCTB) and their interaction with third-country corporate tax practice. The aim is to assess the effectiveness of the CCCTB vis-à-vis third countries, with Egypt as a practical example. The CCCTB has the potential to reduce corporate tax obstacles faced by businesses in the EU in having to comply with up to twenty seven different domestic systems for determining their taxable profits. However, the international taxation rules of the CCCTB system are likely to have an impact on the corporate tax practice in third countries, and may conflict with existing bilateral tax treaties concluded between CCCTB-Member States and third countries. The discussion presents a detailed analysis of the CCCTB’s unilateral framework for the avoidance of double taxation and for the protection of the common consolidated tax base. It reveals that, by means of ordinary credit and exemption methods provided in the CCCTB Directive, international double taxation will be eliminated in relation to third countries. Furthermore, the CCCTB’s anti-abuse rules are effective in protecting the common tax base and in eliminating non-double taxation. Nevertheless, the unilateral measures are in conflict with a number of important provisions of bilateral tax treaties, based on the OECD Model, concluded between the potential CCCTB-Member States and third countries. Egypt exemplifies this – but the problem is generic. These conflicts between the CCCTB and OECD Model bilateral treaties are detrimental to the effective functioning of the CCCTB system vis-à-vis third countries, and need to be redressed. This thesis suggests a simple and practical solution - replacement of the bilateral tax treaties between CCCTB-Member States and third countries with a multilateral tax treaty to be concluded between every third country and all CCCTB-Member States.
|
23 |
Fostering the delivery of wind power : an evaluation of the performance of policy instruments in three European Union member statesOtitoju, Afolabi January 2010 (has links)
Worldwide energy policies are built on three pillars: ‘cost competitiveness’, ‘security of energy supply’, and ‘environmental responsibility.’ This has brought about the integration of renewable energy sources into national systems with the deployment of policy instruments to make renewable energy sources electricity (RES-E) capable of nearly competing on a commercial basis with traditional forms of electricity generation. At the national level within the EU, there has been much experimentation with different policy instruments with varying levels of success. Nevertheless the EU as a whole will not meet its stipulated renewable energy target. This study challenges the theoretical and abstract evaluation presented in the literature about EU wind power delivery systems and has developed an integrative evaluation framework. This evaluation framework is used in this study to present the views of key stakeholders on their experiences with the performance of key policy instruments (feed-in tariff, and renewables obligation) implemented in three EU Member States namely: Germany, The Netherlands, and United Kingdom. It also challenges the EU-wide harmonised renewable energy policy agenda as proposed in Directive 2001/77/EC. The concept of path dependency of the historical institutional approach was adopted in order to explore the diversity of the wind power industry across the three country cases. An indepth semi-structured interview with fifty-five senior wind power policy makers and experts was conducted to explore the historical emergence, the architect, and the outcome of the support and implementation of the policy instruments. Findings showed that the approach to wind power deployment in the three country cases differs significantly and this has affected the pattern of each country’s wind power policy instrument. Also, the role and contribution of the stakeholder groups to the success of the wind power policy instruments differ significantly in each of the country cases. This helps to explain the performance of the different policy instruments adopted. Concerning the harmonisation of EU renewable energy policy instruments which have received much attention in recent times, this study found that harmonisation based on a single policy instrument is not feasible and may ultimately inhibit the growth of the European wind power market. A harmonised system may cause uncertainties amongst willing investors, thereby causing a withdrawal of further investment in the wind power market. If this happens, Europe may also lose its position as the world leader in the wind power market. Furthermore, national histories demonstrates that Member States have different culture, stakeholder groups, political, and business practices that will influence policy instruments and the likelihood of any policy succeeding. Thus, rather than promoting harmonisation and political market for wind power, it is important that Member States adopt and implement, stable, flexible, and transparent policy instruments that enable wind power and other renewable energy sources to emerge, develop, and go through the R&D stage to a point of maturity where they can compete with other energy sources with limited financial support.
|
24 |
Meranie vzájomnej harmonizácie národných účtovných štandardov - prípad vybraných európskych krajín / Measurement of Mutual Harmonisation of National Accounting Standards - the Case of Selected European CountriesMišuráková, Mária January 2015 (has links)
This thesis uses data obtained from 335 annual reports of actual companies from ten European countries to quantify the level of material accounting harmony among them. It employs various specifications of the T index and by comparing their outcomes attempts to fi nd the best possible combination of properties desirable for this purpose. The three main problems addressed in this work are; estimating the scope of material harmonisation over time by comparing our results to the previous research, assessing the current extent of material harmony among studied countries, and comparing the situation of Czech and Slovak companies with respect to the rest of the sample. Powered by TCPDF (www.tcpdf.org)
|
25 |
Attractivité économique des investissements directs étrangers en zone CEMAC : harmonisation des instruments juridiques aux règles internationales / Economic attractivity of foreign direct investments in CEMAC zone : harmonization of the legal instruments to the international rulesMemphil Ndi, Evelyne Patience 21 October 2015 (has links)
Les courants de la mondialisation des marchés, marqués par la libre circulation des capitaux et le phénomène du libre-échange ont favorisé la mise en œuvre de politiques communautaires de relance économique et d’attractivité des territoires. C’est dans cette lancée que des regroupements géographiques à visée économique comme la Communauté Économique et Monétaire de l’Afrique Centrale (CEMAC) sont apparus. Six pays de l’Afrique Centrale dont le Cameroun, le Congo, le Gabon, la Guinée Equatoriale, la République Centrafricaine et le Tchad en sont membres et font l’objet de notre analyse sur l’attractivité économique de l’investissement Direct étranger (IDE) dans cette sous-région. L’IDE est devenu un acteur incontournable du processus de développement, et la zone CEMAC une destination privilégiée pour les investisseurs. Il apparait néanmoins une ambiguïté dans les rapports entre le flux d’IDE, la croissance économique et le développement des pays membres de la CEMAC : le taux sans cesse croissant des flux d’IDE entrants dans la sous-région, n’est malheureusement pas toujours synonyme de croissance économique. Pour comprendre ce paradoxe, l’on procède à une analyse des instruments encadrement de l’IDE dans la sous-région CEMAC. Il en ressort que, pour un rendement optimal de ces dispositifs et la garantie d’une croissance économique à long terme dans ces États, il est nécessaire d’associer les politiques actuelles d’attractivité économique des IDE, à une diversification des domaines économiques exploitables , mais aussi adapter les standards internationaux aux spécificités socioculturelles mais aussi économiques de la sous-région CEMAC. / The currents of the globalization of the markets, marked by the free movement of capital and the phenomenon of free trade supported the implementation of Community policies of economic revival and attractivity of the territories. It is in this impetus that geographical regroupings with economic aiming like the Economic community and Monetarist of Central Africa (CEMAC) appeared. Six countries of Central Africa of which Cameroon, Congo, Gabon, Equatorial Guinea, the Central African Republic and Chad are members and are for it, the object our analysis on the economic attractivity of direct foreign investment (FDI) in this under-area. The FDI became an inevitable actor of the development process, and CEMAC zones, a privileged destination for the investors. It appears nevertheless an ambiguity in the relationship between the flow of FDI, the economic growth and the development of the member countries of the CEMAC : the rate unceasingly crescent of flows of FDI entering the under-area, is unfortunately not always synonymous with economic growth. To understand this paradox, one carries out an analysis of the instruments framing of the IDE under-area CEMAC. This reveals that, for an optimal output of these devices and the warranty of one long-term economic growth in these States, it is necessary to associate the current policies of economic attractivity of the FDI, with a diversification of the exploitable economic domains, but also to adapt the international standards to sociocultural but so economic specificities of under-area CEMAC. The case of the countries of the BRICS can in this respect, being used as illustration for an “other way” of thinking the development.
|
26 |
La "Favor Contractus" dans les Principes Unidroit et l'avant projet d'acte uniforme sur le droit des contrats en OHADA / The "Favor Contractus" in the UNIDROIT Principles and the Preliminary Draft OHADA Uniform Act on tracts.Ngwanza, Achille André 30 November 2011 (has links)
Les Principes d’Unidroit relatifs aux contrats du commerce international ont été élaborés dans la perspective de créer des règles universelles tournées vers le pragmatisme et non la défensed’une tradition juridique. Dans l’espace OHADA, un avant projet d’acte uniforme sur le droitdes contrats a été rédigé sur le modèle des Principes Unidroit, ce en reprenant quasimenttoutes leurs dispositions.Au regard de la neutralité culturelle des Principes Unidroit, il est fondé de se demander s’ilétait opportun de s’en inspirer pour rédiger un texte dans un espace majoritairement civiliste.Le traitement pertinent de cette question postule de s’arrêter sur le substrat philosophiqueinnervant les Principes Unidroit. Dans cette optique, la favor contractus, contrairement à laliberté contractuelle, la bonne foi, l’application des usages et la lutte contre la déloyauté dontl’orientation axiologique est claire, est un bon prisme d’analyse. A travers la protection ducontrat, il est aisé de savoir si les Principes Unidroit constituent une agression à la traditionjuridique majoritaire des pays de l’espace OHADA. Pour maitriser la variété des risquespesant sur l’acte juridique, les Principes Unidroit abordent la sauvegarde du contrat sous leprisme temporel. Ainsi, ils veillent à garantir son existence et à assurer son exécution. Cefaisant, ils n’arbitrent pas entre efficacité économique et civisme contractuel. Il en résulte que,malgré l’imperfection de certaines de leurs règles, les Principes constituent une bonne sourced’inspiration pour le législateur OHADA qui gagnerait à les améliorer avec les avancées desprojets de réforme du droit des contrats en France. / The UNIDROIT Principles of International Commercial Contracts were drafted with the aimof creating universal rules based on a pragmatic approach, and not in defense of a particularlegal tradition. In the OHADA area, a preliminary draft Uniform Act on contract law wasdrafted using the Unidroit Principles as a model, which took up nearly all of the provisions.Given the cultural neutrality of the UNIDROIT Principles, one may wonder whether thisinstrument was indeed an appropriate source of inspiration for a predominantly civil law area.A proper analysis of this issue implies to scrutinize the philosophy underlying the UnidroitPrinciples. In this regard, and contrary to concepts such as freedom of contract, good faith andfair dealings, due consideration given to usages and fight against unfairness which have aclear axiological orientation, favor contractus provides a good lens for analysis. Focusing onthe protection of the contract, it will be easily understandable whether the UNIDROITPrinciples are an assault to the legal tradition of the majority of OHADA countries. With aview to controlling the variety of risks bearing upon the contract, the Unidroit Principles dealwith the protection of the contract under a temporal perspective, keeping it in existence andensuring its performance. In so doing, they do not make a choice between economicefficiency and contractual fairness, but integrate both. As a result, and despite theimperfection of some of their rules, the UNIDROIT Principles provide a valuable source ofinspiration for the OHADA legislator, who could also benefit from certain improvements tobe drawn from the contract law reform projects in France.
|
27 |
Les organisations économiques sous-régionales dans le développement de la réglementation pharmaceutique : cas de l'Afrique de l'ouest / Sub-regional economic organizations in the development of pharmaceutical regulation : case of west AfricaBoka, Paule Mireille 28 September 2018 (has links)
En Afrique de l’ouest, le processus d’harmonisation des réglementations pharmaceutiques se caractérise par des initiatives souvent séparées et propres, d’une part à la Communauté Economiques Des Etats de l’Afrique de l’Ouest (CEDEAO), et d’autre part à l’Union Economique et Monétaire Ouest Africaine (UEMOA). Cette étude dont l’objectif était de contribuer à l’optimisation de la réglementation pharmaceutique montre que la CEDEAO a essentiellement élaboré des lignes directrices, tandis que l’UEMOA, mettant à profit la force et la portée juridique des normes à sa disposition et opposables aux Etats membres a pu obtenir des résultats tangibles. L’optimisation de la réglementation pharmaceutique passe par la prise en compte des autres fonctions réglementaires insuffisamment régulées et par une coopération active entre les deux organisations, renforcée par l’intervention de l’Union Africaine, qui permet de construire une démarche incluant la création d’une agence ouest africaine du médicament et la mise en œuvre d’une source innovante de financement, dans le but ultime de favoriser l’accessibilité des populations à des médicaments de qualité. / In West Africa, pharmaceutical regulations harmonization process is characterized by initiatives on one hand separate and specific to Economic Community Of West African States (ECOWAS) and on the other to West African Economic and Monetary Union (WAEMU). The present study which aims at contributing to pharmaceutical regulation optimization reveals that ECOWAS has essentialy elaborated guidelines while WAEMU by taking advantage of the strength and scope of legal standards available and opposable to member states succeeded to get tangible results. Pharmaceutical regulation optimization involves taking into account other reglementary functions not sufficiently regulated and in an active cooperation between both organisations reinforced by African Union intervention. This permits to build an approach including the creation of a west african agency for medecine and the implementation of inovatives sources of funding, whith the ultimate goal to promote access of populations to good quality medecines.
|
28 |
Essai sur l'européanisation du droit de la consommation / Essay on the europeanization of the consumer lawOuirini, Hanane 19 May 2016 (has links)
L’actualité du droit de la consommation est aujourd’hui intrinsèquement marquée par le droit européen. Qu’il s’agisse du droit européen des contrats en général ou du droit européen de la consommation en particulier, la matière est au cœur d’une tension opposant les institutions communautaires qui, animées par la volonté de construire un Code civil européen couvrant le droit des contrats, de la responsabilité délictuelle, quasi-délictuelle et même la gestion d’affaires, sont confrontées aux craintes et réticences locales attachées à leurs spécificités. Le débat juridique analyse et évalue les impacts structurels et conjoncturels résultant de cette européanisation du droit de la consommation. Que celle-ci soit souhaitée ou subie, la réalité de l’évolution du contexte socio-économique ne permet plus aujourd’hui de faire l’économie d’une approche globale et de portée européenne, ne serait-ce qu’au regard de la nécessité de promouvoir et développer le marché intérieur. Le droit de la consommation représente la matière au carrefour d’intérêts divergents qu’il convient de concilier, d’où les propositions d’homogénéisation du droit au niveau européen, portant la promesse d’un droit homogène dont la lisibilité et l’accessibilité seraient le gage d’une protection efficiente du consommateur, acteur clé dans ce vaste processus. / Consumer protection law is inherently impacted by EU law. European contract law in general, and European consumer protection law specifically, are at the heart of tensions between EU institutions. Driven by a desire to create a European Civil Code covering contract law, tort and negligence law, and negotiorum gestio, EU institutions are confronted with fear and hesitation at the local level regarding their specific characteristics. The legal debate analyses and assesses the short-term and structural impacts resulting from the 'Europeanisation' of consumer protection law. Like it or not, socio-economic conditions are changing and we can no longer disregard a global and European approach, if only to promote and expand the internal European market. Consumer protection law is an area where opposing interests collide, and these should be reconciled. That's why there have been proposals to standardise law at the European level – to create a homogeneous group of laws that are clear and accessible and that would guarantee efficient protection for consumers, who are key to this whole process
|
29 |
Vers un droit communautaire des contratsTruilhé-Marengo, Eve 08 June 2002 (has links) (PDF)
Dans quelle mesure le droit communautaire, gouverné par la logique du marché, est-il susceptible de donner naissance à un corps de règles cohérent gouvernant les relations contractuelles entre particuliers ? Il semble que les diverses dispositions communautaires intervenant en matière contractuelle relèvent davantage du "puzzle" que d'un tout cohérent et ordonné. Constatant les difficultés que rencontre la construction d'un droit commun des contrats à l'échelle communautaire ainsi que les incohérences propres aux nombreuses règles spéciales, l'étude commence donc par formuler le constat, plutôt négatif, des faiblesses du droit communautaire des contrats (Première partie). Mais la spécificité de l'ordre juridique communautaire commande de ne pas s'en tenir aux méthodes d'analyse qui auraient présidé à l'étude du droit national dans la même matière. Seule une analyse à la fois plus poussée et plus pragmatique permettra de mettre en lumière l'essence de l'intégration européenne en matière contractuelle...
|
30 |
Internprissättningsproblematiken i ljuset av förslaget om hemlandsbeskattning för europeiska koncerner / The Issue of Transfer Pricing in the Light of the Proposal for Home State TaxationJohansson, Karolina January 2002 (has links)
Throughout this thesis three main factors have been identified that can be out of significance for transfer pricing in multinational companies if the proposal for Home State Taxation is adopted. These factors are rules for calculation of the tax base, rules for dividing costs over periods and the tax rate. The formula for sharing profits will also become a factor that can have an impact on the European companies'incentives for transfer pricing interacting with above-mentioned factors. The effects of transfer pricing aiming at reducing the total amount of the taxation burden for a group of companies will be strongly reduced in the future if the proposal is adopted. Incentives for transfer pricing will loose importance, though not disappear altogether. Nevertheless new incentives to evade the rules may arise, especially in terms of careful choices concerning the establishment of every company in the group. The most positive effect of the proposal will probably be that the uncertainty of determining which transfer pricing rules apply will disappear, as only the system of rules of one country will be used for the calculation of the base for taxation. The double taxation, which has caused problems in the past since different rules for transfer pricing gave been applied, will disappear resulting in less costs for companies.
|
Page generated in 0.1061 seconds