Regulatory governance in the latinamerican telecommunications sector

Empezando con Chile a comienzos de 1980, los países de América Latina han profundizado la reforma a las telecomunicaciones para crear un entorno regulatorio que incentive la inversión privada, en particular la inversión extranjera. En este artículo, trabajo las tendencias regulatorias en el sector telecomunicaciones de 24 países latinoamericanos y del caribe durante el período 1980-1997 y construyo un índice basado en : autonomía, rendición de cuentas, claridad de las funciones y objetivos, transparencia y participación, y el tipo de mandato legal que crea el ente regulador. El índice muestra que, en promedio, la mayoría de los países llevaron a cabo fuertes reformas regulatorias en la dirección sugerida por expertos e investigadores. El índice también se correlación bien con varias variables políticas, de riesgo, económicas y de telecomunicaciones.

Bioequivalence Evaluation of Single Doses of Two Tramadol Formulations: A Randomized, Open-Label, Two-Period Crossover Study in Healthy Brazilian Volunteers

Background: Tramadol is a well tolerated and effective analgesic used to treat moderate to severe pain. Several generic formulations of tramadol are available in Brazil; however, published information regarding their bioequivalence in the Brazilian population is not available. A study was designed for Brazilian regulatory authorities to allow marketing of a generic formulation. Objective: The purpose of this study was to compare the bioequivalence of 2 commercial tablet preparations containing tramadol 100 mg marketed for use in Brazil. Methods: A randomized, open-label, 2 x 2 crossover study was performed in healthy Brazilian volunteers under fasting conditions with a washout period of 12 days. Two tablet formulations of tramadol 100 mg (test and reference formulations) were administered as a single oral dose, and blood samples were collected over 24 hours. Tramadol plasma concentrations were quantified using a validated HPLC method. A plasma concentration time profile was generated for each volunteer and then mean values were determined, from which C(max), T(max), AUC(0-t), AUC(0-infinity), k(e), and t(1/2) were calculated using a noncompartmental model. Bioequivalence between the products was determined by calculating 90% CIs for the ratios of C(max), AUC(0-t), and AUC(0-infinity) values for the test and reference products using log-transformed data. Tolerability was assessed by monitoring vital signs (temperature, blood pressure, heart rate), laboratory tests (hematology, blood biochemistry, hepatic function, urinalysis), and interviews with the volunteers before medication administration and every 2 hours during the study. Results: Twenty-six healthy volunteers (13 men, 13 women) were enrolled in and completed the study. Mean (SD) age was 30 (6.8) years (range, 21-44 years), mean weight was 64 (8.3) kg (range, 53-79 kg), and mean height was 166 (6.4) cm (range, 155-178 cm). The 90% CIs for the ratios of C(max) (1.01-1.17), AUC(0-t) (1.00-1.13), and AUC(0-infinity) (1.00-1.14) values for the test and reference products fell within the interval of 0.80 to 1.25 proposed by most regulatory agencies, including the Brazilian regulatory body. No clinically important adverse effects were reported; only mild somnolence was reported by 4 volunteers and mild headaches by 5 volunteers, and there was no need to use medication to treat these symptoms. Conclusion: Pharmacokinetic analysis in these healthy Brazilian volunteers suggested that the test and reference formulations of tramadol 100-mg tablets met the regulatory requirements to assume bio-equivalence based on the Brazilian regulatory definition. (Clin Ther 2010;32:758-765) (C) 2010 Excerpta Medica Inc.

An Economic Analysis of the Legal Concept of Trustees' Power of Investment

Authorised trustee status is a legal concept which has economic implications; one of the major implications is that it assists in the direction of investment funds into particular securities and areas of the economy. The concept of authorised trustee status, while attempting to achieve specific outcomes for the beneficiaries of trusts cannot be relied upon to secure these results. Economic analysis of the role of the trustee maintains that this role is one of portfolio manager; a role which is complex but which is explicable in terms of definable procedures and practices. The role of trustee as portfolio manager is one which requires greater financial knowledge than can be assumed is possessed by all trustees. The trustee as portfolio manager is required to maintain a review of decisions make under powers to invest trust assets. A solution to the problem of authorised trustee status is proposed. The solution takes two parts: the first is the adoption of the prudent person approach but with the codification of duties of the trustee and the explicit listing of the factors that a trustee should consider in using the investment powers. The second part of the proposed solution is to link the investment powers of trustees to the best practice features of securities advisers who are now licensed by a regulatory body, the Australian Securities and Investment Commission.

Sähköverkkoliiketoimintojen valvontamallit eräissä Euroopan maissa

Sähkömarkkinauudistukset ovat tuoneet kilpailun sähkön tuotantoon ja myyntiin, mutta samalla vahvistaneet tarvetta valvoa sähkönsiirtoa ja -jakelua, jotka ovat ns. luonnollisia monopolitoimintoja. Monopoleja valvotaan, jotta ne eivät väärinkäytä määräävää markkina-asemaansa. Tässä diplomityössä tarkastellaan sähkönjakeluverkkoliiketoiminnan sääntelyyn yleisesti käytettyjä valvontamalleja sekä niiden soveltamisessa huomioon otettavia seikkoja. Tarkasteltuja valvontamalleja on neljä, joista yleisimpiä ovat hintakattosääntely ja liikevaihdon sääntely. Tuoton sääntely on monesti ollut ensimmäinen keino säännellä alaa. Mittatikkusääntelyllä pyritään selvittämään tarkasteltavien yhtiöiden tehokkuutta. Sitä käytetään yleensä muiden mallien lisänä kannustamaan toiminnan tehostamiseen. Yhä useammin valvotaan myös sähköntoimituksen laatua. Jokainen maa valitsee omaan erityistilanteeseensa parhaiten sopivan valvontamallin. Valvontamallit kehittyvät jatkuvasti, jotta asiakkaiden etujen turvaamiseksi on olemassa toimivat regulatiiviset työkalut ja toisaalta sähkönjakeluyhtiöiden toimintaolosuhteet ovat vakaat ja realistiset. Kansallisen regulaattorin on luotava valvontamallin avulla oikeanlaiset kannustimet yhtiöiden toiminnalle, jotta niiden tekemät investointi- ja toimintapäätökset ovat järkeviä ja takaavat sähkönjakelun jatkuvuuden.

Le développement récent des trois "petites" télévisions francophones de Suisse, de Belgique et du Québec, convergence ou divergence?

Dans le cadre d’une sociologie des organisations portant sur les liens entre organisations télévisuelles et environnement, la présente thèse a pour objectif de cerner les modalités du développement récent de la télévision au Québec en le comparant à celui de la Belgique francophone et de la Suisse. Une telle comparaison repose sur un principe méthodologique simple: on cerne d’autant mieux la réalité que l’on étudie si on peut la comparer à une réalité équivalente d’autres sociétés. En s’appuyant sur des théories de développement organisationnel reliées au courant néo-fonctionnaliste et en adaptant des « histoires de cas » d’études organisationnelles à la réalité télévisuelle des années 90 et 2000, le chercheur a mis au point une grille de classification des données permettant d’étudier les composantes du développement de la télévision dans trois « petites » sociétés industrialisées. Dans un premier temps, il a pu constater une augmentation très importante du nombre de chaînes de télévision par rapport à ce qu’il était dans les années 50 à 70, le tout encadré par les autorités réglementaires en place. Par la suite, dans chacune de ces trois sociétés et sur une période de vingt-cinq ans, il a pu préciser les interactions et échanges entre organisations télévisuelles et environnement lesquels ont été, selon les cas, harmonieux, difficiles, voire même conflictuels. Après avoir comparé les modalités d’une telle augmentation entre les trois sociétés, le chercheur a pu constater une convergence de surface. On note bien quelques similitudes entre les trois sociétés, mais, surtout, chacune d’entre elles est restée sur son quant-à-soi. En Suisse, l’importance accordée au consensus social a favorisé un développement équilibré de l’augmentation des chaines. En Belgique, pays aux divisions profondes constamment réaffirmées, les oppositions ont permis, malgré tout, l’édification d’un ensemble audiovisuel relativement stable. Au Québec, avec une augmentation exponentielle du nombre de chaines, on a assisté à un véritable surdéveloppement de la télévision encouragé et planifié par les autorités gouvernementales canadiennes en réaction à un supposé envahissement culturel américain. Le CRTC, la régie des ondes canadiennes, a pesé de tout son poids pour favoriser l’augmentation du contenu canadien et de la production locale. Par ailleurs, cette augmentation s’est faite avec des ressources limitées. On en fait trop avec trop peu. C’est ce qui permettrait d’expliquer la baisse de qualité de la télévision québécoise contemporaine. Comme élément de solution aux problèmes que la télévision québécoise connait présentement, il faudrait considérer cette dernière pour ce qu’elle est véritablement: une petite télévision dans un univers industriellement hautement développé. Si une telle conception est très bien acceptée aussi bien en Belgique qu’en Suisse, elle ne l’est pas au Québec

La modification des pratiques journalistiques et du contenu des nouvelles télévisées, du quotidien à la situation de crise : analyse France/Québec

Thèse réalisée en cotutelle avec l'Institut d’études politiques d'Aix-en-Provence, École doctorale de Sciences Po, Programme doctoral en sciences de l’information et de la communication

Hacia la aplicación de las guías de la Organización para la Cooperación y el Desarrollo Económicos (OCDE) sobre precios de transferencia para empresas multinacionales y administraciones tributarias en Colombia

Los precios de transferencia ocupan el interés de los Estados en el mundo actual al constituir uno de los retos fundamentales del Derecho Internacional Tributario. En el seno de la Organización para la Cooperación y el Desarrollo Económicos (OCDE), creada en 1961, se discutieron y desarrollaron diversas propuestas para regular el fenómeno. Estas, se materializaron en Modelos de Convenios Tributarios e instrumentos de soft law, que hoy en día constituyen los principios internacionalmente aceptados en la materia. Las Guías de la OCDE sobre precios de transferencia para empresas multinacionales y administraciones tributarias son el cuerpo normativo de soft law que se erigen, en el Ordenamiento Internacional, como el norte de las legislaciones a nivel interno para efectos de regulación de dicha temática. Su adopción por parte de los países miembros y no miembros de la OCDE se enfrenta a problemas teóricos derivados del quebrantamiento del decantado principio de reserva de ley tributaria y el respeto por la seguridad jurídica, razón por la cual su incorporación ha variado de Estado a Estado. El presente trabajo recoge la experiencia en varios países europeos y latinoamericanos y pretende proponer una fórmula de adopción en Colombia, coherente con los principios constitucionales tributarios y con virtualidad de superar las críticas realizadas por la doctrina a la aplicación directa de las Guías.

Análisis de la sentencia n.º 001-10-SIN-CC. Casos n.º 0008-09-IN y 0011-09-IN sobre acción de inconstitucionalidad en contra de la Ley de Minería y efectos posteriores (Jurisprudencia)

This paper aims to analyze the decision issued by the Constitutional Court for Transition within the unconstitutionality presented against the Mining Act. Proponents, in the main, formal allege unconstitutional by the Mining Law have been issued by the Committee on Legislation and Oversight (National Assembly during the Transitional Period after the adoption of the 2008 Constitution) without the prior execution of a legislative pre query, this query being a collective right of national, indigenous peoples and communities recognized in Article 57 paragraph 17 of the Constitution of the Republic. The Constitutional Court ruled Transition to reject the unconstitutionality confirming the constitutionality of the regulatory body and the substantial and non-formal pre-legislative consultation.

CPD records for revalidation: assessing fitness-to-practise using ‘revalidation standards’ and an Outcomes Framework

Background: Currently, all pharmacists and technicians registered with the Royal Pharmaceutical Society of Great Britain must complete a minimum of nine Continuing Professional Development (CPD) record (entries) each year. From September 2010 a new regulatory body, the General Pharmaceutical Council, will oversee the regulation (including revalidation) of all pharmacy registrants in Great Britain. CPD may provide part of the supporting evidence that a practitioner submits to the regulator as part of the revalidation process. Gaps in knowledge necessitated further research to examine the usefulness of CPD in a pharmacy revalidation Project aims: The overall aims of this project were to summarise pharmacy professionals’ past involvement in CPD, examine the usability of current CPD entries for the purpose of revalidation, and to examine the impact of ‘revalidation standards’ and a bespoke Outcomes Framework on the conduct and construction of CPD entries for future revalidation of pharmacy professionals. We completed a comprehensive review of the literature, devised, validated and tested the impact of a new CPD Outcomes Framework and related training material in an empirical investigation involving volunteer pharmacy professionals and also spoke with our participants to bring meaning and understanding to the process of CPD conduct and recording and to gain feedback on the study itself. Key findings: The comprehensive literature review identified perceived barriers to CPD and resulted in recommendations that could potentially rectify pharmacy professionals’ perceptions and facilitate participation in CPD. The CPD Outcomes Framework can be used to score CPD entries Compared to a control (CPD and ‘revalidation standards’ only), we found that training participants to apply the CPD Outcomes Framework resulted in entries that scored significantly higher in the context of a quantitative method of CPD assessment. Feedback from participants who had received the CPD Outcomes Framework was positive and a number of useful suggestions were made about improvements to the Framework and related training. Entries scored higher because participants had consciously applied concepts linked to the CPD Outcomes Framework whereas entries scored low where participants had been unable to apply the concepts of the Framework for a variety of reasons including limitations posed by the ‘Plan & Record’ template. Feedback about the nature of the ‘revalidation standards’ and their application to CPD was not positive and participants had not in the main sought to apply the standards to their CPD entries – but those in the intervention group were more likely to have referred to the revalidation standards for their CPD. As assessors, we too found the process of selecting and assigning ‘revalidation standards’ to individual CPD entries burdensome and somewhat unspecific. We believe that addressing the perceived barriers and drawing on the facilitators will help deal with the apparent lack of engagement with the revalidation standards and have been able to make a set of relevant recommendations. We devised a model to explain and tell the story of CPD behaviour. Based on the concepts of purpose, action and results, the model centres on explaining two types of CPD behaviour, one following the traditional CE pathway and the other a more genuine CPD pathway. Entries which scored higher when we applied the CPD Outcomes Framework were more likely to follow the CPD pathway in the model above. Significant to our finding is that while participants following both models of practice took part in this study, the CPD Outcomes Framework was able to change people’s CPD behaviour to make it more inline with the CPD pathway. The CPD Outcomes Framework in defining the CPD criteria, the training pack in teaching the basis and use of the Framework and the process of assessment in using the CPD Outcomes Framework, would have interacted to improve participants’ CPD through a collective process. Participants were keen to receive a curriculum against which certainly CE-type activities could be conducted and another important observation relates to whether CE has any role to play in pharmacy professionals’ revalidation. We would recommend that the CPD Outcomes Framework is used in the revalidation of pharmacy professionals in the future provided the requirement to submit 9 CPD entries per annum is re-examined and expressed more clearly in relation to what specifically participants are being asked to submit – i.e. the ratio of CE to CPD entries. We can foresee a benefit in setting more regular intervals which would act as deadlines for CPD submission in the future. On the whole, there is value in using CPD for the purpose of pharmacy professionals’ revalidation in the future.

Executive project management structure and the challenges acing its adoption in the Nigerian construction industry

Project management (PM) is a globally recognized discipline and has been widely adopted within the construction industry. Despite advancements in the PM discipline, the ineffective traditional management system, typical of the non-executive PM structure, is still widely used in the Nigerian construction industry. The aim of this paper is thus to explore the challenges facing the adoption of the executive PM structure in Nigeria. The paper first assesses the level of growth of PM in Nigeria using UK best practices as a benchmark and identifies the key PM characteristics in the two countries. Focus group interviews were used to collect the primary data for the study and content analysis was used to present the results in a thematic format. The study revealed the key barriers to the adoption of an executive PM structure in Nigeria as a lack of proper awareness, unfavorable policies, skill shortages, the traditional culture of stakeholders and the absence of a regulatory body. It is recommended that the government, as a major player/client in the Nigerian construction industry, should lead the campaign to change the traditional industry approach to project management. This is necessary if construction stakeholders in Nigeria are to be educated and encouraged towards adopting and putting into practice effective PM.

Balkanisation of banking damages international trade and UK GDP

Balkanisation is a way to describe the breakdown of cross-border banking, as nervous lenders retreat in particular from the more troubled parts of the Eurozone or at least try to isolate operations within national boundaries. It is increasing at the Bank level, however the senior policy makers consider this a negative trend – Mario Draghi, president of the European Central Bank, has talked of the need to “repair this financial fragmentation” and Mark Carney, head of global regulatory body the Financial Stability Board, [and now Governor of the Bank of England] has warned that deglobalising finance will hurt growth and jobs by “reducing financial capacity and systemic resilience”. In this article I would like to examine the impact of banking balkanisation on international trade and provide some initial thoughts about remedies for excessive risk in a banking non-balkanising world.

Conflito de agência no consórcio DPVAT: uma análise à luz da nova economia institucional sob a perspectiva da teoria da agência

Diferentes arranjos institucionais resultam em diferentes incentivos para a realização de trocas econômicas. Com efeito, estruturas regulatórias implementadas em determinado contexto histórico-econômico podem resultar em consequências diversas daquelas originariamente pretendidas, impondo ao regulador a necessidade de constante monitoramento e de intervenções com vistas a diagnosticar e corrigir ou minimizar possíveis distorções nas relações entre os atores envolvidos. Assim, esta dissertação tem por objetivo analisar o funcionamento do Consórcio do Seguro DPVAT como mecanismo de conexão entre seus diversos stakeholders. Pretende-se analisar a existência de conflitos de interesses derivados das diversas relações entre as partes interligadas – geradas pelo arranjo institucional firmado para a gestão dos recursos arrecadados com os prêmios pagos pelos proprietários de veículo automotor para o Seguro de Danos Pessoais Causados por Veículos Automotores de Via Terrestre, ou por sua carga, a Pessoas Transportadas ou Não (DPVAT) – que possam suscitar intervenção regulatória no sentido de evitá-los, ou, ao menos, mitigá-los. A pesquisa é conduzida a partir da identificação dos comportamentos esperados de agentes econômicos autointeressados, tendo por referência os pressupostos da Nova Economia Institucional sob a perspectiva da Teoria da Agência, e do exame das principais mudanças legislativas havidas na estrutura do seguro obrigatório de trânsito no Brasil nos últimos 50 anos. Na sequência, com base em elementos teóricos e empíricos, foram identificados e analisados três conflitos de agência entre os stakeholders do Consórcio DPVAT: o primeiro seria aquele havido entre a entidade gestora do Consórcio DPVAT (agente) e as sociedades seguradoras consorciadas (principal); o segundo conflito observado refere-se à relação mantida entre a entidade gestora do Consórcio DPVAT (agente) e o órgão regulador (principal); e, por fim, o conflito de agência existente entre a seguradora que administra o referido consórcio (agente) e os proprietários de veículo automotor (principal).

O clima em sua regulamentação político-econômica: o acordo de Copenhague - COP 15

We know that the Earth goes through natural cycles that influence its climate and the development of their societies. In recent decades, climate changes and nature began to call world attention to the unbridled exploitation that was carried by the current economic system, causing unrest among scientific, social, political and economic world. The theory that man causes a warming in global temperatures by the release of greenhouse gases made the headlines of major newspapers in the world. From there, it was only a matter of time before environmental concerns became ownership of capital by its excessive appropriation. The fear of nuclear threat by the bombs of Hiroshima and Nagasaki left in fanfare the world, which together with the devastating impact of the exploitation of man and nature gave birth to the Environmental Revolution, a way of trying to change the development patterns of the time and behavior of the population. However, based on the historical form of capitalist domination, this was another measure that was apossada the economic system being transformed into economic value and political exchange. The origin of the conventions, meetings, conferences, parliaments set up to discuss environmental issues, eventually became forums of political and economic talks focused on environmental governance, valuing an asset that is public and everyone. Environmental and climate issue now has a value, thus turning the agenda on the agenda of the United Nations (UN) for its political and economic regulation in the form of global agreement. Given the need for understanding the climate issue, was born the Conference of the Parties (COPs), a regulatory body for climate negotiations, surrounded interests, complexities, conflicts and disagreements between the parties countries, which becomes clear when we analyze their agreements...

O clima em sua regulamentação político-econômica: o acordo de Copenhague - COP 15

We know that the Earth goes through natural cycles that influence its climate and the development of their societies. In recent decades, climate changes and nature began to call world attention to the unbridled exploitation that was carried by the current economic system, causing unrest among scientific, social, political and economic world. The theory that man causes a warming in global temperatures by the release of greenhouse gases made the headlines of major newspapers in the world. From there, it was only a matter of time before environmental concerns became ownership of capital by its excessive appropriation. The fear of nuclear threat by the bombs of Hiroshima and Nagasaki left in fanfare the world, which together with the devastating impact of the exploitation of man and nature gave birth to the Environmental Revolution, a way of trying to change the development patterns of the time and behavior of the population. However, based on the historical form of capitalist domination, this was another measure that was apossada the economic system being transformed into economic value and political exchange. The origin of the conventions, meetings, conferences, parliaments set up to discuss environmental issues, eventually became forums of political and economic talks focused on environmental governance, valuing an asset that is public and everyone. Environmental and climate issue now has a value, thus turning the agenda on the agenda of the United Nations (UN) for its political and economic regulation in the form of global agreement. Given the need for understanding the climate issue, was born the Conference of the Parties (COPs), a regulatory body for climate negotiations, surrounded interests, complexities, conflicts and disagreements between the parties countries, which becomes clear when we analyze their agreements...

Potential issues related to emergency core cooling system strainers performance at boiling water reactors: application to Cofrentes NPP (Spain)

From the 60s to the 90s, a great number of events related to the Emergency Core Cooling Systems Strainers have been happened in all kind of reactors all over the world. Thus, the Nuclear Regulatory Commission of the USA emitted some Bulletins to address the concerns about the adequacy of Emergency Core Cooling Systems (ECCS) strainer performance at boiling water reactors (BWR). In Spain the regulatory body (Consejo de Seguridad Nuclear, CSN) adopted the USA regulation and Cofrentes NPP installed new strainers with a considerable bigger size than the old strainers. The nuclear industry conducted significant and extensive research, guidance development, testing, reviews, and hardware and procedure changes during the 90s to resolve the issues related to debris blockage of BWR strainers. In 2001 the NRC and CSN closed the Bulletins. Thereafter, the strainers issues were moved to the PWR reactors. In 2004 the NRC issued a Generic Letter (GL). It requested the resolution of several effects which were not noted in the past. The GL regarded to be resolved by the PWR reactors but the NRC in USA and the CSN in Spain have requested that the BWR reactors investigate differences between the methodologies used by the BWRs and PWRs. The developments and improvements done for Cofrentes NPP are detailed. Studies for this plant show that the head loss due to the considered debris is at most half of the limited head loss for the ECCS strainer and the NPSH (Net Positive Suction Head) required for the ECCS pumps is at least three times lower than the NPSH available.