Economic evidence in regulatory disputes: revisiting the court-regulatory agency relationship in the US and the UK

This article examines the issue of the appropriate scope of review of economic evidence enshrined in the discretionary assessments of utility regulators in the US and the UK. It advances a balance of institutional competencies approach to the question of the degree of deference owed to the regulatory agency’s economic assessments. In doing so, it revisits the doctrinal positions advanced in the US and UK for the substantive review of administrative discretion, so as to become attuned to the challenges posed by economic evidence. Drawing on insights from political science and economics, the suggested approach illuminates the institutional disadvantages of the courts that may warrant a high degree of deference. At the same time, however, it remains sensitive to the polycentric elements of regulatory disputes as well as to a number of institutional realties that may attenuate the weight of such comparative institutional disadvantages.

Is enterprise value affected by political nominations for a regulatory agency's presidency?

Economists have argued that regulation is the appropriate approach to maintain output in its economically efficient level in a natural monopoly, and that can be achieved by submitting these companies to regulatory agencies’ decisions. The autonomous agencies are, however, not free in an absolute sense, and it is important to ask what the priorities of the new administration are. One answer is that it is designed to give leeway and powers of discretion to unbiased professionals with expertise in their field. In practice, however, professional experts might often be politically motivated. The objective of this study is to investigate whether political nominations to the presidency of regulatory agencies, rather than technical appointments, affect the level of regulatory risk. In order to achieve this purpose, an event study was performed, where the regulatory risk in a political nomination will be compared to a technical nomination, in terms of abnormal return.

Regulatory agency budgets : hearings ... Ninety-second Congress, second session, on S. 448 ...

"S. 448, to provide that the appropriation requests of certain regulatory agencies be transmitted directly to Congress."

Essays on regulatory risk issues

Most studies around that try to verify the existence of regulatory risk look mainly at developed countries. Looking at regulatory risk in emerging market regulated sectors is no less important to improving and increasing investment in those markets. This thesis comprises three papers comprising regulatory risk issues. In the first Paper I check whether CAPM betas capture information on regulatory risk by using a two-step procedure. In the first step I run Kalman Filter estimates and then use these estimated betas as inputs in a Random-Effect panel data model. I find evidence of regulatory risk in electricity, telecommunications and all regulated sectors in Brazil. I find further evidence that regulatory changes in the country either do not reduce or even increase the betas of the regulated sectors, going in the opposite direction to the buffering hypothesis as proposed by Peltzman (1976). In the second Paper I check whether CAPM alphas say something about regulatory risk. I investigate a methodology similar to those used by some regulatory agencies around the world like the Brazilian Electricity Regulatory Agency (ANEEL) that incorporates a specific component of regulatory risk in setting tariffs for regulated sectors. I find using SUR estimates negative and significant alphas for all regulated sectors especially the electricity and telecommunications sectors. This runs in the face of theory that predicts alphas that are not statistically different from zero. I suspect that the significant alphas are related to misspecifications in the traditional CAPM that fail to capture true regulatory risk factors. On of the reasons is that CAPM does not consider factors that are proven to have significant effects on asset pricing, such as Fama and French size (ME) and price-to-book value (ME/BE). In the third Paper, I use two additional factors as controls in the estimation of alphas, and the results are similar. Nevertheless, I find evidence that the negative alphas may be the result of the regulated sectors premiums associated with the three Fama and French factors, particularly the market risk premium. When taken together, ME and ME/BE regulated sectors diminish the statistical significance of market factors premiums, especially for the electricity sector. This show how important is the inclusion of these factors, which unfortunately is scarce in emerging markets like Brazil.

A Critical Perspective of the Indonesian Institutional Framework for PPP Toll Roads

The development of toll roads in Indonesia started around 1978. Initially, the management and development of toll roads sat directly under the Government of Indonesia (GoI) being undertaken through PT JasaMarga, a state owned enterprise specifically established to provide toll roads. Due to the slow growth and low capability of toll roads to fulfil infrastructure needs in the first ten years of operation (only 2.688kms/year), GoI changed its strategy in 1989 to one of using private sector participation for roads delivery through a Public Private Partnership (PPP) scheme. In this latter period, PT JasaMarga had two roles, both as regulator on behalf of the private sector as well as being the operator. However, from 1989 to 2004 the growth rate of toll roads actually decreased further to 2.300kms/year. Facing this challenge of low growth rate of toll roads, in 2004GoI changed the toll road management system and the role of regulator was returned to the Government through the establishment of the Toll Road Regulatory Agency (BPJT). GoI also amended the institutional framework to strengthen the toll road management system. Despite the introduction of this new institutional framework, the growth of toll roads still showed insignificant change. This problem in toll road development has generated an urgent need for research into this issue. The aim of the research is to understand the performance of the new institutional framework in enhancing PPP procured toll road development. The methodology of the research was to undertake a questionnaire survey distributed to private sector respondents involved in toll road development. The results of this study show that there are several problems inherent in the institutional framework, but the most significant problem comes from the uncertainty of the function of the strategic executive body in the land expropriation process.

Is there a role for microsampling in antibiotic pharmacokinetic studies?

- Introduction Clinical pharmacokinetic studies of antibiotics can establish evidence-based dosing regimens that improve the likelihood of eradicating the pathogen at the site of infection, reduce the potential for selection of resistant pathogens, and minimize harm to the patient. Innovations in small volume sampling (< 50 μL) or ‘microsampling’ may result in less-invasive sample collection, self-sampling and dried storage. Microsampling may open up opportunities in patient groups where sampling is challenging. - Areas Covered The challenges for implementation of microsampling to assure suitability of the results, include: acceptable study design, regulatory agency acceptance, and meeting bioanalytical validation requirements. This manuscript covers various microsampling methods, including dried blood/plasma spots, volumetric absorptive microsampling, capillary microsampling, plasma preparation technologies and solid-phase microextraction. - Expert Opinion The available analytical technology is being underutilized due to a lack of bridging studies and validated bioanalytical methods. These deficiencies represent major impediments to the application of microsampling to antibiotic pharmacokinetic studies. A conceptual framework for the assessment of the suitability of microsampling in clinical pharmacokinetic studies of antibiotics is provided. This model establishes a ‘contingency approach’ with consideration of the antibiotic and the type and location of the patient, as well as the more prescriptive bioanalytical validation protocols.

Bronchiolitis

INTRODUCTION: Bronchiolitis is the most common lower respiratory tract infection in infants, occurring in a seasonal pattern, with highest incidence in the winter in temperate climates and in the rainy season in warmer countries. Bronchiolitis is a common reason for attendance at and admission to hospital.

METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of prophylactic interventions for bronchiolitis in high-risk children? What are the effects of measures to prevent transmission of bronchiolitis in hospital? What are the effects of treatments for children with bronchiolitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

RESULTS: We found 59 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics, bronchodilators (oral, inhaled salbutamol, inhaled adrenaline [epinephrine], hypertonic saline), chest physiotherapy, continuous positive airway pressure, corticosteroids, fluid management, heliox, montelukast, nasal decongestants, nursing interventions (cohort segregation, hand washing, gowns, masks, gloves, and goggles), oxygen, respiratory syncytial virus immunoglobulins, pooled immunoglobulins, or palivizumab (monoclonal antibody), ribavirin, or surfactants.

Does Affirmative Action Work? Evidence from the Operation of Fair Employment Legislation in Northern Ireland

An affirmative action programme, established by the Fair Employment (Northern Ireland) Act 1989, has been an important attempt to ensure ‘fair participation’ in employment for both Catholics and Protestants in Northern Ireland since 1990. The programme includes detailed monitoring of the community background of employees and requires employers to undertake remedial action where fair participation is not evident. Agreements were concluded between the regulatory agency and many employers specifying what affirmative action measures were required. Based on the annual monitoring returns submitted between 1990 and 2005, this article evaluates the effectiveness of the affirmative action programme in promoting fair employment participation using fixed effects models. The analysis shows that there has been a general shift towards workforce integration in Northern Ireland but the increase of under-represented groups in agreement concerns is greater than in concerns with no agreement. The success of agreements, however, is limited to certain industrial sectors and medium-sized enterprises.

Use of abatacept in rheumatoid arthritis.

Abatacept (CTLA-Ig), a modulator of T-lymphocyte activation, has been approved by the Swiss health regulatory agency Swissmedic for the treatment of active rheumatoid arthritis (RA). This article summarises the key trial findings for this biologic agent in RA in different situations such as early erosive rheumatoid arthritis (RA), biologic-naïve RA, RA before and after the use of methotrexate or TNF-inhibitors and includes safety information from these trials. Based on these data, recommendations for clinical practice in Switzerland are made by a panel of experts.

Evaluación de intervención de alertas para riesgo cardiovascular por diclofenaco en afiliados al régimen contributivo 2014 -2015

El objetivo fue evaluar la intervención de las alertas en la prescripción de diclofenaco. Estudio observacional, comparativo, post intervención, de un antes después, en pacientes con prescripción de diclofenaco. Se evaluó la intervención de las alertas restrictivas antes y después de su implementación en los pacientes prescritos con diclofenaco y que tenían asociado un diagnóstico de riesgo cardiovascular según CIE 10 o eran mayores de 65 años. Un total de 315.135 transacciones con prescripción de diclofenaco, en 49.355 pacientes promedio mes. El 94,8% (298.674) de las transacciones fueron prescritas por médicos generales.

Pooled analysis of recent studies on magnetic fields and childhood leukaemia

BACKGROUND: Previous pooled analyses have reported an association between magnetic fields and childhood leukaemia. We present a pooled analysis based on primary data from studies on residential magnetic fields and childhood leukaemia published after 2000. METHODS: Seven studies with a total of 10 865 cases and 12 853 controls were included. The main analysis focused on 24-h magnetic field measurements or calculated fields in residences. RESULTS: In the combined results, risk increased with increase in exposure, but the estimates were imprecise. The odds ratios for exposure categories of 0.1-0.2 mu T, 0.2-0.3 mu T and >= 0.3 mu T, compared with <0.1 mu T, were 1.07 (95% Cl 0.81-1.41), 1.16 (0.69-1.93) and 1.44 (0.88-2.36), respectively. Without the most influential study from Brazil, the odds ratios increased somewhat. An increasing trend was also suggested by a nonparametric analysis conducted using a generalised additive model. CONCLUSIONS: Our results are in line with previous pooled analyses showing an association between magnetic fields and childhood leukaemia. Overall, the association is weaker in the most recently conducted studies, but these studies are small and lack methodological improvements needed to resolve the apparent association. We conclude that recent studies on magnetic fields and childhood leukaemia do not alter the previous assessment that magnetic fields are possibly carcinogenic. British Journal of Cancer (2010) 103, 1128-1135. doi: 10.1038/sj.bjc.6605838 www.bjcancer.com (c) 2010 Cancer Research UK

A reconstrução do marco regulatório do sistema financeiro do Brasil: os mercados de capitais, de seguros e previdência privada

The major objective of this paper is to identify, in the light of economic theory and of recent Brazilian and foreign institutional experiences, the best alternative for the reform of the regulatory framework of the domestic financial system, encompassing capital markets, insurance and private complementary social welfare. This paper is divided into four sections: in the first part, we identify the changes in the international and domestic financial systems, currently in an accelerated process of integration (search for similar rules and standards) and convergence (leveling of operational procedures). Next, we evaluate the potential impact of this new environment upon Brazilian economic development. In the second part, we analyze the concept of financial markets efficiency, where a contractualist view of the relationship involving suppliers and consumers of financial services is exposed. We also identify the major differences of focus among the several trends of regulation of the capital markets, insurance and private complementary social welfare In the third part, we present the concepts and the functions of a typical regulatory agency and alternative models of market regulation. In particular, we explore the differences between a regulatory model in which there are several regulatory agencies, each acting in segmented markets, as opposed to one in which there is single agency that regulates, supervises and oversees ali the indicated markets. In the forth and last part, we analyze the Brazilian case, attempting to identify, in the view of economic theory and recent experiences in other countries of the world, the best alternative for reforming present legislation. The basic recommended conclusion is to undertake studies that lead to the establishment of a single regulatory agency, congregating the functions currently performed by the Brazilian Securities Commission (CVM), the Superintendency of Private Insurance (Susep) and the Secretariai of Complementary Welfare (SPC).

Uma Análise dos impactos da privatização da Light sob o enfoque da agência reguladora e do consumidor

The objective of this work is identify the impacts of the Light privatization under the consumer point of view, with special focus to the service's quality, verifying the channels introduced by Light to measure the consumer satifaction and evaluate how the consumers interests have influence on the company's decisions. This study also objective to identify the main challenges faced by the Regulatory Agency and the Brazilian State on the new relationship model implementation STATE - CONSUMER - CONCESSIONARY, propoused to the energy sector after the privatization. A descriptive methodology is used to identify the most significant changes on the Light's trasition process to the private administration, followed by an explicative investigation to find how the consumer has passed throught this change, based on bibliographical research and interviews. The obtained conclusions shows that the impacts of the Light privatization under the consumer point of view are positive and highlights that the Regulatory Agency has to have the power and autonomy to control and advice the conncessionaries, building consulte and evaluation mechanisms to activate the consumer participation.

Um desafio para a regulação do mercado de assistência à saúde no Brasil: a escolha do consumidor de planos de saúde

The objective of this dissertation is to discover and to analyze the way how the consumer uses his/her perception to decide contracting a health plan, to supply elements that can serve to subsidize the State, the market and the consumers, in relation to the knowledge on the process of choice of the consumer and the decisions of purchase and contracting services of private health. The estimated one is to evidence that the brand of health plan is an important variable and decisive to the consumer contracting the service of a company that operates in these sector, because mean for the consumer security about the product, through the symbolism that the same one represents, despite the consumer not knowing to the certainty what is contracting in quality and amount. The theoretical construction is carried through using literature of anthropology of the consumption, theory of modernity, theory of the regulation, economic utilitarism, and marketing. Moreover, referential specific theoretician on the regulation of the market of health plans in Brazil. The health plan market in Brazil is anti-symmetrical and the consumer doesn¿t have knowledge technician who makes possible it to form judgment and to carry through rationality choices. Than the consumer uses to his/her decision symbolic elements that are available to his/her and supply to his/her the security that is look likes in the consumption of this kind of good. These symbolic elements related the confidence and security and are into the strong brands of the companies and are transmitted to the consumer through the mass media. In this dissertation are used as sources of data some information of the regulatory agency of the sector ¿ ANS -, a research of public opinion with health plans users and the results of the application of proper questionnaires for this research.

O debate sobre reformas e regulação e o caso da ANEEL

Este trabalho tem como objetivo verificar em que medida a flexibilização da gestão de recursos humanos na agência reguladora do setor elétrico brasileiro é consistente com a independência regulatória, entendida como autonomia de gestão nas dimensões financeira, técnica e de recursos humanos. A independência das agências reguladoras constitui mecanismo contra os efeitos negativos das ações de interesses privados, ou rent-seekers, e o uso político inadequado, gerador de ineficiências econômicas. O trabalho descreve o processo de constituição da diretoria colegiada, o regime e o quadro de pessoal vigente, e analisa o processo de reestruturação do setor elétrico brasileiro, concluindo que a contratação temporária e a tentativa de implementar regime jurídico diferenciado repete os equívocos e disfunções que caracterizaram a burocracia pública desde os anos trinta.