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.

A qualidade da regulação estatal no Brasil: uma análise a partir de indicadores de qualidade

As primeiras agências reguladoras foram criadas a partir da segunda metade dos anos 1990, e a mais recente delas, em 2005. Com as agências surgiram também os atores privados regulados, os usuários e consumidores, e uma nova forma de interação entre os Poderes Executivo, Legislativo e Judiciário. Esses atores participam e dão forma ao processo de aprendizagem institucional das agências. Passado o período de criação e após quase duas décadas de existência, é necessária uma visão crítica sobre as agências. Propõe-se, então, um método de avaliação regulatória a partir de três variáveis que serão decompostas em diversas subvariáveis (quesitos a serem respondidos objetivamente). A primeira variável, institucionalização, mede as regras aplicáveis à própria agência: características dos mandatos dos dirigentes, autonomia decisória, autonomia financeira e de gestão de pessoal. A segunda, procedimentalização, ocupa-se do processo de tomada de decisão da agência e de sua transparência. Ambas as variáveis procuram medir as agências do ponto de vista formal, a partir de normas aplicáveis (leis, decretos, resoluções, portarias etc.), e pela prática regulatória, com base nos fatos ocorridos demonstrados por meio de documentos oficiais (decretos de nomeação, decisões, relatórios de atividade das próprias agências etc.). A última variável, judicialização, aponta as várias vezes em que a decisão administrativa muda de status e o nível de confirmação dessas decisões pelo Poder Judiciário. O modelo teórico de avaliação das agências ora apresentado é aplicado e testado em três setores que são submetidos à regulação econômica e contam com forte presença de atores sociais e empresa estatal federal. Assim, as agências analisadas foram: Agência Nacional de Energia Elétrica ANEEL, Agência Nacional de Telecomunicações ANATEL e Agência Nacional de Aviação Civil ANAC. Em termos gerais, não é possível garantir a existência de um isoformismo entre essas agências, nem mesmo entre agências criadas em momentos diferentes e por presidentes distintos. Também não foi possível demonstrar que a interferência política seja uma marca de um único governo. A ANATEL, a melhor avaliada das três agências, destaca-se pelo rigor de suas normas que seu processo decisório reflete. A ANEEL e a ANAC tiveram uma avaliação mediana já que apresentaram avaliação sofrível quanto ao processo, mas mostraram ter instituições (regras) um pouco melhores.

El futuro de la regulación del sector del abastecimiento en España

La gestión del servicio de abastecimiento de agua es un tema de muy relevante y de plena actualidad, no solo en España sino a nivel mundial. En España, desde la forma de prestación del servicio a través de la gestión directa o la gestión indirecta, o el tipo en sí de gestión indirecta que se desarrolle –empresa privada, pública o mixta- dan como resultado prácticamente tantas situaciones como ayuntamientos existen ya que la competencia es municipal, según reconoce la Ley de Bases de Régimen Local. La heterogeneidad de circunstancias de gestión de los recursos hídricos, la fragmentación de un sector clave y la falta de indicadores comparables entre diferentes opciones para la prestación de este servicio, parece indicar la necesidad de apostar por la creación de un ente regulador independiente dada la naturaleza monopolística del sector del abastecimiento y el saneamiento, junto con el carácter esencial del bien que se gestiona. Mientras que las instituciones gubernamentales dictan las políticas generales a través de leyes y reglamentos, los operadores -públicos, privados o mixtos- son los responsables de prestar los servicios a la población, y sería el órgano regulador quien velaría por el cumplimiento de las normas. El MAGRAMA está estudiando la posibilidad de elaborar una Ley sobre el Ciclo Integral del Agua de Uso Urbano con las dificultades que esto tiene en consideración a las competencias de las Comunidades Autónomas, lo que sin duda ayudaría a homologar la gestión del agua urbana en España, regulando un monopolio natural, ahora en manos de más de 8.100 municipios y un reducido número de empresas concesionarias, auténticas detentadoras de estos servicios. En este trabajo tratamos de analizar las ventajas que supondría para España contar con una agencia de regulación similar a las existentes en numerosos países, tanto europeos como de América Latina.

Mixed Public-Private Enterprises in Europe: Economic Theory and an Empirical Analysis of Italian Water Utilities. Bruges European Economic Research (BEER) Papers 4/July 2006

Mixed enterprises, which are entities jointly owned by the public and private sector, are spreading all over Europe in local utilities. Well aware that in the vast majority of cases the preference of local authorities towards such governance structure is determined by practical reasons rather than by the ambition to implement new regulatory designs (an alternative to the typical “external” regulation), our purpose is to confer some scientific value to this phenomenon which has not been sufficiently investigated in the economic literature. This paper aims at proposing an economic analysis of mixed enterprises, especially of the specific configuration in which the public partner acts as controller and the private one (or “industrial” partner) as service provider. We suggest that the public service concession to mixed enterprises could embody, under certain conditions, a noteworthy substitute to the traditional public provision and the concession to totally private enterprises, as it can push regulated operators to outperform and limit the risk of private opportunism. The starting point of the entire analysis is that ownership allows the (public) owner to gather more information about the actual management of the firm, according to property rights theory. Following this stream of research, we conclude that under certain conditions mixed enterprises could significantly reduce asymmetric information between regulators and regulated firms by implementing a sort of “internal” regulation. With more information, in effect, the public authority (as owner/controller of the regulated firm, but also as member of the regulatory agency) can stimulate the private operator to be more efficient and can monitor it more effectively with respect to the fulfilment of contractual obligations (i.e., public service obligations, quality standards, etc.). Moreover, concerning the latter function, the board of directors of the mixed enterprise can be the suitable place where public and private representatives (respectively, welfare and profit maximisers) can meet to solve all disputes arising from incomplete contracts, without recourse to third parties. Finally, taking into account that a disproportionate public intervention in the “private” administration (or an ineffective protection of the general interest) would imply too many drawbacks, we draw some policy implications that make an equitable debate on the board of the firm feasible. Some empirical evidence is taken from the Italian water sector.

Report of recommendations, 1983.

Issued pursuant to Section 9 of the "Regulatory Agency Sunset Act."

A Study of Shallow Groundwater Migration through Anthropogenic Fill along a Seawall

This report provides the findings and opinions of a historical document review, hydraulic balance calculation, and proposed additional study for a property that was historically used as a bulk petroleum storage and distribution facility. The property lies along the base, west, of a heavily vegetated bluff with a tidally influenced body of water west-adjacent to the property. The western portion of the property is bounded by a seawall spanning approximately 3,200 linear feet trending north-south. The seawall’s construction details are not known, save for a 225-foot section of driven sheet pile wall located within the northern portion of the property’s seawall. Due to the presence of petroleum hydrocarbons in soil and groundwater at the property, a cleanup action for the property will likely be overseen by the state regulatory agency. The property is currently undergoing remedial investigation in an effort to identify the lateral and vertical extent in which contaminants at the property have come to be located, also known as the “site” as defined by the Model Toxics Control Act (MTCA). The majority of the property bounded within the seawall area has been characterized; however, the shoreline sediments located immediately west-adjacent of the seawall have not been properly delineated. Identifying the bounds of the site to the west within sediment is pivotal for the purposes of the remedial investigation. Since the west-adjacent shoreline is so extensive, conducting a complete sediment sampling event along the entire shoreline would be cost-prohibitive due to analytical costs and logistical issues at the property. Because of the extensive nature of the shoreline, it would greatly benefit the client and project to focus sampling efforts at areas of greater risk for contaminants along the shoreline by identifying potential preferential pathways for contaminants to migrate off of the property and into adjacent shoreline sediments. The review of historical studies of the property yielded some useful information; however much of the findings included within the historical studies were lacking original raw data, therefore limiting the information obtained. The calculated hydraulic balance for the property yielded a relatively large surplus of recharge to groundwater after precipitation events, reinforcing the concept that contaminant have potentially historically, and currently, been migrating into the adjacent shoreline through preferential pathways along the seawall. Due to the limitation within the historical studies for the property as well as the groundwater recharge identified in the hydraulic balance, an additional study was proposed in an effort to provide additional aquifer characteristics along the seawall, and the ability to observe flow propagation at and proximate to the seawall in two-dimensions through time without the need to piece separate studies together. This proposed study includes a single simultaneous tidal study which comprises select monitoring points along the seawall. This report has identified the need for additional data that can be collected through available avenues for the property based upon the client’s desires and project needs. Ultimately, the proposed additional study is suggested based upon its relatively low capital investment, and ability meet the requirements relevant to the specific project needs and scope. Assuming preferential pathways are identified through the additional study proposed within this report, a representative and cost-effective sediment sampling plan can then be put in place in an effort to define the site.

Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes

Objectives: To assess the extent of teaching about the Committee on Safety of Medicine's Yellow Card scheme and adverse drug reactions within UK Schools of Medicine and Pharmacy. Methods: A self-completed questionnaire sent to all heads of undergraduate schools of medicine and pharmacy within the UK. Results: The majority of undergraduate syllabuses feature the Yellow Card Scheme. Knowledge of the Yellow Card Scheme was assessed in 79% of pharmacy programmes and 57% of medical schools. Specialist speakers on the Yellow Card Scheme were infrequently used. Fewer than half of respondents provided students with a guide to reporting ADRs (43% pharmacy and 43% medical). There is some disagreement about the value of supplying students with printed material about the Yellow Card Scheme. Half of medical Schools did not think that supplying 'Current Problems In Pharmacovigilance' would be useful. Conclusions: It was found that in both medicine and pharmacy, courses differed substantially in teaching about the Yellow Card Scheme and adverse drug reactions (ADRs). There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education, in line with recommendations from the National Audit Office.

Políticas de geração distribuída e sustentabilidade do sistema elétrico

Tese (doutorado)—Universidade de Brasília, Centro de Desenvolvimento Sustentável, 2015.

A regulação diante da evolução da essencialidade do serviço público : a reclassificação da banda larga como serviço de telecomunicações nos Estados Unidos

Dissertação (mestrado)—Universidade de Brasília, Faculdade de Direito, Programa de Pós-Graduação em Direito, 2016.

The OHS regulatory challenges posed by agency workers: evidence from Australia

The purpose of this research is to analyse the problems for occupational health and safety (OHS)regulators posed by agency work/leased labour (also known as labour hire in Australasia), using Australian evidence. The analysis is based on an examination of prosecutions involving labour hire firms along with other documentary records (union, industry and government reports and guidance material). The study also draws on interviews with approximately 200 regulatory officials, employers and union representatives since 2001 and workplace visits with 40 OHS inspectors in 2004‐2005.The triangular relationship entailed in labour leasing, in combination with the temporary nature of most placements, poses serious problems for government agencies in terms of enforcing OHS standards notwithstanding a growing number of successful prosecutions for breaches of legislative duties by host and labour leasing firms. Research to investigate these issues in other countries and compare findings with those for Australia is required, along with assessing the effectiveness of new enforcement initiatives. The paper assesses existing regulatory responses and highlights the need for new regulatory strategies to combat the problems posed by labour. The OHS problems posed by agency work have received comparatively little attention. The paper provides insights into the specific problems posed for OHS regulators and how inspectorates are trying to address them.

The role of rules-based compliance systems in the new EU regulatory landscape: perspectives of institutional change and agency

The financial crisis of 2007-2009 and the subsequent reaction of the G20 have created a new global regulatory landscape. Within the EU, change of regulatory institutions is ongoing. The research objective of this study is to understand how institutional changes to the EU regulatory landscape may affect corresponding institutionalized operational practices within financial organizations and to understand the role of agency within this process. Our motivation is to provide insight into these changes from an operational management perspective, as well as to test Thelen and Mahoney?s (2010) modes of institutional change. Consequently, the study researched implementations of an Investment Management System with a rules-based compliance module within financial organizations. The research consulted compliance and risk managers, as well as systems experts. The study suggests that prescriptive regulations are likely to create isomorphic configurations of rules-based compliance systems, which consequently will enable the institutionalization of associated compliance practices. The study reveals the ability of some agents within financial organizations to control the impact of regulatory institutions, not directly, but through the systems and processes they adopt to meet requirements. Furthermore, the research highlights the boundaries and relationships between each mode of change as future avenues of research.

The EU’s Choice of Regulatory Venues for Trade Negotiations: A Tale of Agency Power?

This article focuses on the EU’s strategy for choosing regulatory venues to negotiate trade agreements. It analyses the existence of a clear venue hierarchy since the late 1990s and the recent change leading to a blurring of any clear preference for using bilateral, inter-regional or multilateral settings. The article challenges domestic explanations of the EU’s choice of venue, stressing the autonomy of the Commission as a major factor. Using a principal-agent framework, it shows that the Commission’s agenda-setting powers, the existence of interest divergence among principals (e.g. Member States, business groups) and the multi-level system facilitate agency.

Examining a key aspect of agency-to-business relationships:the effects of regulatory control on the satisfaction of regulated firms

This paper studies an overlooked, but highly important relationship, the relationship that exists between regulatory agencies (e.g., the EPA, OSHA, and the FDA) and the for-profit businesses they attempt to govern. Drawing on business-to-business control and satisfaction research, a framework is developed to understand how regulatory control influences the satisfaction levels of customer firms. Regulatory control is disaggregated into four distinct facets: the controlling agency, the rules and regulations of control, the processes used by the agency to apply the regulations, and sanctions. Each facet is hypothesized to have an effect on satisfaction. A regulator's administration of state food safety regulations provides the empirical context for testing the hypotheses. Results from a survey of 173 restaurants provide empirical support for the conceptual model. Most importantly, the study finds that the informal control process increases customer satisfaction, while the formal control process decreases customer satisfaction. We discuss how these and other findings may contribute to more effective agency-to-business relationships and ongoing research.

Does institutional location protect from political influence? the case of a minimum labour standards enforcement agency in Australia

Among the many factors that influence enforcement agencies, this article examines the role of the institutional location (and independence) of agencies, and an incumbent government's ideology. It is argued that institutional location affects the level of political influence on the agency's operations, while government ideology affects its willingness to resource enforcement agencies and approve regulatory activities. Evidence from the agency regulating minimum labour standards in the Australian federal industrial relations jurisdiction (currently the Fair Work Ombudsman) highlights two divergences from the regulatory enforcement literature generally. First, notions of independence from political interference offered by institutional location are more illusory than real and, second, political need motivates political action to a greater extent than political ideology.

Institutional, policy and regulatory framework for sustainable development of the Egyptian aquaculture sector

This report presents the findings of a mission to critically review the institutional, policy and regulatory framework for sustainable development of the Egyptian aquaculture sector. The study was undertaken by an International Expert on Aquaculture Policy, and a National Expert on Institutions, on behalf of the Project “Improving Employment and Income through the Development of Egypt’s Aquaculture Sector“, implemented by WorldFish and CARE, and funded by the Swiss Agency for Development and Cooperation(SDC). The objective of the mission was to assess the current status of the Egyptian aquaculture sector, in terms of the policy, legal and institutional environment, with a view to suggesting the major issues to be addressed within a future policy dialogue.