Regulatory ambivalence and the limitations of pharmaceutical policy in Spain

Broadly speaking, pharmaceutical policy in Spain has been unable to control either the price or thevolume of drugs prescribed. Limited attempts have been made to bring together the regulation of thepharmaceutical market and policies, in pursuit of the desired goals of efficiency and quality. Thispaper assesses the regulation of the Spanish pharmaceutical market over the last two decades byexamining regulation and policy and the available empirical evidence on their appreciable effects,and presents recommendations for policy design. Our findings suggest that policies aiming to improveefficiency and quality have not managed to contain costs, while cost-effectiveness is still overlooked.We argue that future policies should encourage broader participation in the decision-making processesand promote a higher degree of competition, especially from generic drugs.

OS CONTRACTOS DE CONCESSÃO NO CONTEXTO DO SISTEMA DE NORMALIZAÇÃO CONTABILÍSTICA E DE RELATO FINANCEIRO

A mudança do normativo contabilístico ocorrido em 2009, alterou o paradigma de reconhecimento e mensuração de activos. Embora a natureza das operações contínua presente no processo contabilístico, muitas coisas foram alteradas tendo em conta a substância da informação e a sua realidade económica. O caso dos contratos de concessão é disto um bom exemplo. Há casos em que no normativo anterior eram reconhecidos como activos fixos tangíveis e actualmente são reconhecidos como intangíveis. O estudo em causa tem como objetivo principal analisar o conceito dos contratos de concessão, bem como os procedimentos para o reconhecimento, mensuração e divulgação nas demonstrações financeiras. Considerados activos intangíveis (de facto a entidade acaba por ter um “Direito” de explorar um determinado activo), o processo contabilístico é feito a luz do disposto na Norma de Relato Financeiro nº6 – Activos Intangíveis. Os contractos de concessão apresentam especificidades próprias e por esta razão o IASB emitiu uma IFRIC (nº 12) com o objectivo de clarificar o tratamento contabilístico desta problemática. Não existindo no normativo nacional tal norma interpretativa as empresas nacionais que convivem com esta realidade vêem-se na contingência de, supletivamente, recorrer às normas internacionais de contabilidade para resolver o assunto. É o caso da ELECTRA para os activos afectos a distribuição. Neste sentido, o estudo debruça sobre esta problemática, apresenta um enquadramento teórico, analisar os principais aspectos de reconhecimento a luz dos dois normativos contabilísticos nacionais (o antigo Plano Nacional de Contabilidade e o actual Sistema de Normalização Contabilística e de Relato Financeiro) e termina utilizando as informações da ELECTRA, SARL para ilustrar este processo de reconhecimento contabilístico. The change of a the accounting regulatory occurred in 2009, changed the paradigm for recognizing and measuring assets. Although the continuous nature of the operations in this accounting process, many things have changed in view of the substance of information and its economic reality. The case of concession contracts, it is a good example. There are cases where the former were recognized as legal and tangible fixed assets are currently recognized as intangible assets. The study is aimed to analyzing the concept of concession contracts, as well as procedures for the recognition, measurement and disclosure in the financial statements. Considered intangible assets (in fact the entity turns out to have a “right” to exploit a particular asset) the accounting process is done in light of the provisions of Financial Reporting Standard No. 6 – Intangible Assets. The concession contracts have specific characteristics and for this reason the IASB issued IFRIC one (Ner. 12 ) in order to clarify the accounting treatment of this problem. In the absence of such a standard national regulatory interpretative national companies that live with this reality find themselves in contingency, additionally, make use of international accounting standards to resolve the matter. ELECTRA is the case of the assets connected to the distribution. In this sense, the study focuses on this issue, presents a theoretical framework to analyze the main aspects of recognition light of both national accounting standards (formerly the National Accounting Standards and the current system of accounting and financial reporting) and ends up using the information the Electra SARL to illustrate this process of accounting recognition.

Regulatory B cells shape the development of Th2 immune responses in BALB/c mice infected with Leishmania major through IL-10 production.

Recent evidence indicates that B cells are required for susceptibility to infection with Leishmania major in BALB/c mice. In this study, we analyzed the role of the IL-10 produced by B cells in this process. We showed that B cells purified from the spleen of BALB/c mice produced IL-10 in response to stimulation with L. major in vitro. In vivo, early IL-10 mRNA expression is detected after L. major infection in B cells from draining lymph nodes of susceptible BALB/c, but not of resistant C57BL/6 mice. Although adoptive transfer of naive wild-type B cells prior to infection in B cell-deficient BALB/c mice restored Th2 cell development and susceptibility to infection with L. major of these otherwise resistant mice, adoptive transfer of IL-10(-/-) B cells mice did not. B cells stimulated by L. major, following in vitro or in vivo encounter, express the CD1d and CD5 molecules and the IL-10 produced by these cells downregulate IL-12 production by L. major-stimulated dendritic cells. These observations indicate that IL-10 secreting B cells are phenotypically and functionally regulatory B cells. Altogether these results demonstrate that the IL-10 produced by regulatory CD1d+ CD5+ B cells in response to L. major is critical for Th2 cell development in BALB/c mice.

A house price index defined in the potential outcomes framework

Current methods for constructing house price indices are based on comparisons of sale prices of residential properties sold two or more times and on regression of the sale prices on the attributes of the properties and of their locations. The two methods have well recognised deficiencies, selection bias and model assumptions, respectively. We introduce a new method based on propensity score matching. The average house prices for two periods are compared by selecting pairs of properties, one sold in each period, that are as similar on a set of available attributes (covariates) as is feasible to arrange. The uncertainty associated with such matching is addressed by multiple imputation, framing the problem as involving missing values. The method is applied to aregister of transactions ofresidential properties in New Zealand and compared with the established alternatives.

Active civic participation of immigrants in Portugal

Portugal’s historical past strongly influences the composition of the country’s immigrant population. The main third-country foreign nationals in Portugal originate traditionally from Portuguese-speaking African countries (namely Cape Verde, Angola, Guinea Bissau, and S. Tomé e Príncipe) and Brazil. In 2001, a newly created immigrant status entitled “permanence” authorization uncovered a quantitative and a qualitative change in the structure of immigrant population in Portugal. First, there was a quantitative jump from 223.602 foreigners in 2001 to 364.203 regularized foreigners in 2003. Secondly, there was a substantial qualitative shift in the composition of immigrants. The majority of the new immigrants began coming from Eastern European countries, such as Ukraine, Moldavia, Romania, and the Russian Federation. Thus, European countries outside the E.U. zone now rank second (after African countries) in their contribution of individuals to the stocks of immigrant population in Portugal. The differences between the new and traditional immigration flows are visible in the geographical distribution of immigrants and in their insertion into the labour market. While the traditional flows would congregate around the metropolitan area of Lisbon and in the Algarve, the new migratory flows tend to be more geographically dispersed and present in less urbanized areas of Portugal. In terms of insertion in the labour market, although the construction sector is still the most important industry for immigrant labour, Eastern European workers may also be found in the agriculture and manufacturing sectors. The institutional conditions that encourage immigrants’ civic participation are divided at three different levels: the state, the local, and the civil society levels. At the state level, the High Commissioner for Migrations and Ethnic Minorities is the main organizational structure along with a set of interrelated initiatives operating under specific regulatory frameworks, which act as mediators between state officials and the Portuguese civil society, and more specifically, immigrant communities. At the local level, some municipalities created consultative councils and municipal departments aiming at encouraging the participation and representation of interests from immigrant groups and association in local policies. In the civil society sphere, the main actors in Portugal spurring immigrants civic participation are immigrant associations, mainstream associations directed toward immigration topics, and unions. The legal conditions framing immigrants’ access to social housing, education, health, and social security in Portugal are also considered to be positive. Conditions restricting immigrants’ civic participation are mainly normative and include the Portuguese nationality law, the regulations shaping the political participation of immigrants, namely in what concerns their right to vote, and employment regulations restricting immigrants’ access to public administration positions. Part II of the report focuses on the active civic participation of third country immigrants. First, reasons for the lack of research on this issue in Portugal are explained. On the one hand, the recent immigration history and the more urgent needs regarding school and economic integration kept this issue out of the research spotlight. On the other hand, it was just in the beginning of the 1990s that immigrants took the very first steps toward collective mobilisation. Secondly, the literature review of Portuguese bibliography covers research on third country immigrants’ associative movement, research on local authorities’ policies and discussion about ethnic politics and political mobilisation of immigrants in Portugal. As political mobilisation of these groups has been made mainly through ethnic and/or migrant organisations, a brief history of immigrants' associative movement is given. Immigrant associations develop multiple roles, covering the social, the cultural, the economic and the political domains. Political claiming for the regularisation of illegal immigrants has been a permanent and important field of intervention since the mid-1990s. Research results reveal the com5 plex relations between ethnic mobilisation and the set of legal and institutional frameworks developed by local and national governmental authorities targeted to the incorporation of minority groups. Case studies on the Oeiras district and on the Amadora district are then presented. Conclusions underline that the most active immigrant groups are those from Cape Verde and Guinea Bissau, since these groups have constituted a higher number of ethnic associations, give priority to political claiming and present a more politicised discourse. Reflecting on the future of research on civic participation of third country immigrants in Portugal, the authors state that it would be interesting and relevant to compare the Portuguese situation with those of other European countries, with an older immigration history, and analyse how the Portuguese immigrants’ associative movement will be affected by a changing legal framework and the emergence of new opportunities within the set of structures regarding the political participation of minority groups.

Regulação do sector farmacêutico em Cabo Verde: o desafio da criação de uma agência de regulação

O medicamento é uma tecnologia cuja importância é indiscutível seja para a saúde, como enquanto factor económico de crescimento e desenvolvimento. A sua regulação está fundamentada acrescidos os factores da sua essencialidade, da assimetria de informação, da cadeia de intermediários, dos interesses financeiros, dos requisitos para a demonstração de eficácia e segurança e as normas para promover a sua utilização eficiente. O Estado tem diversas abordagens possíveis para a regulação farmacêutica que implica sempre a existência de uma estrutura orgânica que assuma as atribuições de forma eficaz e eficiente. Este trabalho discute o modelo de regulação farmacêutica para as condições específicas de Cabo Verde usando como linhas de pesquisa (1) o enquadramento geral da prática de regulação a nível internacional, as recomendações da OMS e os países de referência no âmbito da Comunidade dos Países de Língua Oficial Portuguesa para procurar caracterizar esse processo, identificar as diferenças entre a regulação implementada em países mais desenvolvidos e os países em desenvolvimento e decidir se as agências de regulação podem ser vistas como uma transferência de tecnologia de gestão; (2) o modelo de institucionalização da regulação farmacêutica previsto para Cabo Verde e aquele que foi na prática implementado, com ênfase nas competências, estratégia de intervenção e constrangimentos, para por fim (3) proceder-se à elaboração de uma apreciação crítica, sob o pano de fundo da harmonização técnica e normativa, retomando as recomendações da OMS, a prática internacional neste contexto, corporizada pelos casos da experiência no Brasil e em Portugal e o modelo conceptualizado, relacionando as disparidades com os constrangimentos identificados. Feita a apreciação crítica propõe-se um novo modelo de regulação fazendo referência à revisão dos estatutos da autoridade reguladora e a alterações do figurino institucional.

Plasmacytoid dendritic cells promote immunosuppression in ovarian cancer via ICOS costimulation of Foxp3(+) T-regulatory cells.

Epithelial ovarian cancer (EOC) is the fifth most common cause of cancer death among women. Despite its immunogenicity, effective antitumor responses are limited, due, in part, to the presence of forkhead box protein 3-positive (Foxp3(+)) T regulatory (Treg) cells in the tumor microenvironment. However, the mechanisms that regulate the accumulation and the suppressive function of these Foxp3(+) Treg cells are poorly understood. Here, we found that the majority of Foxp3(+) Treg cells accumulating in the tumor microenvironment of EOCs belong to the subset of Foxp3(+) Treg cells expressing inducible costimulator (ICOS). The expansion and the suppressive function of these cells were strictly dependent on ICOS-L costimulation provided by tumor plasmacytoid dendritic cells (pDC). Accordingly, ICOS(+) Foxp3(+) Treg cells were found to localize in close vicinity of tumor pDCs, and their number directly correlated with the numbers of pDCs in the tumors. Furthermore, pDCs and ICOS(+) Foxp3(+) Treg cells were found to be strong predictors for disease progression in patients with ovarian cancer, with ICOS(+) Treg cell subset being a stronger predictor than total Foxp3(+) Treg cells. These findings suggest an essential role for pDCs and ICOS-L in immunosuppression mediated by ICOS(+) Foxp3(+) Treg cells, leading to tumor progression in ovarian cancer.

Indoleamine 2,3-dioxygenase-expressing mature human monocyte-derived dendritic cells expand potent autologous regulatory T cells.

A comprehensive understanding of the complex, autologous cellular interactions and regulatory mechanisms that occur during normal dendritic cell (DC)-stimulated immune responses is critical to optimizing DC-based immunotherapy. We have found that mature, immunogenic human monocyte-derived DCs (moDCs) up-regulate the immune-inhibitory enzyme, indoleamine 2,3-dioxygenase (IDO). Under stringent autologous culture conditions without exogenous cytokines, mature moDCs expand regulatory T cells (Tregs) by an IDO-dependent mechanism. The priming of resting T cells with autologous, IDO-expressing, mature moDCs results in up to 10-fold expansion of CD4(+)CD25(bright)Foxp3(+)CD127(neg) Tregs. Treg expansion requires moDC contact, CD80/CD86 ligation, and endogenous interleukin-2. Cytofluorographically sorted CD4(+) CD25(bright)Foxp3(+) Tregs inhibit as much as 80% to 90% of DC-stimulated autologous and allogeneic T-cell proliferation, in a dose-dependent manner at Treg:T-cell ratios of 1:1, 1:5, and as low as 1:25. CD4(+)CD25(bright)Foxp3(+) Tregs also suppress the generation of cytotoxic T lymphocytes specific for the Wilms tumor antigen 1, resulting in more than an 80% decrease in specific target cell lysis. Suppression by Tregs is both contact-dependent and transforming growth factor-beta-mediated. Although mature moDCs can generate Tregs by this IDO-dependent mechanism to limit otherwise unrestrained immune responses, inhibition of this counter-regulatory pathway should also prove useful in sustaining responses stimulated by DC-based immunotherapy.

Biodiesel Facility Regulatory Assistance Guide, 2008

This guide is a general outline for bio diesel facilities on potential regulatory requirements and regulatory agency approval times. Much of the information is related to environmental permitting by the Iowa Department of Natural Resources (IDNR). Your facility’s permit requirements may differ depending upon the specific operations planned. Information is also provided about regulatory requirements administered by the Iowa Workforce Development, Labor Services Division and the Iowa Department of Public Safety, Fire Marshal Division. Requirements established by local units of government may also apply. Be sure to contact the city in which the facility will be located or the county if the facility is not located in a city, to identify these requirements.

Ethanol Facility Regulatory Assistance Guide, May 19, 2008

This guide is a general outline for ethanol facilities on potential regulatory requirements and regulatory agency approval times. Much of the information is related to environmental permitting by the Iowa Department of Natural Resources (IDNR). Your facility’s permit requirements may differ depending upon the specific operations planned. Information is also provided about regulatory requirements administered by the Iowa Workforce Development, Labor Services Division and the Iowa Department of Public Safety, Fire Marshal Division. Requirements established by local units of government may also apply. Be sure to contact the city in which the facility will be located or the county if the facility is not located in a city, to identify these requirements.

Propane Regulatory Assistance Guilty,

This fact sheets summarizes, in brief form, the compliance requirements for transportation, storage, handling and use of propane. It is not intended to provide comprehensive guidance on regulatory compliance for those dealing with propane, but to highlight those requirements and to assist those who may be affected by the various requirements to obtain detailed information when needed. Information about requirements which apply to the use of propane as a motor fuel is not included.

Regulatory Assistance, March 12, 2009

The Iowa Business and Regulatory Assistance Network ensures access and responsiveness to inquiries and requests for assistance from citizens, small business, industry and local governments. Facilitated by the Iowa Department of Economic Development (IDED), Business Assistance Coordinators in agencies across state government coordinate regulatory response and service. You may contact IDED or any of the agency contacts listed in this publication for assistance.

Pre-Mesozoic Alpine basements - Their place in the European Paleozoic framework

Prior to their Alpine overprinting, most of the pre-Mesozoic basement areas in Alpine orogenic structures shared a complex evolution, starting with Neoproterozoic sediments that are thought to have received detrital input from both West and East Gondwanan cratonic sources. A subsequent Neoproterozoic-Cambrian active margin setting at the Gondwana margin was followed by a Cambrian-Ordovician rifting period, including an Ordovician cordillera-like active margin setting. During the Late Ordovician and Silurian periods, the future Alpine domains recorded crustal extension along the Gondwana margin, announcing the future opening of the Paleotethys oceanic domain. Most areas then underwent Variscan orogenic events, including continental subduction and collisions with Avalonian-type basement areas along Laurussia and the juxtaposition and the duplication of terrane assemblages during strike slip, accompanied by contemporaneous crustal shortening and the subduction of Paleotethys under Laurussia. Thereafter, the final Pangea assemblage underwent Triassic and Jurassic extension, followed by Tertiary shortening, and leading to the buildup of the Alpine mountain chain. Recent plate-tectonic reconstructions place the Alpine domains in their supposed initial Cambrian-Ordovician positions in the eastern part of the Gondwana margin, where a stronger interference with the Chinese blocks is proposed, at least from the Ordovician onward. For the Visean time of the Variscan continental collision, the distinction of the former tectonic lower-plate situation is traceable but becomes blurred through the subsequent oblique subduction of Paleotethys under Laurussia accompanied by large-scale strike slip. Since the Pennsylvanian, this global collisional scenario has been replaced by subsequent and ongoing shortening and strike slip under rising geothermal conditions, and all of this occurred before all these puzzle elements underwent the complex Alpine reorganization.