The Brazilian Network for HIV-1 Genotyping External Quality Control Assurance Programme

The Brazilian network for genotyping is composed of 21 laboratories that perform and analyze genotyping tests for all HIV-infected patients within the public system, performing approximately 25,000 tests per year. We assessed the interlaboratory and intralaboratory reproducibility of genotyping systems by creating and implementing a local external quality control evaluation. Plasma samples from HIV-1-infected individuals (with low and intermediate viral loads) or RNA viral constructs with specific mutations were used. This evaluation included analyses of sensitivity and specificity of the tests based on qualitative and quantitative criteria, which scored laboratory performance on a 100-point system. Five evaluations were performed from 2003 to 2008, with 64% of laboratories scoring over 80 points in 2003, 81% doing so in 2005, 56% in 2006, 91% in 2007, and 90% in 2008 (Kruskal-Wallis, p = 0.003). Increased performance was aided by retraining laboratories that had specific deficiencies. The results emphasize the importance of investing in laboratory training and interpretation of DNA sequencing results, especially in developing countries where public (or scarce) resources are used to manage the AIDS epidemic.

Progress in animal experimentation ethics: a case study from a Brazilian medical school and from the international medical literature

PURPOSE: This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. METHODS: The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. RESULTS: The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). CONCLUSIONS: The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Pacta sunt servanda versus the social role of contracts: the case of Brazilian agriculture contracts

This study explores the instability created by contradictory court decisions related with contract breaches. Forward marketing contracts represent an important source of resources to finance Brazilian agriculture, however a large number of contract breaches were observed during a period of marked increase in soy prices. The study analyzed 161 judicial appeal decisions and a survey was carried with 70 farmers. The results show the difference of judges' interpretation and the existence of second order effects. The effects of court decisions were more requirements of guarantees and the reduction in the number of contracts. Those soybean farmers who did not breach their contracts have also been negatively affected by the strategic reactions of trading and processing companies. The concept of "social function of the contract" introduced in Brazilian civil code led to a higher degree of instability in contracts, raising transaction costs and motivating private economic sanctions.

Morphology, mineralogy and micromorphology of soils associated to summit depressions of the Northeastern Brazilian Coastal Plains

The scarcity of comprehensive characterizations of soils associated to gentle summit depressions of the Northeastern Brazilian Coastal Plains justifies this work, which had as objective to provide basic information for the more diverse agricultural and non-agricultural uses. For that, representative soils (Spodosols or similar soils) from these environments were selected in Alagoas, Sergipe and Bahia states. This approach included characterization of morphological, mineralogical and micromorphological properties of the soil profiles, employing standard procedures. The morphological characterization corroborated the effect of the podzolization process during the formation of these soils. The mineralogy of the clay fraction of these soils was basically composed of kaolinite and quartz, which, associated to the very sandy texture, helped in the understanding of the obtained data. The soil micromorphological study, besides confirming the field morphology, mainly in regard to the strong cementation, aggregated value to the work in terms of the secure identification of the clay illuviation process (non-identified in the field), in association with the dominant podzolization process.

Perceived neighborhood problems: multilevel analysis to evaluate psychometric properties in a Southern adult Brazilian population

Abstract Background Physical attributes of the places in which people live, as well as their perceptions of them, may be important health determinants. The perception of place in which people dwell may impact on individual health and may be a more telling indicator for individual health than objective neighborhood characteristics. This paper aims to evaluate psychometric and ecometric properties of a scale on the perceptions of neighborhood problems in adults from Florianopolis, Southern Brazil. Methods Individual, census tract level (per capita monthly familiar income) and neighborhood problems perception (physical and social disorders) variables were investigated. Multilevel models (items nested within persons, persons nested within neighborhoods) were run to assess ecometric properties of variables assessing neighborhood problems. Results The response rate was 85.3%, (1,720 adults). Participants were distributed in 63 census tracts. Two scales were identified using 16 items: Physical Problems and Social Disorder. The ecometric properties of the scales satisfactory: 0.24 to 0.28 for the intra-class correlation and 0.94 to 0.96 for reliability. Higher values on the scales of problems in the physical and social domains were associated with younger age, more length of time residing in the same neighborhood and lower census tract income level. Conclusions The findings support the usefulness of these scales to measure physical and social disorder problems in neighborhoods.

A cátedra UNESCO de direito à educação da Faculdade de Direito: democracia, cidadania e direito à educação

Regimes democráticos se consolidam na medida de sua aceitação pela maioria, o que supõe conhecimento e confiança nas instituições políticas e jurídicas. A educação de qualidade é relevante para a governança democrática e para a formação da cidadania, posto propiciar o acesso a ferramentas cognitivas necessárias para a participação política relevante. As interações entre a democracia, o direito à educação e as políticas públicas de educação são analisadas pela Cátedra UNESCO no projeto de pesquisa “Brasil 25 anos de democracia” sob o ângulo da função promocional do Direito à Educação da FD, em parceria com o Núcleo de Políticas Públicas da USP, com. O foco da pesquisa é a atividade do Supremo Tribunal Federal (STF), a do Superior Tribunal de Justiça (STJ) e a do Congresso Nacional, no período compreendido entre os anos 2000 e 2010.

Risk factors associated with death in Brazilian children with severe dengue: a case-control study

Objective: The purpose of this case-control study was to evaluate risk factors associated with death in children with severe dengue. Methods: The clinical condition of hospitalized patients with severe dengue who died (cases, n = 18) was compared with that of hospitalized patients with severe dengue who survived (controls, n = 77). The inclusion criteria for this study were age under 13 years; hospital admission in São Luis, northeastern Brazil; and laboratory-confirmed diagnosis of dengue. Results: Severe bleeding (hemoptysis), a defining criterion for dengue severity, was the factor most strongly associated with death in our study. We also found that epistaxis and persistent vomiting, both included as warning signs in the World Health Organization (WHO) classification of dengue, were strongly associated with death. No significant association was observed between any of the laboratory findings and death. Conclusions: The finding that epistaxis and persistent vomiting were also associated with death in children with severe dengue was unexpected and deserves to be explored in future studies. Because intensive care units are often limited in resource-poor settings, any information that can help to distinguish patients with severe dengue with a higher risk to progress to death may be crucial.

GERMANY: Creating New Property Rights on the Basis of General Legal Concepts - Without Limits?

In two cases recently decided by two different senates of the German Federal Supreme Court (Bundesgerichtshof, BGH), the following issue was raised: To what extent can the filming of sports events organized by someone else, on the one hand, and the photographing of someone else’s physical property, on the other hand, be legally controlled by the organizer of the sports event and the owner of the property respectively? In its “Hartplatzhelden.de” decision, the first senate of the Federal Supreme Court concluded that the act of filming sports events does not constitute an act of unfair competition as such, and hence is allowed even without the consent of the organizer of the sports event in question. However, the fifth senate, in its “Prussian gardens and parks” decision, held that photographing someone else’s property is subject to the consent of the owner of the grounds, provided the photographs are taken from a spot situated on the owner’s property. In spite of their different outcomes, the two cases do not necessarily contradict each other. Rather, read together, they may well lead to an unwanted – and unjustified – extension of exclusive protection, thus creating a new “organizer’s” IP right.

Swiss Patent Jurisprudence 2012

The new Swiss Federal Patent Court, with nationwide first-instance jurisdiction over all civil patent matters, has been operating since 1 January 2012. This article reviews and contextualizes the most important patent cases the Swiss Federal Patent Court and the Swiss Federal Supreme Court. It concludes that the revamped Swiss patent litigation system has the potential of turning Switzerland into a competitive venue for the adjudication of patent matters in Europe.

Rechtsmittel gegen Entscheide des juge d'appui bei der internationalen Schiedsgerichtsbarkeit der Schweiz

The author examines whether and by which means the decisions handed down by the State judge giving his support to the arbitral proceeding (juge d'appui) may be appealed. Every relevant Article in the PILA (Private International Law Act) is addressed and analyzed in this regard (Art. 179(2) and (3), Art. 180(3), Art. 183(2), Art. 184(3) and Art. 185) by reference to the present legal doctrine and case law. Concerning the stages of appeal, the view is held that by direct or analogous application of Art. 356(2) CPC (Civil Procedure Code) the juge d'appui has jurisdiction as the sole instance of the Canton to render decisions in support of the arbitral tribunal. On the federal level however, the parties shall have the right to appeal against these decisions by filing a civil law appeal before the Swiss Federal Supreme Court, with the exception of most decisions given by juge d'appui within the meaning of Art. 180(3) PILA. As to this federal appeal, it is established that the case law of the Swiss Federal Supreme Court under the FTA (Act on the Federal Tribunal) indicates the Court's inclination to qualify both negative and positive decisions issued by the juge d'appui as final decisions in terms of Art. 90 FTA. In reference to the upcoming revision of the PILA's 12th Chapter the author concludes that the legislator might implement some clarifications in the current legal framework. It seems particularly advisable to ensure that all relevant Articles in the PILA regarding decisions of the juge d'appui explicitly reference to Art. 356(2) CPC. Moreover, the author is of the opinion that it would also be expedient to specify the

Swiss Patent Jurisprudence 2012

The new Swiss Federal Patent Court, with nationwide first-instance jurisdiction over all civil patent matters, has been operating since January 1, 2012. This article reviews and contextualizes the most important patent cases published in 2012 by the Swiss Federal Patent Court and the Swiss Federal Supreme Court. More specifically, the article covers cases on issues such as the evidentiary status of party expert opinions, the formal requirements for requests for injunctive relief, the infringement and non-obviousness tests employed by the Swiss Federal Patent Court, the use of reports and statements from technical judges in lieu of expert opinions, and the procedural devices for the pre-trial taking of evidence, in particular the new patent-specific device of precise description. The author suggests that designing the Federal Patent Court to include technically trained judges may lead to a more automatic adoption of the practices and case law of the European Patent Office. The article concludes that the revamped Swiss patent litigation system has the potential of turning Switzerland into a competitive venue for the adjudication of patent matters in Europe.

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Gestão de informação : O caso das empresas participantes do programa de incubação de empresas daUniversidade Federal de Goiás

The main objective of this paper is to point out the information management strategic profile of companies participating in the program of business incubation of Universidade Federal de Goiás (PROINE-UFG). This new alignment of social network aims to promote the competitiveness of micro and small business by approaching them to the knowledge producers that, in the Brazilian case, are the universities. The strategic information aligning model, proposed by Marchand, was used as the theoretical framework. The research took the design of a case study, as it limited to study the UFG incubation program. Nine companies of PROINE-UFG were investigated. The main conclusions are that the PROINE-UFG companies have a tendency of proactivity. Nevertheless the financial and technological resources are scarce to monitor the external environment as demanded by the strategy. They use few information sources and the interaction with the university is still incipient

Gestão de informação : O caso das empresas participantes do programa de incubação de empresas daUniversidade Federal de Goiás

The main objective of this paper is to point out the information management strategic profile of companies participating in the program of business incubation of Universidade Federal de Goiás (PROINE-UFG). This new alignment of social network aims to promote the competitiveness of micro and small business by approaching them to the knowledge producers that, in the Brazilian case, are the universities. The strategic information aligning model, proposed by Marchand, was used as the theoretical framework. The research took the design of a case study, as it limited to study the UFG incubation program. Nine companies of PROINE-UFG were investigated. The main conclusions are that the PROINE-UFG companies have a tendency of proactivity. Nevertheless the financial and technological resources are scarce to monitor the external environment as demanded by the strategy. They use few information sources and the interaction with the university is still incipient

Gestão de informação : O caso das empresas participantes do programa de incubação de empresas daUniversidade Federal de Goiás

The main objective of this paper is to point out the information management strategic profile of companies participating in the program of business incubation of Universidade Federal de Goiás (PROINE-UFG). This new alignment of social network aims to promote the competitiveness of micro and small business by approaching them to the knowledge producers that, in the Brazilian case, are the universities. The strategic information aligning model, proposed by Marchand, was used as the theoretical framework. The research took the design of a case study, as it limited to study the UFG incubation program. Nine companies of PROINE-UFG were investigated. The main conclusions are that the PROINE-UFG companies have a tendency of proactivity. Nevertheless the financial and technological resources are scarce to monitor the external environment as demanded by the strategy. They use few information sources and the interaction with the university is still incipient