Sistema d'avaluació de l'impacte organitzatiu i sobre les condicions de seguretat i salut en el treball per l'aplicació de la normativa REACH

L’aparició de la nova normativa sobre productes químics de l’Unió Europea,anomenada REACH ( Registration, Evaluation, Authorization and restriction ofChemicals) i recollida en el reglament (CE) nº1907/2006 del Parlament Europeu i delConsell de 18 de desembre de 2006, suposa un canvi en la forma d’actuació respectea la manipulació de productes químics per part de fabricants, d’importadors, dedistribuïdors i de consumidors finals.Aquesta nova normativa de caràcter europeu es caracteritza per la seva complexitat iper la seva incidència sobre diferents sectors socials, per això dintre de l’estudi s’handefinit els següents objectius:Un primer objectiu d’aquest estudi serà exposar la nova normativa d’abast europeusobre productes químics REACH (Registration, Evaluation, Authorization andrestriction of Chemicals), que ha entrat en vigor el juliol de 2007._ _Un segon objectiu consistirà en avaluar l’acció o impacte que podria causar laimplantació de la normativa sobre les indústries químiques i el seu entorn, tant a nivellde negoci, com a nivell personal.Finalment es definirà una petita empresa fabricant de productes químics a partir de laqual es veuran els impactes que causarà l’aplicació de la nova normativa REACH.Aquest estudi pretén ajudar a quantificar els possibles impactes que puguin sorgir apartir de l’entrada en vigor de la nova normativa sobre productes químics. Aquestsimpactes poden influir sobre la salut dels treballadors, sobre el medi ambient i tambésobre l’economia, tant a nivell local com a nivell internacional.Per poder aconseguir establir els impactes, serà necessari en primer lloc tenir un bonconeixement tant de les lleis químiques actuals, com de les que aniran sorgintsuccessivament, com la nova normativa REACH.D’altra banda, també serà necessari veure els possibles impactes que podrien afectara una petita empresa química, per poder, si és necessari, extrapolar els resultats per aempreses del mateix tipus influenciades també per la normativa REACH.Així doncs, aquest estudi servirà de guia d’iniciació per aquells empresaris i/opersones relacionades amb el món de la química a nivell industrial, que vulguincomençar a determinar el grau en que es veuran afectats per la nova normativa.L’impacte que causarà la nova normativa s’analitzarà a partir d’una empresa virtualdedicada a la fabricació d’adhesius situada a la provincia de Girona.Els impactes es centraran en dos productes, una cola produïda en grans quantitats,però sense gaires implicacions pel medi ambient ni per la seguretat de les persones, iuna altra que es produeix en quantitats més reduïdes però que inclou substànciesperilloses pel medi ambient i per les personesA partir de l’anàlisi dels diferents impactes (pel medi aquàtic, pel sòl, per l’atmosfera, iper la seguretat de les persones al lloc de treball), s’han realitzat unes matriusd’impacte que ajudaran a determinar l’impacte econòmic que causarà la normativasobre l’empresa en qüestió

Research involving biological material from forensic autopsies: legal and ethical issues.

Recommendations and laws do not always contain specific and clear provisions on the use of cadaveric material in research, and even more rarely do they address explicitly the ethical issues related to research on material obtained during forensic autopsy. In this article we analyse existing legal frameworks in Europe by comparing the legal provisions in 2 European Countries which are member states of the Council of Europe, the UK and Switzerland. They were chosen because they have distinct legal frameworks that make comparisons interesting. In addition, the detailed laws of the UK and a specific law project and national ethical recommendations in Switzerland permit us to define more clearly the legal range of options for researchers using cadaveric material obtained during forensic investigations. The Human Tissue Act 2004 in England, Wales and Northern Ireland, its Scottish equivalent with the same title (2006) and the national ethical guidelines in Switzerland all require consent from the deceased person, an appropriate relative or a person with power of attorney for healthcare decisions before cadaveric biological material can be obtained and used for research. However, if the purpose of the autopsy is purely forensic, no such authorization will be sought to carry out the autopsy and related analyses, which might include genetic testing. In order to be allowed to carry out future research projects, families need to be approached for informed consent, unless the deceased person had left written directives including permission to use his or her tissues for research.

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.

Patentes, regulación de precios e innovación en la industria farmacéutica

The trade-off between property rights/price regulation and innovation depends on countrycharacteristics and drug industry specificities. Access to drugs and innovation can bereconciled by seven ways that, among others, include: public health strengthening in thecountries with the largest access problems (those among the poor with the weakestinstitutions); public and private aid to make attractive R&D on neglected diseases; pricediscrimination with market segmentation; to require patent owners to choose eitherprotection in the rich countries or protection in the poor countries (but not both).Regarding price regulation, after a review of theoretical arguments and empirical evidence,seven strategies to reconcile health and industrial considerations are outlined, including:mitigation of the medical profession dependence on the pharmaceutical industry; considerationof a drug as an input of a production process; split drug authorization from public fundingdecisions; establish an efficiency minimum for all health production inputs; and stop theEuropean R&D hemorrhagia.

Les captacions d'aigua destinada al consum humà al Principat d'Andorra: Anàlisi del marc jurídic actual, definició del procediment d'autorització i sistema d'informació geogràfic sobre les captacions i els perímetres de protecció associats

RESUM L’aigua és un recurs limitat necessari per a l’establiment de qualsevol forma de vida sobre la Terra. Aquest recurs, es veu regit pel cicle hidrològic i durant les diferents fases del seu cicle, l’aigua pot ser captada per ser aprofitada per l’ésser humà. En els darrers anys, la necessitat d’aigua per a la població ha estat incrementada provocant un impacte negatiu sobre aquest recurs. Per aquest motiu sorgeix la necessitat de crear polítiques globals per protegir l’aigua que vagin encaminades a minimitzar l’efecte negatiu provocat per l’home. Tota captació d’aigua destinada al consum humà ha de garantir uns paràmetres de qualitat i per tal de poder aconseguir aquest objectiu amb eficàcia és imprescindible l’aplicació d’una eina legal molt important: els perímetres de protecció. A l’article 6 de la Llei de policia i protecció de les aigües del 31 de juliol del 1985, s’estableix que tota captació d’aigua potable haurà de quedar aïllada mitjançant un perímetre de protecció, a l’interior del qual no podrà dur-se a terme cap activitat sense prèvia autorització de Govern. Els objectius principals d’aquest estudi son recopilar la informació existent en referència a les captacions d’aigua i els seus respectius perímetres de protecció, elaborar una base de dades que pugui contenir tota la informació existent i elaborar cartografia especifica amb la finalitat de realitzar una diagnosi de la situació actual de les captacions i perímetres associats i identificar els principals riscos potencials existents en aquestes àrees. Entre les conclusions mes rellevants obtingudes amb aquest treball, cal destacar que s’ha constatat que algunes activitats antròpiques potencialment contaminants es troben situades en zones properes a les captacions destinades a consum humà, inclòs dins dels seus perímetres de protecció, amb el conseqüent risc que aquesta situació comporta.

2011 - 2015 Iowa Transportation Improvement Program

The Iowa Transportation Improvement Program (Program) is published to inform Iowans of planned investments in our state’s transportation system. The Iowa Transportation Commission (Commission) and Iowa Department of Transportation (Iowa DOT) are committed to programming those investments in a fiscally responsible manner. This document serves as the Iowa DOT's annual report as required by Iowa Code section 7A.9. This document reflects Iowa’s multimodal transportation system by the inclusion of investments in aviation, transit, railroads, trails, and highways. A major component of this program is the highway section that documents programmed investments on the primary highway system for the next five years. A large part of funding available for highway programming comes from the federal government. Accurately estimating future funding levels of this federal funding is dependent on having a current enacted multi-year federal transportation authorization. The most recent authorization, Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), expired September 30, 2009, and to date it has been extended five times because a new authorization has not yet been enacted. The current extension expires December 31, 2010. While Iowa law does not require the adoption of a Program when federal transportation funding is being reauthorized, the Commission believes it is important to adopt a Program in order to continue on-going planning and project development efforts and to be well positioned when a new authorization is adopted. However, it is important to recognize that, absent a federal authorization bill, there is significant uncertainty in the forecast of federal revenues. The Commission and the Iowa DOT will continue to monitor federal revenues and will adjust future investments as needed to maintain a fiscally responsible Program. In developing the highway section of the program, the Commission’s primary investment objective remains stewardship (i.e. safety, maintenance and preservation) of Iowa’s existing highway system. In fact, over $1.2 billion is programmed in FY2011 through FY2015 for preservation of Iowa’s existing highway system and for enhanced highway safety features. The highway section also includes significant investments for interstate modernization on I-29 inSioux City, on I-29/80/480 in Council Bluffs, and on I-74 in Bettendorf/ Davenport. Another highway programming objective reflected in this Program is maintaining the scheduled completion of capacity and economic development projects that were identified in the previous Program. Finally, with the limited remaining funds the Commission has furthered the investment in capacity and economic development by adding a few projects to the Program. The Iowa DOT and Commission appreciate the public’s involvement in the state’s transportation planning process. Comments received personally, by letter or through participation in the Commission’s regular meetings or public input meetings held around the state each year, are invaluable in providing guidance for the future of Iowa’s transportation system.

2012-2016 Iowa Transportation Improvement Program

The Iowa Transportation Improvement Program (Program) is published to inform Iowans of planned investments in our state’s transportation system. The Iowa Transportation Commission (Commission) and Iowa Department of Transportation (Iowa DOT) are committed to programming those investments in a fiscally responsible manner. This document reflects Iowa’s multimodal transportation system by the inclusion of investments in aviation, transit, railroads, trails, and highways. A major component of this program is the highway section that documents programmed investments on the primary highway system for the next five years. A large part of funding available for highway programming comes from the federal government. Accurately estimating future federal funding levels is dependent on having a current enacted multi-year federal transportation authorization. The most recent authorization, Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), expired September 30, 2009, and to date it has been extended seven times because a new authorization has not yet been enacted. The current extension will expire September 30, 2011. This leads to significant uncertainty in federal funding; however, it is becoming evident that, in Federal Fiscal Year 2012 and beyond, federal funding revenue will likely be reduced by 25 percent from current levels in order to match revenue that flows into the Highway Trust Fund. This Program reflects this anticipated reduction in federal funding. While Iowa law does not require the adoption of a Program when federal transportation funding is being reauthorized, the Commission believes it is important to adopt a Program in order to continue on-going planning and project development efforts so that Iowa will be well positioned when a new authorization is adopted. However, it is important to recognize that, absent a federal authorization bill, there is significant uncertainty in the forecast of federal revenues. The Commission and the Iowa DOT will continue to monitor federal revenues and will adjust future investments as needed to maintain a fiscally responsible Program. For 2012-2016, approximately $2.3 billion is forecast to be available for highway right of way and construction. In developing the highway section of the Program, the Commission’s primary investment objective remains stewardship (i.e. safety, maintenance and preservation) of Iowa’s existing highway system. Over $1.3 billion is programmed in FY2012 through FY2016 for preservation of Iowa’s existing highway system and for enhanced highway safety features. The highway section also includes significant interstate investments on I-29 in Sioux City, I-29/80/480 in Council Bluffs, and I-74 in Bettendorf/Davenport. The FY2016 programming for construction on I-74 in Bettendorf/Davenport is the first of several years of significant investments that will be monitored for available funding. Approximately $200 million of the investments on these three major urban interstate projects address preservation needs. In total, approximately $1.5 billion is programmed for highway preservation activities for 2012- 2016. Another highway programming objective is maintaining the scheduled completion of capacity and economic development projects. Projects that were previously scheduled to be completed within the previous Program continue on their current schedule. However, due to the reduction of projected federal revenues, the Commission has delayed by one year the initiation of construction of all multi-year non-Interstate capacity and economic development projects that cannot be completed within this Program. These projects are U.S. 20 in Woodbury County, U.S. 30 in Benton County, U.S. 61 in Louisa County, and Iowa 100 in Linn County. The Iowa DOT and Commission appreciate the public’s involvement in the state’s transportation planning process. Comments received personally, by letter or through participation in the Commission’s regular meetings or public input meetings held around the state each year, are invaluable in providing guidance for the future of Iowa’s transportation system. It should be noted that this document is a planning guide. It does not represent a binding commitment or obligation of the Commission or Iowa DOT, and is subject to change.

Temporary Traffic Control and Enforcement of Traffic Laws in Closed Road Sections, June 2007

Public travel by motor vehicles is often necessary in road and street sections that have been officially closed for construction, repair, and/or other reasons. This authorization is permitted in order to provide access to homes and businesses located beyond the point of closure. The MUTCD does address appropriate use of specific regulatory signs at the entrance to closed sections; however, direct guidance for temporary traffic control measures within these areas is not included but may be needed. Interpretation and enforcement of common practices may vary among transportation agencies. For example, some law enforcement officers in Iowa have indicated a concern regarding enforcement and jurisdiction of traffic laws in these areas because the Code of Iowa only appears to address violations on roadways open to “public travel.” Enforcement of traffic laws in closed road sections is desirable to maintain safety for workers and for specifically authorized road users. In addition, occasional unauthorized entry by motor vehicles is experienced in closed road areas causing property damage. Citations beyond simple trespass may be advisable to provide better security for construction sites, reduce economic losses from damage to completed work, and create safer work zones.

Pharmacovigilance et teratovigilance 2008 [Pharmacovigilance and teratovigilance 2008]

Various signals and alerts of pharmacovigilance were issued in 2008. Frequent neuropsychiatric adverse events are reported with varenicline and rimonabant and the marketing authorization of the latter has been suspended. Ezetimibe/simvastatin combination is suspected of causing cancer while it's clinical utility remains to be proved. Neuroleptics, typical and atypical, are associated with an increased risk of death in elderly with dementia. Safety is a concern with various biological drugs. Rituximab, natalizumab and efalizumab are involved in rare cases of progressive multifocal leukoencephalopathy with fatal issue. Screening of HLA-B*5701, a good predictor of hypersensitivity reaction to abacavir, is recommended prior to starting therapy. Mycophenolate turns out to be a human teratogen.

2013 - 2017 Iowa Transportation Improvement Program,

This document describes planned investments in Iowa’s multimodal transportation system including aviation, transit, railroads, trails, and highways. A large part of funding available for highway programming comes from the federal government. Accurately estimating future federal funding levels is dependent on having a multiyear federal transportation authorization bill in place. The most recent authorization, Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), expired September 30, 2009, and to date it has been extended nine times because a new authorization has not yet been enacted. The current extension will expire June 30, 2012.

2013-2018 Highway Program Summary, 2012

The Iowa Transportation Commission (Commission) and the Iowa Department of Transportation (DOT) develop Iowa’s Five Year Highway Program (Program) to inform you of planned investments in our state’s primary and interstate highway system. This brochure summarizes the FY 2013-2017 Program. $2.6 billion is forecast for highway right of way and construction. The Program is updated and approved in June of each year. A large part of funding available for highway programming comes from the federal government. Accurately estimating future federal funding levels is dependent on having a multiyear federal transportation authorization bill in place. The most recent authorization, Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), expired September 30, 2009, and to date it has been extended nine times because a new authorization has not yet been enacted. The current extension will expire June 30, 2012.

2014-2018 Iowa Transportation Improvement Program

This document describes planned investments in Iowa’s multimodal transportation system including aviation, transit, railroads, trails, and highways. A large part of funding available for highway programming comes from the federal government. Accurately estimating future federal funding levels is dependent on having a multiyear federal transportation authorization bill in place and having a sustainable and solvent federal Highway Trust Fund. The most recent federal authorization, Moving Ahead for Progress in the 21st Century (MAP-21), will expire September 30, 2014. At the same time that MAP-21 expires and absent Congressional action, the federal Highway Trust Fund will no longer be able provide funding at current levels resulting in up to a 90 percent reduction in federal highway funding for federal fiscal year 2015. These two issues provide funding uncertainty with this program in fiscal years 2015 and beyond.

2015-2019 Iowa Transportation Improvement Program

This document describes planned investments in Iowa's multimodal transportation system including aviation, transit, railroads, trails, and highways. A large part of funding available for highway programming comes from the federal government. Accurately estimating future federal funding levels is dependent on having a multiyear federal transportation authorization bill in place and having a sustainable and solvent federal Highway Trust Fund. The most recent federal authorization, Moving Ahead for Progress in the 21st Century (MAP-21), will expire September 30, 2014. At the same time that MAP-21 expires and absent Congressional action, the federal Highway Trust Fund will no longer be able to provide funding at current levels resulting in the full elimination of federal highway funding for new projects in federal fiscal year 2015. These two issues provide funding uncertainty with this program in fiscal years 2015 and beyond.

Unlicensed and off-label drug use in a Swiss paediatric university hospital.

BACKGROUND: Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are scarce in Switzerland. OBJECTIVES: The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients. METHODS: This pilot study was conducted prospectively over a six month period in the department of paediatrics of a university hospital. RESULTS: Sixty patients aged from three days to 14 years were included in the study. A total of 483 prescriptions were written for the patients. More than half of all prescriptions (247; 51%) followed the terms of the marketing authorization. 114 (24%) were unlicensed and 122 (25%) off-label. All patients received at least one unlicensed or offlabel medicine. CONCLUSION: The use of unlicensed or off-label medicines to treat children was found to be common. Co-operation between the pharmaceutical industry, national regulatory authorities, clinical researchers, healthcare professionals and parents is required in order to ensure that children do not remain "therapeutic orphans".

Assessing the epidemiology and pattern of care of colorectal cancer in Valais, Switzerland

Background: The Valais's cancer registry (RVsT) of the Observatoire valaisan de le santé (OVS) and the department of oncology of Valais's Hospital conducted a study on the epidemiology and pattern of care of colorectal cancer in Valais. Colorectal cancer is the third cause of death by cancer in Switzerland with about 1600 deaths per year. It is the third most frequent cancer for males and the second most frequent for females in Valais. The number of new colorectal cancer cases (average per year) increased between 1989 and 2009 for males as well as for females in Valais. The number of colorectal cancer death cases (average per year) slightly increased between 1989 and 2009 for males as well as for females in Valais. Age-standardized rates of incidence were stable for males and females in Valais and in Switzerland between 1989 and 2009, while age-standardized rates of mortality decreased for males and females in Valais and Switzerland. Results: 774 cases were recorded (59% males). Median age at diagnosis was 70 years old. Most of cancers were invasive (79%) and the main localization was the colon (71%). The most frequent mode of detection was a consultation for non emergency symptoms (75%), but almost 10% of patients consulted in emergency. 82% of patients were treated within 30 days from diagnosis. 90% of the patients were treated by surgery alone or with combined treatment. The first treatment was surgery, including endoscopic resection in 86% of the cases. The treatment was different according to the localization and the stage of the cancer. Survival rate was 95% at 30 days and 79% at one year. The survival was dependent on the stage and the age at diagnosis. Cox model shows an association between mortality and age (better survival for young people) and between mortality and stage (better survival for the lower stages). Methods: RVsT collects information on all cancer cases since 1989 for people registered in the communes of Valais. RVsT has an authorization to collect non anonymized data. All new incident cancers are coded according to the International Classification of Diseases for Oncology (ICD-O-3) and the stages are coded according to the TNM classification. We studied all cases of in situ and invasive colorectal cancers diagnosed between 2006 and 2009 and registered routinely at the RVsT. We checked for data completeness and if necessary sent questionnaires to avoid missing data. A distance of 15 cm has been chosen to delimitate the colon (sigmoid) and the rectal cancers. We made an active follow-up for vital status to have a valid survival analysis. We analyzed the characteristics of the tumors according to age, sex, localization and stage with stata 9 software. Kaplan-Meier curves were generated and Cox model were fitted to analyze survival. Conclusion: The characteristics of patients and tumors and the one year survival were similar to those observed in Switzerland and some European countries. Patterns of care were close to those recommended in guidelines. Routine data recorded in a cancer registry can be used, not only to provide general statistics, but also to help clinicians assess local practices.