A Blue Print for a Worldwide Multimodal Regime

Resumen: En el nº 2 de 2010 de CDT se publicó un manifiesto del llamado “Grupo de los 9” titulado “Particular concerns with regard to the Rotterdam Rules” en el que estos destacados profesores y juristas expresaban sus dudas acerca de este nuevo instrumento internacional. Este Grupo ofrece ahora un nuevo manifiesto que supone un paso adelante en el que se indica que a pesar de la innegable necesidad de poner al día las Reglas de La Haya-Visby, y de las aportaciones efectuadas en tal sentido por las Reglas de Rótterdam, las perspectivas de éxito de estas últimas se ven ensombrecidas por su pretensión de extenderse más allá de lo que en puridad debía ser su objeto, el transporte marítimo, para convertirse en el texto de referencia para el transporte multimodal que cuente con una fase marítima. Lejos de contribuir a un verdadero y efectivo régimen unificado de la multimodalidad, plantea nuevas dudas a la hora de determinar qué régimen, de entro los existentes para cada tipo de transporte, debe ser de aplicación en cada caso. Mientras tanto, parece que para conseguir los objetivos referidos al transporte marítimo de las Reglas de Rótterdam habría bastado con la introducción de Protocolos a las Reglas de La Haya-Visby, dejando que lo concerniente al transporte multimodal continuara por la senda establecida a tal efecto por el CMR, cuyo sistema quizás debiera traspasar las fronteras europeas con el impulso de las diferentes instituciones internacionales. Palabras clave: Reglas de Rotterdam, transporte multimodal, transporte marítimo, Reglas de La Haya-Visby, CMR.  Abstract: In the issue n. 2 of 2010 of CDT it was published a manifesto of the so-called “Group of the 9” under the title of “Particular concerns with regard to the Rotterdam Rules” where these renowned scholars and attorneys expressed their doubts about this new international legal instrument. The Group offers now a new manifesto providing a step further whereby they indicate that notwithstanding the undeniable necessity to update the Hague-Visby Rules and the contributions carried out in this direction by the Rotterdam Rules, success expectations of the latter rules are hindered because of the aim to expand the scope of application beyond their object in strict sense, namely maritime transport, so as to become the text of reference as for every multimodal transport that includes a sea leg. Far from contributing to a real and effective multimodal unified regime, new doubts arise when determining which regime, of all those for each type of transport, shall apply in each case. In any event, it seems that in order to reach the objectives appointed to by the Rotterdam Rules, introducing Protocols to the Hague-Visby Rules would have been good enough, whereas all that related to multimodal transport continues by the CMR established paths, a system which should trespass European borders with the help of different international institutions. Key words: Rotterdam Rules, multimodal transport, maritime transport, Hague-Visby Rules, CMR

Biologicals in childhood severe asthma : the European PERMEABLE survey on the status quo

Introduction Severe asthma is a rare disease in children, for which three biologicals, anti-immunoglobulin E, anti-interleukin-5 and anti-IL4RA antibodies, are available in European countries. While global guidelines exist on who should receive biologicals, knowledge is lacking on how those guidelines are implemented in real life and which unmet needs exist in the field. In this survey, we aimed to investigate the status quo and identify open questions in biological therapy of childhood asthma across Europe. Methods Structured interviews regarding experience with biologicals, regulations on access to the different treatment options, drug selection, therapy success and discontinuation of therapy were performed. Content analysis was used to analyse data. Results We interviewed 37 experts from 25 European countries and Turkey and found a considerable range in the number of children treated with biologicals per centre. All participating countries provide public access to at least one biological. Most countries allow different medical disciplines to prescribe biologicals to children with asthma, and only a few restrict therapy to specialised centres. We observed significant variation in the time point at which treatment success is assessed, in therapy duration and in the success rate of discontinuation. Most participating centres intend to apply a personalised medicine approach in the future to match patients a priori to available biologicals. Conclusion Substantial differences exist in the management of childhood severe asthma across Europe, and the need for further studies on biomarkers supporting selection of biologicals, on criteria to assess therapy response and on how/when to end therapy in stable patients is evident.Peer reviewe

Biologicals in childhood severe asthma: the European PERMEABLE survey on the status quo

Introduction Severe asthma is a rare disease in children, for which three biologicals, anti-immunoglobulin E, anti-interleukin-5 and anti-IL4RA antibodies, are available in European countries. While global guidelines exist on who should receive biologicals, knowledge is lacking on how those guidelines are implemented in real life and which unmet needs exist in the field. In this survey, we aimed to investigate the status quo and identify open questions in biological therapy of childhood asthma across Europe. Methods Structured interviews regarding experience with biologicals, regulations on access to the different treatment options, drug selection, therapy success and discontinuation of therapy were performed. Content analysis was used to analyse data. Results We interviewed 37 experts from 25 European countries and Turkey and found a considerable range in the number of children treated with biologicals per centre. All participating countries provide public access to at least one biological. Most countries allow different medical disciplines to prescribe biologicals to children with asthma, and only a few restrict therapy to specialised centres. We observed significant variation in the time point at which treatment success is assessed, in therapy duration and in the success rate of discontinuation. Most participating centres intend to apply a personalised medicine approach in the future to match patients a priori to available biologicals. Conclusion Substantial differences exist in the management of childhood severe asthma across Europe, and the need for further studies on biomarkers supporting selection of biologicals, on criteria to assess therapy response and on how/when to end therapy in stable patients is evident