The Pediatric Rheumatology International Trials Organization American-College-of-Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: Prospective validation of the definition of improvement

Objective. To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE).Methods. Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic.Results. The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%.Conclusion. PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.

Trade and the environment in the context of the World Trade Organization

Includes bibliography

Trade policy within the context of the World Trade Organization

Includes bibliography

Ten Years of Operation of the World Trade Organization Dispute Settlement Mechanism: Outcome for Latin America and the Caribbean

Dispute settlement mechanisms help to create a fairly predictable and accurate environment in which economic agents can pursue their activities in the international arena. The World Trade Organization (WTO) Dispute Settlement Body (DSB) has now been in operation for 10 years and it is fitting, at this point to assess the progress achieved by Latin America and the Caribbean, the region that made most use of this mechanism during the period, and whose countries have made significant gains against protectionism in key export sectors. These successes constitute important precedents which will influence upcoming multilateral negotiations and future trade disputes.This article reviews the work carried out by the DSB, the role of the leading stakeholders in the system (the United States and the European Union) and progress made by countries of the region in a global context marked by the complexity of trade issues and the legal framework that regulates them. The findings presented in this article are based on the study "Una década de funcionamiento del Sistema de Solución de Diferencias de la OMC: avances y desafíos".

The changing politics of preference formation in international trade negotiations: the European Union in the Doha Round

This research seeks to provide an explanation for variations of “politics” of preference formation in international trade negotiations. Building on the ‘policy determines politics’ argument, I hypothesize the existence of a causal relationship between issue-characteristics and their variations with politics dynamics and their variations. More specifically, this study seeks to integrate into a single analytical framework two dimensions along which variations in the “politics of preference formation” can be organized: configurations of power relationships among the relevant actors in the structures within which they interact as well as the logic and the motivations of the actors involved in the policy making process. To do so, I first construct a four-cell typology of ‘politics of preference formation’ and, then, I proceed by specifying that the type of state-society configurations as well as the type of actors’ motivations in the “politics of preference formation” depend, respectively, on the degree to which a policy issue is perceived as politically salient and on the extent to which the distributional implications of such an issue can be calculated by the relevant stakeholders in the policy making process. The empirical yardstick against which the validity of the theoretical argument proposed is tested is drawn from evidence concerning the European Union’s negotiating strategy in four negotiating areas in the context of the so-called WTO’s Doha Development Round of multilateral trade negotiations: agriculture, competition, environment and technical assistance and capacity building.

The World Trade Organization at Work: Performance in a Member-Driven Milieu

This article discusses performance in the context of the World Trade Organization (WTO). Applying the framework by Gutner and Thompson and inspired by principal-agent theory, it is argued that existing studies have underspecified the institutional milieu that affects performance. The WTO represents a member-driven organization where Members are part of the international organization (IO) (e.g., through rule-making) and at the same time act outside the IO (e.g., through implementation). Thus, a narrow reading of the IO (focusing on the civil servants and the Director-General and his staff) will not suffice to understand IO performance in the WTO context. Selected evidence is presented to illustrate aspects of the WTO’s inner-working and the institutional milieu of performance. In addition, the article discusses a number of performance parameters, including the relationship between Secretariat autonomy and performance, the role of information, and the mechanisms of performance aggregation. The article ends by cautioning against quick fixes to the system to improve performance.

The EU as an Effective Trade Power? Strategic Choice of Judicial Candidates in the Context of the World Trade Organization

Drawing on the European Union (EU) foreign policy literature on effectiveness, this article studies how the European Union chooses judges to serve on the World Trade Organization’s key judicial institution: the Appellate Body. Conceptually, the article differentiates between effectiveness in representation and effectiveness in impact. The article shows how delegation to the European Commission has increased the strategic agenda-setting power for championing its preferred candidates. The article further compares European and US practice in nominating candidates. Overall, the article finds that effectiveness in representation has increased over time. In terms of effectiveness in impact, the article shows how the international environment conditions the EU’s influence. The article also exposes the difficulties of studying the effectiveness of EU external relations due to the peculiar decision-making processes dominant in judicial bodies.

Principal-Agent Theory and the World Trade Organization: Complex Agency and ‘Missing Delegation’

This paper analyses the World Trade Organization within a principal-agent framework. The concept of complex agency is introduced to focus on the variety of actors that comprise an international organization. Special attention is paid to the relationship between contracting parties’ representatives and the Secretariat. In the empirical part, the paper analyses the role of the Secretariat in assisting negotiations and presents evidence of declining influence. It is shown how principal-agent theory can contribute to addressing this ‘puzzle of missing delegation’. The paper concludes with a cautionary note as to the ‘location’ of international organizations’ emerging pathologies and calls for additional research to address the relationship between material and social sources to explain behaviour of the key actors within the complex agency.

Rezension zu: Inge Govaere and Hanns Ulrich (eds.): Intellectual Property, Public Policy and International Trade

The contemporary intellectual property rights (IPR) system is not a simple, smoothly working block of rules but is complex and full of ambiguities, and as many argue, imperfections. Some deficits relate on the one hand to the inherent centrality of authorship, originality and mercantilism to the ‘Western’ IP model, which leaves numerous non-Western, collaborative or folkloric modes of production outside the scope of protection. On the other hand, some imperfections stem from the way IPR are granted, whereby creators acquire a temporary monopoly over their works and thus exclude the public from having access to them. In this sense, it is often uncertain whether the existent IPR model appropriately reflects the precarious balance between private and public interests, and whether the best incentives to promote creativity and innovation - the initially stated objectives of intellectual property protection - are offered. The matter becomes still more complicated when one considers that the IPR system is not domestically contained but is globalised and strongly affected by rules at the regional and international levels. The question of whether the balance between private interests and public values is sustained within the international legal framework, epitomised by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO), is precisely the topic of the book reviewed here. Review of Intellectual Property, Public Policy, and International Trade, edited by Inge Govaere and Hanns Ullrich, P.I.E. Peter Lang, 2007.

The European Union, the World Trade Organization and Cultural Diversity

The chapter maps these trade versus culture developments in the WTO and the positions of the European Union (EU or the Union) and its member states, which were not always coherent. It also looks at the actual results of the trade versus culture contestation – that is, the rules on trade in goods and services in the WTO and how they reflect the need for more policy space in matters of cultural policy, which the EU so ardently pressed for. The chapter further analyses the evolution of both the international trade regulation and the discourse on cultural policy. This discourse has in fact undergone a major transformation in the last two decades, as it has moved from the ‘exception culturelle’ rhetoric, which dominated the Uruguay trade talks, towards a more positive but also more pro-active agenda under the slogan of cultural diversity. The EU has been a major driver of this transformation, which has succeeded in mobilising the international community and ultimately led to the adoption of the 2005 UNESCO Convention on the Protection and Promotion of the Diversity of Cultural Expressions. The chapter concludes by appraisal of the current state of the debate situating it into the broader picture of contemporary global governance. It asks how the EU could effectively pursue its cultural policy aspirations and endorse its cultural diversity agenda in a world of complexity and rapid technological change, in particular in view of the affordances of digital media.

The Jurisprudence of the World Trade Organization 2014

In 2014, the Dispute Settlement Body (DSB) of the World Trade Organization (WTO) adopted seven panel reports and six Appellate Body rulings. Two of the cases relate to anti-dumping measures. Three cases, comprising five complaints, are of particular interest and these are summarized and discussed below. China – Rare Earths further refines the relationship between protocols of accession and the general provisions of WTO agreements, in particular the exceptions of Article XX GATT. Recourse to that provision is no longer excluded but depends on a careful case-by-case analysis. While China failed to comply with the conditions for export restrictions, the case reiterates the problem of insufficiently developed disciplines on export restrictions on strategic minerals and other commodities in WTO law. EC – Seals Products is a landmark case for two reasons. Firstly, it limits the application of the Agreement on Technical Barriers to Trade (TBT Agreement) resulting henceforth in a narrow reading of technical regulations. Normative rules prescribing conditions for importation are to be dealt with under the rules of the General Agreement on Tariffs and Trade (GATT) instead. Secondly, the ruling permits recourse to public morals in justifying import restrictions essentially on the basis of process and production methods (PPMs). Meanwhile, the more detailed implications for extraterritorial application of such rules and for the concept of PPMs remain open as these key issues were not raised by the parties to the case. Peru – Agricultural Products adds to the interpretation of the Agreement on Agriculture (AoA), but most importantly, it confirms the existing segregation of WTO law and the law of free trade agreements. The case is of particular importance for Switzerland in its relations with the European Union (EU). The case raises, but does not fully answer, the question whether in a bilateral agreement, Switzerland or the EU can, as a matter of WTO law, lawfully waive their right of lodging complaints against each other under WTO law within the scope of their bilateral agreement, for example the Agreement on Agriculture where such a clause exists.

Trade, justice, and the politics of difference: Small developing states in the World Trade Organization

The purpose of this research project was to investigate two distinct types of research questions – one theoretical, the other empirical: (1) What would justice mean in the context of the international trade regime? (2.Using the small developing states of the Commonwealth Caribbean as a case study, what do Commonwealth Caribbean trade negotiators mean when they appeal to justice? Regarding the first question, Iris Young's framework which focuses on the achievement of social justice in a domestic context by acknowledging social differences such as those based on race and gender, was adopted and its relevance argued in the international context of interstate trade negotiation so as to validate the notion of (size, location, and governance capacity) difference in this latter context. The point of departure is that while states are typically treated as equals in international law – as are individuals in liberal political theory – there are significant differences between states which warrant different treatment in the international arena. The study found that this re-formulation of justice which takes account of such differences between states, allows for more adequate policy responses than those offered by the presumption of equal treatment. Regarding the second question, this theoretical perspective was used to analyze the understandings of justice from which Commonwealth Caribbean trade negotiators proceed. Interpretive and ethnographic methods, including participant observation, interviews, field notes, and textual analysis, were employed to analyze their understandings of justice. The study found that these negotiators perceive such justice as being justice to difference because of the distinct characteristics of small developing states which combine to constrain their participation in the international trading system; based on this perception, they seek rules and outcomes in the multilateral trade regime which are sensitive to such different characteristics; and while these issues were examined in a specific region, its findings are relevant for other regions consisting of small developing states, such as those in the ACP group.

The World Trade Organization, competition policy, and developing countries: A cross -country examination of domestic policy actions

This dissertation addresses the following research question: in a particular policy area, why do countries that display unanimity in their international policy behavior diverge from each other in their domestic policy actions? I address this question in the context of the divergent domestic competition policy actions undertaken by developing countries during the period 1996-2007, after these countries had quite conspicuously displayed near-unanimity in opposing this policy measure at the World Trade Organization (WTO). This divergence is puzzling because (a) it does not align with their near-unanimous behavior at the WTO over competition policy and (b) it is at variance with the objectives of their international opposition to this policy at the WTO. Using an interdisciplinary approach, this dissertation examines the factors responsible for this divergence in the domestic competition policy actions of developing countries. ^ The theoretical structure employed in this study is the classic second-image-reversed framework in international relations theory that focuses on the domestic developments in various countries following an international development. Methodologically, I employ both quantitative and qualitative methods of analysis to ascertain the nature of the relationship between the dependent variable and the eight explanatory variables that were identified from existing literature. The data on some of the key variables used in this dissertation was uniquely created over a multi-year period through extensive online research and represents the most comprehensive and updated dataset currently available. ^ The quantitative results obtained from logistic regression using data on 131 countries point toward the significant role played by international organizations in engineering change in this policy area in developing countries. The qualitative analysis consisting of three country case studies illuminate the channels of influence of the explanatory variables and highlight the role of domestic-level factors in these three carefully selected countries. After integrating the findings from the quantitative and qualitative analyses, I conclude that a mix of international- and domestic-level variables explains the divergence in domestic competition policy actions among developing countries. My findings also confirm the argument of the second-image-reversed framework that, given an international development or situation, the policy choices that states make can differ from each other and are mediated by domestic-level factors. ^