An Enabling Regulatory Environment for Sustainable Investment: The Example of Trade Law

There is broad international agreement that investment flows to the agricultural sector in developing countries need to be increased. But there is also agreement that such investments need to be sustainable. For being sustainable, they must not only be beneficial to the public economy, but also to rural households and to the environment in the short and the long run. Whether sustainable investments take place, not least depends on the legal framework within which these investments are situated. This is true for the domestic legal frameworks of both the home country and of the host country of the investment. But also the international legal frameworks in which home and host states are embedded set either positive or negative incentives for investments to be sustainable. The paper presents an overview on regulatory frameworks which come to focus in this regard. It then elaborates on international agricultural trade regulation, by assuming that sustainable investments in agriculture presume a ‘sustainable trade regime’. By doing so, the paper presents parts of the debate about a sustainable agricultural trade regime, as it has been resumed and further developed by the author in recent years. Key words. Agricultural sector, sustainable investment, regulatory environment, sustainable trade regime.

International Investment Law in Latin America: problems and prospects

With the bilingual volume International Investment Law in Latin America: Problems and Prospects, Attila Tanzi, Alessandra Asteriti, Rodrigo Polanco Lazo and Paolo Turrini provide a regional perspective on one of the liveliest branches of international law by situating it in one of the most dynamic areas of the world. Latin America has always had an ambivalent relationship with international investment law and, more recently, it has been the home of harsh and resolute criticisms, questioning the ultimate legitimacy of the regime. By bringing together distinguished scholars of this legal field, the volume analyses ongoing trends and draws lessons from the Continent’s past experiences while identifying possible solutions to the important challenges it faces.

Prospects in International Investment Law and Policy: World Trade Forum

The negotiation of a patchy but burgeoning network of international investment agreements and the increasing use to which they are put is generating a growing body of jurisprudence which, while still evolving, requires closer analytical scrutiny. Drawing on many of the most distinguished voices in investment law and policy, and offering novel, multidisciplinary perspectives on the rapidly evolving landscape shaping international investment activity and treaty-making, this book explores the most important economic, legal and policy challenges in contemporary international investment law and policy. It also examines the systemic implications flowing from frenetic recent judicial activism in investment matters and advances several innovative propositions for how best to promote greater overall coherence in rule-design, treaty use and policy making and thus offer a better balance between the rights and obligations of international investors and host states.

The Board Committee as a Legal Transplant: a Comparative Analysis illustrated by the example of the Audit Committee

Bilanzskandale und Missmanagement haben in den vergangenen Jahren den Ruf nach besseren Kontrollmechanismen in der Unternehmensführung laut werden lassen. Audit Committees sind ein wichtiges Werkzeug um eine solche Kontrolle sicherzustellen und sind inzwischen weltweit zum integralen Bestandteil einer guten "Corporate Governance" geworden. Die Audit Committees haben sich in unterschiedlichen kulturellen und rechtlichen Umgebungen etabliert. Wie der Beitrag zeigt, hat die weltweite Zunahme der Bedeutung der "Corporate Governance" das Audit Committee zum Vorzeigebeispiel eines "legal transplant" gemacht.

El Capítulo de Inversiones en el Acuerdo de Asociación Transpacífico:¿Una Posibilidad de Cambio y Convergencia?

Spanish Abstract: El presente trabajo analiza los posibles efectos que generaría en la regulación internacional de la inversión extranjera, el acuerdo de un capítulo de inversiones en el Acuerdo de Asociación Transpacífico (TPP), actualmente en negociaciones, sobre la base de la información disponible a la fecha. El artículo aborda cuatro aspectos que presentan especial importancia dada la divergencia de intereses entre algunos de los Estados negociadores: el ámbito de protección de la inversión extranjera; las normas sobre transparencia de los regímenes de inversión y sus disputas; la irrupción de entidades estatales como inversionistas extranjeros; y la solución de controversias a través del arbitraje inversionista-Estado. El autor concluye que en comparación a la actual fragmentación regulatoria de la que dan cuenta los acuerdos internacionales de inversión suscritos por los países negociadores del TPP, la incorporación de un capítulo de inversiones en ese Acuerdo es una oportunidad para avanzar en la convergencia de la regulación sobre inversión extranjera, tanto en materia de estándares sustantivos de protección de la inversión como en la mejora del arbitraje inversionista-Estado como mecanismo de solución de controversias.

WTO law issues of emissions trading

Based on existing research in the interface of emissions trading schemes (ETSs) and WTO law, the paper looks more closely at the design elements of an ETS that are most vulnerable to a WTO challenge, including border adjustment on importation and exportation, recycling of revenues and cross-border linking. The analysis of WTO consistency of various ETS regulatory components reveals significant legal uncertainty. One explanation is that an ETS is not yet fully established as a regulatory tool. It does not have a fixed design and its design elements vary significantly with a scheme. Moreover, ETS-related issues have never been raised in WTO disputes. This makes it hard to predict with confidence the outcome of scrutiny of an ETS by a WTO adjudicative body. In this respect, the availability of environmental and/or health exceptions for justification of ETS-related measures is of great importance.

Swiss national guideline for reimbursement of enzyme replacement therapy in late-onset Pompe disease.

Glycogen storage disease type II is a rare multi-systemic disorder characterised by an intracellular accumulation of glycogen due a mutation in the acid alpha glucosidase (GAA) gene. The level of residual enzyme activity, the genotype and other yet unknown factors account for the broad variation of the clinical phenotype. The classical infantile form is characterised by severe muscle hypotonia and cardiomyopathy leading to early death. The late-onset form presents as a limb girdle myopathy with or without pulmonary dysfunction. Enzyme replacement therapy (ERT) with recombinant human GAA (rhGAA) in infants is life saving. In contrast, therapeutic efficacy of rhGAA in the late-onset form is modest. High expenses of rhGAA, on-going infusions and poor pharmacokinetic efficacy raised a discussion of the cost effectiveness of ERT in late-onset Pompe disease in Switzerland. This discussion was triggered by a Swiss federal court ruling which confirmed the reluctance of a health care insurer not to reimburse treatment costs in a 67-year-old female suffering from Pompe disease. As a consequence of this judgement ERT was stopped by all insurance companies in late-onset Pompe patients in Switzerland regardless of their clinical condition. Subsequent negotiations lead to the release of a national guideline of the management of late-onset Pompe disease. Initiation and limitation of ERT is outlined in a national Pompe registry. Reimbursement criteria are defined and individual efficacy of ERT with rhGAA is continuously monitored.

Is a Revision a Revision? An Analysis of National Arthroplasty Registries' Definitions of Revision.

BACKGROUND The reported survival of implants depends on the definition used for the endpoint, usually revision. When screening through registry reports from different countries, it appears that revision is defined quite differently. QUESTIONS/PURPOSES The purposes of this study were to compare the definitions of revision among registry reports and to apply common clinical scenarios to these definitions. METHODS We downloaded or requested reports of all available national joint registries. Of the 23 registries we identified, 13 had published reports that were available in English and were beyond the pilot phase. We searched these registries' reports for the definitions of the endpoint, mostly revision. We then applied the following scenarios to the definition of revision and analyzed if those scenarios were regarded as a revision: (A) wound revision without any addition or removal of implant components (such as hematoma evacuation); (B) exchange of head and/or liner (like for infection); (C) isolated secondary patella resurfacing; and (D) secondary patella resurfacing with a routine liner exchange. RESULTS All registries looked separately at the characteristic of primary implantation without a revision and 11 of 13 registers reported on the characteristics of revisions. Regarding the definition of revision, there were considerable differences across the reports. In 11 of 13 reports, the primary outcome was revision of the implant. In one registry the primary endpoint was "reintervention/revision" while another registry reported separately on "failure" and "reoperations". In three registries, the definition of the outcome was not provided, however in one report a results list gave an indication for the definition of the outcome. Wound revision without any addition or removal of implant components (scenario A) was considered a revision in three of nine reports that provided a clear definition on this question, whereas two others did not provide enough information to allow this determination. Exchange of the head and/or liner (like for infection; scenario B) was considered a revision in 11 of 11; isolated secondary patella resurfacing (scenario C) in six of eight; and secondary patella resurfacing with routine liner exchange (scenario D) was considered a revision in nine of nine reports. CONCLUSIONS Revision, which is the most common main endpoint used by arthroplasty registries, is not universally defined. This implies that some reoperations that are considered a revision in one registry are not considered a revision in another registry. Therefore, comparisons of implant performance using data from different registries have to be performed with caution. We suggest that registries work to harmonize their definitions of revision to help facilitate comparisons of results across the world's arthroplasty registries.