bluuebunny/crossref_metadata_2025 huggingface dataset:
IND-Enabling Studies for a Clinical Trial to Genetically Program a Persistent Cancer-Targeted Immune System
Authors: Puig-Saus Cristina , Parisi Giulia , Garcia-Diaz Angel , Krystofinski Paige E. , Sandoval Salemiz , Zhang Ruixue , Champhekar Ameya S. , McCabe James , Cheung-Lau Gardenia C. , Truong Nhat A. , Vega-Crespo Agustin , Komenan Marie Desiles S. , Pang Jia , Macabali Mignonette H. , Saco Justin D. , Goodwin Jeffrey L. , Bolon Brad , Seet Christopher S. , Montel-Hagen Amelie , Crooks Gay M. , Hollis Roger P. , Campo-Fernandez Beatriz , Bischof Daniela , Cornetta Kenneth , Gschweng Eric H. , Adelson Celia , Nguyen Alexander , Yang Lili , Witte Owen N. , Baltimore David , Comin-Anduix Begonya , Kohn Donald B. , Wang Xiaoyan , Cabrera Paula , Kaplan-Lefko Paula J. , Berent-Maoz Beata , Ribas Antoni
Published: November 2018

Purpose:

To improve persistence of adoptively transferred T-cell receptor (TCR)–engineered T cells and durable clinical responses, we designed a clinical trial to transplant genetically-modified hematopoietic stem cells (HSCs) together with adoptive cell transfer of T cells both engineered to express an NY-ESO-1 TCR. Here, we report the preclinical studies performed to enable an investigational new drug (IND) application.

Experimental Design:

HSCs transduced with a lentiviral vector expressing NY-ESO-1 TCR and the PET reporter/suicide gene HSV1-sr39TK and T cells transduced with a retroviral vector expressing NY-ESO-1 TCR were coadministered to myelodepleted HLA-A2/Kb mice within a formal Good Laboratory Practice (GLP)–compliant study to demonstrate safety, persistence, and HSC differentiation into all blood lineages. Non-GLP experiments included assessment of transgene immunogenicity and in vitro viral insertion safety studies. Furthermore, Good Manufacturing Practice (GMP)–compliant cell production qualification runs were performed to establish the manufacturing protocols for clinical use.

Results:

TCR genetically modified and ex vivo–cultured HSCs differentiated into all blood subsets in vivo after HSC transplantation, and coadministration of TCR-transduced T cells did not result in increased toxicity. The expression of NY-ESO-1 TCR and sr39TK transgenes did not have a detrimental effect on gene-modified HSC's differentiation to all blood cell lineages. There was no evidence of genotoxicity induced by the lentiviral vector. GMP batches of clinical-grade transgenic cells produced during qualification runs had adequate stability and functionality.

Conclusions:

Coadministration of HSCs and T cells expressing an NY-ESO-1 TCR is safe in preclinical models. The results presented in this article led to the FDA approval of IND 17471.
Circulating Cytokines Predict Immune-Related Toxicity in Melanoma Patients Receiving Anti-PD-1–Based Immunotherapy
Authors: Lim Su Y. , Lee Jenny H. , Gide Tuba N. , Menzies Alexander M. , Guminski Alexander , Carlino Matteo S. , Breen Edmond J. , Yang Jean Y.H. , Ghazanfar Shila , Kefford Richard F. , Scolyer Richard A. , Long Georgina V. , Rizos Helen
Published: November 2018

Purpose:

Combination PD-1 and CTLA-4 inhibitor therapy has dramatically improved the survival of patients with advanced melanoma but is also associated with significant immune-related toxicities. This study sought to identify circulating cytokine biomarkers of treatment response and immune-related toxicity.

Experimental Design:

The expression of 65 cytokines was profiled longitudinally in 98 patients with melanoma treated with PD-1 inhibitors, alone or in combination with anti-CTLA-4, and in an independent validation cohort of 49 patients treated with combination anti-PD-1 and anti-CTLA-4. Cytokine expression was correlated with RECIST response and immune-related toxicity, defined as toxicity that warranted permanent discontinuation of treatment and administration of high-dose steroids.

Results:

Eleven cytokines were significantly upregulated in patients with severe immune-related toxicities at baseline (PRE) and early during treatment (EDT). The expression of these 11 cytokines was integrated into a single toxicity score, the CYTOX (cytokine toxicity) score, and the predictive utility of this score was confirmed in the discovery and validation cohorts. The AUC for the CYTOX score in the validation cohort was 0.68 at PRE [95% confidence interval (CI), 0.51–0.84; P = 0.037] and 0.70 at EDT (95% CI, 0.55–0.85; P = 0.017) using ROC analysis.

Conclusions:

The CYTOX score is predictive of severe immune-related toxicity in patients with melanoma treated with combination anti-CTLA-4 and anti-PD-1 immunotherapy. This score, which includes proinflammatory cytokines such as IL1a, IL2, and IFNα2, may help in the early management of severe, potentially life-threatening immune-related toxicity.

See related commentary by Johnson and Balko, p. 1452
What Is the Role of Barbed Suture in Laparoscopic Myomectomy? A Meta-Analysis and Pregnancy Outcome Evaluation
Authors: Gardella Barbara , Dominoni Mattia , Iacobone Anna Daniela , De Silvestri Annalisa , Tinelli Carmine , Bogliolo Stefano , Spinillo Arsenio
Published: November 2018

Background: This work analyzes the feasibility and effectiveness of barbed suture during laparoscopic myomectomy. Methods: Eight works have been carefully examined for the meta-analysis from all papers published online until November 2017. Results: Barbed suture proved to be superior to traditional suture technique in blood loss in laparoscopic myomectomy (Standardized Mean Difference [SMD] –0.650, 95% CI –1.420 to –0.119, p = 0.098, test for heterogenity p < 0.0001, I2 = 95.54%), Hb drop (SMD –1.452, 95% CI –3.590 to 0.687, p = 0.183, test for heterogenity p < 0.0001, I2 = 99.08%), suturing difficulty (SMD –0.638, 95% CI –0.935 to –0.342, p ≤ 0.001, test for heterogenity p = 0.25, I2 = 27.84%), suturing time (SMD –1.197, 95% CI –1.848 to –0.549, p ≤0.001, test for heterogenity p = 0.0001, I2 = 83.30%) and total operative time (SMD –0.687, 95% CI –0.804 to –0.569, p ≤ 0.001, test for heterogenity p = 0.292, I2 = 17.44%). Barbed suture demonstrated to be better in comparison with the control group even with regard to the length of hospitalization (SMD –0.278, 95% CI –0.543 to 0.012, p = 0.040, test for heterogenity p = 0.025, I2 = 61.85%), and to perioperative complications (SMD 0.708, 95% CI 0.503–0.996, p = 0.048, test for heterogenity p = 0.79, I2 = 0%). Conclusion: Barbed suture significantly facilitates laparoscopic myomectomy by reducing the total operative/suturing time, estimated blood loss/Hb drop, and reduction of perioperative complications.
Hepatitis B Reactivation Rate Is Higher Undergoing Some Cytotoxic Chemotherapy in Patients with Solid Tumors: A Large Retrospective Study
Authors: Karaca Mustafa , Tural Deniz , Akar Emre , Çil İbrahim , Bayrak Savaş , Ozet Gulsum , Yucel Orhan Kemal , Hocaoglu Erhan , Ozet Ahmet
Published: November 2018

Objective: The reactivation rate of chronic hepatitis B virus infection in cancer patients and chemotherapy regimens thought to be associated with hepatitis reactivation were investigated. Patients and Methods: In all, 3,890 cancer patients were included in this study. Mortality rates, chemotherapy regimens, cancer types, number of positive hepatitis serology and reactivation rates were obtained. Results: Only 354 patients had positive hepatitis serology results (HBsAg+). Twenty-four patients (6.7%) with HBsAg positive serology had reactivation. In patients with hepatitis reactivation, the rates of usage of 5-fluorouracil (5-FU), cisplatin, cyclophosphamide, doxorubicin, steroid, rituximab, and vincristine were found to be significantly higher than corresponding rates in patients with positive hepatitis serology results but without hepatitis reactivation (p < 0.05 for all). Conclusion: Increased reactivation rates were detected with usage of 5-FU, cisplatin, cyclophosphamide, doxorubicin, steroid, rituximab, and vincristine.
Aktualisierte Leitlinie Immunthrombozytopenie
Authors: Matzdorff Axel
Published: November 2018

Die Immunthrombozytopenie ist eine seltene Erkrankung. Die Patienten kommen meist mit Petechien und Hämatomen zur Vorstellung, schwere Blutungen sind selten. Daneben klagen viele über eine erhöhte Infektneigung und Erschöpfung (Fatigue). Durch das Labor wird dann eine isolierte Thrombozytopenie bestätigt. Bei allen Patienten muss ein Blutausstrich ärztlich begutachtet werden, wobei die Therapieindikation individuell gestellt und nicht auf die Thrombozytenzahl beschränkt werden sollte. In der Regel gibt man als Erstlinientherapie Kortikosteroide, in der Zweitlinie sind heute Thrombopoetin-Rezeptor-Agonisten etabliert. Eine Splenektomie wird nur noch selten angeboten. Bei vielen Patienten kann ein Anstieg der Thrombozytenzahl und eine dauerhafte Besserung erreicht werden.
Pulse Waveform Analysis in Ocular Microcirculation by Laser Speckle Flowgraphy in Patients with Left Ventricular Systolic and Diastolic Dysfunction
Authors: Shiba Tomoaki , Takahashi Mao , Matsumoto Tadashi , Hori Yuichi
Published: November 2018

Purpose: To determine: (1) whether variables of a pulse wave form analysis of ocular microcirculation shown by laser speckle flowgraphy (LSFG) correlate with left ventricular (LV) systolic dysfunction and (2) whether these variables correlate with LV diastolic dysfunction in subjects without LV systolic dysfunction as assessed by echocardiography. Methods: We studied 200 consecutive subjects. LV systolic dysfunction has been determined to be present when the LV ejection fraction was < 50%. LV diastolic dysfunction was diagnosed when subjects had an E/e’ ratio ≥15 and an e’ velocity < 10 cm/s. We evaluated the pulse waveform analysis variables “rising rate” and the blowout score (BOS) using LSFG in the optic nerve head (ONH) and choroid. Results: The brain natriuretic peptide (BNP) level, the rising rate in the choroid area (rising rate-choroid), and heart rate were revealed as independent factors for LV systolic dysfunction, and BOS-choroid was identified as an independent factor for LV diastolic dysfunction. The areas under the curve (AUC) of BNP and rising rate-choroid for LV systolic dysfunction were 0.83 and 0.81, respectively. The AUC of BOS-choroid for LV diastolic dysfunction was 0.73. Conclusion: Pulse waveform analysis in the choroid has a significant correlation with LV systolic and LV diastolic function.
Risk Factors for Recurrence of Right Colonic Diverticulitis
Authors: Kim Yeong-Chan , Chung Jun-Won , Baek Jeong-Heum , Lee Won-Suk , Kim Doojin , Park Yeon-Ho , Yang Jun-Young , Lee Woon-Kee
Published: November 2018

Background: Right colonic diverticulitis (RCD) is more common in Asian countries than in Western countries, and the risk factors for recurrence of RCD are not fully understood. The objective of this study was to assess the risk factors for recurrence of RCD. Methods: We analyzed 296 patients admitted for treatment of RCD in the Gachon University Gil Medical Center from December 2001 to October 2014. Gender, age, BMI, obesity, hypertension, diabetes mellitus, alcohol consumption, smoking, Hinchey classification, and hospital stay were investigated as risk factors for recurrence. Results: Of the 296 patients with RCD, 31 patients recurred after conservative treatment. The median time interval between the initial episode and recurrence of diverticulitis was 10.4 months. In the univariate analysis, a high recurrence rate was observed in patients with a history of alcohol consumption, smoking, and long hospital stay. In the multivariate analysis, the recurrence rate was much higher (p < 0.001) in patients who stayed in the hospital for more than 10 days after the first attack. Smoking also elevated the recurrence rate (p = 0.011). Conclusion: Factors associated with recurrence of RCD may include smoking and the long hospital stay due to complexity when first diverticulitis occurs. Further prospective large-scale studies are needed to draw a definite conclusion.
Effect of Salt Intake on the Serum Cardiotrophin-1 Levels in Chinese Adults
Authors: Wang Keke , Chu Chao , Hu Jiawen , Wang Yang , Zheng Wenling , Lv Yongbo , Yan Yu , Ma Qiong , Mu Jianjun
Published: November 2018

Background: Dietary sodium affects fluctuations in blood pressure (BP) and vascular function. Cardiotrophin-1 (CT-1), a stress-induced cytokine that belongs to the interleukin 6 family, is released by cells in response to potentially harmful stresses and plays a pivotal role in congestive heart failure, hypertension and arterial stiffness. In this study, we performed a randomized trial to confirm the effects of altered salt intake on the serum CT-1 levels in humans. Methods: Forty-four subjects (18–65 years of age) were selected from a rural community in northern China. All subjects initially maintained a baseline period for 3 days, transitioned to a low-salt (LS) diet for 7 days (3.0 g/day of NaCl) and then a high-salt (HS) diet for an additional 7 days (18.0 g/day of NaCl). Results: For the whole group, the serum CT-1 concentrations were significantly increased in the HS period compared to those of the LS period (293.50 ± 137.70 vs. 360.40 ± 162.83 pg/mL, p = 0.040). The serum CT-1 concentrations significantly decreased from the baseline period to the LS diet (419.91 ± 123.50 to 256.49 ± 109.75 pg/mL, p < 0.01) and significantly increased from the LS to HS diet (256.49 ± 109.75 to 414.39 ± 191.21 pg/mL, p < 0.01). These changes were observed in salt-sensitive (SS) individuals but not in salt-resistant (SR) individuals. In addition, a significant positive relationship was observed between the changes in the CT-1 concentrations and systolic BP as well as the changes in the mean arterial pressure from the LS period to the HS period (r = 0.376, p = 0.012; r = 0.311, p = 0.040). The serum CT-1 concentrations were positively correlated with the 24-h urinary sodium-to-potassium (Na/K) excretion ratios during both of the LS and HS diet intervention periods in SS subjects (r = 0.621, p < 0.01), but this correlation was not evident in SR subjects (r = 0.208, p = 0.107). Conclusions: Our study indicates that variations in dietary salt intake affect the serum CT-1 levels in Chinese adults.
Automatic Configuration of Multi-Objective Local Search Algorithms for Permutation Problems
Authors: Blot Aymeric , Kessaci Marie-Éléonore , Jourdan Laetitia , Hoos Holger H.
Published: November 2018

Automatic algorithm configuration (AAC) is becoming a key ingredient in the design of high-performance solvers for challenging optimisation problems. However, most existing work on AAC deals with configuration procedures that optimise a single performance metric of a given, single-objective algorithm. Of course, these configurators can also be used to optimise the performance of multi-objective algorithms, as measured by a single performance indicator. In this work, we demonstrate that better results can be obtained by using a native, multi-objective algorithm configuration procedure. Specifically, we compare three AAC approaches: one considering only the hypervolume indicator, a second optimising the weighted sum of hypervolume and spread, and a third that simultaneously optimises these complementary indicators, using a genuinely multi-objective approach. We assess these approaches by applying them to a highly-parametric local search framework for two widely studied multi-objective optimisation problems, the bi-objective permutation flowshop and travelling salesman problems. Our results show that multi-objective algorithms are indeed best configured using a multi-objective configurator.
Impulsivity and Active Inference
Authors: Mirza M. Berk , Adams Rick A. , Parr Thomas , Friston Karl
Published: November 2018

This paper characterizes impulsive behavior using a patch-leaving paradigm and active inference—a framework for describing Bayes optimal behavior. This paradigm comprises different environments (patches) with limited resources that decline over time at different rates. The challenge is to decide when to leave the current patch for another to maximize reward. We chose this task because it offers an operational characterization of impulsive behavior, namely, maximizing proximal reward at the expense of future gain. We use a Markov decision process formulation of active inference to simulate behavioral and electrophysiological responses under different models and prior beliefs. Our main finding is that there are at least three distinct causes of impulsive behavior, which we demonstrate by manipulating three different components of the Markov decision process model. These components comprise (i) the depth of planning, (ii) the capacity to maintain and process information, and (iii) the perceived value of immediate (relative to delayed) rewards. We show how these manipulations change beliefs and subsequent choices through variational message passing. Furthermore, we appeal to the process theories associated with this message passing to simulate neuronal correlates. In future work, we will use this scheme to identify the prior beliefs that underlie different sorts of impulsive behavior—and ask whether different causes of impulsivity can be inferred from the electrophysiological correlates of choice behavior.
Grasping Neurons in the Ventral Premotor Cortex of Macaques Are Modulated by Social Goals
Authors: Coudé Gino , Toschi Giulia , Festante Fabrizia , Bimbi Marco , Bonaiuto James , Ferrari Pier Francesco
Published: November 2018

Although it is established that F5 neurons can distinguish between nonsocial goals such as bringing food to the mouth for eating or placing it in a container, it is not clear whether they discriminate between social and nonsocial goals. Here, we recorded single-unit activity in the ventral premotor cortex of two female macaques and used a simple reach-to-grasp motor task in which a monkey grasped an object with a precision grip in three conditions, which only differed in terms of their final goal, that is, a subsequent motor act that was either social (placing in the experimenter's hand [“Hand” condition]) or nonsocial (placing in a container [“Container” condition] or bringing to the mouth for eating [“Mouth” condition]). We found that, during the execution of the grasping motor act, the response of a sizable proportion of F5 motor neurons was modulated by the final goal of the action, with some having a preference for the social goal condition. Our results reveal that the representation of goal-directed actions in ventral premotor cortex is influenced by contextual information not only extracted from physical cues but also from cues endowed with biological or social value. Our study suggests that the activity of grasping neurons in the premotor cortex is modulated by social context.
Vertical, Horizontal, Concentric: The Mechanics of Differential Treatment in the Climate Regime
Authors: Deleuil Thomas , Honkonen Tuula
Published: November 2018

Through a policy analysis and comparative study of the parties’ submissions regarding differential treatment, this article explains why the concept of differentiation needs to evolve. In addition, the article discusses how the parties’ proposals will impact the form and structure of differentiation in a future agreement. We thus hope to provide insights into the future of the cbdrrc principle in terms both of its formulation and implementation.
Does the ‘No-Harm’ Rule Have a Role in Preventing Transboundary Harm and Harm to the Global Atmospheric Commons from Geoengineering?
Authors: Brent Kerryn , McGee Jeffrey , Maguire Amy
Published: November 2018

Solar Radiation Management (srm) geoengineering poses a significant risk of transboundary and global atmospheric harm. How might international law regulate the future use of srm? We explore how the ‘no-harm rule’ from customary international law might contribute to the international governance of future attempts at srm. The no-harm rule imposes a legal duty on states to prevent significant damage across borders and in the global commons. Existing geoengineering literature assumes that, as the international law system lacks a mandatory enforcement mechanism, the no-harm rule will play little or no role in the governance of srm. We challenge this assumption by focusing on the possibilities of compliance with the no-harm rule through bolstering its legitimacy and sense of legal obligation. We explain how Brunnée and Toope’s theory of ‘interactional international law’ might provide a useful lens for developing the no-harm rule in this way to independently respond to the risks posed by srm.
State Responsibility for Environmental Harm from Climate Engineering
Authors: Reichwein David , Hubert Anna-Maria , Irvine Peter J. , Benduhn Francois , Lawrence Mark G.
Published: November 2018

Some have proposed that climate-engineering methods could be developed to offset climate change. However, whilst some of these methods, in particular a form of solar-radiation management referred to as stratospheric aerosol injection (sai), could potentially reduce the overall degree of global warming as well as some associated risks, they are also likely to redistribute some environmental risks globally. Moreover, they could give rise to new risks, raising the issue of legal responsibility for transboundary harm caused. This article examines the question of international accountability of states for an increased risk of environmental harm arising from a large-scale climate intervention using sai, and the legal consequences that would follow. Examination of the applicability of customary rules on state responsibility to sai are useful for understanding the limitations of the existing accountability framework for climate engineering, particularly in the context of global environmental problems involving risk-risk trade-offs and large uncertainties.
Public Participation and Norm Formation for Risky Technology: Adaptive Governance of Solar-Radiation Management
Authors: Payne Cymie R. , Shwom Rachael , Heaton Samantha
Published: November 2018

As the international community comes to grips with climate destabilization, it has begun to evaluate potentially risky technologies, such as geoengineering, to mitigate the effects of warming. The geoengineering technology known as solar-radiation management (srm) poses many risks. There is also great uncertainty about whether society will decide to deploy srm in the future. Managing these risks and uncertainties requires adaptive governance that will be responsive to new knowledge and changing social systems. We analyse the dimensions of public participation and norm-formation mechanisms of current srm-related legal regimes and governance proposals. We find that there is a need for the social sciences, including legal and governance scholars, to engage with the theoretical and pragmatic challenges of engaging diverse and vulnerable publics fairly and efficiently.
Differentiation in the Paris Agreement
Authors: Voigt Christina , Ferreira Felipe
Published: November 2018

The need for equitable effort-sharing lies at the heart of the global response to climate change. Yet, until the very moment of the adoption of the Paris Agreement, the question of differentiation between the state parties remained controversial. This article seeks to examine the contemporary understanding of the concept of differentiation, as finally reflected in the Paris Agreement, and to track the concept’s negotiation history leading up to the Agreement. The authors argue that differentiation between parties in the Paris Agreement is nuanced, balancing different considerations for each of the Agreement’s elements. Rather than taking a non-differentiated or purely self-differentiated approach, as expected by some, the Agreement sets out the opposite: it allows for differentiation along a much broader set of parameters, in a manner that allows for more diversity and dynamism, while building on the normative legacy of the Convention. The article analyses differentiation as reflected in the Agreement in three different, but interconnected ways: First, on a principled basis, reflecting common but differentiated responsibilities and respective capabilities, in the light of different national circumstances; second, on the basis of the legal content of various provisions of the Agreement, in particular on mitigation, finance, and transparency; and third, on the basis of the parameters of progression and highest possible ambition, which represent new and dynamic aspects of differentiation. By doing so, the Agreement enhances differentiation to an unparalleled extent.1
Linked Carbon Markets: Silver Bullet, or Castle in the Air?
Authors: Jevnaker Torbjørg , Wettestad Jørgen
Published: November 2018

Does the Paris Agreement provide a boost to carbon markets? Although carbon markets are spreading globally, so far relatively few links have been established between them. The history of linking indicates that successful efforts are characterized by converging ets design, and, related to this, political will. Moreover, existing links have been facilitated by prior economic and political ties. Such linking processes face significant challenges related to distribution of power and political feasibility. The Paris Agreement does not make the more intrinsic challenges of political linking go away. Moreover, a significant amount of elaboration and clarification of the Paris Agreement remains subject to further negotiations. Nevertheless, Paris confirmed an increasing support for carbon markets: the periodic reviews of state climate policies, shared fulfilment, and common guidance for accounting, together provide a new momentum for the development of carbon markets and the process of linking them. What this boost means for the prospects of a globally interlinked carbon market remains to be seen.
The Paris Climate Change Agreement: China and India
Authors: Gupta Joyeeta
Published: November 2018

This paper assesses how the Paris Agreement on climate change affects China and India. Taking a twail (third-world approaches to international law) approach, it argues that patterns of exploitation are repeated in different fields. The unfccc required developed countries to reduce their emissions before developing countries would be required to do so. While some developed countries are keeping to their side of the bargain, others are failing to do so. Nevertheless, China and India have accepted an agreement with targets for all countries which requires considerable sacrifices in the energy field but possible gains in the water field. While both countries have agreed to reduce the rate of growth of their emissions, they have high expectations of climate finance, which are unlikely to be fulfilled. Their commitments require major changes to national policy, scarcely the sort of tinkering that the no-regrets policy in India has achieved.
Float Like a Butterfly, Sting Like a Bee: Judicial Challenges to Renewable-Energy Support Schemes in Europe
Authors: Talus Kim
Published: November 2018

The past few years have witnessed a surge of judicial activity relating to renewable energy in the European Union. Several renewable-energy disputes have come before dispute-settlement bodies, such as the Court of Justice of the European Union, wto bodies, investment-dispute tribunals, and national courts. Behind these disputes is often a tension between, on the one hand, state- or European Union-level regulations seeking to promote renewable energy and achieve climate-policy objectives, and, on the other, economic considerations related to investor protection and free movement of goods.
Renewable-Energy Support Schemes in the Case Law of the Court of Justice of the eu: Tensions Between Trade and Climate Objectives
Authors: Tsifopoulou Eirini
Published: November 2018

This article discusses the application of eu law by the Court of Justice of the eu to the renewable-energy promotion policies. The key question in the case law is whether national policies designed to promote locally produced renewable energy are consistent with eu law, and specifically with the principle of the free movement of goods. The article analyses the recent Ålands Vindkraft and Essent Belgium cases, focusing on the interaction and potential conflict between trade objectives and the objective of promoting renewable energy. It is argued that the Court has consistently accommodated national support policies with competing trade objectives while emphasizing the need for proportionality in restrictions on trade. The article also discusses the impact of the Court’s rulings on eu renewables policies against the backdrop of recent developments towards increased market integration of renewable energy.
New Directions of Legal Reform for Renewable Energy in Europe: From Single-Plant Support to Whole-of-System Approaches
Authors: Kallies Anne
Published: November 2018

As the proportion of renewable energy in the electricity system increases, a new suite of barriers becomes apparent. These include the unsuitability of traditional network configurations for often remote renewable resources, and the need to develop a diverse range of renewable-energy sources to ensure electricity system stability and security. Substantial legal reform will be necessary to develop an electricity system that can accommodate high volumes of renewable energy. This paper analyses recent legal reforms for renewable energy in the United Kingdom and Germany to illuminate a regulatory shift away from single-plant support to whole-of-system approaches to electricity system development. Regulatory attention has shifted to reform regulatory frameworks for electricity networks to be more accommodating of renewable energy, rather than simply providing financial support for renewable sources. These changes have been supported by a high-level commitment to develop an electricity system that is both efficient and sustainable.
Towards a Regulatory Design for Reducing Emissions from Agriculture: Lessons from Australia’s Carbon Farming Initiative
Authors: Verschuuren Jonathan
Published: November 2018

The land sector is essential to achieve the Paris Agreement’s goals. Agriculture and land use contribute between 20 and 25 per cent of global greenhouse gas emissions. The Paris Agreement’s aim to keep the average global temperature rise between 1.5 and 2 degrees Celsius implies that drastic emission cuts from agriculture are needed. The sequestration potential of agriculture and land use offers an important mechanism to achieve a transition to net-zero carbon emissions worldwide. So far, however, states have been reluctant to address emissions from, and sequestration by, the agricultural sector. Some states that have or are setting up a domestic emission-trading scheme allow for the generation of offsets in agriculture, but only to a limited extent. Australia is the only country that has a rather broad set of methodologies in place to award credits to farmers for all kinds of carbon-farming projects. This article reviews the experience with the Australian model so far, with the objective of articulating transferable lessons for regulatory design aimed at reducing greenhouse gas emissions from agriculture. It finds that it is possible to regulate for the reduction of emissions from agriculture
and for increased sequestration in agricultural soils and in vegetation on agricultural lands, provided that certain conditions are met. Regulation must focus on individual projects at farms, based on a long-term policy that has a wider focus than just emission reduction. Such projects must comply with climate-smart methodologies that ensure the delivery of real, additional, measurable, and verifiable emission reductions and also foster long-term innovation and create economic, social, and environmental co-benefits. Moreover, a robust and reliable mrv system must be put in place.
Traditional commercial model or distributed generation? Finding the proper scale for wind energy
Authors: Martin Thomas A.
Published: November 2018

In this paper, I attempt to compare costs and benefits of the traditional model with distributed generation within the scope of wind-energy generation. In part II, I examine the following economic aspects of both models: in Section II.1, economies of scale; II.2, economics of permanence; II.3, allocation of costs and benefits among stakeholders. Traditional notions of economies of scale favour a larger model of production, though economist E.F. Schumacher presents an alternative view of production that would favour smaller-scale development. In part III, I discuss logistical and technological barriers to widespread application of the two models. In III.1, I examine the smart grid. Distributed generation may be dependent on a smart grid to maximize the benefits inherent in its “grassroots” structure, while the traditional model can flourish with or without technological advances in the grid. In III.2, I discuss facility-siting in both the rural and urban contexts. I examine the biggest logistical challenge for the traditional model, which is the transmission of energy from its rural generation facilities to population centers. I also discuss the potential for distributed generation in urban areas. While distributed generation in urban centers has been limited thus far to solar generation rather than wind, numerous companies are working on wind solutions that will work in an urban setting, with the potential for a tremendous impact on the way we think about energy.
Auctioning EU ETS allowances: An assessment of market manipulation from the perspective of Law and Economics
Authors: Weishaar Stefan E. , Woerdman Edwin
Published: November 2018

We analyse whether Auction Regulation 1031/2010/EU under the EU ETS efficiently addresses market manipulation. Two strategies for manipulating the allowance auction market are considered, namely demand reduction and signalling. In the Auction Regulation the legislature has opted for the sealed-bid uniform-price auction. This auction-mechanism design addresses in-auction signalling, but does not eliminate all incentives for demand reduction. For this reason the legal framework should ensure efficient monitoring and enforcement with a view to preventing market abuse. However, we have observed several inefficiencies, due to (a) concurring competences of enforcement agents, (b) inconsistencies in the enforcement schedules, and (c) imbalances in the mix of public and private enforcement. As a whole, though, the framework is nuanced, with the result that some of the inefficiencies are likely to be addressed. We conclude that market abuse in EU ETS auctions could be prevented more efficiently through improving the legal enforcement structure.
All things not being equal: Aviation in the EU ETS
Authors: Borger Gudo
Published: November 2018

The EU ETS lays down distinctions between the aviation sector and other covered sectors with regard to the determination of the emission cap and the manner in which allowances are allocated to operators in different sectors. The choices made by the legislature could infringe upon the principle of equality. I rely upon the criteria set out by the Court of Justice of the European Union to assess whether the principle is respected under the EU ETS. The decision to use different base years for the aviation sector in the calculation of the emission cap can be justified by the undue burden that would be placed on the sector if the base year were set to 1990, in view of its rapid growth over the past two decades. The use of a different allocation method for aviation is not so easily explained. Whether the principle of equality is respected as between different sectors and within the aviation sector will depend on the material effect that the EU ETS will have. In turn, this depends on the development of the price of EUAs. The treatment of aviation under the EU ETS in phase three could give rise to a challenge in a national court once the effects of it become clear.
A pale reflection of political reality: Integration of global climate, wetland, and biodiversity agreements
Authors: Pittock Jamie
Published: November 2018

Avoiding dangerous climate change, conserving biodiversity, and sustaining water resources are three of the greatest environmental challenges facing humanity: their expression and management are inextricably linked. National governments have adopted multilateral environmental agreements to respond to these issues by providing mandates for action, setting higher environmental standards, mobilizing resources, and sharing knowledge. This article examines whether three relevant, global conventions—the UN Framework Convention on Climate Change, the Convention on Biological Diversity, and the Ramsar Convention on Wetlands—are being implemented as effectively and efficiently as possible by managing conflicts and enhancing positive synergies among them through integrative mechanisms. Systematic analysis of the conventions identifies many conflicts between measures adopted under the UNFCCC and the two biodiversity-related conventions, as well as unrealized positive synergies. Detailed assessment of integrative mechanisms reveals isolated examples of good practice. More commonly, integrative measures were not being used, particularly by the UNFCCC. After more than a decade of attempts to expand interconvention collaboration and harmonization, I conclude that voluntary efforts need to be replaced by financial incentives or governance reforms if perverse impacts are to be avoided and these agreements are to be better implemented.
The EU ETS and the role of the courts: Emerging contours in the case of Arcelor
Authors: Peeters Marjan
Published: November 2018

This article presents an in-depth examination of how one of the EU’s courts has assessed a foundational claim against the EU ETS. It concerns the Arcelor case, in which a large steel company filed an application before the General Court of the EU requesting the partial annulment of the European legislation establishing the EU ETS and claiming damages. The industry lost the case, but the considerations of the court offer a valuable contribution to the much-needed broader discussion about the proper design of legislative frameworks for trading greenhouse gas emissions rights. In particular, the court provided an interesting discussion on the principle of equal treatment, the cancellation of allowances in the case of the closure of an installation, and the need for price regulation. However, some shortcomings in the court’s decision are evident. The article concludes by observing that, besides the interest in examining what the actual case law means for the specific design and application of emissions-trading schemes like the EU ETS, it is equally important to examine the ways in which courts succeed in assessing claims about this complicated regulatory instrument.
Deploying carbon capture and storage “safely”: The scope for Member States of the EU to adopt more stringent CO2 stream-purity criteria under EU law
Authors: Holwerda Marijn
Published: November 2018

In several European countries, recent initiatives to launch Carbon Capture and Storage demonstration projects faced strong local opposition over perceived health, environmental, and property risks, putting policy makers under pressure to provide additional safety guarantees. One way to increase safety standards is to strengthen the criteria in Article 12 of Directive 2009/31/EC on the geological storage of CO2, which are based on the London Protocol and OSPAR Convention requirements on the purity of the captured CO2 stream. The German and the Dutch draft legislation implementing Directive 2009/31/EC both provide for the possibility to impose additional CO2 stream-purity requirements. The paper examines the scope for EU Member States to adopt stricter CO2 stream-purity criteria under EU law. Based on an analysis of the relevant case lawof the European Court of Justice and the content of Directive 2009/31/EC, it concludes that the scope for EU Member States to adopt stricter CO2 stream-purity criteria under EU law is likely to be narrow. The room for non-EU parties to the London Protocol and OSPAR Convention to adopt such stricter requirements might likewise be limited.
The regional governance of climate adaptation: A framework for developing legitimate, effective, and resilient governance arrangements
Authors: Termeer Catrien , Dewulf Art , Rijswick Helena van , Buuren Arwin van , Huitema Dave , Meijerink Sander , Rayner Tim , Wiering Mark
Published: November 2018

Adaptation to climate change raises important governance issues. Notwithstanding the increasing attention on climate adaptation at the global and European level, the variety of local conditions and climate impacts points towards a prime role for regional actors in climate change adaptation. They face the challenge of developing and implementing adaptation options and increasing the adaptive capacity of regions so that expected or unexpected impacts of future climate change can be addressed. This paper presents a conceptual framework to analyse the regional governance of climate adaptation. It addresses the following key questions: (1) What are the distinct challenges for the regional governance of climate adaptation? (2) Which concepts can guide the design of new governance arrangements and strategies? (3) What challenges to legal principles are posed by the climate? (4) What research methods are suitable for developing and testing governance arrangements and strategies? We present a framework designed to address each of these questions; it has analytical, design, normative, and methodological components. In the paper, examples from the Dutch regional governance of climate adaptation serve as illustrations of the conceptual argumentation.
Manifestations of adaptive capacity: An institutional analysis of adaptation of a local stormwater drainage system
Authors: Ploeg Tineke Ruijgh-van der
Published: November 2018

Local institutions are important in shaping the outcome of adaptation to climate change. In the case of adaptation of local man-made systems, like a water drainage system, both the engineering system design and the institutional design need to be changed. What aspects of institutional design are relevant for the adaptive capacity of such systems? A well-documented case of adaptation in Dutch local water management was studied in order to reveal the manifestations of adaptation. A four-by-four matrix was used for institutional analysis to understand the interdependencies of institutions in the operation, design, financing, and building of water systems. In this case, four types of “institution” facilitated the adaptation of the water system: (1) new principles, norms, and values of local inhabitants with regard to water-system management, tax allocation, and land-use zoning; (2) the presence of stable, national laws that grant responsibility for adaptation of the physical system to local government; (3) adaptable, formal institutions that can be adjusted in response to local changes; and (4) a formalized master plan for implementation and a sufficient budget for steering the water board and stakeholders in their interactions. These lessons were drawn from a case of adaptation to changes in land use: the economy and demography of the area had changed the demand for stormwater drainage. Planned adaptation in response to other changes, like climate change, may benefit from a similar combination of institutions to integrate decisions on operation, design, financing, and building of public water works.
Reducing greenhouse gas emissions by forest protection: The transaction costs of implementing REDD
Authors: Alston Lee J. , Andersson Krister
Published: November 2018

Understanding and minimizing the transaction costs of policy implementation are critical for reducing tropical forest losses. As the international community launches REDD, a global initiative to reduce greenhouse gas emissions from tropical deforestation, policymakers need to pay attention to the transactions costs associated with negotiating, monitoring and enforcing contracts between forest users, governments, and donors. The existing institutional design forREDDrelies heavily on central government interventions in program countries. Analysing new data on forest conservation outcomes, we identify several problems with this centralized approach to forest protection. We describe options for a more diversified policy approach that could reduce the full set of transaction costs and thereby improve the efficiency of the market-based approach to conservation.
From global to polycentric climate governance
Authors: Cole Daniel H.
Published: November 2018

Global governance institutions for climate change, such as those established by the UNFCCC and the Kyoto Protocol, have so far failed to make a significant impact on greenhouse gas emissions. Following the lead of Elinor Ostrom, this paper offers an alternative theoretical framework for reconstructing global climate policy in accordance with the polycentric approach to governance pioneered in the early 1960s by Vincent Ostrom, Charles Tiebout, and RobertWarren. Instead of a thoroughly top-down global regime, in which lower levels of government simply carry out the mandates of international negotiators, a polycentric approach provides for greater experimentation, learning, and cross-influence among different levels and units of government, which are both independent and interdependent. After exploring several of the design flaws of the existing set of global institutions and organizations for greenhouse gas mitigation, the paper explores how those global institutions and organizations might be improved by learning from various innovative policies instituted by local, state, and regional governments. The paper argues that any successful governance system for stabilizing the global climate must function as part of a larger, polycentric set of nested institutions and organizations at various governmental levels.
The Adaptation Fund of the Kyoto Protocol: A model for financing adaptation to climate change?
Authors: Horstmann Britta , Abeysinghe Achala Chandani
Published: November 2018

The Adaptation Fund of the Kyoto Protocol is seen by many as a model for financing adaptation activities, which should also play a strong role in the institutional design of the Green Climate Fund under the UNFCCC. The article analyses whether the status of operationalization of the Adaptation Fund meets international institutional criteria and requirements for an effective and efficient fund arrangement. These are derived from the UNFCCC and the Paris Agenda on Aid Effectiveness. The analysis shows that the Adaptation Fund meets most of the funding requirements. Due to its institutional features, particularly the direct-access modality, the Adaptation Fund has the potential to practically link international climate change with development finance for adaptation to climate change. However, the analysis also shows that there are a number of challenges remaining, including criteria which the fund does not meet yet and the practical implementation of fund operations, particularly at the national level.