Prospects and challenges of a Pan-European post-trade infrastructure. ECMI Policy Brief No. 20, 8 November 2012

After more than a decade of indecision, the EU is finally now set to implement a consistent regulatory architecture for clearing and settlement. Following the agreement on a European market infrastructure Regulation (EMIR), the European Commission has proposed harmonised rules for centralised settlement depositaries (CSDs), while the European Central Bank is moving forward with its plans for a central eurozone settlement engine. This paper analyses three components of the new post-trade infrastructure measures: 1) the regulatory framework for and supervision of central counterparties under the new EMIR legislation, 2) the authorisation requirements of trade repositories and 3) the draft CSD Regulation and the progress with the ECB’s Target 2 Securities project. It then discusses the impact of the new rules, and argues that, analogous to the unexpected impact of MiFID on trading infrastructures, a similar EMIR revolution may be on its way.

The UN Security Council and the question of humanitarian intervention in Darfur

This article explores the different moral and legal arguments used by protagonists in the debate about whether or not to conduct a humanitarian intervention in Darfur. The first section briefly outlines four moral and legal positions on whether there is (and should be) a right and/or duty of humanitarian intervention: communitarianism, restrictionist and counter-restrictionist legal positivism and liberal cosmopolitanism. The second section then provides an overview of the Security Council's debate about responding to Darfur's crisis, showing how its policy was influenced by both normative concerns and hard-nosed political calculations. The article concludes by asking what Darfur's case reveals about the legitimacy and likelihood of humanitarian intervention in such catastrophes and the role of the UN Security Council as the primary authorising body for the use of international force. The authors argue that this case demonstrates that for the cosmopolitan/counter-restrictionist case to prevail pivotal states need to put humanitarian emergencies on the global agenda and express a willingness to act without Council authorisation, though the question of how to proceed in cases where the Council is deadlocked remains vexed.

Advanced computing for systems biology

Systems biology is based on computational modelling and simulation of large networks of interacting components. Models may be intended to capture processes, mechanisms, components and interactions at different levels of fidelity. Input data are often large and geographically disperse, and may require the computation to be moved to the data, not vice versa. In addition, complex system-level problems require collaboration across institutions and disciplines. Grid computing can offer robust, scaleable solutions for distributed data, compute and expertise. We illustrate some of the range of computational and data requirements in systems biology with three case studies: one requiring large computation but small data (orthologue mapping in comparative genomics), a second involving complex terabyte data (the Visible Cell project) and a third that is both computationally and data-intensive (simulations at multiple temporal and spatial scales). Authentication, authorisation and audit systems are currently not well scalable and may present bottlenecks for distributed collaboration particularly where outcomes may be commercialised. Challenges remain in providing lightweight standards to facilitate the penetration of robust, scalable grid-type computing into diverse user communities to meet the evolving demands of systems biology.

Registry of all stations from the Tara Oceans Expedition (2009-2013)

The Tara Oceans Expedition (2009-2013) sampled the world oceans on board a 36 m long schooner, collecting environmental data and organisms from viruses to planktonic metazoans for later analyses using modern sequencing and state-of-the-art imaging technologies. Tara Oceans Data are particularly suited to study the genetic, morphological and functional diversity of plankton. The present data set is a registry of all stations conducted during the Tara Oceans Expedition (2009-2013). The registry provides details about the scientific interest of each station, including (1) the geographic context, (2) legal context, (3) the environmental features that were targeted, and (4) a detailed account of devices deployed during the station. Uniform resource locators (URLs) offer direct links to the corresponding (1) physical oceanographic context reports, (2) list of samples collected during the station, (3) environmental data published at PANGAEA, and (4) nucleotides data published at the European Nucleotides Archive (EBI-ENA).

Cabazitaxel for hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen (review of TA255)

Prostate cancer is the most common cancer amongst men in the England and currently affects ~40,000 people around 6,000 of whom suffer from metastatic disease. Overall patients with metastatic disease have a life expectancy of less than 24 months and a poor prognosis.

Docetaxel was the first agent to show survival benefit in metastatic Hormone Refractory Prostate Cancer (mHRPC) and since approval by NICE in 2006 (TA101) has for many years been the mainstay of treatment.

To appraise the clinical and cost effectiveness of cabazitaxel within its marketing authorisation for treating hormone-relapsed metastatic prostate cancer previously treated with a docetaxel-containing regimen.

A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. Setting: USA, the EU, India and South Africa. Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa. Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.

Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation: A Single Technology Appraisal. Evidence Review Group Report to NICE

1.1 Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors, including: congestive heart failure hypertension diabetes prior stroke or transient ischaemic attack age 75 years or older

The legitimation of risk and Bt cotton: a case study of Bantala village in Warangal, Andhra Pradesh, India

This article explores Ulrich Beck’s theorisation of risk society through focusing on the way in which the risk of Bt cotton is legitimated by six cultivators in Bantala, a village in Warangal, Andhra Pradesh, in India. The fieldwork for this study was conducted between June 2010 and March 2011, a duration chosen to coincide with a cotton season. The study explores the experience of the cultivators using the ‘categories of legitimation’ defined by Van Leeuwen. These are authorisation, moral evaluation, rationalisation and mythopoesis. As well as permitting an exploration of the legitimation of Bt cotton by cultivators themselves within the high-risk context of the Indian agrarian crisis, the categories also serve as an analytical framework with which to structure a discourse analysis of participant perspectives. The study examines the complex trade-off, which Renn argues the legitimation of ambiguous risk, such as that associated with Bt technology, entails. The research explores the way in which legitimation of the technology is informed by wider normative conceptualisations of development. This highlights that, in a context where indebtedness is strongly linked to farmer suicides, the potential of Bt cotton for poverty alleviation is traded against the uncertainty associated with the technology’s risks, which include its purported links to animal deaths. The study highlights the way in which the wider legitimation of a neoliberal approach to development in Andhra Pradesh serves to reinforce the choice of Bt cotton, and results in a depoliticisation of risk in Bantala. The research indicates, however, that this trade-off is subject to change over time, as economic benefits wane and risks accumulate. It also highlights the need for caution in relation to the proposed extension of Bt technology to food crops, such as Bt brinjal (aubergine).

Risk definition and the struggle for legitimation: a case study of Bt cotton in Andhra Pradesh, India

This article explores the struggle for legitimation associated with the attempt to define the risk of Bt cotton, a genetically modified crop, in Andhra Pradesh, India. Beck asserts that, given the uncertainty associated with risk society, efforts to define risk are creating the need for a new political culture. This article argues that this political culture emerges from attempts to legitimate power within risk definition. This is examined using critical discourse analysis on interview excerpts with key figures in the Bt cotton debate. Legitimation is explored using the categories of legitimation developed by Van Leeuwen. These are (a) authorisation; (b) moral evaluation; (c) rationalisation; and (d) mythopoesis. The analysis highlights that the political culture which emerges in response to risk society is in a state of constant flux and contingent upon the ongoing struggle for legitimation with regard to the definition of risk.