Offshoring Clinical Trials: The Mutable Ethics, Weak Protections and Vulnerable Subjects of EU Law

In this paper I engage with science and technology studies work on pharmaceuticalisation to explore how European Union (EU) law helps to produce and support the preference for pharmaceutical responses in public health governance, while authorising the production of vulnerable subjects through the growing off-shoring of clinical trials. Drawing on the analysis of legal and policy documents, I demonstrate how EU law allows and legitimates the use of data procured from vulnerable subjects abroad for market authorisation and corporate profitability at home. This is possible because the EU has (de)selected international ethical frameworks in order to support the continued and growing use of clinical trials data from abroad. This has helped to stimulate the revision of international ethical frameworks in light of market needs, inscribing EU public health law within specific politics (that often remained obscured by the joint workings of legal and technological discourses). I suggest that law operates as part of a broader ‘technology’ – encompassing ethics and human rights discourses – that functions to optimise life through resort to market reasoning. Law is thereby reoriented, instrumentalised and deployed as part of a broader project aimed at (re)defining and limiting the boundaries of the EU's responsibility for public health, including the broader social production of public health problems and the unequal global order that the EU represents and helps to depoliticise and perpetuate. Overall, this limits the EU's responsibility and accountability for these failures, as well as another: the weak and mutable protections and insecure legacies for vulnerable trial subjects abroad.

Income ineqaulity from 1960-2012: a brief time-series history of capital and labour

This commentary examines two principal forms of inequality and their evolution since the 1960s: the division of national income between capital and labour, and the share of total income held by the top 1 per cent of earners. Trends are linked to current discussions of inequality drivers such as financialisation, and a brief time-series analysis of the effects of trade and financial sector growth on top incomes is presented.

An anthropometric history of the World, 1810-1980: did migration and globalization influence country trends?

We find that regional height levels around the world were fairly uniform throughout most of the 19th century, with two exceptions: above-average levels in Anglo-Saxon settlement regions and below-average levels in Southeast Asia. After 1880, substantial diver- gences began to differentiate other regions -- making the world population taller, but more unequal. During the late 19th century and 20th century, heights between world regions devi- ated significantly, when incomes also became very unequal. Interestingly, during the “breaking point period” between the two regimes, heights declined significantly in the cattle-rich New World countries, whereas they started to increase in Old Europe. We discuss in this study whether immigration was a core factor to influence the height decline in the “Anthropometric Decline of the Cowboy and Gaucho Empires”.

An Analysis of Soft Law Applicable to Humanitarian Assistance: Relative Normativity in Action?

There is limited binding international law specifically covering the provision of humanitarian assistance in response to natural and human-made disasters. Yet a variety of authoritative soft law texts have been developed in the past 20 years, including the UN Guiding Principles on Internal Displacement, the Red Cross Red Crescent Code of Conduct and the Sphere Project’s Humanitarian Charter and Minimum Standards in Disaster Response. While such ‘non-binding normative standards’ do not carry the weight of international law, they play an essential role in the provision of humanitarian assistance albeit subject to their limited enforceability vis-à-vis intended beneficiaries and to their voluntary application by humanitarian actors. Notwithstanding a lack of legal compulsion, certain non-binding normative standards may directly influence the actions of States and non-State actors, and so obtain a strongly persuasive character. Analysis of texts that influence the practice of humanitarian assistance advances our understanding of humanitarian principles and performance standards for disaster response. As the International Law Commission debates draft articles on the Protection of Persons in the Event of Disasters, such non-binding normative standards are crucial to the development of an internationally accepted legal framework to protect victims of disasters.

Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.

History of several mistakes: on differences between Lev Gumilev and Eurasians

This article challenges prevalent views about Gumilev’s relation to classic Eurasianism. On the basis of previously unavailable correspondence and interviews, it is argued that Lev Gumilev had substantial degree of affinity with the original Eurasian movement understood as a scholarly tradition. This was manifested both in his personal contacts with some of its key members, and in his scholarly work on the nomad history, which remained Eurasian in its spirit. However, the most significant departure from Eurasianism, under-appreciated by most scholars, was his theory of ethnogenesis, which attempted to establish a new naturalistic paradigm for study of history.

Germany and the New Global History of Secularism: Questioning the Postcolonial Genealogy

Secularism has emerged as a central category of twenty-first century political thought that in many ways has replaced the theory of secularization. According to postcolonial scholars, neither the theory nor the practice of secularization was politically neutral. They define secularism as the set of discourses, policies, and constitutional arrangements whereby modern states and liberal elites have sought to unify nations and divide colonial populations. This definition is quite different from the original meaning of secularism, as an immanent scientific worldview linked to anticlericalism. Anthropologist Talal Asad has connected nineteenth-century worldview secularism to twenty-first century political secularism through a genealogical account that stresses continuities of liberal hegemony. This essay challenges this account. It argues that liberal elites did not merely subsume worldview secularism in their drive for state secularization. Using the tools of conceptual history, the essay shows that one reason that “secularization” only achieved its contemporary meaning in Germany after 1945 was that radical freethinkers and other anticlerical secularists had previously resisted liberal hegemony. The essay concludes by offering an agenda for research into the discontinuous history of these two types of secularism.

Broadening the Scope and the Norms of EU Gender Equality Law: Towards a Multidimensional Conception of Equality Law

The aim of this article is to discuss some consequences of placing the combating of discrimination and the promotion of equality among the principles of Community law. The focus is firstly on the ensuing widening of the scope of EU (gender) equality law and secondly on the increase of grounds of forbidden discrimination. In concluding, steps towards a multidimensional conception of equality law are proposed.