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.

Historical data reveal power-law dispersal patterns of invasive aquatic species

Understanding how invasive species spread is of particular concern in the current era of globalisation and rapid environmental change. The occurrence of super-diffusive movements within the context of Lévy flights has been discussed with respect to particle physics, human movements, microzooplankton, disease spread in global epidemiology and animal foraging behaviour. Super-diffusive movements provide a theoretical explanation for the rapid spread of organisms and disease, but their applicability to empirical data on the historic spread of organisms has rarely been tested. This study focuses on the role of long-distance dispersal in the invasion dynamics of aquatic invasive species across three contrasting areas and spatial scales: open ocean (north-east Atlantic), enclosed sea (Mediterranean) and an island environment (Ireland). Study species included five freshwater plant species, Azolla filiculoides, Elodea canadensis, Lagarosiphon major, Elodea nuttallii and Lemna minuta; and ten species of marine algae, Asparagopsis armata, Antithamnionella elegans, Antithamnionella ternifolia, Codium fragile, Colpomenia peregrina, Caulerpa taxifolia, Dasysiphonia sp., Sargassum muticum, Undaria pinnatifida and Womersleyella setacea. A simulation model is constructed to show the validity of using historical data to reconstruct dispersal kernels. Lévy movement patterns similar to those previously observed in humans and wild animals are evident in the re-constructed dispersal pattern of invasive aquatic species. Such patterns may be widespread among invasive species and could be exacerbated by further development of trade networks, human travel and environmental change. These findings have implications for our ability to predict and manage future invasions, and improve our understanding of the potential for spread of organisms including infectious diseases, plant pests and genetically modified organisms.

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.

The German Federal Constitutional Court's Ruling on Outright Monetary Transactions (OMT) - Another Step Towards National Closure?

The German Federal Constitutional Court (FCC) ruling of 14 January 2014 deserves a thorough evaluation on several accounts: It is the first ever reference by the FCC to the Court of Justice of the European Union (CJEU), it represents a continuation of FCC case law aimed at restricting the impact of European Union law as interpreted by the Court of Justices of the European Union (CJEU) on German law as well as questioning Germany’s participation in an ever closer European Union, and it has the potential to dictate the future course of the EU’s Economic and Monetary Union (EMU).

This case note discusses three aspects of this decision. First, it considers the aims of challenging the youngest measures to contain the euro currency crisis before the FCC, focusing on the question in how far the claims are based on national closure as opposed to an ever closer union of the peoples of Europe. Secondly it analyzes in how far the aims the claims pursue are reflected in the FCC’s response. Thirdly, it considers the substantive relevance of this reference, highlighting the surprisingly vague consequences the FCC envisages should the CJEU not re-interpret the OMT decision as the FCC suggests, and illuminating the strategic aims of the reference without deference. In conclusion, it sketches the remaining scope for the EU to engage in or at least facilitate transnational solidarity.

Speaking with One Voice?: Ethno-national Division on the Constitutional Court of Bosnia-Herzegovina

The challenge of designing institutions to manage ethno-national conflict is one of the enduring concerns of political science. One important but relatively understudied aspect of this challenge is the design of constitutional courts. Courts are likely to play a key role in the maintenence of a constitutional settlement. But this role can be especially onerous in a deeply divided and post-conflict setting where the rule of law is weak and judges have ethno-national affiliations that may undermine the appearance of judicial neutrality. In such contexts, a court’s authority (including compliance with its decisions) cannot be taken for granted.

With reference the Constitutional Court of Bosnia-Herzegovina, and using an original dataset of the Court's non-unanimous plenary decisions, we test several hypotheses about the degree to which ethno-national affiliation influences judicial behavior. We find that (1) judges on the Constitutional Court do in fact divide predictably along ethno-national lines, (2) that these patterns are robust to changes in the tenure system, and (3) are independent of party political background.

The EU Equal Treatment Directives - implementation in German labour law

This article in one of the leading German journals on labour law analyses the shortcomings of German labour law at the time (2004) in relation to the EU non-discrimination directives. It states that the reluctance to legislate against race, sex and disability discrimination must be overcome, if the demands of the directives are to be fulfilled. It also explains how those forms of discrimination could already be addressed by interpreting German labour law in line with those directives and constitutional requirements. Only in 2006 was the relevant legislation finally passed (three years later than required).

European Union Non-Discrimination Law: Comparative Perspectives on Multidimensional Equality Law

EU equality law is multidimensional in being based on different rationales and concepts. Consequently, the concept of discrimination has become fragmented, with different instruments envisaging different scopes of protection. This raises questions as to the ability of EU law to address the situation of persons excluded on a number of grounds. This edited collection addresses the increasing complexity of European Equality Law from jurisprudential, sociological and political science perspectives. Internationally renowned researchers from Scandinavian, Continental and Central European countries and Britain analyse consequences of multiplying discrimination grounds within EU equality law, considering its multidimensionality and intersectionality. The contributors to the volume theorise the move from formal to substantive equality law and its interrelation to new forms of governance, demonstrating the specific combination of non-discrimination law with welfare state models which reveal the global implications of the European Union. The book will be of interest to academics and policy makers all over the world, in particular to those researching and studying law, political sciences and sociology with an interest in human rights, non discrimination law, contract and employment law or European studies.

Time for Reform? Refugees, Asylum-seekers and Protection Under International Human Rights Law

The aim is to explore the protection that international human rights law offers to refugees, asylum-seekers, and the forcibly displaced. The ambition of the global rights framework is to guarantee a defined range of rights to all human beings, and thus move the basis for normative entitlement from exclusive reliance on national membership to a common humanity. This comprehensive and international perspective remains formally tied to states - acting individually or collectively - in terms of creation and implementation. The norms must find an entry point into the empirical world, and there must be clarity on responsibilities for practical delivery. It should remain unsurprising that the expectations raised by the normative reach of the law are frequently dashed in the complex and difficult human world of instrumental politics, power, and conflict. The intention here is to outline the international human rights law context, and indicate the value and limitations for the protection of refugees and asylum-seekers. A question is then raised about possible reform.

Constitutional Questions

Constitutional Questions
Professor John Morison MRIA School of Law, Queen’s University Belfast
How should we live together? Is there any ethical question more fundamental than this?
Is a constitution only about who does what in government or is it about what is to be done? Does a constitution provide the ground rules for deciding this or is it part of the answer itself? Is it the repository of fundamental values about how to live? What is the good life anyway? Is it about the preservation of life and liberty, and the pursuit of happiness? Or something more? What about preserving (or radically reordering) the distribution of property? Or ensuring that everyone has the same chances? Is it the job of the constitution to simply promise dignity, equality and freedom, or to deliver these values?
If the constitution is the place where the state undertakes “to promote the welfare of the whole people”, what does this actually mean in practical terms? And who pays for it? Should a constitution give us an entitlement to at least a basic minimum by way of a lifestyle? Or is it the job only of the political process to decide issues about the allocation of resources? What do we do if we feel that we cannot trust our politicians? Are there basic rules that should govern the operation of politics and are there fundamental values that should not be overridden? Are these “sacred and undeniable”? Or to be interpreted in line with modern conditions and within a “margin of appreciation”? Who decides on this in individual cases?
Who is entitled to any of this, and on what basis? Is everyone equal? Is the constitution about making it clear that no-one is better than you, and that in turn, you are better than no-one? Is a constitution about ensuring that you will always be an end in yourself and never simply a means to anyone else’s end? Or does it simply reinforce the existing distribution of power and wealth?
Are citizens to be given more than those who are not citizens? Is more to be expected from them, and what might that be? Can the constitution tell us how we should treat those from outside who now live with us?
What is the relationship between a constitution and a nation? Who is in the nation anyway? Should we talk about “we the people” or “we the peoples”? Should a constitution confirm a nationality or facilitate diversity? Is the constitution the place to declare aspirations for a national territory? Or to confirm support for the idea of consent? What about all our neighbours – on the island of Ireland and in Great Britain? Or in Europe? And beyond?
What is the relationship between a constitution and democracy? Is a constitution simply the rules by which the powerful govern the powerless? In what sense does a constitution belong to everyone, across past, present and future generations? Is it the place where we state common values? Are there any? Do they change across time? Should the people be asked about changes they may want? How often should this be done? Should the constitution address the past and its problems? How might this be done? What do we owe future generations?
Finally, if we can agree that the constitution is about respecting human rights, striving for social justice and building a fair and democratic Ireland – North and South – how do we make it happen in practice?

Comparative International Human Rights Law

This chapter locates of international human rights in current discussion of comparative international law, and distinguishes comparative international human rights law from both the 'fragmentation' literature, and from comparative constitutional rights discourse.

Bringing Women In: Global strategies for gender parity in political representation

this article discusses the three main strategies employed across the globe to raise the levels of women's political representation

BOOK: Property Rights and Human Rights in a Global Context

Property as a human rights concern is manifested through its incorporation in international instruments and as a subject of the law through property-related cases considered by international human rights organs. Yet, for the most part, the relationship between property and human rights has been discussed in rather superficial terms, lacking a clear substantive connection or common language. That said, the currents of globalisation have witnessed a new era of interrelation between these two areas of the law, including the emergence of international intellectual property law and the recognition of indigenous claims, which, in fundamental ways, speak to an engagement with human rights law.

This collection starts the conversation between human rights lawyers and property lawyers and explores analytical approaches to the increasing relationship between property and human rights in a global context. The chapters engage with key theoretical and policy debates and range across three main themes: the re-evaluation of the public/private divide in the law; the tensions between the market and social justice in development and the balance between the rights of individuals and those of communities. The chapters adopt a global, comparative perspective and engage in case studies from countries including India, Philippines, Brazil, the United States, the United Kingdom and includes various regions of Africa and Europe.

Global Systemic Risk and International Regulatory Coordination: Squaring Sovereignty and Financial Stability

In recent years much attention has been given to systemic risk and maintaining financial stability. Much of the focus, rightly, has been on market failures and the role of regulation in addressing them. This article looks at the role of domestic policies and government actions as sources of global instability. The global financial system is built upon global markets controlled by national financial and macroeconomic policies. In this context, regulatory asymmetries, diverging policy preferences, and government failures add a further dimension to global systemic risk not present at the national level.
Systemic risk is a result of the interplay between two independent variables: an underlying trigger event, in this analysis a domestic policy measure, and a transmission channel. The solution to systemic risk requires tackling one of these variables. In a domestic setting, the centralization of regulatory power into one single authority makes it easier to balance the delicate equilibrium between enhancing efficiency and reducing instability. However, in a global financial system in which national financial policies serve to maximize economic welfare, regulators will be confronted with difficult policy and legal tradeoffs.
We investigate the role that financial regulation plays in addressing domestic policy failures and in controlling the danger of global financial interdependence. To do so we analyse global financial interconnectedness, and explain its role in transmitting instability; we investigate the political economy dynamics at the origin of regulatory asymmetries and government failures; and we discuss the limits of regulation.

Tutela processual de direitos humanos fundamentais : inflexões no "due process of law"

Tese de doutoramento, Direito (Ciências Jurídico-Civis), Universidade de Lisboa, Faculdade de Direito, 2014