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.

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.

Cases, Materials and Text on National, Supranational and International Non-Discrimination Law

This casebook, the result of the collaborative efforts of a panel of experts from various EU Member States, is the latest in the Ius Commune Casebook series developed at the Universities of Maastricht and Leuven. The book provides a comprehensive and skilfully designed resource for students, practitioners, researchers, public officials, NGOs, consumer organisations and the judiciary. In common with earlier books in the series, this casebook presents cases and other materials (legislative materials, international and European materials, excerpts from books or articles). As non-discrimination law is a comparatively new subject, the chapters search for and develop the concepts of discrimination law on the basis of a wide variety of young and often still emerging case law and legislation. The result is a comprehensive textbook with materials from a wide variety of EU Member States. The book is entirely in English (i.e. materials are translated where not available in English). At the end of each chapter a comparative overview ties the material together, with emphasis, where appropriate, on existing or emerging general principles in the legal systems within Europe.
The book illustrates the distinct relationship between international, European and national legislation in the field of non-discrimination law. It covers the grounds of discrimination addressed in the Racial Equality and Employment Equality Directives, as well as non-discrimination law relating to gender. In so doing, it covers the law of a large number of EU Member States, alongside some international comparisons.
The Ius Commune Casebook on Non-Discrimination Law
- provides practitioners with ready access to primary and secondary legal material needed to assist them in crafting test case strategies.
- provides the judiciary with the tools needed to respond sensitively to such cases.
- provides material for teaching non-discrimination law to law and other students.
- provides a basis for ongoing research on non-discrimination law.
- provides an up-to-date overview of the implementation of the Directives and of the state of the law.
This Casebook is the result of a project which has been supported by a grant from the European Commission's Anti-Discrimination Programme.

Sex equality law after Kalanke and Marschall

In Marschall, the ECJ looked for the second time into the admissibility of positive action in German public services; a third reference on this issue is still pending.
Despite the Court’s positive response to the ‘women’s quota’ in Marschall, its application in Germany remains controversial. This article tries to shed some light on the specific conditions under which women’s quotas were implemented in Germany and on the different approaches to anti-discrimination, indirect discrimination law and structural discrimination, which underlie efforts to justify women’s quotas against equality standards derived from EC Law.

The current state of abortion law and practice in Northern Ireland

This paper reviews current abortion law and practice in Northern Ireland (NI). It explores the origins of NI's abortion law and its complexity in relation to current practice. it reviews issues relating to women seeking terminations in NI and Great Britain and reviews attempts by the Family Planning Association NI to require the Department of Health and Social Services and Public Safety NI to provide guidance for health professionals engaged in this practice. The paper also discusses some of the issues surrounding abortion in NI and seeks to explain why this subject is causing controversy and debate, especially following a judicial review in February and Marie Stopes opening a termination service in Belfast.

Village Greens, Commons Land and the Emergence of Sports Law in the UK

This article traces the legal development of recreational rights surrounding village greens and, later, urban public spaces in the UK. The article highlights that at a critical juncture in the development of modern sport in Britain - in the mid-nineteenth century - the law helped embed not only just a space for sport in the emerging industrialised and increasingly urbanised environment, but also the place of sport in the Victorian era's evolving socio-economic landscape and, further, the relevant case law was the precursor for what is known today as sports law.

New governance for higher education institutions:prospects for female university careers and equality law

This paper analyses the reforms in employment conditions at German public universities from the 1990s to the 2000s, considering how these impact on practical equal opportunities between women and men. It concludes that while the so called "new governance" in universities would have offered opportunities to integrate positive measures to increase female participation in research and teaching, these opportunities were missed in most German states.

Sports Law

The term sports law is fourfold in nature and encompasses: (a) traditional areas of law, such as contract, tort, criminal, administrative and EU law, as applied to disputes of a sporting origin; (b) the particular impact that a range of statutory provisions might have on sport; for example, legislation governing discriminatory and unsafe practices in a workplace or monopolistic or fraudulent behaviour in an industry; (c) issues of public and social policy otherwise influencing the legislature and the courts, from the allocation of resources to the allocation of risk; and (d) lex sportiva, where that term is taken to reflect the various internal administrative regulations and awards by dispute-resolving mechanisms in sport. As a matter of practice, sports law tends to be concerned with the application of contract and commercial law principles to professional sport - and namely the application of such branches of law to disputes relating to the following "three pillars" of modern, professional sport i.e., disputes relating to the payment, sponsorship or endorsement of those who play sport for a living; disputes arising from decisions made by sports governing bodies; and disputes arising from the application of law to the holding of sports events.

EU Social and Labour Rights and EU Internal Market Law: Study for the EMPL Committee

EU Social and Labour Rights have developed incrementally, originally through a set of legislative initiatives creating selective employment rights, followed by a non-binding Charter of Social Rights. Only in 2009, social and labour rights became legally binding through the Charter of Fundamental Rights for the European Union (CFREU). By contrast, the EU Internal Market - an area without frontiers where goods, persons, services and capital can circulate freely – has been enshrined in legally enforceable Treaty provisions from 1958. These comprise the economic freedoms guaranteeing said free circulation and a system ensuring that competition is not distorted within the Internal Market (Protocol 27 to the Treaty of Lisbon). Tensions between Internal Market law and social and labour rights have been observed in analyses of EU case law and legislation. This study explores responses by socio-economic and political actors at national and EU levels to such tensions, focusing on collective labour rights, rights to fair working conditions and rights to social security and social assistance (Articles 12, 28, 31, 34 Charter of Fundamental Rights for the European Union). On the basis of the current Treaties and the CFREU, the constitutionally conditioned Internal Market emerges as a way to overcome the perception that social and labour rights limit Internal Market law, or vice versa. On this basis, alternative responses to perceived tensions are proposed, focused on posting of workers, furthering fair employment conditions through public procurement and enabling effective collective bargaining and industrial action in the Internal Market.

European Union Biomedical Research Law and Policy and Citizen Science

In this chapter I focus on the EU's emerging biomedical research law and policy and examine the development of citizen science in this setting. The chapter argues that while what the analysis reveals might not be specific to the EU, attention to this organisation underlines important but often overlooked aspects of citizen science. That is, citizen science is (being) made less about promoting substantive involvement by citizens in the fashioning of biomedical trajectories and their empowerment as participants that pursue aims defined by themselves rather than others. Instead citizen science is underpinned by a more longstanding EU level approach to participation in science-based issues that sees it being harnessed, shaped and directed towards supporting the production and legitimation of organisational identity and sociotechnical order (in this case the EU’s). Within biomedical research law and policy citizen science might therefore be expected to support market-optimised biomedical futures and a dynamic internal market and economy. Citizen science is thereby implicated in the delineation of the boundaries of responsibility and accountability (and blame) for the (non-)realisation of public health priorities and objectives. In this way law and policy on participation and citizen science might support current research trajectories that do not serve all health needs.

Portugal's Quota-Parity Law: An Analysis of its Adoption

In August 2006, Portugal approved a new quota law, called the parity law. According to this, all candidate lists presented for local, parliamentary, and European elections must guarantee a minimum representation of 33 per cent for each sex. This article analyses the proximate causes that led to the adoption of gender quotas by the Portuguese Parliament. The simple answer is that the law’s passage was a direct consequence of a draft piece of legislation presented by the Socialist Party (PS), which enjoyed a majority. However, the reasons that led the PS to push through a quota law remain unclear. Using open-ended interviews with key women deputies from all the main Portuguese political parties, and national public opinion data, among other sources, the role of four actors/factors that were involved in the law’s adoption are critically examined: notably, civil society actors, state actors, international and transnational actors, and the Portuguese political context.

The Triveneto transhumance: law, land, movement

North Italy's nomadic shepherds are a phenomenon unique in the world. Their nomadic nature is taken to the extreme since they move constantly rather than solely in the winter or the summer, as in the usual nomadism. Their home is on wheels and their territory is the tightly regulated yet sprawling Triveneto area. The Triveneto transhumance moves beyond private/public property divides, and indeed beyond lawful/unlawful distinctions, giving rise to what I have called an animal normativity. Relying on Valentina De Marchi's text 'Fame d'Erba' on the Triveneto transhumance, I show how territory becomes a question of animal hunger, and movement becomes an atmospheric, silent and imperceptible affect that crosses private property boundaries, state law limitations, reservation areas and road networks. This way of being, beyond the usual distinctions, offers an example of an alternative political and legal organisation that brings forth the continuum between the human, the natural and the legal/political.