European Law and New Health Technologies

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money.

To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation.

This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

Rape Myths, Law, and Feminist Research: 'Myths About Myths?'

In an article recently published in the Oxford Journal of Legal Studies, the legal scholar Helen Reece argues that the prevalence and effects of rape myths have been overstated and the designation of certain beliefs and attitudes as myths is simply wrong. Feminist researchers, she argues, are engaged 'in a process of creating myths about myths' in a way that serves to close down and limit productive debate in this 'vexed' area. In this article we argue that Reece's analysis is methodologically flawed, crudely reductionist and rhetorically unyielding. We locate Reece's analysis within the wider theoretical field to show how her failure to engage with feminist literature on rape other than in the narrowest, most exclusionary terms, yields an approach which impedes rather than advances public understanding and panders to a kind of simplistic thinking which cannot begin to grapple with the complexity of the phenomenon that is rape. We conclude by emphasizing the continuing commitment of feminist researchers carefully to theorizing and (re)mapping the fraught field of progressive legal strategizing in order to identify and counter the kinds of risks and shortcomings of political activism with which Reece is rightly concerned.

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.

Crisis Cartels:Non-Economic Values, the Public Interest and Institutional Considerations

This paper considers the use of non-economic considerations in Article 101(3) analysis of industrial restructuring agreements, using the Commission's Decisions in Synthetic Fibres, Stichting Baksteen, and the recent UK Dairy Initiative as examples. I argue that contra to the Commission's recent economics-based approach; there is room for non-economic considerations to be taken into account within the framework of the European Treaties. The competition law issue is whether the provisions of Article 101(3) can save such agreements.
I further argue that there is legal room for non-economic considerations to be considered in evaluating these restructuring agreements, it is not clear who the appropriate arbiter of these considerations should be given the institutional limitations of courts (which have no democratic mandate), specialised competition agencies (which may be too technocratic in focus) and legislatures (which are susceptible to capture by rent-seeking interest groups).

Political Liberalism, Free Speech and Public Reason

In this paper, I critically assess John Rawls' repeated claim that the duty of civility is only a moral duty and should not be enforced by law. In the first part of the paper, I examine and reject the view that Rawls' position may be due to the practical difficulties that the legal enforcement of the duty of civility might entail. I thus claim that Rawls' position must be driven by deeper normative reasons grounded in a conception of free speech. In the second part of the paper, I therefore examine various arguments for free speech and critically assess whether they are consistent with Rawls' political liberalism. I first focus on the arguments from truth and self-fulfilment. Both arguments, I argue, rely on comprehensive doctrines and therefore cannot provide a freestanding political justification for free speech. Freedom of speech, I claim, can be justified instead on the basis of Rawls' political conception of the person and of the two moral powers. However, Rawls' wide view of public reason already allows scope for the kind of free speech necessary for the exercise of the two moral powers and therefore cannot explain Rawls' opposition to the legal enforcement of the duty of civility. Such opposition, I claim, can only be explained on the basis of a defence of unconstrained freedom of speech grounded in the ideas of democracy and political legitimacy. Yet, I conclude, while public reason and the duty of civility are essential to political liberalism, unconstrained freedom of speech is not. Rawls and political liberals could therefore renounce unconstrained freedom of speech, and endorse the legal enforcement of the duty of civility, while remaining faithful to political liberalism.

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<br/>- 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.