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.

The EU Deep Trade Agenda: Law and Policy

Providing the first comprehensive examination of the key regulatory disciplines included in the new generation of EU free trade agreements (FTAs), this book investigates the EU's supposed deep trade agenda through a legal analysis of these FTAs. In doing so, Billy A. Melo Araujo determines whether there is any substance behind the EU's foreign policy rhetoric regarding the need to introduce regulatory issues within the remit of international trade law.

At a time when the EU is busily negotiating so-called 'mega-FTAs', such as the Transatlantic Trade and Investment Partnership (TTIP) and the plurilateral Trade in Services Agreement (TISA), Melo Araujo offers a timely insight into the important questions raised by such FTAs, in particular concerning the future of the multilateral trade system, the loss of policy autonomy, and the democratic legitimacy of regulating through treaty-making. The book provides a detailed analysis of the regulatory disciplines included in the more recent EU FTAs and explores the possible implications of such disciplines. Offering a significant contribution to a wider debate, this is a must read for those interested in the legal dimension of the EU's deep trade agenda.

EU Non-Discrimination Law and Intersectionality:investigating the triangle of racial, gender and disability discrimination

This book contributes to a critical reflection of current legislative and jurisprudential developments in Non-Discrimination Law, focusing on the European Union. The book is focused on intersectionality between gender, race and disability and the question of whether, and to what extent, this intersection can be adequately addressed in (EU) law. The discussion rests on two basic assumptions. First, the multiplication of 'discrimination grounds' in EU law and other legal regimes should not result in a dilution of the demands of equality law. Accordingly, the book focuses on the three key grounds - race, gender and disability. These constitute nodes around which other discrimination grounds can be grouped. Second, any multi-ground non-discrimination law framework needs to engage with the question of discrimination on several grounds. This book provides a critical evaluation of some of the problems presented by such intersectionality and an opportunity to explore the issues in depth. This collection offers some new proposals relating to the regrouping of identity categories and to the general approach to socio-legal research in the field. It also contains a comparative section, which expands on practical experiences with intersectionality and law, and a section dedicated to juridical responses to intersectionality.

The book will be a valuable resource for researchers, academics and those working in the area of EU non-discrimination law and policy.

European Law and New Health Technologies: The Research Agenda

Maps the research agenda that underpinned the edited collection 'European Law and New Health Technologies', that this pieces introduces.

European Law and New Health Technologies ESRC End of Award Report, RES-451-26-0764

End of award report for the funded research seminar series of the same name.

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.

The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.