Maastricht Journal of European and Comparative Law

This paper uses ‘revolution as a frame for examining rights and new technologies. It begins by trying to pin down the meaning of key terms, principally ‘new technologies' and ‘revolution’. It fails in this task; nonetheless, it goes on to argue that something revolutionary does seem to be underway in how human rights are viewed and valued. Describing this phenomenon as a new (anti-rights) ‘rights revolution’, it calls for a fight-back by human rights advocates. Two strategies to assist the fight-back are described in some detail: the first focuses on bringing out ‘the dignity of choice’; the second on bringing out ‘risk within rights’.

This paper examines the politics of EU risk governance in relation to human material. It is argued that the political context has informed the way in which risks in relation to various types of human material have come to be defined as policy problems at EU level. In turn, this has influenced the design and/or persistence of institutional arrangements to manage such problems. It is further argued that this political context has resulted in a significant level of disconnection in risk governance in the area. This has happened in two ways. First, there has been a growing level of disconnection between institutional and stakeholder demands for a more expansive approach to risk governance in the area and the narrowly-circumscribed competence under Article 152(4)(a) EC, which permits the adoption of risk regulation regimes that set minimum standards of quality and safety in relation to blood, tissue/cells and organs. Second, it has led to the development of institutional arrangements that promote a bifurcated approach to risk governance, specifically in relation to blood and tissues/cells. Although a hybrid of traditional and new governance mechanisms have been employed to address this problem of disconnection, this has nevertheless added a further layer to already complex institutional arrangements for risk governance in the area. It is suggested that a more integrated approach to EU risk governance in relation to human material is needed. Implementing such an approach would contribute to greater clarity, transparency and accountability in decision-making processes, and this could enhance public trust in what is a politically-sensitive area of governance at EU level.

The development of nanomedicine has the potential to revolutionise care and treatment of patients. However the rise of this new technology has been subject to considerable controversy. The EU itself while promoting the development of nanomedicine and nanotechnology has become increasingly concerned to address some of the reservations which have been expressed regarding this technology. This paper explores what legal, ethical and regulatory challenges are posed by nanomedicine, how the EU has engaged with these to date and how EU law and policy in this area may develop in the future.

The unprecedented expansion of EU controls on biological materials under the aegis of the EU's expanding remit on public health has caused a major reshaping of the regulatory landscape of the life-sciences in Member States. This article analyzes the challenges to national and supranational legal orders posed by the integration of ethical norms within the EU Human Tissue and Cells Directive 2004/23/EC and the Advanced Therapies Regulation (EC) 1394/2007. We show how the infiltration of substantive moral norms in morally contested fields of biotechnology is facilitated by the incorporation into the EU legislative texts of fundamental norms such as respect for human dignity contained in the EU Charter of Fundamental Rights and the Council of Europe's Convention on Human Rights and Biomedicine. The first part of the article sets out the constitutional and normative challenges posed by the EU legislative intervention on ethical matters in the field of health and new biotechnologies. The second part examines the substantive content of the integrated fundamental norms highlighting their open-ended and indeterminate character and the areas of overlap and disjunction. The third part introduces an analytical matrix which is deployed to analyze the reach of fundamental norms in shaping the more specific ethical controls in the legislative texts and reveals how the mix of technical and evaluative norms resolves the ethical and constitutional tensions in the EU texts.

This paper focuses on the specific example of the newly operational Regulation on Advanced Therapy Medicinal Products to explore the potential for biopolitics, an arena in which biocitizens can demand and contest the exercise of EU power over life. The paper shows how the discourses producing, organizing and orchestrating citizen participation in the EU's governance of advanced therapies from above figure a ‘deficit model’ of citizens in need of education inter alia through their membership of patients' associations who have membership of the Committee on Advanced Therapies established by the Regulation. Biocitizens are shown to be incorporated to service the EU's legitimacy needs. The paper then warns against assuming biocitizens' (self-) reflexivity ensures they do not reiterate and reinforce their construction within the ‘deficit model’ by unwittingly deploying the terms of their subjection. After which the paper highlights some elements that provide a rhetorical and operational opening for participation, and which therefore can be used by biocitizens to reconstruct their engagement with EU governance from below, the wider governance of advanced therapies, as well as in their self-governance.