Framing and legitimating EU legal regulation of human gene-editing technologies: key facets and functions of an imaginary.

Gene-editing technologies, ie those able to make changes in the DNA of an organism, are the object of global competition and a regulatory race between countries and regions. There is an attempt to craft legal frameworks protective enough for users, but flexible enough for developers of gene-editing technologies. This article examines the imaginary built into the framing of EU-level legal regulation of human gene-editing technologies and identifies its three key related facets: the tension around naturalness; safeguarding morality and ethics; and the pursuit of medical objectives for the protection of human health. Concerns around the use of gene-editing technologies in relation to eugenics and human enhancement have produced a multifaceted imaginary. We argue that this imaginary not only places a limit on EU-level regulation, despite a strong EU competence in respect of the internal market, but also seeks to ensure its legitimation.

Expectations as techniques of legitimation? Imagined futures through global bioethics standards for health research.

I argue that expectations or strong beliefs about what can occur, and the imaginaries they construct, can be shaped by organizations and used by them as techniques for public legitimation of their governance and regulatory activities. I advance this argument by reference to the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The expectations and imaginary flowing from the ICH's mission and framing, 'harmonisation for better health', support a focus on technological development for the production of safe, quality, and effective pharmaceuticals and individual ethical conduct to achieve it. The expectations also marginalize wider systemic issues relating to social justice, particularly those affecting the global South. The central role of scientific-technical knowledge and expertise to harmonization abets the latter by minimizing the value to governance of public knowledges on systemic issues. Instead of ensuring the contribution of these knowledges to governance through public participation, there is an attempt to bolster legitimation through communication of expectations and transparency to show practices are in accordance with them (ie expectations are met).

Health "Brexternalities": The Brexit Effect on Health and Health Care outside the United Kingdom.

The principal effects of Brexit on health and health care will fall within the United Kingdom, and all forms of Brexit have overwhelmingly negative implications for health care and health within the UK. This article focuses on the external effects of Brexit ("Brexternalities") for health and health care. The EU is a particularly powerful institutional and legal arrangement for managing economic and political externalities in health policy as in any other policy. Equally, when a state leaves the EU, the manner of leaving will result in better or worse management of relevant externalities. Brexternalities thus involve questions about policy legitimacy and accountability. Health Brexternalities do not fall equally in all EU countries. They are felt more distinctly in the context of those elements of health policy that are most closely entwined with the UK's health policy (e.g., on the island of Ireland, certain areas of Spain, and other parts of southern Europe). Some health Brexternalities, such as in medicine safety, will be imposed on the whole population of the EU. And some health Brexternalities, such as communicable disease control, will be felt globally.

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.

Regulatory or regulating publics? The European Union's regulation of emerging health technologies and citizen participation.

'Citizen participation' includes various participatory techniques and is frequently viewed as an unproblematic and important social good when used as part of the regulation of the innovation and implementation of science and technology. This is perhaps especially evident in debates around 'anticipatory governance' or 'upstream engagement'. Here, we interrogate this thesis using the example of the European Union's regulation of emerging health technologies (such as nanotechnology). In this case, citizen participation in regulatory debate is concerned with innovative objects for medical application that are considered to be emergent or not yet concrete. Through synthesising insights from law, regulatory studies, critical theory, and science and technology studies, we seek to cast new light on the promises, paradoxes, and pitfalls of citizen participation as a tool or technology of regulation in itself. As such we aim to generate a new vantage point from which to view the values and sociotechnical imaginaries that are both 'designed-in' and 'designed-out' of citizen participation. In so doing, we show not only how publics (do not) regulate technologies, but also how citizens themselves are regulated through the techniques of participation.