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The threat posed by 2019-nCoV and the fragmentation of existing health protection systems caused by Brexit call for urgent assessment of cross Europe cooperation, say Mark Flear, Anniek de Ruijter, and Martin McKee

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.

The effects of the Community right to migrate for healthcare services on patients have yet to be studied extensively. This paper uses a sociological institutionalist perspective to show how such migration might cause change in patients, especially their motivations, agency, self-understanding, identity and citizenship. This suggests the development of Euro-biocitizenship and patients as Euro-biocitizens, as well as providing a rejoinder to critiques of the right, and calls for new governance to address its effects.

‘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.

While policy attention is understandably diverted to COVID-19, the end of the UK's post-Brexit ‘transition period’ remains 31 December 2020. All forms of future EU−UK relationship are worse for health than EU membership, but analysis of the negotiating texts shows some forms are better than others. The likely outcomes involve major negative effects for NHS staffing, funding for health and social care, and capital financing for the NHS; and for UK global leadership and influence. We expect minor negative effects for cross border healthcare (except in Northern Ireland); research collaboration; and data sharing, such as the Early Warning and Response System for health threats. Despite political narratives, the legal texts show that the UK seeks de facto continuity in selected key areas for pharmaceuticals, medical devices, and equipment [including personal protective equipment (PPE)], especially clinical trials, pharmacovigilance, and batch-testing. The UK will be excluded from economies of scale of EU membership, e.g. joint procurement programmes as used recently for PPE. Above all, there is a major risk of reaching an agreement with significant adverse effects for health, without meaningful oversight by or input from the UK Parliament, or other health policy stakeholders.

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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.