The European Union is increasingly moving toward an integrated policy approach, which also acknowledges linkages between public health and (external) security policy. This introduction to the Special Issue sets out a research agenda on the emerging health-security nexus. It analyses recent policy developments with respect to the public health and security, and discusses interactions along the health-security nexus in the context of the European Union. It suggests drivers behind the integrated approach and it critically examines the health-security nexus from the perspective of effectiveness and legitimacy.

There have been relatively few serious incidents of chemical or biological terrorism in Europe; however, there is growing concern over how non-state groups might exploit chemistry and biology for hostile purposes in the future. This article uses the historical record of past incidents of chemical and biological weapons (CBW) adoption by non-state actors to inform understandings of the current and future risks. To achieve this, the article analyses six interlinked clusters of factors that can be seen as important in assessing the risk of whether or not to adopt such weapons. These are: the perceived relative advantage of CBW and their utilities; the complexity of such weapons; their ideological compatibility; the role of organisational structures; the visibility and ‘fashionability’ of such weapons; and the wider environmental context. Drawing from past cases of CBW adoption and the present European context, an analysis of these factors suggests that sophisticated CBW with gigantic effect are possible, but unlikely; however, the adoption and use of scruffy low-level chemical weapons is a distinct possibility. Accordingly, European public health agencies need to prepare for the possibility of a variety of CBW, not all of which are likely to be weapons of “mass destruction”.

Chemical terrorist attacks by non-state actors have traditionally been characterised as low probability events; however, the apparent normalisation of chemical weapons use, including by terrorists, in the ongoing conflict in Syria is causing some in the international security community to question whether it will remain low probability. For Europe there is an additional potential concern, namely the numbers of EU citizens who are “foreign fighters” and whose return from the conflict zone might also result in “importing” chemical weapons use. This article examines the rise of the “chemical weapons-returning foreign fighter” narrative and considers aspects of the European response. These responses predate the current concerns and include important efforts to create a robust public health response, such as early alert and communication systems, so that the attractiveness of these weapons being used within a European context might be reduced. Although there are limitations as to how far one can transfer what happens in a Syrian context to Europe, the suggestion is made that some of the framing assumptions within this response architecture may be now inadvertently limiting the potential to identify and respond to chemical attacks.

Critiques of global public health security (GPHS) and proposed solutions tend to overlook the potential of the individuals and groups that are subject to and governed by GPHS – “the governed” – to contribute their “on the ground” knowledge and experience to decision-making in order to improve regulatory responses. This article argues for the development of a more reflexive approach as a way of ensuring the epistemic integration of these knowledges with the scientific-technical knowledges that currently dominate decision-making processes. I identify human rights as the conceptual lens that is most likely to enable reflexivity by the governed and regulators, and understanding and communication between them. The governed can use perceived or actual breaches of human rights to articulate “on the ground” knowledges as institutional risks to reputation and standing and, in turn, threaten the production and legitimation of organisational identity, socio-political orders and projects of rule. The particular sensitivity of regulators to these risks could compel epistemic integration. This more reflexive approach to GPHS promises to improve the knowledge base, efficacy, accountability and legitimacy of decision-making at multiple levels: WHO, EU, national and “on the ground”.

The EU is continuously developing strategies, policies and regulations to confront pandemic and epidemic diseases. The actions of the EU in this field do not happen in a vacuum but are instead embedded in a complex international and transnational network. This article suggests the existence of a tension between public health policy and a twofold set of competing considerations: growing security concerns and market pressures. To structure the argument the article examines three distinct but related aspects: first, it clarifies the different levels of decision-making impacting on the EU’s policy and regulation of vaccines for PEDs: these levels are described as international, transnational and domestic, and the key players involved at each level are also identified; second, it analyses levels of responsiveness to and preparedness for outbreaks and analyses how past experiences have oriented the policy debate; third, it discusses issues of accountability of vaccine developers, authorising authorities and rule-makers involved in preparedness and response to emerging PEDs.

The article tackles the issue of personal data protection in case of tracing (looking for) individual persons who have been exposed to health risks pursuant to the EU Decision 1082/2013 on Serious, Cross-border Health Threats. This problem exemplifies just one among many challenges of the health-security nexus in the EU. That is, it regards a certain trade-off between the limitation of individual rights and securing populations’ safety. The text appraises the safeguards for the (lawful) limitation of the right to data protection after an in-depth examination of the provisions of the Health Threats Decision, its implementing measures, the reports on its operation, and in light of the general EU data protection laws. In conclusion, it claims that a number of improvements are needed because of the incompleteness, and the insufficient coherence and transparency of the EU regime for health threats. The established shortcomings are, at least in part, caused by the new EU “integrated approach” to health and security. In effect, an overall philosophy of reforms of public health policy in the name of “all-hazards security” applied in the Health Threats Decision can result in a reduction of the adequate level of protection of individuals’ personal data.

Currently, there is ongoing discussion about the role of regulatory oversight bodies in relation to the implementation of regulatory impact assessments (RIAs). In fact, one can witness a diffusion of regulatory oversight systems, including in CEE countries, where introduction of an RIA oversight body became part of the modernisation of the overall RIA process to become more effective. In fact, the regulatory oversight mechanism is seen as a tool for the instrumental role of regulation governance. However, this approach does not adequately explain the rationale behind setting up such a body; strategic and symbolic roles may be significant as well. This article first compares the manner in which oversight mechanisms have been institutionalised in five Central and East European countries: the Czech Republic, Estonia, Hungary, Slovakia and Slovenia. Second, it explores how differences in institutionalisation and operation shed light on understanding what stakeholders expect and understand in relation to control of RIA quality. The paper concludes that there are marked differences in regulatory oversight set-up and roles across Central and Eastern Europe, notably as a consequence of the presence or absence of internal learning.

Modern financial regulation has predominantly been economically-driven,1 progressing from addressing market failures to making markets more competitive and work better.2 The UK Financial Conduct Authority is expressly mandated to pursue regulatory objectives that maintain market integrity and protect consumers (addressing market failures) and to promote competition (making markets work better).3 Both the FCA and its sister regulator, the Prudential Regulation Authority (for banks), have recently adopted innovative regulatory initiatives to promote technologically-driven innovation, aimed at making markets work better. These initiatives are also a response to the recent explosion of technologically-led financial innovation outside of the regulatory perimeter.

In promoting financial innovation, we argue that the regulators have insufficiently focused on the need to govern financial innovation more generally. Although this concern may seem premature, the regulatory innovations are increasingly extending the perimeter for regulatory oversight of financial innovations. As the regulatory innovations have the potential to develop into more mature regulatory frameworks for governing financial innovation, we argue that regulators should manage the risks of their current approach and develop a regulatory strategy framework for balancing regulatory objectives and developing regulatory policy. We propose a framework anchored in rationality, consistency and accountability in governing financial innovation.