Using comparative methods of policy analysis, this paper explores the institutional factors shaping the transfer and adaptation of risk-based approaches to regulation within and between the regimes for occupational health and safety (OHS) and food safety in the UK. Over the past two decades successive governments have enthusiastically promoted risk as a key concept for regulatory reform and 'better regulation'. Rather than trying to prevent all possible harms, 'risk-based' approaches promise to make regulation more proportionate and effective by using various risk-based metrics and policy instruments to focus regulatory standard-setting and enforcement activity on the highest priority risks, as determined through formal assessments of their probability and consequences. But despite facing similar external pressures and sharing many historical and structural features as OHS, food safety regulation has proven much less receptive to risk-based reforms of its organizing principles and practices. To explain that anomaly, we consider a range of explanations highlighted in the policy transfer and mobilities literatures. We find that coercive drivers for the adoption of risk, in the form of top-down political pressure for deregulation or hard EU mandates, are much less influential than voluntary ones, which reflect both normative (ie, shared commitments to proportionality, resource prioritization, and blame deflection) and mimetic (ie, imitation of private sector corporate governance models) isomorphism. We conclude with wider reflections about the significance of our cases for policy transfer and mobilities research and for the limits to risk as a universal principle for organizing, and accounting for, governance activity.

In this paper, we examine why risk-based policy instruments have failed to improve the proportionality, effectiveness, and legitimacy of healthcare quality regulation in the National Health Service (NHS) in England. Rather than trying to prevent all possible harms, risk-based approaches promise to rationalise and manage the inevitable limits of what regulation can hope to achieve by focusing regulatory standard-setting and enforcement activity on the highest priority risks, as determined through formal assessments of their probability and consequences. As such, risk-based approaches have been enthusiastically adopted by healthcare quality regulators over the last decade. However, by drawing on historical policy analysis and in-depth interviews with 15 high-level UK informants in 2013–2015, we identify a series of practical problems in using risk-based policy instruments for defining, assessing, and ensuring compliance with healthcare quality standards. Based on our analysis, we go on to consider why, despite a succession of failures, healthcare regulators remain committed to developing and using risk-based approaches. We conclude by identifying several preconditions for successful risk-based regulation: goals must be clear and trade-offs between them amenable to agreement; regulators must be able to reliably assess the probability and consequences of adverse outcomes; regulators must have a range of enforcement tools that can be deployed in proportion to risk; and there must be political tolerance for adverse outcomes.

BackgroundThe Care Quality Commission (CQC) is responsible for ensuring the quality of the health and social care delivered by more than 30 000 registered providers in England. With only limited resources for conducting on-site inspections, the CQC has used statistical surveillance tools to help it identify which providers it should prioritise for inspection. In the face of planned funding cuts, the CQC plans to put more reliance on statistical surveillance tools to assess risks to quality and prioritise inspections accordingly.ObjectiveTo evaluate the ability of the CQC's latest surveillance tool, Intelligent Monitoring (IM), to predict the quality of care provided by National Health Service (NHS) hospital trusts so that those at greatest risk of providing poor-quality care can be identified and targeted for inspection.MethodsThe predictive ability of the IM tool is evaluated through regression analyses and χ2 testing of the relationship between the quantitative risk score generated by the IM tool and the subsequent quality rating awarded following detailed on-site inspection by large expert teams of inspectors.ResultsFirst, the continuous risk scores generated by the CQC's IM statistical surveillance tool cannot predict inspection-based quality ratings of NHS hospital trusts (OR 0.38 (0.14 to 1.05) for Outstanding/Good, OR 0.94 (0.80 to −1.10) for Good/Requires improvement, and OR 0.90 (0.76 to 1.07) for Requires improvement/Inadequate). Second, the risk scores cannot be used more simply to distinguish the trusts performing poorly—those subsequently rated either ‘Requires improvement’ or ‘Inadequate’—from the trusts performing well—those subsequently rated either ‘Good’ or ‘Outstanding’ (OR 1.07 (0.91 to 1.26)). Classifying CQC's risk bandings 1-3 as high risk and 4-6 as low risk, 11 of the high risk trusts were performing well and 43 of the low risk trusts were performing poorly, resulting in an overall accuracy rate of 47.6%. Third, the risk scores cannot be used even more simply to distinguish the worst performing trusts—those subsequently rated ‘Inadequate’—from the remaining, better performing trusts (OR 1.11 (0.94 to 1.32)). Classifying CQC's risk banding 1 as high risk and 2-6 as low risk, the highest overall accuracy rate of 72.8% was achieved, but still only 6 of the 13 Inadequate trusts were correctly classified as being high risk.ConclusionsSince the IM statistical surveillance tool cannot predict the outcome of NHS hospital trust inspections, it cannot be used for prioritisation. A new approach to inspection planning is therefore required.

This article advances scholarship on comparative regulation by moving beyond the conventional focus on formal law and EU comitology to assess the extent of 'practice convergence' in the implementation of EU regulation. Drawing on 50 key informant interviews, a survey, and policy document analysis, we compare how regulators in England, Germany, France and the Netherlands have implemented EU requirements that food safety inspections be 'risk-based'. Focusing on a clear dependent variable -risk-scoring methods -we find important differences in the conception and targeting of risk-based inspections; with starkly different conclusions about what kind of food businesses they need to target to ensure safety within an ostensibly harmonised single market. We attribute variation in the implementation of risk-based inspection to the ways that EU requirements were filtered through long-entrenched regulatory styles and modes of food business organisation in each country, reinforcing pre-existing inspection practices in the design of new risk-based tools.

No abstract

What could a European Union (EU) response mechanism to health emergencies look like in the context of a more integrated Health Union? Despite an increased EU role in the preparedness, monitoring and coordination of health emergencies over the past two decades, Member States’ responses to the first wave of COVID-19 were surprisingly uncoordinated. In light of calls to improve cooperation regarding future health emergencies, this article discusses the creation of EU surveillance, preparedness and response mechanisms for health emergencies. Using insights from previous research and secondary literature, we highlight gaps in the existing serious cross-border health threats regulatory framework and discuss opportunities for further EU action. Based on a comparison with other EU crisis management mechanisms (the Banking Union, risk preparedness in the electricity sector and food safety), we discuss different crisis decision-making and coordination models and their potential applicability to the health sector. We then formulate several propositions to strengthen Decision 1082/2013/EU on serious cross-border health threats to streamline ex ante pandemic preparedness and organise emergency responses.

This article tests the extent to which the organization and stringency of occupational health and safety regulation complements the dominant mode of coordination in the political economy. While the UK explicitly sanctions risk-cost-benefit trade-offs, other European countries mandate ambitious safety goals. That contrast appears to reflect cleavages identified in the Varieties of Capitalism literature, which suggests worker protection regimes are stronger in coordinated market economies than in liberal market economies. Our analysis of Germany, France, UK and the Netherlands, shows that the varied organization of their regulatory regimes is explained through a three-way complementarity with their welfare systems and modes of coordination. However, despite varied headline goals, we find no systematic differences in the stringency of those countries’ regulatory protections insofar as they all make trade-offs on safety. Instead, the explicitness, rationalizations and logics of trade-offs vary according to each country’s legal system, state tradition and coupling between regulation and welfare system.

No abstract