When risk‐based regulation aims low: Approaches and challenges

Risk‐based regulation is becoming a familiar regulatory strategy in a wide range of areas and countries. Regulatory attention tends to focus, at least initially, on high risks but low‐risk regulatees or activities tend to form the bulk of the regulated population. This article asks why regulators need to address low risks and it outlines the potential difficulties that such risks present. It then considers how regulators tend to deal with lower risks in practice. A body of literature and survey‐based research is used to develop a taxonomy of intervention strategies that may be useful in relation to low‐risk activities, and, indeed, more widely. In an article to be published in the subsequent issue of this journal, we will then develop a strategic framework for regulators to employ when choosing intervention strategies and we will assesses whether, and how, such a framework could be used by regulatory agencies in a manner that is operable, dynamic, transparent, and justifiable.     

Regulatory regimes and accountability

This research considers accountability issues for new forms of regulation that shift the emphasis from prescribing actions to regulating systems or regulating for results. Shortfalls at various levels of accountability are identified from experiences with these regimes in the regulation of building and fire safety, food safety and nuclear power plant safety. These experiences illustrate how accountability shortfalls can undermine regulatory performance and introduce a potential for subtle forms of regulatory capture. These concerns underscore the importance of finding the right fit between regulatory circumstances and the design of regulatory regimes.     

The regulatory state and the UK Labour Government's re‐regulation of provision in the English National Health Service

Following its election in 1997, the UK Labour Government embarked upon a 10 year program of reform of the National Health Service (NHS). By 2005, Labour had doubled the NHS budget and dramatically transformed the shape of the Service. In England, a basic characteristic of the NHS is the organizational split between provider and commissioning agencies. In this article I argue that Labour's re‐regulation of NHS provision is a coherent representation of the influence of the “regulatory state” in restructuring arrangements between government, market, and society. The article offers an account of the regulatory state based on a discussion of five key theses: The Audit Society, Regulation Inside Government, The New Regulatory State, The British Regulatory State, and Regulatory Capitalism. The article unfolds Labour's program of reform across themes common to these accounts: the division of labor between state and society, the division of labor within the state, the formalization of previously informal controls, and the development of meta‐regulatory techniques of enforced self‐regulation. It concludes that the key themes of the regulatory state are at work in Labour's transformation of NHS provision and it offers a discussion of the implications for both scholars of regulation and the UK and European health policy literature.     

Political accountability,fiscal conditions and local government performance—cross‐sectional evidence from Indonesia

Why are some local governments more successful than others in managing resources and delivering services? And even more vitally, how can malfunctioning governments be reformed so that they perform their responsibilities more effectively? This article contributes to our understanding of theses overarching questions by exploring the interactions between political institutions and public sector performance in the context of decentralisation and local governance. It shows–both theoretically and empirically–that performance outcomes are determined by the extent to which people can hold their governments accountable through political institutions. The basic hypothesis underlying this research is that political accountability, either by encouraging sanctions upon non‐compliant public agents or simply by reducing the informational gap regarding government activities, will create forceful incentives for elected officials and civil servants to reduce opportunistic behaviour and improve performance. Using a cross‐sectional regression the hypothesis is empirically tested against evidence from newly empowered local governments in Indonesia. The empirical findings broadly support our hypotheses. Improved public services on the ground, both in terms of quantity and quality, require informed and well functioning decision‐making processes that allocate resources to priority areas that meet the demand of the broader community. Copyright © 2008 John Wiley & Sons, Ltd.     

Responsive regulation in public‐private partnerships: Between deterrence and persuasion

Design‐Build‐Finance‐Maintain‐Operate (DBFMO) contracts are a particular type of public‐private partnership whereby governments transfer the responsibility for the design, construction, financing, maintenance, and operation of a public infrastructure or utility service building to a multi‐headed private consortium through a long‐term performance contract. These arrangements present a typical principal‐agent problem because they incorporate a “carrot and stick” approach in which the agent (consortium) has to fulfill the expectations of the principal (procurer). This article deals with a neglected aspect in the literature related to the actual use of “the sticks or sanctions” in DBFMOs and assesses to what extent and under which conditions contract managers adopt a deterrence‐based enforcement approach or switch to a persuasion‐based approach, specifically when the contract clauses require the use of (automatic) deterrence. An empirical analysis of four DBFMOs in the Netherlands shows that the continuation of service delivery, the need to build trust, and the lack of agreement on output specifications play a role in the willingness of the procurer to apply a more responsive behavior that uses persuasion, even when deterrence should be automatically applied. © 2016 John Wiley & Sons Australia, Ltd     

Enabling global principle‐based regulation: The case of risk analysis in the Codex Alimentarius

This paper deals with the creation of global principle‐based standards. For such standards to be accepted and effective, particular conditions must be fulfilled. One such condition, little explored, is that standard‐makers and ‐takers share knowledge about the meaning of the principles, as well as the practices through which they are likely to be applied. The paper shows that this condition is fulfilled when transnational cultural systems exist, by means of which both types of actors engage in the explication and representation of their practices so that a common, standard understanding emerges of how principles may be interpreted on the ground and informs the negotiations. A transnational cultural system is a crucial governance infrastructure to set global standards, as shown by the long history of creating a risk analysis guideline by the Codex Alimentarius, the inter‐governmental body for food standards.     

When doctors shape policy: The impact of self‐regulation on governing human biotechnology

This paper investigates the development and adoption of governance modes in the field of human biotechnology. As the field of human biotechnology is relatively new, voluntary professional self‐regulation constituted the initial governing mode. In the meantime, with the exception of Ireland, all Western European countries have moved toward greater state intervention. Nevertheless, they have done so in contrasting ways and the resulting governance modes for assisted reproductive technology and embryonic stem‐cell research vary greatly. Instead of imposing their steering capacity in a “top‐down” fashion, governments have taken pre‐existing self‐regulatory arrangements in the field into account and built up governance mechanisms in conjunction with private actors and pre‐existing modes of private governance. Our analysis demonstrates that the form and content of the initial self‐regulation explain why the self‐steering capacity of the medical profession was largely or at least partially preserved through hybrid governance systems in Britain and Germany, while in France the self‐regulation was entirely replaced by governmental intervention.     

Risk and the limits of governance: Exploring varied patterns of risk‐based governance across Europe

Risk‐based approaches to governance are widely promoted as universally applicable foundations for improving the quality, efficiency, and rationality of governance across policy domains. Premised on the idea that governance cannot eliminate all adverse outcomes, these approaches provide a method for establishing priorities and allocating scarce resources, and, in so doing, rationalise the limits of what governance interventions can, and should, achieve. Yet cursory observation suggests that risk‐based approaches have spread unevenly across countries. Based on a comparison of the UK, France, and Germany, this article explores the ways in which, and why, such approaches have “colonised” governance regimes in the UK, but have had much more limited application in France and Germany. We argue that the institutionally patterned adoption of risk‐based governance across these three countries is related to how entrenched governance norms and accountability structures within their national polities handle both the identification and acceptance of adverse governance outcomes.     

Explaining the content of impact assessment in the United Kingdom: Learning across time,sectors, and departments

While several studies have documented how evidence‐based policy instruments affect public policy, less research has focused on what causes changes over time in the analyses mandated by the instruments, especially in Britain. Thus, we take the analytical content of a pivotal regulatory reform instrument (impact assessment) as a dependent variable, draw on learning as a conceptual framework, and explain the dynamics of learning processes across departments, policy sectors, and time. Empirically, our study draws on a sample of 517 impact assessments produced in Britain (2005–2011). Experience and capacity in different departments matter in learning processes. Guidelines also matter, but moderately so. Departments specialize in their core policy sectors when performing regulatory analysis, but some have greater analytical capacity overall. Peripheral departments invest more in impact assessment than core executive departments. The presence of a regulatory oversight body enhances the learning process. Elections have different effects, depending on the context in which they are contested. These findings contribute to the literature on regulation, policy learning, and policy instruments.     

RegData: A numerical database on industry‐specific regulations for all United States industries and federal regulations, 1997–2012

We introduce RegData, formerly known as the Industry‐specific Regulatory Constraint Database. RegData annually quantifies federal regulations by industry and regulatory agency for all federal regulations from 1997–2012. The quantification of regulations at the industry level for all industries is without precedent. RegData measures regulation for industries at the two, three, and four‐digit levels of the North American Industry Classification System. We created this database using text analysis to count binding constraints in the wording of regulations, as codified in the Code of Federal Regulations, and to measure the applicability of regulatory text to different industries. We validate our measures of regulation by examining known episodes of regulatory growth and deregulation, as well as by comparing our measures to an existing, cross‐sectional measure of regulation. Researchers can use this database to study the determinants of industry regulations and to study regulations’ effects on a massive array of dependent variables, both across industries and time.     

The effectiveness of NGO self‐regulation: theory and evidence from Africa

Non‐governmental organizations (NGOs) play an increasingly important role in public service provision and policy making in sub‐Saharan Africa, stimulating demand for new forms of regulatory oversight. In response, a number of initiatives in NGO self‐regulation have emerged. Using cross‐national data on 20 African countries, the article shows that self‐regulation in Africa falls into three types: national‐level guilds, NGO‐led clubs and voluntary codes of conduct. Each displays significant weaknesses from a regulatory policy perspective. National guilds have a broad scope, but require high administrative oversight capacity on the part of NGOs. Voluntary clubs have stronger standards but typically have much weaker coverage. Voluntary codes are the most common form of self‐regulation, but have the weakest regulatory strength. This article argues that the weakness of current attempts to improve the accountability and regulatory environment of NGOs stems in part from a mismatch between the goals of regulation and the institutional incentives embedded in the structure of most self‐regulatory regimes. The article uses the logic of collective action to illustrate the nature of this mismatch and the tradeoffs between the potential breadth and strength of various forms of NGO self‐regulation using three detailed case studies. Copyright © 2008 John Wiley & Sons, Ltd.     

Measuring multi‐level regulatory governance: Organizational proliferation,coordination, and concentration of influence

As regulation increasingly results from the interplay of a wide array of different actors operating at different levels, it has become crucial to focus on how these constellations of regulatory actors operate. Although this research field presents huge potential for theoretical development, we still lack the measurement techniques to allow systematic comparative research. We contribute to filling this gap with four indices measuring crucial characteristics of multi‐actor regulatory arrangements: (i) the scope of organizational proliferation; (ii) the extent of coordination between regulatory actors; (iii) the amount of influence that each individual regulatory actor has on the sector regulation; and (iv) the extent to which the regulatory influence is concentrated in the hands of one or a few actors. We argue that our indices are sufficiently systematic, reliable, and flexible to be applied in a variety of research contexts relating to multi‐level and multi‐actor regulatory governance.     

Courage,regulatory responsibility,and the challenge of higher‐order reflexivity

Contemporary regulators must respond to ever‐increasing societal demands in various domains. Regulators must cope with these demands under conditions of extreme epistemic scarcity and ideological divide. This leaves regulators perplexed about what action they should take. Regulatory praxis offers two primary responses to this moral and epistemic dilemma: technical canonization and reflexive regulation. While these two approaches represent contrary regulatory philosophies, they suffer from two common blind spots: (a) disregard of the critical role of discretionary judgment in regulatory action; and (b) disregard of the dilemma of higher‐order reflexivity. The article explores the idea of higher‐order reflexivity in the regulatory context. This exploration renders visible the abysses that are faced by regulators as they attempt to resolve regulatory dilemmas through a cognizant and introspective process. The article argues that the Socratic concept of courage and the idea of forward‐looking responsibility provide a plausible framework for thinking about the challenge of regulatory judgment. It concludes with a discussion of the legal and institutional mechanisms that could both facilitate and put to scrutiny the realization of this ideal (but noting also several features of the contemporary regulatory system which constitute potential barriers).     

Public‐private partnerships: consultation,cooperation and collusion

In late 2002, public‐private partnerships (PPP) rose to the attention of the New Zealand public and gained media attention due to what became known as the ‘Armstrong affair’. This paper provides an overview of the Armstrong affair and of the issues engendered by the affair for the formation of policy in relation to PPP. The most fundamental of these issues was the correct relationship between the public and private sectors. The Armstrong case illustrates the way in which the demarcation between the two sectors must be maintained—and seen to be maintained—in the conduct of public affairs. If it is not, the accusation may rightly be levelled that the processes of consultation and cooperation have crossed over into collusion. Copyright © 2003 Henry Stewart Publications     

“Embedded regulation:” The migration of objects,scripts, and governance

This paper asks why an officially unregulated market in pharmaceuticals in a least developed country, Djibouti, behaves as if it were strictly regulated, with limited access to a small number of high‐cost drugs. We use Actor‐Network Theory (ANT) to show that the explanation is more complex than critics of the international pharmaceutical industry have supposed. Regulation and property rights generated in developed countries have become embedded in the drugs and “black boxed” to the point of invisibility. This has allowed them to travel to Djibouti with the drugs, while maintaining their effects in action. This case study develops our understanding of the way in which materials that are not designated as regulatory agents may still have regulatory impacts through their ability to enrol complex networks of actors, rules, values, and practices. Finally, it argues against the notion of law as a fixed and distinctive space for action, as opposed to the ANT vision of a fluid and contingent order, where law is part of a socio‐technico‐legal alliance that happens to achieve certain effects.     

A Concurrent Analysis of Three Institutions that Transform Health Technology‐Based Ventures: Economic Policy,Capital Investment,and Market Approval

Drawing on institutional theory, this article articulates qualitative insights from a program of research on Canadian health technology‐based ventures to examine the rules that characterize economic policy, capital investment, and regulatory approval as well as the way these institutions enable and constrain the development of ventures at an early stage. Our findings clarify how economic policy integrates these ventures into the entrepreneurial domain, how capital investment configures them for economic value extraction, and how regulatory approval fully releases their market value. These findings help to revisit current policy modernization initiatives by calling attention to the convergence among the three institutions. Rather than operating solely as a source of constraints, these institutions provide a highly integrated market‐oriented space for health technology‐based entrepreneurial activities to unfold.     

The Limits to Evidence‐Based Policy: Evidence,Emotion and Criminal Justice1

While ‘evidence‐based’ or ‘rationalist’ approaches to criminal policy may appeal to technocrats, bureaucrats and a number of academics, they often fail to compete successfully with the affective approaches to law and order policies which resonate with the public and which appear to meet deep‐seated psychological needs. They also often fail to recognise that ‘policy’ and ‘politics’ are related concepts and that debates about criminal justice are played out in broader arenas than the academy, the bureau or the agency. To be successful, penal reform must take account of the emotions people feel in the face of wrongdoing. Further, successful reform must take into account changes in public ‘mood’ or emotions over time and be sensitive to different political and social cultures. This article argues that criminal justice policies are more likely to be adopted if, in addition to the gathering and presentation of evidence, they recognise and deal with the roles of emotions, symbols, faith, belief and religion in the criminal justice system. It also recognises that evidence alone is unlikely to be the major determinant of policy outcomes and that the creation and successful implementation of policy also requires extensive engagement and evidence‐based dialogue with interested and affected parties. This necessitates a different kind of modelling for evidence‐based policy processes.     

The limits and variety of risk‐based governance: The case of flood management in Germany and England

Risk‐based governance is argued by many to hold the promise of a more rational and efficient state, by making explicit the limitations of state interventions and focusing finite resources on those targets where probable damage is greatest. This paper challenges the assumption that risk‐based governance has the potential for universal and uniform application, by comparing contemporary flood management in Germany and England. On first inspection, flooding appears to be a paradigmatic case of risk colonizing European policy discourses, with the traditional notion of flood defense giving way to flood risk management in the context of climate change, increasingly frequent flood disasters, political and cost pressures on flood protection, and publicly available European‐wide flood assessments. Drawing on in‐depth empirical research, this paper shows how the role, and even the definition, of “risk” is institutionally shaped, and how the respective institutional environments of German and English flood management practices impede and promote risk colonization. In particular, the use and conceptualizations of risk in governance are variously promoted, filtered, or constrained by the administrative procedures, structures, and political expectations embedded within flood management and wider polities of each country. The findings of this research are important for the design and implementation of supranational policies and regulations that endorse risk‐based approaches, such as the recent EU Flood Directive, as well as scholarly debate as to how to legitimately define the limits of governance in the face of uncertainty and accountability pressures.