Bridget M. Hutter

Reforming regulation of the medical profession : The risks of risk-based approaches

Abstract Risk-based regulation is growing in popularity and in the UK has official backing as part of the governments modernization programme. State and non-state regulators alike are under pressure to adopt risk-based approaches. With radical reform of the General Medical Council (GMC) in progress, the rhetoric of risk-based regulation is used by both the Department of Health and the GMC, and is evident in the 2007 White Paper Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century. This paper focuses on the dilemmas inherent in risk-based approaches to regulation by the GMC. Two sources of difficulty are examined. First, the evidential demands can be heavy and costly. Databases and information sources related to patient safety and the performance of doctors are proliferating, but have important limitations. Second, decisions about which risk factors to include and how to weight them are riddled with difficulties, both technical and normative. One attraction of risk-based approaches is that they seem to offer objectivity, but it is questionable how far this is possible in practice. Risk information is neither generated nor used against a neutral background. In the medical regulation arena, questions of public trust and confidence are crucial: risk-based regulation does not help deal with these. Furthermore, a focus on individual doctors and a certain amount of blame and sanctioning would seem to be integral to regulatory functions of such bodies as the GMC. The paper poses fundamental questions about how blame-free these systems really can be.

Understanding the New Regulatory Governance: Business Perspectives

This article considers business understandings of two of the principal features of the new regulatory governance. First, it focus on attempts to place greater responsibility for risk regulation on business and asks how well equipped they are to manage this. Second, it examines the decentering of the state and considers how business organizations view the influence of nonstate actors on their business regulation. These issues are discussed with reference to data from two different research projects in the United Kingdom. The findings question the implicit assumptions the new regulatory governance makes about how well equipped businesses are to manage the risks they generate and how able nonstate influences are to influence the full range of businesses.

Managing Food Safety and Hygiene

Food safety and hygiene is of critical importance to us all, yet, as periodic food crises in various countries each year show we are all dependent on others in business and public regulation to ensure that the food we consume in the retailing and hospitality sectors is safe. Bridget Hutter considers the understandings of risk and regulation held by those in business and considers the compliance pressures on managers and owners, and how these relate to understandings of risk and uncertainty.

Risk regulation and health care

Abstract Risk regulation analyses the organization and institutional settings for risk regulation and regulatory practice. This special issue focuses on risk regulation research with respect to two main areas of health care: infrastructure and service provisions and the risk regulation of critical areas relating to patient safety. This editorial draws out some of the main themes in risk regulation studies as they relate to these papers. Risk and governance issues consider which risks attract state regulatory responses and how risk debates connect with regulatory policy making. The emergence and reform of risk regulation and governance regimes is examined and varying perspectives offered on the status of experts, expertise and professionals in risk regulation. Many risk regulation initiatives are the result of public sector modernization programmes where the transferability of approaches and tools are taken for granted. How organizations respond to risk regimes and the extent to which organizations create their own risk regulation regimes thus become a clear focus in this volume. In medical situations, risk regulation may lead to resistance rather than openness and learning. The unintended consequences of risk regulation is an important theme: new financial frames of reference come into collision with other professional perspectives and performance data may be misinterpreted and misused. One strong message is that risk regulation in the UK is in a state of flux and that learning from crises and routine organizational data and experience are crucial in the resolution of the present difficult web of risk regulation initiatives.

Geopolitics and the Regulation of Economic Life

The nation-state should be a central unit of analysis for research into international and transnational regulation. Considering the research implications of this, we focus on the emergence stage of the regulatory process. We discuss how knowledge is contested in discussions between states over regulatory problems. We argue that a range of factors, not just a narrowly conceived national interest, influence their incentive to cooperate. Research is needed into whether regulatory problems at this level pose new or additional issues for states. Other stages of the regulatory process need to be similarly examined, likewise the interaction between the stages themselves.

Is regulation right

Most of us think it proper to study regulation but it is harder to say how regulation can be carried out properly. Regulators, indeed, seem to be on a hiding to nothing - they are routinely savaged in the press, they are seldom informed that they have got it right and hardly ever told what a balanced or successful regime of regulation would like. It is accordingly worth pausing to consider why regulators have such a rough ride, whether they can ever get it right, what sort of future they can look forward to.

Risk, resilience, inequality and environmental law.

This insightful book considers how the law has adapted to the environmental challenges of the 21st Century and the ways in which it might be used to cope with environmental risks and uncertainties whilst promoting resilience and greater equality. These issues are considered in social context by contributors from different disciplines who examine some of the experiments tried in different parts of the world to govern the environment, improve the available legal tools and give voice to more diverse groups.

Risk and responsibility

![Figure][1] Awareness of financial, technological, physical, and terrorist disasters across the globe is high as modern communication systems relay details and graphic footage into our homes. Yet the solutions seem remote, as if they can only be handled and understood by specialists and experts and not by us. Kathleen Tierney very effectively disabuses us of this in a powerfully written account of how all types of disaster are socially produced, that is, the result of social processes and decision-making. She carefully constructs her case using familiar social science literatures and a wide range of examples of disasters from different geographical regions. It is good to see work on risks and disasters coming together, because so often they are considered apart. The transatlantic divide on these topics is also partially overcome by using the work of European theorists to set the scene about the relationship between risk, modern societies, and technological risks. Tierney skillfully and critically pushes the boundaries of her arguments to embrace the social production of natural risks. A popular example would be climate change, socially produced and exacerbated by a collective failure to control its causes. ![Figure][1] Rethinking our roles in preparing for and responding to catastrophic events. PHOTO: CHARLIE RIEDEL/AP Decision-making is crucial to the social production of risk. It takes place at different levels of social living, from social cognition, through organizational, social, structural, and ultimately global levels of decision-making. Navigating through these levels and the complex theories that help us to understand the social roots and channels of risk is difficult. We need to grasp the parameters that shape what we see and know, for example, cultural assumptions that inform our prioritization of goals and our ability to envision worst-case scenarios. There may be institutional blindness and organizational barriers to collective sense-making and risk management. The literatures on these subjects are large, scattered, and multidisciplinary and brought together admirably in this work. A strong theme of the book is inequality: why are some communities and countries much more severely affected by disasters than other communities experiencing similar events? Power is part of the answer: the power to define, frame, and prioritize risks. Economic power is regarded as paramount, especially the power to sanction rapid urbanization and the concentration of populations alongside large industrial sites in areas of natural hazard. Here, we have a clear example of the social production of risk as the result of decision-making that has unequal, socially structured effects: they render the poor, elderly and migrant communities particularly vulnerable. There are also significant inequalities between nations, where developed nations tend to experience the greatest monetary loss from disasters and less-developed countries tend to suffer the greatest loss of life. Just as risks are socially constructed, so are their solutions. The main focus of this work is “resilience,” a relatively new concept in which a great deal of faith has been placed. Resilience refers to the ability to absorb system shocks and to cope, adapt, and bounce back from disruption. This can entail major reorganizations at different social levels from the individual to the household, community, and economy. Tierney shares faith in resilience but is careful to explain the difficulties in implementing this approach. Her discussion of the concept is comprehensive, cutting through multiple literatures to identify its core characteristics. How to achieve resilience is the bottom-line question and one she tackles head on. She explores sources of resilience and how it might be assessed and promoted. Notions of robustness, redundancy, resourcefulness, and rapidity emerge as important. These allow the strength and flexibility necessary to promote resilience. “Social capital” emerges as a precondition for developing and maintaining other forms of capital that might help overcome vulnerability in the event of a disaster. Cooperation and social contacts within and between groups can enhance resilience and help to access wider networks and resources. Resilience planning is not about abandoning predisaster planning but having the flexibility to adapt plans or knowing when to put them aside. This may involve new emergent groups, especially networks that appear much more resilient than hierarchies: They can tap into diverse sources of information and resources and build on preexisting social capital. Predisaster planning enhances adaptive capacity. Policy recommendations flow from this. For instance, civil society groups often take the lead in disasters, and they can be helped to be better prepared to enhance community resilience. Governance and regulation are also important. They are embedded in the social, economic, and political structures that produce them. Tierney recognizes this in relation to the ability to resist regulation, but the sections on capture are less convincing. The forces that weaken regulators are much more subtle and complex than the notion of capture conveys. Regulators often work in political and legal conditions that prevent them from doing their job. There are moments of resistance, most often in the wake of disasters, such as the new confidence in regulation that has emerged in the wake of the financial crisis. It may be helpful to coopt and embrace a mix of state and nonstate regulation, combining civil and even economic regulation to help in the transformational change Tierney envisages but sees as unlikely to take effect. This book has high and perhaps unrealistic aspirations, but it is important reading. It makes a convincing case about why natural and social science disciplines need to work together toward risk and disaster reduction. In doing so, we need to be mindful of some of the danger of expecting that we can fully anticipate and manage risks, allowing space for resilience and unorthodox approaches to develop. [1]: pending:yes