Risk versus Hazard – How to Regulate in the 21st Century

2011 ◽  
Vol 2 (2) ◽  
pp. 149-168 ◽  
Author(s):  
Ragnar E. Lofstedt

In Europe, debate as to whether one should regulate chemicals based on intrinsic hazard or assessment of risk, or possibly a combination of both, has been gaining momentum. This article first provides a brief history of this risk versus hazard debate. Secondly, it examines how European regulators are currently handling the regulation of two chemical compounds, namely Bisphenol A and Deca BDE (a brominated flame retardant), based on forty-five expert interviews with regulators, policy makers and industry representatives in eight Member States, as well as with European Commission officials. The paper shows that there is no clear consensus as to when risk or hazard considerations should be the basis for regulatory decision-making, with wide discrepancies between Member States (e.g. the UK is overall more risk based than Sweden) and between regulatory agencies within Member States. The penultimate section puts forward a series of recommendations to help regulators and policy makers develop more consistent and science based regulations for Europe.

Author(s):  
Despoina Mantzari

Abstract UK sectoral regulatory authorities are hybrid communities of, among others, lawyers and economists. Since the liberalization of essential services, expert economists enjoy broad discretionary powers in advancing the agencies’ broad statutory objectives. Yet, despite the significant societal impact of economic regulation, existing scholarship in the fields of competition law and regulation and public law has, with very few exceptions, disregarded these actors and the very essence of their work. This article aims to address this gap in the literature by blending theoretical with empirical insights deriving from 14 semi-structured elite interviews with regulatory economists in the regulatory agencies for energy (Office for Gas and Electricity Markets), telecoms (Office for Communications), and water (Office of Water Services). It explores the increased reliance on economics in the regulatory decision-making process and the impact this has had on the authorities’ decision-making and discretion, when making complex trade-offs between the various goals of the regulatory enterprise. In doing so, it puts forward a theoretical framework inspired by Craig Parsons’ typology of political action so as to identify and examine the nature and scope of the constraints that inform and shape the influence of economics in the exercise of regulatory discretion. This endeavour is significant in the sense that it is the first of its kind and, in that it provides a normative framework of analysis that can be applied in other areas of regulation heavily infused with and influenced by economic evidence and analysis, such as ‘pure’ competition law enforcement by both sectoral and competition authorities.


2014 ◽  
Vol 11 (4) ◽  
pp. 481-498
Author(s):  
Justin Smith

This article charts the history of an experiment, conducted during the autumn and winter of 1986–7, in which Channel 4 trialled an on-screen visual warning symbol to accompany screenings of a series of international art-house films. The so-called ‘red triangle’ experiment, though short-lived, will be considered as a case study for exploring a number of related themes. Firstly, it demonstrates Channel 4's commitment during the 1980s to fulfilling its remit to experiment and innovate in programme form and content, in respect of its acquired feature film provision. Channel 4's acquisitions significantly enlarged the range of international classic and art-house cinema broadcast on British television. Secondly, it reflects contemporary tensions between the new broadcaster, its regulator the IBA, campaigners for stricter censorship of television and policy-makers. The mid-1980s was a period when progressive developments in UK film and television culture (from the rise of home video to the advent of Channel 4 itself) polarised opinions about freedom and regulation, which were greatly exacerbated by the press. Thirdly, it aims to shed light on the paradox that, while over thirty years of audience research has consistently revealed the desire on the part of television viewers for an on-screen ratings system, the UK is not among some forty countries that currently employ such devices on any systematic basis. In this way the history of a specific advisory experiment may be seen to have a bearing on current policy trends.


2019 ◽  
Vol 3 (2) ◽  
pp. 1-36
Author(s):  
Mubashar M. Qadri ◽  
Umer Ayub ◽  
Usman R. Mir

The debate of Globalization and Regionalization is becoming extensive and significant and in response to these observations, various standpoints, in favor or against, are also emerging and have fueled the debate. Huge complexities are emerging to comprehend what is intended by both. The proponents of both are presenting contrasting, conflicting and debatable explanations and interpretations; however, a clear demarcation between these is still blurry. Due to broadness of both concepts, in this study, instead of making another attempt to provide the summary of different forms, definitions, contradictory or conflicting debate about globalization and regionalization, attention is given on those aspects which are contested by the proponents of regionalization. After rigorous examination and comparisons of various viewpoints of proponents of both, few guidelines are proposed for policy makers to develop some policies to ease the challenge currently micro and macro players are facing about decision making about these two. The policy makers should understand that survival of countries resides in internally connected dynamic and pluralistic business blocs in which the member states not only trade freely but fairly and fearlessly.


2008 ◽  
Vol 16 (3) ◽  
pp. 343-354 ◽  
Author(s):  
Michael Gallagher ◽  
Kay M. Tisdall ◽  
John Davis

AbstractThe article interrogates how children and young people's participation in public decision-making has been promoted in the UK. It considers critically the reasons typically (and persuasively) put forward for such participation, which can be categorized as: the promotion of children's rights; alignment with consumerism and service user involvement; enhancing democracy; and developing children's well-being and development. Each of these reasons can appeal to particular agendas of policy-makers, professionals and other influential adults, to provide room and support for participation. But inevitably each reason has certain advantages and disadvantages, acted out in current trends and accompanying dilemmas in children and young people's participation activities.


2012 ◽  
Vol 14 (04) ◽  
pp. 1250025 ◽  
Author(s):  
JOS ARTS ◽  
HENS A. C. RUNHAAR ◽  
THOMAS B. FISCHER ◽  
URMILA JHA-THAKUR ◽  
FRANK VAN LAERHOVEN ◽  
...  

The European Union (EU) Environmental Impact Assessment (EIA) Directive which was introduced some 25 years ago has had a major impact on decision-making practices in EU member states. In the professional literature, this impact has mostly been discussed under the heading of "effectiveness", with an emphasis being given in particular to procedural elements. The extent to which EIA has contributed to objectives, such as raising environmental awareness and leading to an incorporation of environmental values in decision-making has only been rarely investigated. This paper reflects on these latter two aspects of EIA effectiveness in two EU member states; the Netherlands and the United Kingdom. Empirical evidence was compiled mainly on the basis of a comprehensive literature review and online surveys with EIA professionals in both countries. Our results indicate that overall the instrument is about equally effective in both countries with regards to the incorporation of environmental concerns in decision-making. As both countries have different governance mechanisms, further research is needed on why perceived effectiveness does not differ more.


2020 ◽  
Vol 23 ◽  
pp. 1s-47s
Author(s):  
Real World Data Workshop Group CSPS/Health Canada

Real world data (RWD) and real world evidence (RWE) are playing increasing roles in health-care decisions. Real world data are routinely employed to support reimbursement and coverage decisions for drugs and devices. More recently, clinical trials incorporating pragmatic designs and observational studies are considered to supplement traditional clinical trials (e.g., randomized clinical trials). Regulatory agencies and large co-operative groups including academia and industry are exploring whether leveraging big databases such as electronic medical records and claims databases can be used to garner clinical insights extending beyond those gained from randomized controlled studies. Whether RWE can ultimately replace or improve traditional clinical trials is the big question. The workshop held on December 3, 2019 at Health Canada included presenters from regulatory agencies, industry and academia. Health Canada, US FDA and European Medicine Agency presented current thinking, draft frameworks and guidance available in the public domain. While the three agencies might be at different stages of utilizing RWE for regulatory decision making, the consensus is not whether RWE would be used but when and how it can be incorporated into regulatory decision making while maintaining a high evidentiary bar. The complexity of data sourcing, curating databases, aligning on common data models, illustrated by high-profile work conducted as part of Sentinel, DSEN, OHDSI and Duke-Margolis initiatives, was presented and discussed during the workshop, creating great learning opportunities for the attendees. The design and analysis of RWE studies were compared and contrasted to those of RCTs. While there are gaps, they are closing quickly as novel analytical methods are employed and innovative ways of curating data, including natural language processing and artificial intelligence, are explored.   This proceeding contains summaries of information presented by the speakers, including current highlights about the use of RWE in regulatory decision making. In the world where the uptake of “big data” in everyday life is happening at unprecedented speed, we can expect RWE to be a fast-moving area and with the potential for big impact in health-care decision making in the years to come.


2009 ◽  
Vol 38 (1) ◽  
pp. 63-81 ◽  
Author(s):  
IAN GREENER ◽  
MARTIN POWELL

AbstractScholarship in social policy in recent years has examined how policy positions users in a range of roles, particularly most recently in terms of their roles as ‘choosers’ through the increased use of markets in welfare. This article considers how choice policies have positioned users since the creation of the modern welfare state, presenting a history of choice policies, but also a comparative examination of how they have differed in the UK between housing, education and healthcare. It concludes by suggesting that although approaches to choice vary considerably between the three public services examined, policy-makers often appear unaware of these differences, leading to mistaken assumptions that policies can be transferred or transplanted unproblematically.


FACETS ◽  
2017 ◽  
Vol 2 (2) ◽  
pp. 1045-1064 ◽  
Author(s):  
Justin N. Marleau ◽  
Kimberly D. Girling

Policy-makers are confronted with complex problems that require evaluating multiple streams of evidence and weighing competing interests to develop and implement solutions. However, the policy interventions available to resolve these problems have different levels of supporting scientific evidence. Decision-makers, who are not necessarily scientifically trained, may favour policies with limited scientific backing to obtain public support. We illustrate these tensions with two case studies where the scientific consensus went up against the governing parties’ chosen policy. What mechanisms exist to keep the weight of scientific evidence at the forefront of decision-making at the highest levels of government? In this paper, we propose that Canada create “Departmental Chief Science Advisors” (DCSAs), based on a program in the UK, to help complement and extend the reach of the newly created Chief Science Advisor position. DCSAs would provide advice to ministers and senior civil servants, critically evaluate scientific work in their host department, and provide public outreach for the department’s science. We show how the DCSAs could be integrated into their departments and illustrate their potential benefits to the policy making process and the scientific community.


Author(s):  
Gordon Lynch

AbstractThis concluding chapter explores why it was that post-war child migration to Australia was allowed to resume and continue by the UK Government despite known failings in these schemes. It is argued that one factor was the sheer administrative complexity of a multi-agency programme operating over different national jurisdictions and large distances which made control and oversight of conditions for British child migrants harder to achieve. Despite concerns that the post-war welfare state would be a powerful, centralised mechanism, the history of these programmes demonstrates British policy-makers’ sense of the limits of their powers—limits arising from lack of resource, the perceived need to avoid unproductive conflict with powerful stakeholders, the wish to respect boundaries of departmental policy remits and assumptions about the value of following policy precedents. The chapter concludes by considering how fine-grained analyses of such policy failures can contribute to public debates about suitable redress.


Author(s):  
C. Coglianese

Throughout the world, governments use regulation to combat monopoly power, protect consumers, and reduce health, safety, and environmental risks. Regulation promotes the safety of transportation, the cleanliness of the air, and the quality of their food and drugs. Today, nearly every major aspect of contemporary public life is significantly affected by rules made by regulatory agencies, ministries, or bureaus (Kerwin, 2003). Given the consequential and complex nature of regulatory decision-making, crafting rules presents government agencies with significant informational challenges. Government regulators must collect information to understand the causes of regulatory problems, identify available regulatory options, and predict the effects of each alternative (Coglianese, Zeckhauser, & Parson, 2004). To develop a new rule, regulators must often undertake extensive studies and analyses and respond to comments from industry groups and other interested organizations. E-rulemaking—or the use of information technology in government rulemaking—promises to help regulatory agencies make rules more efficiently and with better quality (Brandon & Carlitz, 2002; Johnson, 1998). E-rulemaking may also help expand public access to and participation in government decision making. Despite the significance of regulatory decisions, they have often been made in relative obscurity, with organized business lobbies sometimes having disproportionate influence over policymaking. Information technology may facilitate greater transparency and democratic accountability in the rulemaking process. Already, regulatory agencies are making use of information technology to create Websites containing notices of new regulatory proposals and various background documents. They have also begun to allow citizens to use the Internet to share comments on new regulatory policies or engage in online dialogues (Beierle, 2003; Brandon & Carlitz, 2002). In early 2003, for example, the United States government launched a new Web portal called Regulations.Gov that allows the public to locate and comment on all new regulatory proposals announced by hundreds of federal regulatory agencies (Skrzycki, 2003). In addition, American officials are currently at work developing a government-wide, online docket system that will make available all the extensive information contained in each agency’s rulemaking files (Skrzycki, 2004). Efforts such as these are likely to continue and can be expected in other regulatory jurisdictions around the world.


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