Deficits, expectations and paradigms in British and American drug safety assessment: prising open the black box of regulatory science

This article examines the regulation of nonsteroidal anti-inflammatory drugs (NSAIDs), with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science (including deficits), on the other

Evolving Standards and Regulation: Exploring the Development and Provision of Closed Circuit Television in the United Kingdom

This article explores the emergence of standards and regulation associated with the provision of Closed Circuit Television (CCTV) surveillance systems in the United Kingdom. It argues that despite the intrusive and controlling nature of CCTV technology there is limited formal intervention in the form of legislation, governing its introduction and use. Instead government has sought to influence the regulation of the technology indirectly through its ability to shape and govern policy networks in the policy arena. In doing so, it is argued here, that government remains the dominant actor in the policy process

The English National Health Service: 1979-2005

This article aims to assess the development of the English National Health Service (NHS) over the period 1979-2005, against the original, and often repeated, core objectives of the system: that it be universal in offering coverage to all members of the population in times of health care need; that it be comprehensive in its provision of health care services; and that it be (largely) free at the point of use. Comprehensiveness is open to interpretation, and may depend upon the wealth of the nation. Universality and (largely) free care at the point of use, which lend themselves to the principle of equal access for equal need, are more concrete, and it is not difficult to ascertain if they have been substantially and|or systematically violated. The article details briefly the developments in resource allocation, provider payment mechanisms, incentives and accountability, and notes that much of the emphasis on health sector change since the mid 1980s has been placed upon improving supply side efficiency and reducing waiting lists|times. Improving NHS efficiency, and indeed related aspirations associated with choice and health outcomes, can be perceived as 'secondary' objectives, in that they should not serve to undermine the core objectives of the system, assuming that the security offered by having an accessible, universal health care system is considered worthy of protection. The overall conclusion is that the NHS has performed quite well against its core objectives to date, although it is possible that the current preoccupation with choice and health outcomes will lead us down a different policy path in the future. Copyright © 2005 John Wiley & Sons, Ltd.