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Regulating and legislating safety: the case for candour
  1. Oliver Quick
  1. Correspondence to Dr Oliver Quick, University of Bristol Law School, Wills Memorial Building, Queens Rd, Bristol BS8 1RJ, UK; Oliver.Quick{at}

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Public inquiries into healthcare-associated harm have a depressing sense of déjà vu. The past 12 years have seen (among others) exhaustive and expensive inquiries into the failures of paediatric heart surgery,1 systems for obtaining informed consent,2 the killings of Harold Shipman,3 and now the story of neglect and maladministration at Mid Staffordshire NHS Trust,4 where mortality rates were persistently higher than expected over the period 2005–2009. Indeed, the vast three-volume Francis Report echoes the findings of the first major NHS public inquiry into events at Ely Hospital as far back as 1967.5 While these different events have their own histories and causes, they tell similar stories of ineffective regulation and weak safety cultures. The Francis report is reminiscent of the Kennedy inquiry report into Bristol6 in observing closed hierarchical systems, fear of blame and punishment, toleration of bad practices, and a failure to learn from patient and staff feedback. Robert Francis QC is clear (and surely correct) that the fundamental problem lies in the prevailing culture of healthcare organisations. However, the report tends to gloss over some of the complexities of culture.7 Thus, whilst heavy on detailed recommendations (there are an unmanageable 290), only four are specifically made in relation to culture.8 Instead, the report gives much detail of—and places much faith in—the capacity of law and regulation to improve the safety of patients. This short paper evaluates the recommendations made in relation to reforming the legal and regulatory landscape around patient safety, and focuses on the potential that a legal duty of candour has for contributing to an improved safety culture in healthcare.

Regulatory failure?

Mid Staffordshire is a story of regulatory failure. This should be surprising given the seemingly robust structures in the ‘pluralistic regulatory landscape’9 that surrounds healthcare. Professional regulators, such …

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