reason for Japan's distinctive vaccination policies is the
long history of outside influences on its institutional framework. German, and
more recently, American contacts have had a profound effect on Japan's most
fundamental regulatory institutions as well as other features such as
regulators’ preference for full self-sufficiency in vaccines and
domestically developed strains. Another area where Japan remains distinctive is
should move to the Care Quality Commission, while its
research licensing work and the functions of the HTA were to be
absorbed by ‘a new super-regulator’.55 After the coalition approved
the Rawlins report in its March 2011 budget, it announced that this
super-regulator would be a new Health Research Authority, which
was established in December 2011 and began work on creating ‘a
unified approval process’ for biomedical research (after concerted
appeals, the HFEA was ultimately saved from this ‘bonfire of the
quangos’ in 2013).56 The government’s ‘simplification’ of the
A national ethics committee and bioethics during the 1990s
–Patient Relationship’, p. 777.
186 Richard Horton, ‘Why Is Ian Kennedy’s Healthcare Commission
Damaging NHS Care?’, Lancet, Vol. 364 (2004) pp. 401–2 (p. 401).
187 Ibid, p. 402.
189 Ian Kennedy, ‘Setting of Clinical Standards’, Lancet, Vol. 364 (2004)
191 Charlotte Santry, ‘Healthcare Regulator Longed for Government’s
Embrace’, Health Service Journal, 12 November 2008, available
online at www.hsj.co.uk (accessed 6 February 2014).
192 Charlotte Santry, ‘Sir Ian Kennedy Champions “Fearless” NHS
Regulator’, Health Service Journal, 12 November 2009
Marguerite Dupree, Anne Marie Rafferty, and Fay Bound Alberti
high political stakes for governments. 17
Regulators see issues surrounding hospital hygiene standards and cleanliness as symptomatic of wider systems failures, and as a principal measure of healthcare quality. Thus, hospital infections serve as a key performance indicator, and infection prevention and control are an important part of a wider patient safety agenda within hospitals. 18
Foreshadowed in the 1970s by the criticisms in Ivan Illich’s influential polemic, Medical Nemesis , in which he argued that modern medicine was a major threat to world health
women, the Bader Committee argued that the ‘home environment’ was essential for the emotional health of pilots and was particularly important to mitigate the effects of personal stress ‘leading to fatigue’.
Time at home had, the Bader Committee held, both physical and emotional benefits. To this end, pilot fatigue was transformed in regulatory discourse. Once framed in primarily physiological terms, by the 1970s the psychological and social pressures of commercial aviation were central to regulators’ understanding
rise of clinical trials was massively predicated on their internalisation by drug companies, on their blending with scientific marketing, and on the absence of alternative producers of drug-related clinical knowledge.
This does not imply that state authorities and administrative regulation played no role in these developments. The contrast between the trajectories of Ludiomil and Levoprotiline readily show the opposite, since the first one passed the regulatory test without difficulties while Ciba-Geigy never convinced German regulators that the
process, which owes as much to agency as to conditioning’. See E. P. Thompson, The Making of the English Working Class
(Harmondsworth: Penguin, 2013) p. 8.
64 See also De Vries et al., ‘Social Science and Bioethics’.
65 Imber, ‘Medical Publicity before Bioethics’, p. 21.
66 Michael Moran, The British Regulatory State: High Modernism and
Hyper-Innovation (Oxford: Oxford University Press, 2003).
67 Culliton and Waterfall, ‘Flowering of American Bioethics’, p. 1270.
68 Charlotte Santry, ‘Healthcare Regulator Longed for Government’s
Embrace’, Health Service Journal, 12
The working lives of paid carers from 1800 to the 1990s
Anne Borsay and Pamela Dale
relatives frequently raise questions about
nursing care, not realising that only part of the workforce are trained
nurses with professional qualifications.93 In these circumstances
nurses and nurse managers (with and without specialist responsibilities for the mentally disordered) are vulnerable to criticism with
regard to their own clinical practice, information-sharing with colleagues/regulators, maintenance of minimum care standards and/or
staffing ratios, and the management of subordinate care staff. Official
reports and media coverage from the present will surely
The historian’s dilemmas in a time of health-care reform
the Affordable Care Act does not
operate ‘in [an] are[a] … where States historically have been
sovereign’. As evidenced by Medicare, Medicaid, the Employee
Retirement Income Security Act of 1974 (ERISA), and the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), the Federal
Government plays a lead role in the health-care sector, both as a direct
payer and as a regulator
responsibility for action to individuals. Actors as diverse as self-help authors, public health practitioners, patients’ organisations, health and safety regulators and food and pharmaceutical companies all positioned individual subjects as the locus of imbalance and agent for change. To achieve or maintain balance, these actors suggested that individual citizens, consumers or patients needed to develop new relations to their minds and bodies, to how they perceived, represented and conducted themselves. Such ministrations were only partially altruistic, only partially aimed