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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 regulators’ approach
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
–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. 188 Ibid. 189 Ian Kennedy, ‘Setting of Clinical Standards’, Lancet, Vol. 364 (2004) p. 1399. 190 Ibid. 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
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’. 69 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
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 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