Abstract
This paper elaborates on Abraham's thesis of ‘neo-liberal corporate bias’ as an account and explanation of UK medicines regulation. It is argued that Edgley is wrong to represent the thesis as explaining regulatory change solely by reference to the interests of the pharmaceutical industry. On the contrary, it is demonstrated that the theory incorporates the role of the interests of the state, particularly in connection with budgetary savings within the national health-care system. Following on from this, it is shown that, far from disproving the thesis, as Edgley contends, the case of statins switching in the UK is actually entirely predictable from the theory, although not necessarily because Edgley's account of statins switching is correct.
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Notes
In connection with some of my work comparing UK and US drug safety withdrawals, Edgley (2007, p. 14) refers to my finding that there were fewer such withdrawals in the US than the UK because the US drug regulatory agency applied ore stringent pre-market regulatory review than its UK counterpart. I would just like to clarify that those findings related to a study of drug safety withdrawals in the UK and US between 1971 and 1992. We are currently conducting a sequel study of the period 1993–2004, which is likely to have rather different results.
Patent medicines were ‘secret remedies’, whose ingredients were not fully disclosed on the label. They are no longer part of legal trade in the UK. The term ‘patent medicine’ should not be confused with the patenting of pharmaceuticals, which remains a common and lawful practice with which firms seek to protect intellectual property.
In addition to the interests of the pharmaceutical industry, the state and public health, I also looked for evidence of the influence of professional interests, such as the medical profession and public analysts (of chemicals), but it is not necessary to discuss that any further here.
Despite opposition from the drug and pharmacy trade, the UK Home Office, concerned about policing social unrest, introduced the 1920 Dangerous Drugs Act which meant that powerfully addictive drugs, such as cocaine, morphine and opium, could no longer be lawfully sold to the public without a doctor's prescription (Abraham, 1995, p. 50).
The NHS was established in 1948.
It might be argued that this has been driven by patients' interests in faster access to needed therapies. However, the acceleration in regulatory review times was not accompanied by any regulations requiring pharmaceutical firms to demonstrate that their new drugs offered any significant therapeutic advance over existing therapies. Furthermore, the reductions in review times actually coincided with declining pharmaceutical innovation (Martin et al., 2006).
There is a considerable amount of evidence to suggest that the switching of statins to OTC status is not in the interests of patients or public health, some of which is outlined by Edgley (2007, pp. 18–20). For more details on this, see House of Commons Health Committee (2005, pp. 88–89).
It is important to appreciate that with high drug prices comes a degree of unpopularity with professionals, health-care organizations and the public. Hence, there are limits on the extent to which high drug prices are in the overall interests of the industry – witness the industry's public relations disaster over access to AIDS drugs because of its initial insistence on high drug prices for very poor countries.
Despite support from the European Commission's DG Enterprise, the industry's efforts were ultimately defeated due to the opposition by the European Parliament.
To name a few examples, other mechanisms could be: the introduction of comparative efficacy testing regulations; the expansion of the role of drug cost-effectiveness analysis by the National Institute for Clinical Excellence (NICE); the introduction of a new and more extensive ‘limited list’; or the negotiation of tougher drug price controls.
References
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Acknowledgements
In writing this paper, I have benefited from discussion with Courtney Davis.
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Abraham, J. From Evidence to Theory: Neo-Liberal Corporate Bias as a Framework for Understanding UK Pharmaceuticals Regulation – Response to Alison Edgley. Soc Theory Health 5, 161–175 (2007). https://doi.org/10.1057/palgrave.sth.8700097
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DOI: https://doi.org/10.1057/palgrave.sth.8700097