Skip to main content
Log in

‘A Spoonful of Regulation Helps the Medicine Go Down’: The Changing Face of Medicine Regulation

  • Medicine Regulation
  • Published:
Social Theory & Health Aims and scope Submit manuscript

Abstract

The number of medicines that are being switched from prescription only to over-the-counter are rapidly increasing. The government has said it wishes to double the number of switches in the next 10 years. To assist with this ambition, the MHRA has made it easier and commercially more attractive for pharmaceutical companies to apply for a switch. This paper explores the interests and drivers behind these developments. In particular, it interrogates Abraham's thesis that medicine regulation is neo-liberal and thus ‘industry-friendly’. By examining the recent switch of statins, a cholesterol-lowering drug that can be used preventatively – the first switch of its kind – it is argued that far from being clearly an ‘industry-friendly’ regulatory development, in the UK context it is instead a ‘state-friendly’ regulatory development.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

Notes

  1. It is not here being argued that market relationships necessarily generate accountability. The tendency in market systems towards oligopoly and monopoly also means that there is a tendency for accountability to be compromised in systematic ways. However, competition in markets is traditionally heralded as one means of ensuring accountability.

  2. Over the years, Abraham has worked and published his thesis with a number of other people. Reference to his theory is made to identify him as the central protagonist of this thesis. However, references are made to a number of papers he has written with collaborators.

  3. Lifestyle drugs are defined as ‘those that primarily enhance performance, assist patients in managing their lifestyle, treat the diseases of civilization, or make cosmetic improvements’ (Scrip, 2000, p. 89).

References

  • Abraham J (1995). Science, Politics and the Pharmaceutical Industry. UCL/St Martins Press: London.

    Google Scholar 

  • Abraham J (2002). The pharmaceutical industry as a political player. The Lancet 360: 1489–1502.

    Article  Google Scholar 

  • Abraham J (2005). Regulating the drugs industry transparently. BMJ 331: 528–529.

    Article  Google Scholar 

  • Abraham J, Davis C (2005a). A comparative analysis of drug safety withdrawals in the UK and the US (1971–1992): implications for current regulatory thinking and policy. Social Science and Medicine 61: 881–892.

    Article  Google Scholar 

  • Abraham J, Davis C (2005b). Regulation of Innovative Pharmaceuticals in the EU and the US. Final Report to ESRC Project L218252001.

  • Abraham J, Lewis G (1998). Secrecy and transparency of medicines licensing in the EU. Lancet 352: 480–482.

    Article  Google Scholar 

  • Abraham J, Lewis G (1999). Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval? Social Science and Medicine 48: 1655–1667.

    Article  Google Scholar 

  • Abraham J, Lewis G (2002). Citizenship, medical expertise and the capitalist regulatory state in Europe. Sociology 36: 67–88.

    Article  Google Scholar 

  • Abraham J, Reed T (2003). Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both? Social Science and Medicine 57: 195–204.

    Article  Google Scholar 

  • Anon (2003). Lifting advertising ban could lead to more switches to pharmacy medicines. The Pharmaceutical Journal 271: 198.

  • Baxter J (ed) (2004). Keynote Market Report, OTC Pharmaceuticals, 11th edition, May 2004.

  • Bond C (2001). POM to P – Implications for practice pharmacists. Primary Care Pharmacy 2: 5–7.

  • Braithwaite J (1984). Corporate Crime in the Pharmaceutical Industry. London: Routledge, Kegan Paul.

    Google Scholar 

  • Bunney R (2004). Has the lesson of HRT been learnt before mass prescribing of statins to 40% of the adult population? BMJ, http://bmj.bmjjournals.com/cgi/eletters/328/7436/400 (accessed 5 May 2004).

  • Busfield J (2006). Pills, power, people: sociological understandings of the pharmaceutical industry. Sociology 40: 297–314.

    Article  Google Scholar 

  • Department of Health (1996). Doctor/patient partnership campaign.

  • Department of Health (2000). The NHS Plan: a plan for investment, a plan for reform.

  • Department of Health (2004) Heart drug available without a prescription, http://www.dh/gov/uk/PublicationsAndStatistics/PressReleasesNotices2004/0186 (accessed 18 May 2004).

  • Edgley A (2002). The Social and Political Thought of Noam Chomsky. Routlege: London.

    Google Scholar 

  • Edgley A, Bissell P, James V (2003). Conflict and collaboration between professions and state: the case of nurse prescribing in the UK and USA, Conference paper, British Sociological Society Medical Sociology Group: York.

  • Francis S-A, Barnett N, Denham M (2005). Switching of prescription drugs to over-the-counter status: is it a good thing for the elderly? Drugs and Aging 22: 5 pp 361–370 (10).

    Article  Google Scholar 

  • Department of Health (2005). Nurse and Pharmacist Prescribing Powers Extended. http://www.dh.gov.uk/Home/fs/en (accessed 15.11.05).

  • Gibson L (2004). Move to sell statins over the counter raises concerns. BMJ 328: 1221.

    Article  Google Scholar 

  • House of Common Health Committee (2005). The influence of the pharmaceutical industry 22 March 2005, http://www.parliament.the-stationery-office.co.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf (accessed 20 February 2006).

  • Isles CG, Paterson JR (2000). Identifying patients at risk for coronary heart disease: implications from trials of lipid lowering drug therapy. BMJ 321: 971–972.

    Article  Google Scholar 

  • Jessop N (2003). Global pharmaceutical parallel trade: can it ever happen? Pharmiweb 15 October 2003, accessed 7 May 2004.

  • Mann S (2004). Interview with Vice President Research and Development, Europe. Johnson and Johnson 2 August 2004, unpublished.

    Google Scholar 

  • Mann S, Cottrell J (2004). No benefit in primary prevention trials? The Pharmaceutical Journal 272: 804.

    Google Scholar 

  • Marshall TP (2004). Why statins? BMJ http://bmj.bmjjournals.com/cgi/eletters/328/7436/400 (accessed 5 May 2004).

  • Merton RK (1936). The unintended consequences of purposive social action. American Sociological Review 1: 894.

    Article  Google Scholar 

  • MHRA (2005). Legal status and reclassification. Licensing of Medicines, http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=107.

  • Moran M (1999). Governing the Health Care State: A Comparative Study of the United Kingdom, and the United States and Germany. Manchester University Press: Manchester.

    Google Scholar 

  • Moran M, Wood B (1993). States, Regulation and the Medical Profession. Open University Press: Buckingham.

    Google Scholar 

  • Noerreslet M, Larsen JB, Traulsen JM (2005). The medicine user – lost in translation? Analysis of the official political debate prior to the deregulation of the Danish medicine distribution system. Social Science and Medicine 61: 1733–1740.

    Article  Google Scholar 

  • PAGB (2004). Recent Regulatory Developments Affecting the OTC Sector. http://www.pagb.co.uk/pagb/primarysections/selfcare/regulatoryinselfcare.htm (accessed 8 June 20050).

  • Perry G, Mansell P (2000). RX-to-OTC: The Way Forward for the Global Pharmaceutical Industry? Informa Publishing Group Ltd: London.

    Google Scholar 

  • Pignone M, Philips C, Mulrow C (2000). Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials. Monthly Journal of the Association of Physicians 93: 567–574.

    Article  Google Scholar 

  • Raithatha N, Smith RD (2004). Paying for statins. BMJ 328: 400–402.

    Article  Google Scholar 

  • Reid J (2003). Heart drug could be available in High Street pharmacies. Department of Health Press Release 2003/0463 17 November 2003 (accessed 18 May 2004).

  • Rodrigues LL (2003). Corporatism, liberalism and the accounting profession in Portugal since 1755. Journal of Accounting Historians 6 (June), http://www.findarticles.com/p/articles/mi_qa3657/is_200306/ai_n9301506/print (accessed 21 July 2005).

  • Scrip Reports (2000). Direct-to-Consumer Advertising: Changing the Face of the Pharmaceutical Marketing. Morpace Pharma Group Ltd: Massachusetts.

  • Soller RW (1999). The over the counter scientific/Regulatory Paradigm. Drug Information Journal 33: 799–804.

    Google Scholar 

  • Timmins N (2004). Ministers set rules for medicines regulators. Financial Times Friday November 12, 2004.

  • Zwillich T (2005). Panel Rejects Over-the-Counter Cholesterol Drug. http://dailynews.att.net/cgi-bin/health?e=pub&dt=common&cat=cholesterol&st=cholesterol105234&src=webmd (accessed 20 February 2006).

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Edgley, A. ‘A Spoonful of Regulation Helps the Medicine Go Down’: The Changing Face of Medicine Regulation. Soc Theory Health 5, 145–160 (2007). https://doi.org/10.1057/palgrave.sth.8700095

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1057/palgrave.sth.8700095

Keywords

Navigation