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Regulatory theory: commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods1

Published online by Cambridge University Press:  17 April 2017

Amanda Warren-Jones
Amanda Warren-Jones*
Affiliation:
Director, SIBLE - Health, Senior Law Lecturer, Sheffield University School of Law, Bartolome House, Sheffield, UK
*
*Correspondence to: A. Warren-Jones, Director, SIBLE - Health, Senior Law Lecturer, Sheffield University School of Law, Bartolome House, Winter Street, Sheffield, S3 7ND, UK. Email: a.warren-jones@sheffield.ac.uk
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Abstract

Regulatory theory is premised on the failure of markets, prompting a focus on regulators and industry from economic perspectives. This article argues that overlooking the public interest in the sustainability of commercial markets risks markets failing completely. This point is exemplified through health care markets – meeting an essential need – and focuses upon innovative medicines as the most desired products in that market. If this seemingly invulnerable market risks failure, there is a pressing need to consider the public interest in sustainable markets within regulatory literature and practice. Innovative medicines are credence goods, meaning that the sustainability of the market fundamentally relies upon the public trusting regulators to vouch for product quality. Yet, quality is being eroded by patent bodies focused on economic benefits from market growth, rather than ensuring innovatory value. Remunerative bodies are not funding medicines relative to market value, and market authorisation bodies are not vouching for robust safety standards or confining market entry to products for ‘unmet medical need’. Arguably, this failure to assure quality heightens the risk of the market failing where it cannot be substituted by the reputation or credibility of providers of goods and/or information such as health care professionals/institutions, patient groups or industry.

Type
Articles
Information
Health Economics, Policy and Law , Volume 12 , Special Issue 4: SPECIAL ISSUE: Healthcare and Health Innovation in Europe: Regulating for public benefit or for commercial profit? , October 2017 , pp. 471 - 493
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Copyright
© Cambridge University Press 2017 

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Footnotes

1

Exemplified in a European context, but applicable globally.

References

Academic Health Science Network (2015), ‘Spreading Innovation, Improving Health, Promoting Economic Growth’, Impact Report, http://www.ahsnnetwork.com/wp-content/uploads/2014/12/AHSNs-impact-report-2015.pdf.Google Scholar
Agarwal, A., Ressler, D. and Snyder, G. (2015), ‘The current and future state of companion diagnostics’, Journal of Pharmacogenomics and Personalised Medicine, 8: 99–110.Google Scholar
Allsop, J., Jones, K. and Baggott, R. (2004), ‘Health consumer groups in the UK’, Sociology of Health & Illness, 26(6): 737–756.Google Scholar
Arrow, K. J. (1963), ‘Uncertainty and the welfare economics of medical care’, American Economic Review, 53(5): 941–973.Google Scholar
BBC News (2014), ‘GlaxoSmithKline fined $490m by China for bribery’, BBC News, 19 September, http://www.bbc.co.uk/news/business-29274822.Google Scholar
Ben-Dov, Y. (2013), ‘The patent cliff in the pharmaceutical industry’, Transfer Pricing International Journal, 14(6): 30–31.Google Scholar
Bernstein, M. (1955), Regulating Business by Independent Commission, Princeton, NJ: Princeton University Press.Google Scholar
Bremmer, I. (2015), ‘The new world of business’, Fortune, 22 January, http://fortune.com/ 2015/01/22/the-new-world-of-business/.Google Scholar
CAMbrella (2012), ‘CAM Use in Europe – The Patients’ Perspective: Part I: A Systematic Literature Review of CAM Prevalence in the EU, 19 August, http://www.cam-europe.eu/dms/files/CAMbrella_Reports/CAMbrella-WP4-part_1final.pdf.Google Scholar
Chustecka, Z. (2014), ‘Price of New Cancer Drugs as High as Market Can Bear’. Medscape, http://www.medscape.com/viewarticle/830145 [19 August].Google Scholar
Clinical Trials Regulation (2014), ‘Regulation 536/2014/EU on clinical trials for medicinal products for human use’, Official Journal of European Union, L158: 1–76.Google Scholar
Davis, C. and Abraham, J. (2011), ‘Rethinking innovation accountability in pharmaceutical regulation’, Journal of Science, Technology and Human Values, 36(6): 791–815.Google Scholar
Davis, C. and Abraham, J. (2013), Unhealthy Pharmaceutical Regulation, Basingstoke: Palgrave Macmillan.Google Scholar
Dulleck, U., Kerschbamer, R. and Sutter, M. (2009), ‘The Economics of Credence Goods’, Discussion Paper No. 4030, IZA-Institute of the Study of Labour, https://www.econstor.eu/bitstream/10419/35714/1/593991354.pdf [January 2017].Google Scholar
Dutfield, GM (2017), ‘Healthcare innovation and patent law’s “pharmaceutical privilege”: is there a pharmaceutical privilege? And if so, should we remove it?’ Health Economics, Policy and Law.Google Scholar
European Federation of Pharmaceutical Industries and Associations (EFPIA) (2013), ‘The Pharmaceutical Industry in Figures’, www.efpia.eu/uploads/Figures_Key_Data_2013.pdf.Google Scholar
European Commission (2009), ‘Pharmaceutical Sector Inquiry Report’, Communication from the Commission SEC(2009) 952.Google Scholar
European Commission (2012), ‘The 4th Report on the Monitoring of Patent Settlements’, January–December, http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/.Google Scholar
European Group on Ethics in Science and New Technologies (2015), ‘Ethical Implications of New Health Technologies and Citizen Participation’, Opinion No. 29, https://ec.europa.eu/research/ege/index.cfm.Google Scholar
Francis, R. (2013), ‘Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry’, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/279124/0947.pdf.Google Scholar
Hardin, G. (1968), ‘The tragedy of the commons’, Science, 162: 1243–1248.Google Scholar
Heads of Medicines Agencies (2015), ‘EU Medicines Agencies Network Strategy to 2020’, EMA/MB/151414/2015, http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199060.pdf [January 2017].Google Scholar
Heller, M. (2013), ‘The tragedy of the anticommons: a concise introduction and lexicon’, Modern Law Review, 76(1): 6–25.Google Scholar
Hsieh, Y.-C., Chiu, H-C. and Chiang, M-Y. (2005), ‘Maintaining a committed online customer’, Journal of Retailing, 81(1): 75–82.CrossRefGoogle Scholar
Jarvis, L. M. (2010), ‘Pharmaceuticals: big firms will fight the patent cliff’, Chemical and Engineering News, 88(2): 17.Google Scholar
Liu, T. (2011), ‘Credence goods markets with conscientious and selfish experts’, International Economic Review, 52(1): 227–244.Google Scholar
Long, H. (2016), ‘Here’s what happened to AIDS drug that spiked 5,000%’, CNN, 25 August, http://money.cnn.com/2016/08/25/news/economy/daraprim-aids-drug-high-price/.Google Scholar
Motola, D., De Ponti, F., Poluzzi, E., Martini, N., Rossi, P., Silvani, M.C., Vaccheri, A. and Montanaro, N. (2006), ‘An update on the first decade of the European centralised procedure’, British Journal of Clinical Pharmacology, 62(5): 610–616.Google Scholar
National Institute for Healthcare Excellence (NICE) (2013), ‘Guide to the Methods of Technology Appraisal’, 6.3.3, https://www.nice.org.uk/article/pgmg9/chapter/6-the-appraisal-of-the-evidence-and-structured-decision-making#decision-making.Google Scholar
NICE and NHS England (2016), Proposals for changes to the arrangments for evaluating and funding drugs and other health technologies appraised through NICE's technology appraisal and highly specialised technologies programmes (October). https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/technology-appraisals/NICE_NHSE_TA_and_HST_consultation_document.PDF.Google Scholar
Organisation for Economic Co-operation and Development (OECD) (2014), Science, Technology and Industry Outlook, OECD Publishing, Paris, 211pp.Google Scholar
Ostrom, E. (2015), Governing the Commons, Cambridge: Cambridge University Press.Google Scholar
Pan, L.-Y. and Chiou, J.-S. (2011), ‘How much can you trust online information?’ Journal of Interactive Marketing, 25: 67–74.Google Scholar
Pauly, M. V. (1978), ‘Is Medical Care Different?’ in W. Greenberg (ed.), Competition in the Health Care Sector, Germantown, MD: Aspen Systems, 11–35.Google Scholar
Polk Wagner, R. (2009), ‘Understanding patent-quality mechanisms’, University of Pennsylvania Law Review, 157(6): 2135–2173.Google Scholar
Rawlins, M. (2005), ‘Select Committee on Health “Minutes of Evidence”’, Question 894, 20 January, http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/5012011.htm.Google Scholar
Roland, D. (2014), ‘GSK bribery scandal could cause “irreparable damage”, says China’, The Telegraph, 16 July, http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10835271/GSK-bribery-scandal-could-cause-irreparable-damage-says-China.html [January 2017].Google Scholar
Royal Liverpool Children’s Inquiry (2001), Report, https://www.gov.uk/government/ publications/the-royal-liverpool-childrens-inquiry-report.Google Scholar
Sloan, F. A. (2001), ‘Arrow’s concept of the health care consumer’, Journal of Health Politics, Policy and Law, 26(5): 899–911.Google Scholar
Srivastava, R. (2016), ‘Statins: patients are allowed to make poor choices but the media shouldn’t help them’, The Guardian, 13 September, https://www.theguardian.com/commentisfree/2016/sep/13/statins-patients-are-allowed-to-make-poor-choices-but-the-media-shouldnt-help-them [January 2017].Google Scholar
Stigler, G. J. (1971), ‘The theory of economic regulation’, Bell Journal of Economics & Management Science, 2: 3.Google Scholar
Taylor, H. (2016), ‘Accelerated Access Review: Final Report’, https://www.gov.uk/government/publications/accelerated-access-review-final-report [January 2017].Google Scholar
Thambisetty, S. (2007), ‘Patents as credence goods’, Oxford Journal of Legal Studies, 27(4): 707–740.Google Scholar
UK Intellectual Property Office (UKIPO) (2015), ‘Examining Patent Cases at the Patents Court and Intellectual Property Enterprise Court 2007–2013’, https://www.gov.uk/government/publications/examining-patent-cases-at-the-patents-court-and-ipec-2007-2013 [January 2017].Google Scholar
US Department of Justice (2012), ‘GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data’, 2 July, www.justice.gov/opa/pr/ 2012/July/12-civ-842.html.Google Scholar
US National Institute of Health (2016), https://clinicaltrials.gov/ct2/resources/trends#TypesOf RegisteredStudies.Google Scholar
Vaish, A., Grossmann, T. and Woodward, A. (2008), ‘Not all emotions are created equal: the negativity bias in social-emotional development’, Psychological Bulletin, 134(3): 383–403.Google Scholar
Warren-Jones, A. (2016), ‘Regulatory justifications’, Law, Innovation and Technology, 8(1): 61–99.Google Scholar
WHO, WIPO, WTO (2013), ‘Promoting Access to Medical Technologies and Innovation’, Trilateral Report, https://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf [January 2017]. particularly 87, Executive Summary and Chapter IV, section C.2. WHO, WIPO, WTO.Google Scholar