IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v304y2022ics0277953620301489.html
   My bibliography  Save this article

The Consultant's intermediary role in the regulation of molecular diagnostics in the US

Author

Listed:
  • Holloway, Kelly
  • Miller, Fiona A.

Abstract

Molecular diagnostics are fast becoming a big business, with the promise of personalized medicine fueling the growth of “blockbuster” tests with high expectations for health system impact and commercial success. We investigate the polycentric regulatory regime for molecular diagnostics in the US, drawing attention to the prominent role of coverage and reimbursement systems in setting regulatory standards for this industry. We hone in on the private consultants who assist molecular diagnostics companies to gain broad clinical uptake of their products. Through a web-based search of consulting companies, analysis of their online materials, and 13 qualitative interviews with consultants, we describe the role of these actors in the coverage and reimbursement of novel diagnostics and highlight the production of evidence as a critical part of the process. We argue that consultants operate as regulatory intermediaries, helping to develop the evidentiary standards for payment decisions that ultimately benefit their clients, the manufacturers. We suggest that public policy discussions over how best to realize the promise of personalized medicine should be re-oriented to consider whose interests are represented in the regulatory regime governing access to these technologies.

Suggested Citation

  • Holloway, Kelly & Miller, Fiona A., 2022. "The Consultant's intermediary role in the regulation of molecular diagnostics in the US," Social Science & Medicine, Elsevier, vol. 304(C).
    • Handle: RePEc:eee:socmed:v:304:y:2022:i:c:s0277953620301489
    DOI: 10.1016/j.socscimed.2020.112929
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277953620301489
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.socscimed.2020.112929?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Morgan Meyer & Matthew Kearnes, 2013. "Introduction to special section: Intermediaries between science, policy and the market," Science and Public Policy, Oxford University Press, vol. 40(4), pages 423-429, July.
    2. repec:dau:papers:123456789/13776 is not listed on IDEAS
    3. Kenneth W. Abbott & David Levi-Faur & Duncan Snidal, 2017. "Introducing Regulatory Intermediaries," The ANNALS of the American Academy of Political and Social Science, , vol. 670(1), pages 6-13, March.
    4. Mike Raco, 2012. "The privatisation of urban development and the London Olympics 2012," City, Taylor & Francis Journals, vol. 16(4), pages 452-460, August.
    5. Meckley, Lisa M. & Neumann, Peter J., 2010. "Personalized medicine: Factors influencing reimbursement," Health Policy, Elsevier, vol. 94(2), pages 91-100, February.
    6. Julia Black, 2008. "Constructing and contesting legitimacy and accountability in polycentric regulatory regimes," Regulation & Governance, John Wiley & Sons, vol. 2(2), pages 137-164, June.
    7. Morgan Meyer & Matthew Kearnes, 2013. "Introduction to special section: Intermediaries between science, policy and the market," Post-Print hal-00850565, HAL.
    8. Ross Beveridge, 2012. "Consultants, depoliticization and arena-shifting in the policy process: privatizing water in Berlin," Policy Sciences, Springer;Society of Policy Sciences, vol. 45(1), pages 47-68, March.
    9. David Levi-Faur, 2005. "The Global Diffusion of Regulatory Capitalism," The ANNALS of the American Academy of Political and Social Science, , vol. 598(1), pages 12-32, March.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Svenja Keele, 2019. "Consultants and the business of climate services: implications of shifting from public to private science," Climatic Change, Springer, vol. 157(1), pages 9-26, November.
    2. Nicola Francesco Dotti & André Spithoven, 2017. "Spatial perspectives on knowledge brokers: Evidence from Brussels," Environment and Planning A, , vol. 49(10), pages 2203-2222, October.
    3. Taheri, Mozhdeh & van Geenhuizen, Marina, 2016. "Teams' boundary-spanning capacity at university: Performance of technology projects in commercialization," Technological Forecasting and Social Change, Elsevier, vol. 111(C), pages 31-43.
    4. Mónica Ramos-Mejía & Alejandro Balanzo, 2018. "What It Takes to Lead Sustainability Transitions from the Bottom-Up: Strategic Interactions of Grassroots Ecopreneurs," Sustainability, MDPI, vol. 10(7), pages 1-20, July.
    5. Miller, Fiona A. & Lehoux, Pascale, 2020. "The innovation impacts of public procurement offices: The case of healthcare procurement," Research Policy, Elsevier, vol. 49(7).
    6. Dieuwke Lamers & Marc Schut & Laurens Klerkx & Piet van Asten, 2017. "Compositional dynamics of multilevel innovation platforms in agricultural research for development," Science and Public Policy, Oxford University Press, vol. 44(6), pages 739-752.
    7. Albats, Ekaterina & Alexander, Allen T. & Cunningham, James A., 2022. "Traditional, virtual, and digital intermediaries in university-industry collaboration: exploring institutional logics and bounded rationality," Technological Forecasting and Social Change, Elsevier, vol. 177(C).
    8. Peltomaa, Juha & Hildén, Mikael & Huttunen, Suvi, 2016. "Translating institutional change - forest journals as diverse policy actors," Forest Policy and Economics, Elsevier, vol. 70(C), pages 172-180.
    9. Paula Kivimaa & Wouter Boon & Riina Antikainen, 2017. "Commercialising university inventions for sustainability—a case study of (non-)intermediating ‘cleantech’ at Aalto University," Science and Public Policy, Oxford University Press, vol. 44(5), pages 631-644.
    10. Wynanda I. Van Enst & Peter P. J. Driessen & Hens A. C. Runhaar, 2017. "Working at the Boundary: An Empirical Study into the Goals and Strategies of Knowledge Brokers in the Field of Environmental Governance in the Netherlands," Sustainability, MDPI, vol. 9(11), pages 1-14, October.
    11. Marina van Geenhuizen, 2018. "A framework for the evaluation of living labs as boundary spanners in innovation," Environment and Planning C, , vol. 36(7), pages 1280-1298, November.
    12. Xie Kaiji & Antonio Crupi & Alberto Minin & Fabrizio Cesaroni, 2022. "Team boundary-spanning activities and performance of technology transfer organizations: evidence from China," The Journal of Technology Transfer, Springer, vol. 47(1), pages 33-62, February.
    13. Ronlyn Duncan & Melissa Robson-Williams & Sarah Edwards, 2020. "A close examination of the role and needed expertise of brokers in bridging and building science policy boundaries in environmental decision making," Palgrave Communications, Palgrave Macmillan, vol. 6(1), pages 1-12, December.
    14. Leopold, C. & Vogler, S. & Habl, C. & Mantel-Teeuwisse, A.K. & Espin, J., 2013. "Personalised medicine as a challenge for public pricing and reimbursement authorities – A survey among 27 European countries on the example of trastuzumab," Health Policy, Elsevier, vol. 113(3), pages 313-322.
    15. Nicholas A. Phelps & Andrew Wood, 2018. "Promoting the global economy: The uneven development of the location consulting industry," Environment and Planning A, , vol. 50(6), pages 1336-1354, September.
    16. Ayako Hirata, 2021. "How networks among frontline offices influence regulatory enforcement: Diffusion and justification of interpretation of risk," Regulation & Governance, John Wiley & Sons, vol. 15(4), pages 1388-1405, October.
    17. Daniel Fitzpatrick & Rebecca Monson, 2022. "Property rights and climate migration: Adaptive governance in the South Pacific," Regulation & Governance, John Wiley & Sons, vol. 16(2), pages 519-535, April.
    18. Josefina Erikson & Oscar L. Larsson, 2022. "Beyond client criminalization: Analyzing collaborative governance arrangements for combatting prostitution and trafficking in Sweden," Regulation & Governance, John Wiley & Sons, vol. 16(3), pages 818-835, July.
    19. John Allen & Allan Cochrane, 2014. "The Urban Unbound: London's Politics and the 2012 Olympic Games," International Journal of Urban and Regional Research, Wiley Blackwell, vol. 38(5), pages 1609-1624, September.
    20. Fernando Filgueiras & Pedro Palotti & Graziella G. Testa, 2023. "Complexing Governance Styles: Connecting Politics and Policy in Governance Theories," SAGE Open, , vol. 13(1), pages 21582440231, March.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:304:y:2022:i:c:s0277953620301489. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.