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Comparing the Burden: What Can We Learn by Comparing Regulatory Frameworks in Abortion and Fertility Services?

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Abstract

In the UK, regulation of clinical services is being restructured. We consider two clinical procedures, abortion and IVF treatment, which have similar ethical and political sensitivities. We consider factors including the law, licensing, inspection, amount of paperwork and reporting requirements, the reception by practitioners and costs, to establish which field has the greater ‘regulatory burden’. We test them based on scientific, ethical, social, political factors that might explain differences. We find that regulatory burden borne by IVF services is greater than in abortion, but none of the explanatory theses can provide a justification of this phenomenon. We offer an alternative explanation based on regulatory ‘overspill’ from research regulation and policy making, conceptualisation of risk regulation and a high public profile that locks a regulator into self-preservation.

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References

  1. Allan, H., De Lacey, S., & Payne, D. (2009). The shaping of organisational routines and the distal patient in assisted reproductive technologies. Nursing Inquiry, 16(3), 241–250.

    Article  PubMed  Google Scholar 

  2. Allyse, M. (2010). Embryos, ethics and expertise: The emerging model of the research ethics regulator. Science and Public Policy, 37(8)5, 97–609.

    Google Scholar 

  3. Baily, M. (2008). Harming through protection? New England Journal of Medicine, 358, 768–769.

    Article  PubMed  CAS  Google Scholar 

  4. Baird, A. S., & Porter, C. (2010). Termination of pregnancy. Obstetrics, Gynaecology & Reproductive Medicine, 20(7), 212–218.

    Article  Google Scholar 

  5. Baldwin, R. (2006). Better regulation in troubled times. Health Economics, Policy and Law, 1, 203–207.

    Google Scholar 

  6. Better Regulation Executive. (2009). Human fertilisation and embryology authority-a Hampton implementation review report. http://www.berr.gov.uk/files/file53852.pdf.

  7. Bickerdyke, I., & Lattimore, R. (1997). Reducing the regulatory burden: Does firm size matter? Commonwealth of Australia industry commission staff research paper. www.pc.gov.au/ic/research/information/regburd/regburd.pdf.

  8. Bonaccorsi, A., & Daraio, C. (2005). Exploring size and agglomeration effects on public research productivity. Scientometrics, 63(1), 87–120.

    Article  CAS  Google Scholar 

  9. Boseley, S. (2011). Human embryos ‘at risk of losing legal protection’ in research. The Guardian http://www.guardian.co.uk/science/2011/jan/05/human-embryo-losing-legal-protection.

  10. Brinsden, P. (2000). Has clinical practice been changed by the Human Fertilisation and Embryology Act 1990? Human Fertility, 3, 116–120.

    Article  PubMed  Google Scholar 

  11. Callus, T. (2007). Patient perception of the human fertilisation and embryology authority. Medical Law Review, 15(1), 62–85.

    Article  PubMed  Google Scholar 

  12. Carpenter, D. P. (2004). The political economy of FDA drug review: Processing, politics, and lessons for policy. Health Affairs, 23(1), 52–63.

    Article  PubMed  Google Scholar 

  13. Cunningham, R. L. (1991). Legislating on human fertilization and embryology in the United Kingdom. Statute Law Review, 12(3), 214–227.

    Article  Google Scholar 

  14. Davies, T., & Veble, K. (2008). Authority paper: Regulatory enforcement and sanctions act, 2008 p. 4. http://www.hfea.gov.uk/docs/AM_Item7_Dec08.pdf.

  15. Dawson, A. (2004). The human fertilisation and embryology authority: Evidence based policy formation in a contested context. Health Care Analysis, 12, 1–6.

    Article  PubMed  Google Scholar 

  16. Department of Health Approved independent sector places for the termination of pregnancy under the Abortion Act. (1967). http://www.publications.parliament.uk/pa/cm200405/cmselect/cmsctech/7/4120801.htm.

  17. Department of Health. (2009). UK Department of Health. Reference guide to consent for examination or treatment (2nd ed.) (2009) available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_103643.

  18. Department of Health. (2011). Personal communication in response to freedom of information request, August 2011.

  19. Doran A. (2009). Statement responding to the Hampton Review of the HFEA. HFEA press release. http://www.hfea.gov.uk/5639.html.

  20. Doyle, P. (1999). The U.K. human fertilisation and embryology authority: How it has contributed to the evaluation of assisted reproduction technology. International Journal of Technology Assessment in Health Care, 15(1), 3–10.

    Article  PubMed  CAS  Google Scholar 

  21. English, V. (2006). Autonomy versus protection—who benefits from the regulation of IVF? Human Reproduction, 21(12), 3044–3049.

    Article  PubMed  Google Scholar 

  22. ESHRE. (2001). ESHRE campus course report, 2001. Prevention of twin pregnancies after IVF/ICSI by single embryo transfer. Human Reproduction, 16(4), 790–800.

    Article  Google Scholar 

  23. Fletcher, J. C. (1990). Evolution of ethical debate about human gene therapy. Human Gene Therapy, 1, 55–68.

    Article  PubMed  CAS  Google Scholar 

  24. Green, D. (1968). Notes on the Abortion Act 1967. British Journal of Criminology, 8(1), 2–86.

    Google Scholar 

  25. Greenwood, J. (2001). The new ethics of abortion. Journal of Medical Ethics, 27, ii2–ii4.

    Google Scholar 

  26. Hartshorne, G. (2008). Thirty years of IVF. Human Fertility, 11(2), 77–83.

    Article  PubMed  Google Scholar 

  27. HFEA Annual Report. (2010). (data from Annex A, counting only centres with a treatment license). http://www.hfea.gov.uk/146.html.

  28. HFEA-b. (2010). http://www.hfea.gov.uk/docs/2010-03-18_Premises_timeline.pdf.

  29. House of Commons. (2002). House of Commons Science and Technology Committee, “Fourth report—developments in human genetics and embryology” Session 2001-02 HC 791. http://www.publications.parliament.uk/pa/cm200102/cmselect/cmsctech/791/79102.htm.

  30. House of Commons. (2007). House of Commons Joint Committee on the Human Tissue and Embryos (Draft) Bill 2007. Minutes of evidence, Publications and Records, http://www.publications.parliament.uk/pa/jt/jtembryos.htm.

  31. House of Commons. (2010). House of Commons Science and Technology Committee, Seventh report—bioengineering session, 2009–2010.

  32. Holm, S. (2004). Like a frog in boiling water: The public, the HFEA and sex selection. Health Care Analysis Volume, 12(1), 27–39.

    Article  Google Scholar 

  33. Hutter, B. M. (2005). The attractions of risk-based regulation: Accounting for the emergence of risk ideas in regulation. CARR Discussion paper, 33. Centre for Analysis. http://www2.lse.ac.uk/researchAndExpertise/units/CARR/aboutUs/staff/hutterDetails.aspx.

  34. ISD Scotland. (2009). Scotland Information services, NHS National Services Scotland http://www.isdscotland.org/isd/1918.html.

  35. Johnson, M., & Petersen, K. (2008). Public interest or public meddling? Towards an objective framework for the regulation of assisted reproduction technologies. Human Reproduction, 23(8) 3, 716–728.

    Google Scholar 

  36. Källén, B. (2008). Maternal morbidity and mortality in in vitro fertilization. Best practice and research. Clinical Obstetrics and Gynaecology, 22(3), 549–558.

    PubMed  Google Scholar 

  37. Keown, J. (1988). Abortion, doctors and the law: Some aspects of the legal regulation of abortion in England from 1803 to 1982. Cambridge: Cambridge University Press.

  38. Kerr, A. (2008). Assisted conception and the audit culture. Human Fertility, 11(1), 9–16.

    Article  PubMed  Google Scholar 

  39. Kirkpatrick, C., & Parker, D. (2004). Regulatory impact assessment and regulatory governance in developing countries. Public Administration and Development, 24, 333–344.

    Article  Google Scholar 

  40. Lansley, A. (2010). Written ministerial statement: NHS white paper supporting information. http://www.dh.gov.uk/en/MediaCentre/Statements/DH_117843.

  41. Leather, S. (2005). The HFEA then and now. Human Fertility, 8(2), 63–64.

    Article  PubMed  Google Scholar 

  42. Ledger, W. (2005). Regulation of reproduction in the UK. Human Fertility, 8(2), 65–67.

    Article  PubMed  Google Scholar 

  43. Lee, R., & Morgan, D. (2001). Human fertilisation & embryology: Regulating the reproductive revolution. Blackstone Press.

  44. Lipp, A. (2008). Supporting the significant other in women undergoing abortion. British Journal of Nursing, 17(19), 1232–1236.

    PubMed  Google Scholar 

  45. Lloyd-Bostock, S. M., & Hutter, B. M. (2008). Reforming regulation of the medical profession: The risks of risk-based approaches. Health, Risk & Society, 10(1), 69–83.

  46. Marsh, B. (2009). IVF babies in health alert: Test-tube children 30 per cent more likely to have defects, warns watchdog. Daily Mali online, http://www.dailymail.co.uk/news/article-1163580/IVF-babies-health-alert-Test-tube-children-30-cent-likely-defects-warns-watchdog.html.

  47. Mladovsky, P., & Sorenson, C. (2010). Public financing of IVF: A review of policy rationales. Health Care Analysis, 18(2), 113–128.

    Article  PubMed  Google Scholar 

  48. Morgan, D. (2004). Ethics, economics and the exotic: The early career of the HFEA. Health Care Analysis, 12(1), 1–6.

    Article  Google Scholar 

  49. Mota, N. P., Burnett, M., & Sareen, J. (2010). Associations between abortion, mental disorders, and suicidal behaviour in a nationally representative sample. Canadian Journal of Psychiatry, 55(4), 239–247.

    Google Scholar 

  50. Mulkay, M. (1995). Political parties, parliamentary lobbies and embryo research. Public Understanding of Science, 4, 31–55.

    Article  Google Scholar 

  51. Parsons, J, & Savvas, M. (2010). Why we shouldn’t abolish the HFEA. Bionews. http://www.bionews.org.uk/page_71776.asp.

  52. Power, M., Scheytt, T., Soin, K., & Sahlin, K. (2009). Reputational risk as a logic of organizing in late modernity. Organization Studies l, 30(2–3), 301–324.

    Article  Google Scholar 

  53. Richens, H. (2009). Multiple births: Moving towards a year 2 target. HFEA Paper MBSET, Annex A http://www.hfea.gov.uk/docs/2009-12-09_Authority_papers_-_527_Multiple_Births.pdf.

  54. Savage, W., & Francom, C. (2009). British gynaecologists’ attitudes in 2008 to the provision of legal abortion. Journal of Obstetrics and Gynaecology, May 2011, 31(4), 322–332.

    Google Scholar 

  55. Shapps, G. (2009). All your eggs in one basket—a comprehensive study into the continuing postcode lottery in IVF provision through the NHS. http://www.shapps.com/reports/.

  56. Shaw, R. L., & Giles, D. C. (2009). Motherhood on ice? A media framing analysis of older mothers in the UK news. Psychology and Health, 24(2), 221–236.

    Google Scholar 

  57. Sheldon, S. (2009). A missed opportunity to reform an outdated law. Clinical Ethics, 4, 3–5.

    Article  Google Scholar 

  58. Tasdemir, M., Tasdemir, I., Kodama, H., Fukuda, J., & Tanaka, T. (1995). Two instead of three embryo transfer in in vitro fertilization. Human Reproduction, 10(8), 2155–2158.

    PubMed  CAS  Google Scholar 

  59. Toft, B. (2004). Independent review of the circumstances surrounding four adverse events that occurred in the reproductive medicine units at the leeds teaching hospitals NHS trust, West Yorkshire. Department of Health. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4084441.

  60. Van Maanen, J., & Pentland, B. (1994). Cops and auditors: The rhetoric of records. In S. Sitkin, R. Bies (Eds.), The legalistic organization (pp. 53–90). Sage Publications.

  61. Yeager, P. C. (1987) Structural bias in regulatory law enforcement: The case of the U.S. environmental protection agency. Social Problems, 330–344.

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Acknowledgments

We are grateful to delegates at a 2009 workshop of the NorthEast England Stem Cell Institute and in particular to James Lawford Davies for comments.

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Correspondence to Alison Murdoch.

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Sethe, S., Murdoch, A. Comparing the Burden: What Can We Learn by Comparing Regulatory Frameworks in Abortion and Fertility Services?. Health Care Anal 21, 338–354 (2013). https://doi.org/10.1007/s10728-011-0196-6

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