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Pharmaceutical Promotion and Its Influence on Prescription Behavior: Ethical Issues and Legal Framework in India

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Abstract

Pharmaceutical companies employ various techniques to promote their drugs to the physicians. Some of these techniques are purely informational like advertisements in medical journals and detailing by medical representatives, but some other techniques aim to induce the physicians to prescribe particular drugs by offering them financial incentives like gifts, sponsorship of visits to attend educational conferences, funding of research, etc. The latter category of promotional techniques may unduly influence the prescribing behavior of physicians leading to irrational prescription of drugs that are not in the best interests of the patient. Given the potential of these techniques to cause harm to patients, efforts have been made to regulate it in India as well as other countries. In India, the regulations issued by the Medical Council of India regulate the conduct of physicians in their relationship with the pharmaceutical industry; however, they are ambiguous, non-comprehensive, and not enforced properly. The pharmaceutical companies, on the other hand, are subject only to self-regulatory codes issued by the pharmaceutical associations and by the government that lack teeth. These regulatory measures have not been sufficient in curbing the undue influence of the promotional techniques on physicians’ prescribing behavior, and thus, there is a need to overhaul the regulatory framework in India by taking guidance from other countries. However, ultimately, it is the reflection by the pharmaceutical companies and especially the physicians on their ethical duties and adherence to them that will result in ethically appropriate prescription of drugs.

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Notes

  1. Freitas et al. 2013 (hereafter Freitas et al., Ethics of Pharmaceutical Industry Influence).

  2. Freitas et al., Ethics of Pharmaceutical Industry Influence, 16; Connors, “Big Bad Pharma”.

  3. Navelkar and Banker 1978 (hereafter Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”).

  4. Parker and Pettijohn 2003 (hereafter Parker, “Ethical Considerations in Pharmaceutical Promotion”); Connors 2010 (hereafter Connors, “Big Bad Pharma”).

  5. See generally, Hafemeister and Bry 2009 (hereafter Hafemeister and Bry, “Beware Those Bearing Gifts”).

  6. Hurwitz and Caves, “Persuasion or Information”.

  7. Capella et al. 2009 (hereafter, Capella et al., “Pharmaceutical Marketing Activities Raise Prices”); Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”; Parker, “Ethical Considerations in Pharmaceutical Promotion”); Hurwitz and Caves, “Persuasion Or Information”; Manchanda and Honka, “The Effects and Role of DTC”.

  8. Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”; Hurwitz and Caves, “Persuasion or Information”; Manchanda and Honka, “The Effects and Role of DTC”.

  9. Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”.

  10. Capella et al., “Pharmaceutical Marketing Activities Raise Prices”; Hurwitz and Caves, “Persuasion or Information”

  11. Capella et al., “Pharmaceutical Marketing Activities Raise Prices”; Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”; Parker, “Ethical Considerations in Pharmaceutical Promotion”; Johar 2013 (hereafter Johar, “An Insider’s Perspective”); Manchanda and Honka, “The Effects and Role of DTC”; Santoro and Gorrie 2005 (hereafter Santoro et al., Ethics and the Pharmaceutical Industry).

  12. Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”; Hurwitz and Caves, “Persuasion or Information”; Manchanda and Honka, “The Effects and Role of DTC”; Velasquez, “Free Lunch”.

  13. Capella et al., “Pharmaceutical Marketing Activities Raise Prices”; Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”.

  14. Capella et al., “Pharmaceutical Marketing Activities Raise Prices”; Navelkar and Banker, “Marketing of Pharmaceuticals in Rural India”; Parker, “Ethical Considerations in Pharmaceutical Promotion”; Johar, “An Insider’s Perspective”; Santoro et al., Ethics and the Pharmaceutical Industry.

  15. Manchanda and Honka, “The Effects and Role of DTC”.

  16. Velasquez, “Free Lunch”.

  17. Parker, “Ethical Considerations in Pharmaceutical Promotion”; Manchanda and Honka, “The Effects and Role of DTC”; Lodha and Bhargava, “Financial Incentives”; Bansal and Das 2005 (hereafter Bansal and Das, “Unethical Relationship”); Freitas et al., Ethics of Pharmaceutical Industry Influence, at 35; Santoro et al., Ethics and the Pharmaceutical Industry; Jost 2010 (hereafter Jost, “Oversight of Marketing Relationships”); Velasquez, “Free Lunch”; The Council On Ethical And Judicial Affairs Of The American Medical Association 2001 (hereafter, AMA, “Guidelines on Gifts”).

  18. Hurwitz and Caves, “Persuasion Or Information”; Santoro et al., Ethics and the Pharmaceutical Industry; Manchanda and Honka, “The Effects and Role of DTC”; Lodha and Bhargava, “Financial Incentives”; The Council On Ethical And Judicial Affairs Of The American Medical Association 2001.

  19. Vukadin, “Failure-To-Warn”.

  20. Manchanda and Honka, “The Effects and Role of DTC”; Lodha and Bhargava, “Financial Incentives”; Jost 2010.

  21. Lodha and Bhargava 2010 (hereafter Lodha and Bhargava, “Financial Incentives”); Hurwitz and Caves 1988 (hereafter Hurwitz and Caves, “Persuasion or Information”); Manchanda and Honka 2005 (hereafter Manchanda and Honka, “The Effects and Role of DTC”).

  22. Velasquez 2008 (hereafter Velasquez, “Free Lunch”).

  23. Campbell, Bioethics; Synder and Gauthier, Evidence-Based Medical Ethics, 11; Orr, Medical Ethics and The Faith Factor; Lodha and Bhargava, “Financial Incentives”.

  24. Orr, Medical Ethics and The Faith Factor; Synder and Gauthier, Evidence-Based Medical Ethics, 13.

  25. Velasquez, “Free Lunch”.

  26. This appears to be the approach in the context of biomedical research. See: Ho 2012; Council for International Organizations of Medical Sciences (CIOMS) 2016.

  27. Parker, “Ethical Considerations in Pharmaceutical Promotion”.

  28. Manchanda and Honka, “The Effects and Role of DTC”; Vukadin 2015 (hereafter, Vukadin, “Failure-To-Warn”); AMA, “Guidelines on Gifts”; Connors, “Big Bad Pharma”; Bansal and Das, “Unethical Relationship”.

  29. Rickard and Fehn 2007 (hereafter, Lori-Ann and Fehn, “Recent Developments”); Lodha and Bhargava, “Financial Incentives”; AMA, “Guidelines on Gifts”; Grande 2010 (hereafter Grande, “Limiting the Influence”).

  30. Lori-Ann and Fehn, “Recent Developments” Lodha and Bhargava, “Financial Incentives”; AMA, “Guidelines on Gifts”; Vukadin, “Failure-To-Warn”.

  31. Velasquez, “Free Lunch”; Vukadin, “Failure-To-Warn”.

  32. Parker, “Ethical Considerations in Pharmaceutical Promotion”; Connors, “Big Bad Pharma”; Vukadin, “Failure-To-Warn”.

  33. Vukadin, “Failure-To-Warn”; Parker, “Ethical Considerations in Pharmaceutical Promotion”.

  34. Ibid.

  35. Parker, “Ethical Considerations in Pharmaceutical Promotion”.

  36. See Jost, “Oversight of Marketing Relationships”; AMA, “Guidelines on Gifts”.

  37. Lodha and Bhargava, “Financial Incentives”.

  38. Parker, “Ethical Considerations in Pharmaceutical Promotion”; Matharu 2012 (hereafter Matharu, “15 Doctors Went”); Lodha and Bhargava, “Financial Incentives”.

  39. The Indian Medical Council Act, 1956.

  40. Ibid., S. 20A.

  41. Regs. 7 & 8.

  42. Reg. 1.B.1.5.

  43. Ibid.

  44. Regs. 1.B.1.1.2 & 1.B.1.8.

  45. The Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009.

  46. Regs. 6.8.1 (a), (b), (c) & (d).

  47. Regs. 6.8.1 (e) & (h).

  48. Reg 6.8.1 (f).

  49. Rathi 2009 (hereafter Rathi, “MCI Quantifies Punishment”); Vashishtha 2010 (hereafter, Vashishtha, “MCI’s New Code”) (“While many medical professionals have hailed the new initiative and dubbed it an encouraging sign to prevent rampant commercialization of health sector, many have criticized the move by the apex body questioning their real intentions and calling it as a trivial, non-serious issue.”)

  50. http://www.mciindia.org/meetings/GB/2010/MNGB%2011-03-2010.pdf.

  51. Ibid.

  52. Matharu, “15 Doctors Went”; Vashishtha, “MCI’s New Code”; Ernst and Young 2011 (hereafter, Ernst & Young, “Pharmaceutical Marketing”).

  53. Rathi, “MCI Quantifies Punishment”.

  54. Baker & McKenzie, “Promoting Medical Products”.

  55. Organisation of Pharmaceutical Producers of India 2012. The industry associations that are IFMPA members are required to adopt codes that are consistent with and as comprehensive as the IFMPA Code.

  56. Cls. 6 & 7.

  57. Cl. 5.

  58. Cl. 5.3.

  59. Cl. 4.3.

  60. Cl. 4.4.

  61. Cls. 8–14.

  62. Cl. 12.

  63. Cl. 12.

  64. For a write-up on the report of the Parliamentary Standing Committee, see Pandya 2016

  65. Department Related Parliamentary Standing Committee on Health and Family Welfare 2016

  66. [2011] Insc 981 (23 September 2011)

  67. Baker and McKenzie 2012 (hereafter, Baker & McKenzie, “Promoting Medical Products”).

  68. Ibid.

  69. See for instance, the Health Sciences Authority in Singapore, which has authority under the Health Products Act, the Medicines Act and subsidiary legislations, to control advertisements and sales promotion of therapeutic and medicinal products.

  70. Velasquez, “Free Lunch”; Grande, “Limiting the Influence”.

  71. Connors, “Big Bad Pharma”.

  72. The Dy. CIT 8 (2), Mumbai Versus PHL Pharma P Ltd. - 2017 (1) TMI 771 - ITAT MUMBAI

  73. Connors, “Big Bad Pharma”.

  74. Ibid.

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Authors and Affiliations

  1. SpicyIP, Bangalore, India

    Pankhuri Agarwal

  2. Faculty of Law, University of Malaya, Singapore, Singapore

    Sharon Kaur

  3. Centre for Biomedical Ethics, National University of Singapore, Singapore, Singapore

    Sharon Kaur

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  1. Pankhuri Agarwal
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Correspondence to Pankhuri Agarwal.

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Agarwal, P., Kaur, S. Pharmaceutical Promotion and Its Influence on Prescription Behavior: Ethical Issues and Legal Framework in India. ABR 9, 73–85 (2017). https://doi.org/10.1007/s41649-017-0011-2

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