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Asian Bioethics Review

, Volume 9, Issue 1–2, pp 87–101 | Cite as

Selling pharmaceuticals ethically in resource-limited settings: the case of Sofosbuvir

  • Carl H. Coleman
  • Calvin Wai Loon Ho
Original Paper
  • 317 Downloads

Abstract

In countries without universal health insurance systems, is it ethically acceptable for pharmaceutical companies to sell their products only to the relatively small segment of the population that can afford private insurance coverage or to pay for medications out of pocket? Are there certain drugs that companies should be expected to sell in these economies even if they are unable to do so profitably? Within a human rights framework, this paper identifies these and related ethical challenges and proposes some responses. The paper begins by considering general ethical responsibilities that arise from commitment to the Universal Health Coverage initiative as a Sustainable Development Goal. It then discusses ethical responsibilities on the part of pharmaceutical companies as distinct from those of national governments or the broader international community. Some proposals follow for thinking through specific ethical challenges that arise when making decisions about whether, and on what terms, to introduce a new drug into a particular setting. Finally, the paper considers a number of these issues and responses in the context of the sale of sofosbuvir in the Asia-Pacific region.

Keywords

Pharmaceuticals Developing economies Emerging markets Equity Access to medicines Corporate social responsibility 

References

  1. Adamski, Jakub, et al. 2010. Risk sharing arrangements for pharmaceuticals: Potential considerations and recommendations for European payers. BMC Health Services Research 10: 153.CrossRefGoogle Scholar
  2. Carl H Coleman, Ethical Considerations in Selling Pharmaceuticals in Emerging Economies, June 2017. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2978538 (Last visited: 15 June 2017).
  3. European Society for the Study of Liver. 2015. EASL-ALEH clinical practice guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. Journal of Hepatology 63 (1): 237–264.CrossRefGoogle Scholar
  4. Evens, R., and K. Kaitin. 2015. The evolution of biotechnology and its impact on health care. Health Affairs 34 (2): 210–219.CrossRefGoogle Scholar
  5. Gilead. Chronic Hepatitis C Treatment Expansion: Generic Manufacturing for Developing Countries. Available at: http://www.gilead.com/responsibility/developing-world-access/viral%20hepatitis (Last visited: 10 June 2017).
  6. Hans V. Hogerzeil, 2012. Essential Medicines. In: Gunilla Backman (ed.), The Right to Health: Theory and Practice, 263–279. Pozkal: Studentlitteratur.Google Scholar
  7. Lim, S.-G., A. Aghemo, P.-J. Chen, Y.-Y. Dan, E. Gane, R. Gani, R.G. Gish, R. Guan, J.-D. Jia, K. Lim, T. Piratvisuth, S. Shah, M.L. Shiffman, F. Tacke, S.-S. Tan, T. Tanwandee, K.-M. Win, and C. Yurdaydin. 2017. Management of hepatitis C virus infection in the Asia-Pacific region: An update. Lancet Gastroenterology & Hepatology 2: 52–62.CrossRefGoogle Scholar
  8. Luna, Florencia. 2016. Responsibility in public health. In Global Ethics for Leadership: Values and Virtues for Life 111, 126, ed. Christoph Stückelberger, Walter Fust, and Obiora Ike, 125–126. Geneva: Globethics.net. Available at: http://www.globethics.net/documents/4289936/13403236/GE_Global_13_web.pdf/b5588b85-6471-4125-8d2f-39b0caf9e3ba.
  9. Mohd Hanafiah, K., J. Groeger, A.D. Flaxman, and S.T. Wiersma. 2013. Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence. Hepatology 57: 1333–1342.CrossRefGoogle Scholar
  10. Moon, Suerie. 2013. Respecting the right to access to medicines: Implications of the UN guiding principles on business and human rights for the pharmaceutical industry. Health and Human Rights 15 (1): 32–43.Google Scholar
  11. Mouton, Johannes P., Christine Njuguna, Nicole Kramer, Annemie Stewart, Ushma Mehta, Marc Blockman, Melony Fortuin-De Smidt, Reneé De Waal, Andy G. Parrish, Douglas P.K. Wilson, Ehimario U. Igumbor, Getahun Aynalem, Mukesh Dheda, Gary Maartens, and Karen Cohen. 2016. Adverse drug reactions causing admission to medical wards: A cross-sectional survey at 4 hospitals in South Africa. Medicine 95 (19): e3437.CrossRefGoogle Scholar
  12. Office of the United Nations High Commissioner for Human Rights & World Health Organization. 2008. The Right to Health: Fact Sheet No. 31, 23. Geneva: World Health Organization. Available at: http://www.ohchr.org/Documents/Publications/Factsheet31.pdf (Last visited: 10 June 2017).
  13. Organisation for Economic Co-operation and Development. (2008). OECD Health Policy Study: Pharmaceutical Pricing Policies in a Global Market 111, http://apps.who.int/medicinedocs/documents/s19834en/s19834en.pdf.
  14. Organization of American States. Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, 17 November 1988.Google Scholar
  15. Organisation of African Unity. African Charter on Human and Peoples’ Rights, June 1981.Google Scholar
  16. Pickett, Kate, and Richard G. Wilkinson. 2009. The Spirit level: Why more equal societies almost always do better. London: Allen Lane.Google Scholar
  17. Saadj, Emily, and Greg White. 2014. Rewarding innovation in drug development. Am. Health & Drug Benefits 373: 7. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4268767/ (Last visited: 10 June 2017).
  18. The Foundation for AIDS Research. Hepatitis C and Drug Pricing: The Need for a Better Balance. Washington DC: The Foundation for AIDS Research, 2015, at 2. Available at: http://www.amfar.org/uploadedFiles/_amfarorg/Articles/On_The_Hill/2015/amfAR%20HCV%20Issue%20Brief%20Feb%202015.pdf (Last visited: 15 June 2017).
  19. United Nations. Charter of the United Nations, 24 October 1945, 1 UNTS XVI. Available at: http://www.refworld.org/docid/3ae6b3930.html (Last visited: 10 June 2017).
  20. United Nations. Universal Declaration of Human Rights, G.A. Res. 217 (III) A, U.N. Doc. A/RES/217(III) (10 December 1948).Google Scholar
  21. United Nations. International Convention on the Elimination of All Forms of Racial Discrimination, G.A. Res. 2106 (XX), U.N. Doc. 2106 (21 December 1965).Google Scholar
  22. United Nations. International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200 (XXI) A, Art. 12, U.N. Doc. A/RES/2200(XI) (3 January 1976).Google Scholar
  23. United Nations. Convention on the Elimination of All Forms of Discrimination Against Women, G.A. Res. 34/180, U.N. Doc. 34/180 (18 December 1979).Google Scholar
  24. United Nations. Convention on Rights of the Child, G.A. Res. 44/25, U.N. Doc. 44/25 (2 September 1990).Google Scholar
  25. United Nations Committee on Economic, Social and Cultural Rights, General Comment No. 14, The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant), paragraph 39, U.N. Doc. E/C.12/2000/4 (11 Aug 2000).Google Scholar
  26. United Nations Global Compact. The Ten Principles of the UN Global Compact, Principle One: Human Rights. Available at: https://www.unglobalcompact.org/what-is-gc/mission/principles/principle-1 (Last visited: 24 Mar 2017).
  27. United Nations Human Rights Office of the High Commissioner. 2011. Guiding Principles on Business and Human Rights: Implementing the United Nations “Protect, Respect, and Remedy” Framework, HR/PUB/11/04. New York and Geneva: United Nations, 2011. Available at: http://www.ohchr.org/Documents/Publications/GuidingPrinciplesBusinessHR_EN.pdf (Last visited: 10 June 2017).
  28. United Nations Secretary-General, The Right to Health: Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, Annex (by Paul Hunt), U.N. Doc. A/63/263 (11 Aug 2008).Google Scholar
  29. United Nations Secretary-General, Promotion and Protection of all Human Rights, Civil, Political, Economic, Social and Cultural Rights, Including the Right to Development: Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Health, Annex (5 May 2009).Google Scholar
  30. Urrutia, J., T. Porteny, and N. Daniels. 2016. What does it mean to put new hepatitis C drugs on a list of essential medicines? BMJ 353: i2035.CrossRefGoogle Scholar
  31. Williams, Owain D., G. Ooms, and P.S. Hill. 2015. Cautionary notes on a global tiered pricing framework for medicines. American Journal of Public Health 105 (7): 1290–1293.CrossRefGoogle Scholar
  32. World Health Organization. 2003. The Selection and Use of Essential Medicines. Geneva: World Health Organization. Available at: http://apps.who.int/medicinedocs/pdf/s4875e/s4875e.pdf (Last visted: 10 June 2017).
  33. World Health Organization. 2010. The world health report: Health systems financing: The path to universal coverage. Geneva: World Health Organization.Google Scholar
  34. World Health Organization, Medium-Term Strategic Plan 2008–2013 and Proposed Programme Budget 2012–2013, 79 (4 Apr 2011). Available at: http://apps.who.int/iris/bitstream/10665/3228/1/B128_24-en.pdf.
  35. World Health Organization. 2014. Making fair choices on the path to universal health coverage: Final report of the WHO consultative group on equity and universal health coverage. Geneva: World Health Organization.Google Scholar
  36. World Health Organization. Patent Situation of Key Products for Treatment of Hepatitis C: Sofosbuvir. Geneva: World Health Organization, March 2015. Available at: http://www.who.int/phi/implementation/ip_trade/sofosbuvir_report_updated.pdf (Last visited: 10 June 2017).
  37. World Health Organization. 2016. Guidelines for the screening care and treatment of persons with chronic hepatitis C infection: Updated version. Geneva: World Health Organization.Google Scholar
  38. World Health Organization, Essential medicines and health products. Available at: http://www.who.int/medicines/services/essmedicines_def/en/ (Last visited: 15 June 2017a).
  39. World Health Organization. WHO updates patent information on sofosbuvir and ledipasvir for the treatment of Hepatitis C Virus. Available at: http://who.int/medicines/news/patent_info_sofo-ledis-vir/en/ (Last visited: 10 June 2017b).
  40. World Health Organization. Constitution of the World Health Organization, 45th edition, October 2006. Available at: http://www.who.int/governance/eb/who_constitution_en.pdf (Last visited: 10 June 2017c).
  41. World Health Organization. Model List of Essential Medicines, 20th edition. Available at: http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017.pdf?ua=1 (Last visited: 15 June 2017d).

Copyright information

© National University of Singapore and Springer Nature Singapore Pte Ltd. 2017

Authors and Affiliations

  1. 1.Seton Hall University School of LawNewarkUSA
  2. 2.Centre for Biomedical Ethics, Yong Loo Lin School of MedicineNational University of SingaporeSingaporeSingapore
  3. 3.WHO Collaborating Centre for Bioethics (Singapore)SingaporeSingapore

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